Escherichia Coli Diarrhea
Conditions
Keywords
ETEC diarrhea, Escherichia Coli (ETEC)
Brief summary
The purpose of this study is to determine if the ETEC vaccine ETVAX with and without dmLT adjuvant is safe and immunogenic in adults, children, toddlers and infants in Bangladesh.
Detailed description
This Phase I/II trial will serve to assess whether ETVAX is safe and provides mucosal as well as systemic immune responses against the key protective antigens when tested in different age-groups in Bangladesh. This study provides an opportunity to test the safety profile of a mucosal adjuvant, double-mutant LT (dmLT), in adults and children, as well as provide the opportunity to potentially assess the ability of dmLT to further enhance the mucosal and systemic antibody responses to key antigens in the ETVAX vaccine among age groups in developing country sites, like Bangladesh, that have proved refractory to oral immunization with enteric vaccines. In addition, this study also allows for the evaluation of the potential dose-sparing effect of dmLT when combined with a lower dose of vaccine. Finally, this clinical trial is considered an essential study along the critical path of the overall clinical development plan before determining whether the vaccine can be tested for protective efficacy in children in developing countries.
Interventions
BIOLOGICALETVAX
Varying dosages of liquid ETVAX vaccine (Batch BX1003574). A full dose consisted of: * Hybrid protein between the B-subunit of the E. coli heat-labile enterotoxin and the B-subunit of the cholera toxin (LCTBA): 1 mg * E. coli ETEX 21 formalin inactivated: 1.3 mg colonization factor 1 (CFA/I) * E. coli ETEX 22 formalin inactivated: 6.4 mg coli surface antigen 3 (CS3) * E. coli ETEX 23 formalin inactivated: 1.1 mg coli surface antigen 5 (CS5) * E. coli ETEX 24 phenol inactivated: 0.5 mg coli surface antigen 6 (CS6) The vaccine was given together with sodium bicarbonate effervescent granules (Recip), which was dissolved in water and mixed with the vaccine suspension prior to oral administration. The buffer was used to prevent degradation of LCTBA hybrid protein by the gastric acid.
BIOLOGICALdmLT
Varying dosages of dmLT, a derivative of wild-type enterotoxigenic Escherichia coli LT that has been genetically modified by replacing the arginine at amino acid position 192 with glycine and the leucine at amino acid position 211 with alanine. These two amino acid substitutions take place in proteolytic cleavage sites which are critical for activation of the secreted toxin molecules.
OTHERBicarbonate Buffer
Sodium bicarbonate buffer dissolved in 150 ml of potable water
Sponsors
Scandinavian Biopharma AB
International Centre for Diarrhoeal Disease Research, Bangladesh
PATH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Months to 45 Years
Healthy volunteers
Yes
Inclusion criteria
Adults Inclusion Criteria: 1. Healthy male or female adults 18-45 years old, inclusive 2. General good health as determined by the screening evaluation no greater than 7days before enrollment and vaccination 3. Properly informed about the study, able to understand it and sign or thumb print the informed consent form 4. Available for the entire period of the study and reachable by study staff throughout the entire follow-up period 5. Females of childbearing potential who are willing to take a urine pregnancy test at screening and before the second vaccination. Pregnancy tests must be negative before each vaccination. Females of childbearing potential must agree to use an efficacious hormonal or barrier method of birth control during the study. Abstinence is also acceptable. 6. Informed Consent (signature or thumb print provided, with witness signature)
Exclusion criteria
1. Presence of any significant known systemic disorder (cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological, cancer or autoimmune disease) as determined by medical history and/or physical examination which would endanger the participant's health or is likely to result in non-conformance to the protocol. 2. History of congenital abdominal disorders, intussusception, abdominal surgery or any other congenital disorder or presence of a significant medical condition that in the opinion of the Investigator precludes participation in the study. Known or suspected impairment of immunological function based on medical history and physical examination. Clinical evidence of active gastrointestinal illness and acute disease at the time of enrollment 3. Screening positive with hepatitis B antigen and/or hepatitis C antibodies 4. Participation in research involving another investigational product (defined as receipt of investigational product) during the 30 days before planned date of first vaccination or concurrently participating in another clinical study at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational product 5. Clinically significant abnormalities in screening hematology or serum chemistry, as determined by the Study Physician 6. History of febrile illness within 48 hours prior to vaccination and fever at the time of immunization (fever is defined as a temperature ≥ 37.5 C (99.5 F) on axillary, oral, or tympanic measurement) 7. Prior receipt of any cholera (e.g., Dukoral, Shanchol) or ETEC vaccine 8. Prior receipt of a blood transfusion or blood products, including immunoglobulins 9. Evidence of current illicit drug use or drug dependence 10. Current use of iron or zinc supplements within the past 7 days; current use of antacids (H2 blockers, omeprazole, over-the-counter (OTC) agents) or immunosuppressive drug 11. Any condition which, in the opinion of the investigator, might jeopardize the safety of study participants or interfere with the evaluation of the study objectives 12. Receipt of antimicrobial drugs for any reason within 14 days before vaccination 13. History of diarrhea during the 7 days before vaccination (see protocol definition of diarrhea) 14. Culture positive for ETEC, Shigella, V. Cholerae or Salmonella within 7 days before vaccination. 15. Acute disease at the time of enrollment or 3 days prior to enrollment 16. History of chronic administration (defined as more than 14 days) of immunosuppressant medications, including corticosteroids. Children, Toddlers and Infants Inclusion Criteria 1. Healthy male or female infants/toddlers/children ages: * Part B: \>24 and ≤59 months old at the time of enrollment * Part C: ≥12 and \<24 months old at the time of enrollment * Part D: ≥6 and \<12 months at the time of enrollment 2. General good health as determined by the screening evaluation no greater than 7 days before enrollment and vaccination 3. Parent properly informed about the study, able to understand it and sign or thumb print the informed consent form 4. Parent and child available for the entire study period of the study and reachable by study staff throughout the entire follow-up period 5. Informed Consent (signature or thumb of parent, with signature of witness, provided)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | 7 days after each vaccination (Day 7 and Day 21) | Adverse events (AEs) were assessed post-vaccination using participant/parent/guardian interview (including memory aids), targeted physical examinations, vital signs and clinical laboratory tests and reactogenicity assessments which were completed following each vaccination. The solicited AEs of nausea (adults only), abdominal pain/stomach ache (adults and children 24-59 months only), fever, vomiting and diarrhea were evaluated daily for 7 days post vaccination. |
| Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | 6 months ± 14 days after the first dose | Adverse events (AEs) were assessed post-vaccination using participant/parent/guardian interview (including memory aids), targeted physical examinations, vital signs and clinical laboratory tests and reactogenicity assessments which were completed following each vaccination. Unsolicited AEs were assessed through Day 42 and serious adverse events (SAEs) were assessed over the entire duration of the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | 19 days | Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second). Antigen in ETVAX were: E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin |
| Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | 19 days | Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second). Antigen in ETVAX were: E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin |
| Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | 28 days | Fecal secretion was measured on Day 7, Day 19, and Day 28; number in table is subjects experiencing a two-fold rise at any of these time points. Antigen in ETVAX were: E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin |
| Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | 28 days | Fecal secretion was measured on Day 7, Day 19, and Day 28; number in table is subjects experiencing a four-fold rise at any of these time points. Antigens in ETVAX were: E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin |
| Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects, by Antigen | 28 days | Fecal secretion was measured on Day 7, Day 19, and Day 28; number in table is based on the maximum value for each subject. Antigen in ETVAX were: E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin |
| Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects, by Antigen | 28 days | Fecal secretion was measured on Day 7, Day 19, and Day 28; number in table is based on the maximum value for each subject. Antigen in ETVAX were: E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin |
| Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | 19 days | Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second). Antigen in ETVAX were: E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin |
| Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | 19 days | Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second). Antigen in ETVAX were: E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin |
| Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | 19 days | Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second). Antigen in ETVAX were: E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin |
| Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | 19 days | Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second). Antigen in ETVAX were: E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin |
| Number and Percentage of Adult Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for O78 Antigen | 19 days | Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second). |
| Geometric Mean Titer (GMT) for Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for O78 Antigen, Among Adults | 19 days | Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second). |
| Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for O78 Antigen, Among Adults | 19 days | Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second). |
| Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | 19 days | Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second). B-subunit of the E. coli heat-labile enterotoxin (LTB) was one of the antigens in the ETVAX vaccine. |
| Geometric Mean Titer (GMT) of Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | 19 days | Measured 7 days after the first dose and 5 days after the second). B-subunit of the E. coli heat-labile enterotoxin (LTB) was one of the antigens in the ETVAX vaccine. |
| Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | 19 days | Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second). Antigen in ETVAX were: E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin |
| Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | 19 days | — |
| Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | 19 days | — |
| Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | 7 days | Fecal secretion was measured on Day 0 and Day 7 (7 days after administration of first dose of vaccine). Antigens in ETVAX were: E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin |
| Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | 7 days | Fecal secretion was measured on Day 0 and Day 7 (7 days after administration of first dose of vaccine). Antigens in ETVAX were: E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin |
| Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 7, by Antigen | 7 days | Fecal secretion was measured on Day 7 (7 days after administration of first dose of vaccine). Antigen in ETVAX were: E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin |
| Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 7, by Antigen | 7 days | Fecal secretion was measured on Day 0 and Day 7 (7 days after administration of first dose of vaccine). Antigen in ETVAX were: E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin |
| Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | Day 19 | Fecal secretion was measured on Day 0 and Day 19 (5 days after administration of second dose of vaccine). Antigen in ETVAX were: E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin |
| Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | 19 days | Fecal secretion was measured on Day 0 and Day 19 (5 days after administration of second dose of vaccine). Antigens in ETVAX were: E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin |
| Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 19, by Antigen | 19 days | Fecal secretion was measured on Day 19 (5 days after administration of second dose of vaccine). Antigen in ETVAX were: E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin |
| Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 19, by Antigen | 19 days | Fecal secretion was measured on Day 0 and Day 19 (5 days after administration of second dose of vaccine). Antigen in ETVAX were: E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin |
| Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | 28 days | Fecal secretion was measured on Day 0 and Day 28 (2 weeks after administration of second dose of vaccine). Antigen in ETVAX were: E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin |
| Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | 28 days | Fecal secretion was measured on Day 0 and Day 28 (2 weeks after administration of second dose of vaccine). Antigens in ETVAX were: E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin |
| Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 28, by Antigen | 28 days | Fecal secretion was measured on Day 28 (2 weeks after administration of second dose of vaccine). Antigen in ETVAX were: E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin |
| Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 28, by Antigen | 28 days | Fecal secretion was measured on Day 0 and Day 28 (2 weeks after administration of second dose of vaccine). Antigen in ETVAX were: E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin |
| Geometric Mean Fold Change of Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | 19 days | Between baseline and after vaccination (measured 7 days after the first dose and 5 days after the second). B-subunit of the E. coli heat-labile enterotoxin (LTB) was one of the antigens in the ETVAX vaccine. |
| Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | 19 days | Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second). Antigen in ETVAX were: E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin |
Countries
Bangladesh
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Adult: Placebo Adult arm (18-45 year olds) receiving a placebo on days 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water | 15 |
| Adult: ETVAX (Full) Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) added to bicarbonate buffer solution administered orally on Day 0 and 14 | 15 |
| Adult: ETVAX (Full) + 10 ug dmLT Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14 | 15 |
| 24-59 Months: Placebo 24-59 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water | 52 |
| 24-59 Months: ETVAX (1/4) 24-59 month old children receiving a quarter adult dose (2.5 x 10\^10 inactivated E. coli bacteria) of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14 | 15 |
| 24-59 Months: ETVAX (1/2) 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14 | 15 |
| 24-59 Months: ETVAX (Full) 24-59 month old children receiving a full adult dose of ETVAX vaccine (10\^11 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14 | 3 |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14 | 15 |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14 | 15 |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT 24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 10 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14 | 15 |
| 12-23 Months: Placebo 12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water | 40 |
| 12-23 Months: ETVAX (1/4) 12-23 month old children receiving a quarter adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14 | 15 |
| 12-23 Months: ETVAX (1/2) 12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14 | 15 |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT 12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14 | 15 |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT 12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14 | 15 |
| 6-11 Month Olds: Placebo 6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water | 50 |
| 6-11 Months: ETVAX (1/8) 6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14 | 30 |
| 6-11 Months: ETVAX (1/4) 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14 | 30 |
| 6-11 Months: ETVAX (1/2) 6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10\^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14 | 30 |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14 | 30 |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT 6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10\^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14 | 30 |
| Total | 475 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 | FG014 | FG015 | FG016 | FG017 | FG018 | FG019 | FG020 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Received Vaccination 2 | Adverse Event | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 1 | 0 | 1 |
| Received Vaccination 2 | Medication interfering with study taken | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Received Vaccination 2 | Physician Decision | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Received Vaccination 2 | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 1 | 1 | 0 | 0 | 1 | 1 | 1 | 0 |
Baseline characteristics
| Characteristic | Adult: ETVAX (Full) | Adult: ETVAX (Full) + 10 ug dmLT | 24-59 Months: Placebo | 24-59 Months: ETVAX (1/4) | 24-59 Months: ETVAX (1/2) | 24-59 Months: ETVAX (Full) | 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | 24-59 Months: ETVAX (1/2) + 5 ug dmLT | 24-59 Months: ETVAX (1/2) + 10 ug dmLT | 12-23 Months: Placebo | 12-23 Months: ETVAX (1/4) | 12-23 Months: ETVAX (1/2) | 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | 12-23 Months: ETVAX (1/2) + 5 ug dmLT | 6-11 Month Olds: Placebo | 6-11 Months: ETVAX (1/8) | 6-11 Months: ETVAX (1/4) | 6-11 Months: ETVAX (1/2) | 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Adult: Placebo | 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 30.1 years STANDARD_DEVIATION 6.96 | 29.4 years STANDARD_DEVIATION 6.96 | 3.7 years STANDARD_DEVIATION 0.77 | 4.1 years STANDARD_DEVIATION 0.62 | 3.4 years STANDARD_DEVIATION 0.68 | 4.2 years STANDARD_DEVIATION 0.59 | 3.4 years STANDARD_DEVIATION 0.86 | 3.6 years STANDARD_DEVIATION 0.91 | 3.4 years STANDARD_DEVIATION 0.73 | 1.4 years STANDARD_DEVIATION 0.27 | 1.3 years STANDARD_DEVIATION 0.21 | 1.5 years STANDARD_DEVIATION 0.3 | 1.6 years STANDARD_DEVIATION 0.28 | 1.4 years STANDARD_DEVIATION 0.27 | 0.7 years STANDARD_DEVIATION 0.13 | 0.7 years STANDARD_DEVIATION 0.15 | 0.7 years STANDARD_DEVIATION 0.14 | 0.7 years STANDARD_DEVIATION 0.11 | 0.7 years STANDARD_DEVIATION 0.15 | 31.5 years STANDARD_DEVIATION 5.58 | 0.6 years STANDARD_DEVIATION 0.1 | 4.4 years STANDARD_DEVIATION 8.7 |
| Height | 155.29 centimeters STANDARD_DEVIATION 9.38 | 154.26 centimeters STANDARD_DEVIATION 10.16 | 97.02 centimeters STANDARD_DEVIATION 6.84 | 97.73 centimeters STANDARD_DEVIATION 5.33 | 93.73 centimeters STANDARD_DEVIATION 7.08 | 96.67 centimeters STANDARD_DEVIATION 2.52 | 90.33 centimeters STANDARD_DEVIATION 6.11 | 94.13 centimeters STANDARD_DEVIATION 7.27 | 92.2 centimeters STANDARD_DEVIATION 6.59 | 77.83 centimeters STANDARD_DEVIATION 4.6 | 76.27 centimeters STANDARD_DEVIATION 2.99 | 79.33 centimeters STANDARD_DEVIATION 4.27 | 79.2 centimeters STANDARD_DEVIATION 4.69 | 76.6 centimeters STANDARD_DEVIATION 2.59 | 67.64 centimeters STANDARD_DEVIATION 3.44 | 68.83 centimeters STANDARD_DEVIATION 3.04 | 67.77 centimeters STANDARD_DEVIATION 3.45 | 68.83 centimeters STANDARD_DEVIATION 3.04 | 66.73 centimeters STANDARD_DEVIATION 3.14 | 154.69 centimeters STANDARD_DEVIATION 8.01 | 67.57 centimeters STANDARD_DEVIATION 2.58 | 85.6 centimeters STANDARD_DEVIATION 25.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 15 Participants | 15 Participants | 52 Participants | 15 Participants | 15 Participants | 3 Participants | 15 Participants | 15 Participants | 15 Participants | 40 Participants | 15 Participants | 15 Participants | 15 Participants | 15 Participants | 50 Participants | 30 Participants | 30 Participants | 30 Participants | 30 Participants | 15 Participants | 30 Participants | 475 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 8 Participants | 11 Participants | 26 Participants | 10 Participants | 6 Participants | 2 Participants | 6 Participants | 7 Participants | 9 Participants | 20 Participants | 6 Participants | 5 Participants | 7 Participants | 10 Participants | 23 Participants | 14 Participants | 19 Participants | 16 Participants | 18 Participants | 10 Participants | 16 Participants | 249 Participants |
| Sex: Female, Male Male | 7 Participants | 4 Participants | 26 Participants | 5 Participants | 9 Participants | 1 Participants | 9 Participants | 8 Participants | 6 Participants | 20 Participants | 9 Participants | 10 Participants | 8 Participants | 5 Participants | 27 Participants | 16 Participants | 11 Participants | 14 Participants | 12 Participants | 5 Participants | 14 Participants | 226 Participants |
| Weight | 56.86 kilograms STANDARD_DEVIATION 11.776 | 55.25 kilograms STANDARD_DEVIATION 11.441 | 13.71 kilograms STANDARD_DEVIATION 2.043 | 13.59 kilograms STANDARD_DEVIATION 1.488 | 13.61 kilograms STANDARD_DEVIATION 1.914 | 12.43 kilograms STANDARD_DEVIATION 0.513 | 12.1 kilograms STANDARD_DEVIATION 1.465 | 13.35 kilograms STANDARD_DEVIATION 1.957 | 12.61 kilograms STANDARD_DEVIATION 1.936 | 9.47 kilograms STANDARD_DEVIATION 1.226 | 9.23 kilograms STANDARD_DEVIATION 0.959 | 9.64 kilograms STANDARD_DEVIATION 0.946 | 9.5 kilograms STANDARD_DEVIATION 1.271 | 9.24 kilograms STANDARD_DEVIATION 0.998 | 7.66 kilograms STANDARD_DEVIATION 0.958 | 7.84 kilograms STANDARD_DEVIATION 1.006 | 7.37 kilograms STANDARD_DEVIATION 0.728 | 7.85 kilograms STANDARD_DEVIATION 1.226 | 7.41 kilograms STANDARD_DEVIATION 0.876 | 56.65 kilograms STANDARD_DEVIATION 9.867 | 7.76 kilograms STANDARD_DEVIATION 0.598 | 14.2 kilograms STANDARD_DEVIATION 14.3 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk | EG016 affected / at risk | EG017 affected / at risk | EG018 affected / at risk | EG019 affected / at risk | EG020 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 | 0 / 15 | 0 / 15 | 0 / 15 | 0 / 3 | 0 / 15 | 0 / 15 | 0 / 15 | 0 / 52 | 0 / 15 | 0 / 15 | 0 / 15 | 0 / 15 | 0 / 40 | 0 / 30 | 0 / 30 | 0 / 30 | 0 / 30 | 0 / 30 | 0 / 50 |
| other Total, other adverse events | 0 / 15 | 4 / 15 | 1 / 15 | 2 / 15 | 1 / 15 | 2 / 3 | 4 / 15 | 1 / 15 | 3 / 15 | 4 / 52 | 5 / 15 | 2 / 15 | 6 / 15 | 9 / 15 | 5 / 40 | 4 / 30 | 8 / 30 | 13 / 30 | 9 / 30 | 8 / 30 | 10 / 50 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 | 0 / 15 | 0 / 15 | 0 / 15 | 0 / 3 | 0 / 15 | 0 / 15 | 0 / 15 | 1 / 52 | 1 / 15 | 0 / 15 | 0 / 15 | 0 / 15 | 0 / 40 | 0 / 30 | 0 / 30 | 1 / 30 | 0 / 30 | 0 / 30 | 0 / 50 |
Outcome results
Primary
Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity
Adverse events (AEs) were assessed post-vaccination using participant/parent/guardian interview (including memory aids), targeted physical examinations, vital signs and clinical laboratory tests and reactogenicity assessments which were completed following each vaccination. The solicited AEs of nausea (adults only), abdominal pain/stomach ache (adults and children 24-59 months only), fever, vomiting and diarrhea were evaluated daily for 7 days post vaccination.
Time frame: 7 days after each vaccination (Day 7 and Day 21)
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Adult: ETVAX (Full) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Loose stools | Moderate | 0 Participants |
| Adult: ETVAX (Full) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Any symptom | Moderate | 0 Participants |
| Adult: ETVAX (Full) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Vomiting | Moderate | 0 Participants |
| Adult: ETVAX (Full) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Any symptom | Mild | 0 Participants |
| Adult: ETVAX (Full) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Nausea | None | 15 Participants |
| Adult: ETVAX (Full) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Elevated oral temperature | Mild | 0 Participants |
| Adult: ETVAX (Full) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Acute systemic allergic reaction | None | 15 Participants |
| Adult: ETVAX (Full) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Diarrhea | Moderate | 0 Participants |
| Adult: ETVAX (Full) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Diarrhea | Mild | 0 Participants |
| Adult: ETVAX (Full) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Abdominal pain/stomach ache | Moderate | 0 Participants |
| Adult: ETVAX (Full) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Acute systemic allergic reaction | Moderate | 0 Participants |
| Adult: ETVAX (Full) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Diarrhea | None | 15 Participants |
| Adult: ETVAX (Full) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Nausea | Mild | 0 Participants |
| Adult: ETVAX (Full) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Elevated oral temperature | None | 15 Participants |
| Adult: ETVAX (Full) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Acute systemic allergic reaction | Mild | 0 Participants |
| Adult: ETVAX (Full) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Vomiting | None | 15 Participants |
| Adult: ETVAX (Full) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Loose stools | Mild | 0 Participants |
| Adult: ETVAX (Full) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Abdominal pain/stomach ache | Mild | 0 Participants |
| Adult: ETVAX (Full) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Nausea | Moderate | 0 Participants |
| Adult: ETVAX (Full) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Loose stools | None | 15 Participants |
| Adult: ETVAX (Full) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Elevated oral temperature | Moderate | 0 Participants |
| Adult: ETVAX (Full) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Vomiting | Mild | 0 Participants |
| Adult: ETVAX (Full) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Abdominal pain/stomach ache | None | 15 Participants |
| Adult: ETVAX (Full) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Any symptom | None | 15 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Loose stools | Moderate | 0 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Diarrhea | None | 15 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Acute systemic allergic reaction | Moderate | 0 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Elevated oral temperature | Moderate | 0 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Acute systemic allergic reaction | Mild | 0 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Any symptom | Moderate | 0 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Vomiting | None | 15 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Abdominal pain/stomach ache | Mild | 0 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Vomiting | Moderate | 0 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Acute systemic allergic reaction | None | 15 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Nausea | None | 15 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Loose stools | None | 15 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Loose stools | Mild | 0 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Any symptom | Mild | 1 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Abdominal pain/stomach ache | Moderate | 0 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Vomiting | Mild | 0 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Nausea | Mild | 0 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Nausea | Moderate | 0 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Abdominal pain/stomach ache | None | 15 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Elevated oral temperature | Mild | 1 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Any symptom | None | 14 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Diarrhea | Mild | 0 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Elevated oral temperature | None | 14 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Diarrhea | Moderate | 0 Participants |
| Adult: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Abdominal pain/stomach ache | Moderate | 0 Participants |
| Adult: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Diarrhea | None | 15 Participants |
| Adult: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Elevated oral temperature | Moderate | 0 Participants |
| Adult: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Nausea | Moderate | 0 Participants |
| Adult: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Acute systemic allergic reaction | None | 15 Participants |
| Adult: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Abdominal pain/stomach ache | None | 15 Participants |
| Adult: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Acute systemic allergic reaction | Moderate | 0 Participants |
| Adult: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Acute systemic allergic reaction | Mild | 0 Participants |
| Adult: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Vomiting | None | 15 Participants |
| Adult: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Loose stools | Moderate | 0 Participants |
| Adult: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Nausea | Mild | 0 Participants |
| Adult: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Abdominal pain/stomach ache | Mild | 0 Participants |
| Adult: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Loose stools | Mild | 0 Participants |
| Adult: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Any symptom | None | 15 Participants |
| Adult: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Loose stools | None | 15 Participants |
| Adult: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Nausea | None | 15 Participants |
| Adult: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Any symptom | Moderate | 0 Participants |
| Adult: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Vomiting | Moderate | 0 Participants |
| Adult: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Any symptom | Mild | 0 Participants |
| Adult: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Diarrhea | Mild | 0 Participants |
| Adult: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Diarrhea | Moderate | 0 Participants |
| Adult: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Vomiting | Mild | 0 Participants |
| Adult: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Elevated oral temperature | Mild | 0 Participants |
| Adult: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Elevated oral temperature | None | 15 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Abdominal pain/stomach ache | Mild | 0 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Diarrhea | Mild | 0 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Nausea | None | 15 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Diarrhea | Moderate | 0 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Elevated oral temperature | Mild | 0 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Diarrhea | None | 15 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Elevated oral temperature | Moderate | 0 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Elevated oral temperature | None | 15 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Loose stools | Moderate | 0 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Loose stools | Mild | 0 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Loose stools | None | 15 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Vomiting | None | 13 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Vomiting | Mild | 2 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Any symptom | Moderate | 0 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Vomiting | Moderate | 0 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Any symptom | Mild | 2 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Any symptom | None | 13 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Abdominal pain/stomach ache | None | 15 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Nausea | Moderate | 0 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Nausea | Mild | 0 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Acute systemic allergic reaction | Moderate | 0 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Abdominal pain/stomach ache | Moderate | 0 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Acute systemic allergic reaction | Mild | 0 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Acute systemic allergic reaction | None | 15 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Nausea | Mild | 0 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Abdominal pain/stomach ache | Moderate | 0 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Diarrhea | Mild | 0 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Elevated oral temperature | None | 14 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Loose stools | Mild | 0 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Any symptom | None | 14 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Abdominal pain/stomach ache | Mild | 0 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Vomiting | Mild | 0 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Elevated oral temperature | Moderate | 0 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Acute systemic allergic reaction | Moderate | 0 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Vomiting | None | 15 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Loose stools | Moderate | 0 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Nausea | None | 15 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Abdominal pain/stomach ache | None | 15 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Vomiting | Moderate | 0 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Diarrhea | Moderate | 0 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Acute systemic allergic reaction | Mild | 0 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Any symptom | Mild | 1 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Nausea | Moderate | 0 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Acute systemic allergic reaction | None | 15 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Any symptom | Moderate | 0 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Elevated oral temperature | Mild | 1 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Loose stools | None | 15 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Diarrhea | None | 15 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Loose stools | None | 3 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Any symptom | None | 1 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Any symptom | Moderate | 2 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Elevated oral temperature | None | 3 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Vomiting | Mild | 0 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Abdominal pain/stomach ache | None | 3 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Nausea | Moderate | 0 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Vomiting | None | 1 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Nausea | Mild | 0 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Diarrhea | Moderate | 0 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Abdominal pain/stomach ache | Mild | 0 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Loose stools | Mild | 0 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Acute systemic allergic reaction | Moderate | 0 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Diarrhea | Mild | 0 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Loose stools | Moderate | 0 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Acute systemic allergic reaction | Mild | 0 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Elevated oral temperature | Moderate | 0 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Elevated oral temperature | Mild | 0 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Abdominal pain/stomach ache | Moderate | 0 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Nausea | None | 3 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Acute systemic allergic reaction | None | 3 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Any symptom | Mild | 0 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Diarrhea | None | 3 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Vomiting | Moderate | 2 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Abdominal pain/stomach ache | Mild | 0 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Diarrhea | None | 15 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Loose stools | None | 15 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Diarrhea | Moderate | 0 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Any symptom | Mild | 3 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Abdominal pain/stomach ache | Moderate | 0 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Vomiting | None | 13 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Nausea | Moderate | 0 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Abdominal pain/stomach ache | None | 15 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Diarrhea | Mild | 0 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Vomiting | Moderate | 0 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Nausea | Mild | 0 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Loose stools | Mild | 0 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Nausea | None | 15 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Acute systemic allergic reaction | Moderate | 0 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Acute systemic allergic reaction | None | 15 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Elevated oral temperature | None | 12 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Any symptom | None | 11 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Vomiting | Mild | 2 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Loose stools | Moderate | 0 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Elevated oral temperature | Moderate | 1 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Acute systemic allergic reaction | Mild | 0 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Any symptom | Moderate | 1 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Elevated oral temperature | Mild | 2 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Nausea | Mild | 0 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Elevated oral temperature | None | 15 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Elevated oral temperature | Mild | 0 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Elevated oral temperature | Moderate | 0 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Vomiting | None | 14 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Vomiting | Mild | 0 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Abdominal pain/stomach ache | Mild | 0 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Abdominal pain/stomach ache | Moderate | 0 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Diarrhea | None | 15 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Diarrhea | Mild | 0 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Diarrhea | Moderate | 0 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Acute systemic allergic reaction | None | 15 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Acute systemic allergic reaction | Mild | 0 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Acute systemic allergic reaction | Moderate | 0 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Nausea | None | 15 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Nausea | Moderate | 0 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Any symptom | None | 14 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Any symptom | Mild | 0 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Any symptom | Moderate | 1 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Vomiting | Moderate | 1 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Loose stools | None | 15 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Loose stools | Mild | 0 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Loose stools | Moderate | 0 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Abdominal pain/stomach ache | None | 15 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Acute systemic allergic reaction | Moderate | 0 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Nausea | Moderate | 0 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Diarrhea | Mild | 0 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Any symptom | None | 12 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Vomiting | Moderate | 0 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Nausea | Mild | 0 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Abdominal pain/stomach ache | Moderate | 0 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Loose stools | Mild | 0 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Vomiting | Mild | 3 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Elevated oral temperature | Mild | 0 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Acute systemic allergic reaction | Mild | 0 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Elevated oral temperature | None | 15 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Any symptom | Mild | 3 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Elevated oral temperature | Moderate | 0 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Diarrhea | Moderate | 0 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Abdominal pain/stomach ache | Mild | 0 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Abdominal pain/stomach ache | None | 15 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Vomiting | None | 12 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Diarrhea | None | 15 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Loose stools | Moderate | 0 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Nausea | None | 15 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Any symptom | Moderate | 0 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Acute systemic allergic reaction | None | 15 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Loose stools | None | 15 Participants |
| 24-59 Months: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Acute systemic allergic reaction | None | 52 Participants |
| 24-59 Months: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Abdominal pain/stomach ache | Mild | 0 Participants |
| 24-59 Months: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Nausea | Mild | 0 Participants |
| 24-59 Months: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Abdominal pain/stomach ache | None | 52 Participants |
| 24-59 Months: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Loose stools | None | 52 Participants |
| 24-59 Months: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Elevated oral temperature | Mild | 2 Participants |
| 24-59 Months: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Elevated oral temperature | None | 50 Participants |
| 24-59 Months: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Vomiting | None | 52 Participants |
| 24-59 Months: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Any symptom | Moderate | 0 Participants |
| 24-59 Months: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Diarrhea | Mild | 0 Participants |
| 24-59 Months: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Abdominal pain/stomach ache | Moderate | 0 Participants |
| 24-59 Months: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Loose stools | Mild | 0 Participants |
| 24-59 Months: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Acute systemic allergic reaction | Mild | 0 Participants |
| 24-59 Months: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Any symptom | Mild | 2 Participants |
| 24-59 Months: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Vomiting | Moderate | 0 Participants |
| 24-59 Months: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Any symptom | None | 50 Participants |
| 24-59 Months: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Diarrhea | Moderate | 0 Participants |
| 24-59 Months: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Elevated oral temperature | Moderate | 0 Participants |
| 24-59 Months: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Acute systemic allergic reaction | Moderate | 0 Participants |
| 24-59 Months: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Loose stools | Moderate | 0 Participants |
| 24-59 Months: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Nausea | None | 52 Participants |
| 24-59 Months: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Nausea | Moderate | 0 Participants |
| 24-59 Months: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Diarrhea | None | 52 Participants |
| 24-59 Months: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Vomiting | Mild | 0 Participants |
| 12-23 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Elevated oral temperature | Moderate | 1 Participants |
| 12-23 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Nausea | None | 15 Participants |
| 12-23 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Loose stools | Moderate | 0 Participants |
| 12-23 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Diarrhea | None | 14 Participants |
| 12-23 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Diarrhea | Mild | 1 Participants |
| 12-23 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Abdominal pain/stomach ache | Mild | 0 Participants |
| 12-23 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Acute systemic allergic reaction | Moderate | 0 Participants |
| 12-23 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Acute systemic allergic reaction | None | 15 Participants |
| 12-23 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Any symptom | Moderate | 1 Participants |
| 12-23 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Abdominal pain/stomach ache | None | 15 Participants |
| 12-23 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Diarrhea | Moderate | 0 Participants |
| 12-23 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Nausea | Moderate | 0 Participants |
| 12-23 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Elevated oral temperature | None | 14 Participants |
| 12-23 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Vomiting | None | 13 Participants |
| 12-23 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Any symptom | Mild | 2 Participants |
| 12-23 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Abdominal pain/stomach ache | Moderate | 0 Participants |
| 12-23 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Vomiting | Mild | 2 Participants |
| 12-23 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Vomiting | Moderate | 0 Participants |
| 12-23 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Any symptom | None | 12 Participants |
| 12-23 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Elevated oral temperature | Mild | 0 Participants |
| 12-23 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Acute systemic allergic reaction | Mild | 0 Participants |
| 12-23 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Loose stools | None | 15 Participants |
| 12-23 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Nausea | Mild | 0 Participants |
| 12-23 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Loose stools | Mild | 0 Participants |
| 12-23 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Elevated oral temperature | Moderate | 0 Participants |
| 12-23 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Loose stools | None | 15 Participants |
| 12-23 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Acute systemic allergic reaction | None | 15 Participants |
| 12-23 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Vomiting | None | 14 Participants |
| 12-23 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Diarrhea | Mild | 1 Participants |
| 12-23 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Diarrhea | None | 14 Participants |
| 12-23 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Acute systemic allergic reaction | Moderate | 0 Participants |
| 12-23 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Abdominal pain/stomach ache | Mild | 0 Participants |
| 12-23 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Nausea | None | 15 Participants |
| 12-23 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Acute systemic allergic reaction | Mild | 0 Participants |
| 12-23 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Abdominal pain/stomach ache | Moderate | 0 Participants |
| 12-23 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Nausea | Mild | 0 Participants |
| 12-23 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Diarrhea | Moderate | 0 Participants |
| 12-23 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Abdominal pain/stomach ache | None | 15 Participants |
| 12-23 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Nausea | Moderate | 0 Participants |
| 12-23 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Loose stools | Moderate | 0 Participants |
| 12-23 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Elevated oral temperature | None | 15 Participants |
| 12-23 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Any symptom | None | 13 Participants |
| 12-23 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Vomiting | Moderate | 0 Participants |
| 12-23 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Loose stools | Mild | 0 Participants |
| 12-23 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Any symptom | Mild | 2 Participants |
| 12-23 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Vomiting | Mild | 1 Participants |
| 12-23 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Any symptom | Moderate | 0 Participants |
| 12-23 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Elevated oral temperature | Mild | 0 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Loose stools | None | 12 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Elevated oral temperature | Moderate | 1 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Elevated oral temperature | Mild | 2 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Abdominal pain/stomach ache | None | 15 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Diarrhea | None | 15 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Nausea | None | 15 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Vomiting | Moderate | 0 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Any symptom | Moderate | 1 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Any symptom | None | 9 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Diarrhea | Moderate | 0 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Loose stools | Mild | 3 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Nausea | Moderate | 0 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Diarrhea | Mild | 0 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Vomiting | Mild | 2 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Elevated oral temperature | None | 12 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Any symptom | Mild | 5 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Loose stools | Moderate | 0 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Vomiting | None | 13 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Acute systemic allergic reaction | None | 15 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Acute systemic allergic reaction | Moderate | 0 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Abdominal pain/stomach ache | Moderate | 0 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Abdominal pain/stomach ache | Mild | 0 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Nausea | Mild | 0 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Acute systemic allergic reaction | Mild | 0 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Nausea | Moderate | 0 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Abdominal pain/stomach ache | None | 15 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Loose stools | Moderate | 0 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Nausea | None | 15 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Acute systemic allergic reaction | Moderate | 0 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Elevated oral temperature | None | 14 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Abdominal pain/stomach ache | Mild | 0 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Elevated oral temperature | Moderate | 0 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Diarrhea | None | 14 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Loose stools | None | 15 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Any symptom | None | 7 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Loose stools | Mild | 0 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Vomiting | Moderate | 0 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Diarrhea | Moderate | 0 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Elevated oral temperature | Mild | 1 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Acute systemic allergic reaction | Mild | 0 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Any symptom | Mild | 8 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Diarrhea | Mild | 1 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Vomiting | Mild | 8 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Any symptom | Moderate | 0 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Acute systemic allergic reaction | None | 15 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Vomiting | None | 7 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Abdominal pain/stomach ache | Moderate | 0 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Nausea | Mild | 0 Participants |
| 12-23 Months: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Acute systemic allergic reaction | None | 40 Participants |
| 12-23 Months: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Elevated oral temperature | Mild | 1 Participants |
| 12-23 Months: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Elevated oral temperature | Moderate | 0 Participants |
| 12-23 Months: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Abdominal pain/stomach ache | Moderate | 0 Participants |
| 12-23 Months: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Any symptom | Moderate | 0 Participants |
| 12-23 Months: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Acute systemic allergic reaction | Moderate | 0 Participants |
| 12-23 Months: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Nausea | Mild | 0 Participants |
| 12-23 Months: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Vomiting | None | 40 Participants |
| 12-23 Months: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Any symptom | Mild | 0 Participants |
| 12-23 Months: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Vomiting | Mild | 0 Participants |
| 12-23 Months: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Loose stools | None | 40 Participants |
| 12-23 Months: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Acute systemic allergic reaction | Mild | 0 Participants |
| 12-23 Months: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Nausea | Moderate | 0 Participants |
| 12-23 Months: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Diarrhea | Mild | 0 Participants |
| 12-23 Months: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Loose stools | Mild | 0 Participants |
| 12-23 Months: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Nausea | None | 40 Participants |
| 12-23 Months: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Any symptom | None | 40 Participants |
| 12-23 Months: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Vomiting | Moderate | 0 Participants |
| 12-23 Months: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Loose stools | Moderate | 0 Participants |
| 12-23 Months: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Diarrhea | None | 40 Participants |
| 12-23 Months: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Diarrhea | Moderate | 0 Participants |
| 12-23 Months: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Elevated oral temperature | None | 39 Participants |
| 12-23 Months: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Abdominal pain/stomach ache | Mild | 0 Participants |
| 12-23 Months: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Abdominal pain/stomach ache | None | 40 Participants |
| 6-11 Months: ETVAX (1/8) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Acute systemic allergic reaction | Mild | 0 Participants |
| 6-11 Months: ETVAX (1/8) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Nausea | None | 30 Participants |
| 6-11 Months: ETVAX (1/8) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Any symptom | Mild | 4 Participants |
| 6-11 Months: ETVAX (1/8) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Diarrhea | Moderate | 0 Participants |
| 6-11 Months: ETVAX (1/8) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Nausea | Moderate | 0 Participants |
| 6-11 Months: ETVAX (1/8) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Elevated oral temperature | Moderate | 0 Participants |
| 6-11 Months: ETVAX (1/8) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Nausea | Mild | 0 Participants |
| 6-11 Months: ETVAX (1/8) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Vomiting | Mild | 2 Participants |
| 6-11 Months: ETVAX (1/8) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Vomiting | Moderate | 0 Participants |
| 6-11 Months: ETVAX (1/8) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Elevated oral temperature | Mild | 2 Participants |
| 6-11 Months: ETVAX (1/8) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Abdominal pain/stomach ache | None | 30 Participants |
| 6-11 Months: ETVAX (1/8) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Acute systemic allergic reaction | None | 30 Participants |
| 6-11 Months: ETVAX (1/8) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Vomiting | None | 28 Participants |
| 6-11 Months: ETVAX (1/8) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Acute systemic allergic reaction | Moderate | 0 Participants |
| 6-11 Months: ETVAX (1/8) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Any symptom | Moderate | 0 Participants |
| 6-11 Months: ETVAX (1/8) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Abdominal pain/stomach ache | Moderate | 0 Participants |
| 6-11 Months: ETVAX (1/8) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Loose stools | Moderate | 0 Participants |
| 6-11 Months: ETVAX (1/8) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Loose stools | None | 30 Participants |
| 6-11 Months: ETVAX (1/8) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Any symptom | None | 26 Participants |
| 6-11 Months: ETVAX (1/8) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Diarrhea | Mild | 0 Participants |
| 6-11 Months: ETVAX (1/8) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Loose stools | Mild | 0 Participants |
| 6-11 Months: ETVAX (1/8) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Abdominal pain/stomach ache | Mild | 0 Participants |
| 6-11 Months: ETVAX (1/8) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Diarrhea | None | 30 Participants |
| 6-11 Months: ETVAX (1/8) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Elevated oral temperature | None | 28 Participants |
| 6-11 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Abdominal pain/stomach ache | Moderate | 0 Participants |
| 6-11 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Diarrhea | None | 30 Participants |
| 6-11 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Acute systemic allergic reaction | None | 30 Participants |
| 6-11 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Acute systemic allergic reaction | Mild | 0 Participants |
| 6-11 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Abdominal pain/stomach ache | Mild | 0 Participants |
| 6-11 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Acute systemic allergic reaction | Moderate | 0 Participants |
| 6-11 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Nausea | None | 30 Participants |
| 6-11 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Nausea | Mild | 0 Participants |
| 6-11 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Abdominal pain/stomach ache | None | 30 Participants |
| 6-11 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Nausea | Moderate | 0 Participants |
| 6-11 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Any symptom | None | 23 Participants |
| 6-11 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Any symptom | Mild | 7 Participants |
| 6-11 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Vomiting | Mild | 5 Participants |
| 6-11 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Elevated oral temperature | None | 28 Participants |
| 6-11 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Any symptom | Moderate | 0 Participants |
| 6-11 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Elevated oral temperature | Mild | 2 Participants |
| 6-11 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Vomiting | None | 25 Participants |
| 6-11 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Vomiting | Moderate | 0 Participants |
| 6-11 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Loose stools | None | 29 Participants |
| 6-11 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Elevated oral temperature | Moderate | 0 Participants |
| 6-11 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Loose stools | Mild | 1 Participants |
| 6-11 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Loose stools | Moderate | 0 Participants |
| 6-11 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Diarrhea | Moderate | 0 Participants |
| 6-11 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Diarrhea | Mild | 0 Participants |
| 6-11 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Elevated oral temperature | None | 28 Participants |
| 6-11 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Loose stools | Moderate | 0 Participants |
| 6-11 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Diarrhea | None | 28 Participants |
| 6-11 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Acute systemic allergic reaction | None | 30 Participants |
| 6-11 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Any symptom | None | 17 Participants |
| 6-11 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Nausea | Moderate | 0 Participants |
| 6-11 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Abdominal pain/stomach ache | Moderate | 0 Participants |
| 6-11 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Loose stools | Mild | 1 Participants |
| 6-11 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Diarrhea | Moderate | 0 Participants |
| 6-11 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Acute systemic allergic reaction | Moderate | 0 Participants |
| 6-11 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Loose stools | None | 29 Participants |
| 6-11 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Vomiting | Mild | 8 Participants |
| 6-11 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Elevated oral temperature | Mild | 1 Participants |
| 6-11 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Diarrhea | Mild | 2 Participants |
| 6-11 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Vomiting | Moderate | 2 Participants |
| 6-11 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Any symptom | Moderate | 3 Participants |
| 6-11 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Acute systemic allergic reaction | Mild | 0 Participants |
| 6-11 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Elevated oral temperature | Moderate | 1 Participants |
| 6-11 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Abdominal pain/stomach ache | Mild | 0 Participants |
| 6-11 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Nausea | None | 30 Participants |
| 6-11 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Abdominal pain/stomach ache | None | 30 Participants |
| 6-11 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Nausea | Mild | 0 Participants |
| 6-11 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Vomiting | None | 20 Participants |
| 6-11 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Any symptom | Mild | 10 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Vomiting | Mild | 6 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Vomiting | None | 23 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Elevated oral temperature | Moderate | 0 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Loose stools | None | 30 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Any symptom | Moderate | 1 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Any symptom | Mild | 7 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Any symptom | None | 22 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Elevated oral temperature | None | 28 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Loose stools | Mild | 0 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Nausea | Moderate | 0 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Loose stools | Moderate | 0 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Nausea | Mild | 0 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Abdominal pain/stomach ache | None | 30 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Nausea | None | 30 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Elevated oral temperature | Mild | 2 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Acute systemic allergic reaction | Moderate | 0 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Abdominal pain/stomach ache | Mild | 0 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Diarrhea | Mild | 1 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Diarrhea | None | 29 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Diarrhea | Moderate | 0 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Abdominal pain/stomach ache | Moderate | 0 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Acute systemic allergic reaction | None | 30 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Acute systemic allergic reaction | Mild | 0 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Vomiting | Moderate | 1 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Vomiting | Mild | 5 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Elevated oral temperature | Moderate | 0 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Elevated oral temperature | None | 27 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Abdominal pain/stomach ache | Mild | 0 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Abdominal pain/stomach ache | Moderate | 0 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Vomiting | Moderate | 0 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Any symptom | Moderate | 0 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Abdominal pain/stomach ache | None | 30 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Diarrhea | Moderate | 0 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Loose stools | Mild | 0 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Acute systemic allergic reaction | Mild | 0 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Acute systemic allergic reaction | Moderate | 0 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Acute systemic allergic reaction | None | 30 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Nausea | Moderate | 0 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Elevated oral temperature | Mild | 3 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Diarrhea | None | 29 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Diarrhea | Mild | 1 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Nausea | None | 30 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Nausea | Mild | 0 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Any symptom | None | 22 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Loose stools | None | 30 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Vomiting | None | 25 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Loose stools | Moderate | 0 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Any symptom | Mild | 8 Participants |
| 6-11 Month Olds: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Acute systemic allergic reaction | None | 50 Participants |
| 6-11 Month Olds: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Any symptom | Mild | 4 Participants |
| 6-11 Month Olds: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Abdominal pain/stomach ache | None | 50 Participants |
| 6-11 Month Olds: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Nausea | None | 50 Participants |
| 6-11 Month Olds: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Vomiting | Mild | 2 Participants |
| 6-11 Month Olds: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Elevated oral temperature | Mild | 2 Participants |
| 6-11 Month Olds: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Vomiting | None | 48 Participants |
| 6-11 Month Olds: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Diarrhea | None | 50 Participants |
| 6-11 Month Olds: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Acute systemic allergic reaction | Mild | 0 Participants |
| 6-11 Month Olds: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Elevated oral temperature | Moderate | 0 Participants |
| 6-11 Month Olds: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Loose stools | None | 50 Participants |
| 6-11 Month Olds: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Abdominal pain/stomach ache | Moderate | 0 Participants |
| 6-11 Month Olds: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Diarrhea | Mild | 0 Participants |
| 6-11 Month Olds: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Diarrhea | Moderate | 0 Participants |
| 6-11 Month Olds: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Elevated oral temperature | None | 48 Participants |
| 6-11 Month Olds: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Abdominal pain/stomach ache | Mild | 0 Participants |
| 6-11 Month Olds: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Vomiting | Moderate | 0 Participants |
| 6-11 Month Olds: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Loose stools | Mild | 0 Participants |
| 6-11 Month Olds: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Loose stools | Moderate | 0 Participants |
| 6-11 Month Olds: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Nausea | Moderate | 0 Participants |
| 6-11 Month Olds: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Any symptom | Moderate | 0 Participants |
| 6-11 Month Olds: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Acute systemic allergic reaction | Moderate | 0 Participants |
| 6-11 Month Olds: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Nausea | Mild | 0 Participants |
| 6-11 Month Olds: Placebo | Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity | Any symptom | None | 46 Participants |
Primary
Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine
Adverse events (AEs) were assessed post-vaccination using participant/parent/guardian interview (including memory aids), targeted physical examinations, vital signs and clinical laboratory tests and reactogenicity assessments which were completed following each vaccination. Unsolicited AEs were assessed through Day 42 and serious adverse events (SAEs) were assessed over the entire duration of the study.
Time frame: 6 months ± 14 days after the first dose
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Adult: ETVAX (Full) | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Alanine aminotransferase increased | No AE related to vaccine | 15 Participants |
| Adult: ETVAX (Full) | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Leukocytosis | Mild | 0 Participants |
| Adult: ETVAX (Full) | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Leukocytosis | No AE related to vaccine | 15 Participants |
| Adult: ETVAX (Full) | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Alanine aminotransferase increased | Mild | 0 Participants |
| Adult: ETVAX (Full) | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Leukocytosis | Severe | 0 Participants |
| Adult: ETVAX (Full) | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Alanine aminotransferase increased | Severe | 0 Participants |
| Adult: ETVAX (Full) | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Alanine aminotransferase increased | Moderate | 0 Participants |
| Adult: ETVAX (Full) | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Leukocytosis | Moderate | 0 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Alanine aminotransferase increased | Moderate | 0 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Alanine aminotransferase increased | Mild | 0 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Leukocytosis | Mild | 0 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Alanine aminotransferase increased | No AE related to vaccine | 15 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Alanine aminotransferase increased | Severe | 0 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Leukocytosis | Severe | 0 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Leukocytosis | No AE related to vaccine | 14 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Leukocytosis | Moderate | 1 Participants |
| Adult: Placebo | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Leukocytosis | Moderate | 0 Participants |
| Adult: Placebo | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Leukocytosis | Severe | 0 Participants |
| Adult: Placebo | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Alanine aminotransferase increased | Mild | 0 Participants |
| Adult: Placebo | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Alanine aminotransferase increased | No AE related to vaccine | 15 Participants |
| Adult: Placebo | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Alanine aminotransferase increased | Severe | 0 Participants |
| Adult: Placebo | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Alanine aminotransferase increased | Moderate | 0 Participants |
| Adult: Placebo | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Leukocytosis | Mild | 0 Participants |
| Adult: Placebo | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Leukocytosis | No AE related to vaccine | 15 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Leukocytosis | Severe | 0 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Alanine aminotransferase increased | Severe | 0 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Leukocytosis | Moderate | 0 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Alanine aminotransferase increased | Moderate | 0 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Alanine aminotransferase increased | Mild | 0 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Leukocytosis | No AE related to vaccine | 15 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Leukocytosis | Mild | 0 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Alanine aminotransferase increased | No AE related to vaccine | 15 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Leukocytosis | Moderate | 0 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Alanine aminotransferase increased | No AE related to vaccine | 15 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Alanine aminotransferase increased | Mild | 0 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Leukocytosis | Mild | 0 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Alanine aminotransferase increased | Severe | 0 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Alanine aminotransferase increased | Moderate | 0 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Leukocytosis | No AE related to vaccine | 15 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Leukocytosis | Severe | 0 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Leukocytosis | Severe | 0 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Leukocytosis | Mild | 0 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Alanine aminotransferase increased | Severe | 0 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Alanine aminotransferase increased | No AE related to vaccine | 3 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Alanine aminotransferase increased | Moderate | 0 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Leukocytosis | Moderate | 0 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Alanine aminotransferase increased | Mild | 0 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Leukocytosis | No AE related to vaccine | 3 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Alanine aminotransferase increased | Moderate | 0 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Alanine aminotransferase increased | Severe | 0 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Alanine aminotransferase increased | Mild | 0 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Leukocytosis | Severe | 0 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Alanine aminotransferase increased | No AE related to vaccine | 15 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Leukocytosis | Mild | 0 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Leukocytosis | No AE related to vaccine | 15 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Leukocytosis | Moderate | 0 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Leukocytosis | No AE related to vaccine | 15 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Leukocytosis | Severe | 0 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Alanine aminotransferase increased | Mild | 0 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Alanine aminotransferase increased | Moderate | 0 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Alanine aminotransferase increased | Severe | 0 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Alanine aminotransferase increased | No AE related to vaccine | 15 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Leukocytosis | Moderate | 0 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Leukocytosis | Mild | 0 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Leukocytosis | Mild | 0 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Leukocytosis | Moderate | 0 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Alanine aminotransferase increased | Mild | 0 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Alanine aminotransferase increased | Severe | 0 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Alanine aminotransferase increased | Moderate | 0 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Leukocytosis | No AE related to vaccine | 15 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Alanine aminotransferase increased | No AE related to vaccine | 15 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Leukocytosis | Severe | 0 Participants |
| 24-59 Months: Placebo | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Alanine aminotransferase increased | Moderate | 0 Participants |
| 24-59 Months: Placebo | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Leukocytosis | Mild | 0 Participants |
| 24-59 Months: Placebo | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Leukocytosis | Moderate | 0 Participants |
| 24-59 Months: Placebo | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Leukocytosis | No AE related to vaccine | 52 Participants |
| 24-59 Months: Placebo | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Alanine aminotransferase increased | Mild | 0 Participants |
| 24-59 Months: Placebo | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Alanine aminotransferase increased | No AE related to vaccine | 52 Participants |
| 24-59 Months: Placebo | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Leukocytosis | Severe | 0 Participants |
| 24-59 Months: Placebo | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Alanine aminotransferase increased | Severe | 0 Participants |
| 12-23 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Leukocytosis | Severe | 1 Participants |
| 12-23 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Leukocytosis | Moderate | 0 Participants |
| 12-23 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Alanine aminotransferase increased | No AE related to vaccine | 15 Participants |
| 12-23 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Alanine aminotransferase increased | Moderate | 0 Participants |
| 12-23 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Alanine aminotransferase increased | Mild | 0 Participants |
| 12-23 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Leukocytosis | No AE related to vaccine | 14 Participants |
| 12-23 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Leukocytosis | Mild | 0 Participants |
| 12-23 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Alanine aminotransferase increased | Severe | 0 Participants |
| 12-23 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Leukocytosis | Severe | 0 Participants |
| 12-23 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Alanine aminotransferase increased | Mild | 0 Participants |
| 12-23 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Leukocytosis | Moderate | 0 Participants |
| 12-23 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Alanine aminotransferase increased | Moderate | 0 Participants |
| 12-23 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Alanine aminotransferase increased | Severe | 0 Participants |
| 12-23 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Alanine aminotransferase increased | No AE related to vaccine | 15 Participants |
| 12-23 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Leukocytosis | Mild | 0 Participants |
| 12-23 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Leukocytosis | No AE related to vaccine | 15 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Leukocytosis | Moderate | 1 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Alanine aminotransferase increased | Moderate | 0 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Alanine aminotransferase increased | Severe | 0 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Alanine aminotransferase increased | Mild | 0 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Leukocytosis | Mild | 0 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Leukocytosis | No AE related to vaccine | 14 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Alanine aminotransferase increased | No AE related to vaccine | 15 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Leukocytosis | Severe | 0 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Leukocytosis | No AE related to vaccine | 15 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Alanine aminotransferase increased | No AE related to vaccine | 15 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Alanine aminotransferase increased | Moderate | 0 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Alanine aminotransferase increased | Mild | 0 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Leukocytosis | Severe | 0 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Leukocytosis | Mild | 0 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Alanine aminotransferase increased | Severe | 0 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Leukocytosis | Moderate | 0 Participants |
| 12-23 Months: Placebo | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Leukocytosis | Severe | 0 Participants |
| 12-23 Months: Placebo | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Leukocytosis | No AE related to vaccine | 38 Participants |
| 12-23 Months: Placebo | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Leukocytosis | Mild | 0 Participants |
| 12-23 Months: Placebo | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Alanine aminotransferase increased | Moderate | 1 Participants |
| 12-23 Months: Placebo | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Alanine aminotransferase increased | No AE related to vaccine | 39 Participants |
| 12-23 Months: Placebo | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Leukocytosis | Moderate | 2 Participants |
| 12-23 Months: Placebo | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Alanine aminotransferase increased | Mild | 0 Participants |
| 12-23 Months: Placebo | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Alanine aminotransferase increased | Severe | 0 Participants |
| 6-11 Months: ETVAX (1/8) | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Alanine aminotransferase increased | Severe | 0 Participants |
| 6-11 Months: ETVAX (1/8) | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Leukocytosis | Moderate | 0 Participants |
| 6-11 Months: ETVAX (1/8) | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Leukocytosis | Severe | 0 Participants |
| 6-11 Months: ETVAX (1/8) | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Leukocytosis | Mild | 0 Participants |
| 6-11 Months: ETVAX (1/8) | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Alanine aminotransferase increased | Mild | 0 Participants |
| 6-11 Months: ETVAX (1/8) | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Leukocytosis | No AE related to vaccine | 30 Participants |
| 6-11 Months: ETVAX (1/8) | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Alanine aminotransferase increased | Moderate | 0 Participants |
| 6-11 Months: ETVAX (1/8) | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Alanine aminotransferase increased | No AE related to vaccine | 30 Participants |
| 6-11 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Leukocytosis | No AE related to vaccine | 30 Participants |
| 6-11 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Alanine aminotransferase increased | No AE related to vaccine | 30 Participants |
| 6-11 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Alanine aminotransferase increased | Moderate | 0 Participants |
| 6-11 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Leukocytosis | Mild | 0 Participants |
| 6-11 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Leukocytosis | Moderate | 0 Participants |
| 6-11 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Leukocytosis | Severe | 0 Participants |
| 6-11 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Alanine aminotransferase increased | Mild | 0 Participants |
| 6-11 Months: ETVAX (1/4) | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Alanine aminotransferase increased | Severe | 0 Participants |
| 6-11 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Leukocytosis | No AE related to vaccine | 30 Participants |
| 6-11 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Alanine aminotransferase increased | Mild | 0 Participants |
| 6-11 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Alanine aminotransferase increased | Moderate | 0 Participants |
| 6-11 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Alanine aminotransferase increased | Severe | 0 Participants |
| 6-11 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Leukocytosis | Severe | 0 Participants |
| 6-11 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Alanine aminotransferase increased | No AE related to vaccine | 30 Participants |
| 6-11 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Leukocytosis | Moderate | 0 Participants |
| 6-11 Months: ETVAX (1/2) | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Leukocytosis | Mild | 0 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Alanine aminotransferase increased | Mild | 0 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Leukocytosis | No AE related to vaccine | 30 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Leukocytosis | Mild | 0 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Alanine aminotransferase increased | Moderate | 0 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Alanine aminotransferase increased | No AE related to vaccine | 30 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Leukocytosis | Severe | 0 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Leukocytosis | Moderate | 0 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Alanine aminotransferase increased | Severe | 0 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Alanine aminotransferase increased | Moderate | 0 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Alanine aminotransferase increased | Mild | 0 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Alanine aminotransferase increased | No AE related to vaccine | 30 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Leukocytosis | Moderate | 0 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Leukocytosis | Severe | 0 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Leukocytosis | Mild | 0 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Leukocytosis | No AE related to vaccine | 30 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Alanine aminotransferase increased | Severe | 0 Participants |
| 6-11 Month Olds: Placebo | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Alanine aminotransferase increased | Severe | 0 Participants |
| 6-11 Month Olds: Placebo | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Leukocytosis | Mild | 0 Participants |
| 6-11 Month Olds: Placebo | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Alanine aminotransferase increased | Moderate | 1 Participants |
| 6-11 Month Olds: Placebo | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Leukocytosis | Severe | 0 Participants |
| 6-11 Month Olds: Placebo | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Alanine aminotransferase increased | No AE related to vaccine | 49 Participants |
| 6-11 Month Olds: Placebo | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Alanine aminotransferase increased | Mild | 0 Participants |
| 6-11 Month Olds: Placebo | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Leukocytosis | Moderate | 0 Participants |
| 6-11 Month Olds: Placebo | Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine | Leukocytosis | No AE related to vaccine | 50 Participants |
Secondary
Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX
Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second). Antigen in ETVAX were: E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin
Time frame: 19 days
Population: Subjects who received both vaccinations and had valid baseline and endline immunologic samples.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Adult: ETVAX (Full) | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | 20 fold change |
| Adult: ETVAX (Full) | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | 2.75 fold change |
| Adult: ETVAX (Full) | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | 3.34 fold change |
| Adult: ETVAX (Full) | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | 2.98 fold change |
| Adult: ETVAX (Full) | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | 8.54 fold change |
| Adult: ETVAX (Full) + 10 ug dmLT | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | 36 fold change |
| Adult: ETVAX (Full) + 10 ug dmLT | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | 3.11 fold change |
| Adult: ETVAX (Full) + 10 ug dmLT | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | 3.57 fold change |
| Adult: ETVAX (Full) + 10 ug dmLT | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | 7.43 fold change |
| Adult: ETVAX (Full) + 10 ug dmLT | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | 3.46 fold change |
| Adult: Placebo | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | 1.2 fold change |
| Adult: Placebo | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | 1.23 fold change |
| Adult: Placebo | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | 1.62 fold change |
| Adult: Placebo | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | 0.994 fold change |
| Adult: Placebo | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | 1.03 fold change |
| 24-59 Months: ETVAX (1/4) | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | 1.87 fold change |
| 24-59 Months: ETVAX (1/4) | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | 2.92 fold change |
| 24-59 Months: ETVAX (1/4) | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | 6.49 fold change |
| 24-59 Months: ETVAX (1/4) | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | 5.42 fold change |
| 24-59 Months: ETVAX (1/4) | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | 2.81 fold change |
| 24-59 Months: ETVAX (1/2) | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | 6 fold change |
| 24-59 Months: ETVAX (1/2) | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | 3.52 fold change |
| 24-59 Months: ETVAX (1/2) | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | 3.12 fold change |
| 24-59 Months: ETVAX (1/2) | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | 3.11 fold change |
| 24-59 Months: ETVAX (1/2) | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | 20.2 fold change |
| 24-59 Months: ETVAX (Full) | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | 12.7 fold change |
| 24-59 Months: ETVAX (Full) | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | 2.21 fold change |
| 24-59 Months: ETVAX (Full) | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | 3.87 fold change |
| 24-59 Months: ETVAX (Full) | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | 2.93 fold change |
| 24-59 Months: ETVAX (Full) | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | 3.21 fold change |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | 9.6 fold change |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | 5.65 fold change |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | 1.92 fold change |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | 1.62 fold change |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | 3.16 fold change |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | 6.84 fold change |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | 4.3 fold change |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | 15.3 fold change |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | 2.38 fold change |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | 1.77 fold change |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | 1.17 fold change |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | 1.23 fold change |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | 1.41 fold change |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | 1.12 fold change |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | 1.19 fold change |
| 24-59 Months: Placebo | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | 1.37 fold change |
| 24-59 Months: Placebo | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | 2.4 fold change |
| 24-59 Months: Placebo | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | 2.56 fold change |
| 24-59 Months: Placebo | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | 2.02 fold change |
| 24-59 Months: Placebo | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | 10.7 fold change |
| 12-23 Months: ETVAX (1/4) | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | 1.73 fold change |
| 12-23 Months: ETVAX (1/4) | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | 1.62 fold change |
| 12-23 Months: ETVAX (1/4) | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | 2.59 fold change |
| 12-23 Months: ETVAX (1/4) | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | 1.96 fold change |
| 12-23 Months: ETVAX (1/4) | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | 5.68 fold change |
| 12-23 Months: ETVAX (1/2) | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | 1.51 fold change |
| 12-23 Months: ETVAX (1/2) | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | 9.43 fold change |
| 12-23 Months: ETVAX (1/2) | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | 1.44 fold change |
| 12-23 Months: ETVAX (1/2) | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | 2.15 fold change |
| 12-23 Months: ETVAX (1/2) | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | 1.68 fold change |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | 34.8 fold change |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | 2.17 fold change |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | 2.82 fold change |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | 2.28 fold change |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | 2.94 fold change |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | 1.25 fold change |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | 1.28 fold change |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | 1.12 fold change |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | 1.28 fold change |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | 1.25 fold change |
| 12-23 Months: Placebo | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | 2.33 fold change |
| 12-23 Months: Placebo | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | 5.66 fold change |
| 12-23 Months: Placebo | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | 1.54 fold change |
| 12-23 Months: Placebo | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | 2.02 fold change |
| 12-23 Months: Placebo | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | 1.5 fold change |
| 6-11 Months: ETVAX (1/8) | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | 2.54 fold change |
| 6-11 Months: ETVAX (1/8) | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | 1.73 fold change |
| 6-11 Months: ETVAX (1/8) | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | 1.43 fold change |
| 6-11 Months: ETVAX (1/8) | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | 2.2 fold change |
| 6-11 Months: ETVAX (1/8) | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | 9.09 fold change |
| 6-11 Months: ETVAX (1/4) | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | 1.55 fold change |
| 6-11 Months: ETVAX (1/4) | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | 2.24 fold change |
| 6-11 Months: ETVAX (1/4) | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | 11.6 fold change |
| 6-11 Months: ETVAX (1/4) | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | 1.96 fold change |
| 6-11 Months: ETVAX (1/4) | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | 1.66 fold change |
| 6-11 Months: ETVAX (1/2) | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | 3.08 fold change |
| 6-11 Months: ETVAX (1/2) | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | 2.08 fold change |
| 6-11 Months: ETVAX (1/2) | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | 2.06 fold change |
| 6-11 Months: ETVAX (1/2) | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | 2.4 fold change |
| 6-11 Months: ETVAX (1/2) | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | 10.8 fold change |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | 1.81 fold change |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | 1.83 fold change |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | 1.84 fold change |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | 13 fold change |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | 2.93 fold change |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | 2.14 fold change |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | 1.47 fold change |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | 1.53 fold change |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | 1.62 fold change |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | 1.51 fold change |
Secondary
Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for O78 Antigen, Among Adults
Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second).
Time frame: 19 days
Population: Subjects who received both vaccinations and had valid baseline and endline immunologic samples.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Adult: ETVAX (Full) | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for O78 Antigen, Among Adults | 3.15 fold change |
| Adult: ETVAX (Full) + 10 ug dmLT | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for O78 Antigen, Among Adults | 4.66 fold change |
| Adult: Placebo | Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for O78 Antigen, Among Adults | 0.976 fold change |
Secondary
Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen
Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second). Antigen in ETVAX were: E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin
Time frame: 19 days
Population: Subjects who received both vaccinations and had valid baseline and endline immunologic samples.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Adult: ETVAX (Full) | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | 65.6 fold change |
| Adult: ETVAX (Full) | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | 45.5 fold change |
| Adult: ETVAX (Full) | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | 97 fold change |
| Adult: ETVAX (Full) | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | 44.5 fold change |
| Adult: ETVAX (Full) | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | 97.5 fold change |
| Adult: ETVAX (Full) + 10 ug dmLT | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | 59.4 fold change |
| Adult: ETVAX (Full) + 10 ug dmLT | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | 74.5 fold change |
| Adult: ETVAX (Full) + 10 ug dmLT | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | 57.1 fold change |
| Adult: ETVAX (Full) + 10 ug dmLT | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | 73.6 fold change |
| Adult: ETVAX (Full) + 10 ug dmLT | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | 49.3 fold change |
| Adult: Placebo | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | 1.17 fold change |
| Adult: Placebo | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | 1.11 fold change |
| Adult: Placebo | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | 1.43 fold change |
| Adult: Placebo | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | 1.05 fold change |
| Adult: Placebo | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | 1.91 fold change |
| 24-59 Months: ETVAX (1/4) | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | 82.6 fold change |
| 24-59 Months: ETVAX (1/4) | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | 12.5 fold change |
| 24-59 Months: ETVAX (1/4) | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | 57.2 fold change |
| 24-59 Months: ETVAX (1/4) | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | 44.3 fold change |
| 24-59 Months: ETVAX (1/4) | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | 85.2 fold change |
| 24-59 Months: ETVAX (1/2) | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | 36.9 fold change |
| 24-59 Months: ETVAX (1/2) | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | 22.5 fold change |
| 24-59 Months: ETVAX (1/2) | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | 20.2 fold change |
| 24-59 Months: ETVAX (1/2) | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | 16.8 fold change |
| 24-59 Months: ETVAX (1/2) | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | 7.1 fold change |
| 24-59 Months: ETVAX (Full) | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | 106 fold change |
| 24-59 Months: ETVAX (Full) | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | 38.2 fold change |
| 24-59 Months: ETVAX (Full) | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | 14.9 fold change |
| 24-59 Months: ETVAX (Full) | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | 26.5 fold change |
| 24-59 Months: ETVAX (Full) | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | 82.9 fold change |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | 12.3 fold change |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | 25 fold change |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | 15.3 fold change |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | 26.9 fold change |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | 5.84 fold change |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | 35.2 fold change |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | 6 fold change |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | 11.1 fold change |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | 34 fold change |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | 41.3 fold change |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | 1.23 fold change |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | 1.6 fold change |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | 1.43 fold change |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | 1.26 fold change |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | 1.28 fold change |
| 24-59 Months: Placebo | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | 4.62 fold change |
| 24-59 Months: Placebo | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | 17.5 fold change |
| 24-59 Months: Placebo | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | 7.38 fold change |
| 24-59 Months: Placebo | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | 3.2 fold change |
| 24-59 Months: Placebo | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | 16 fold change |
| 12-23 Months: ETVAX (1/4) | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | 35.6 fold change |
| 12-23 Months: ETVAX (1/4) | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | 13.2 fold change |
| 12-23 Months: ETVAX (1/4) | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | 5.26 fold change |
| 12-23 Months: ETVAX (1/4) | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | 2.83 fold change |
| 12-23 Months: ETVAX (1/4) | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | 31.9 fold change |
| 12-23 Months: ETVAX (1/2) | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | 39 fold change |
| 12-23 Months: ETVAX (1/2) | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | 3.98 fold change |
| 12-23 Months: ETVAX (1/2) | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | 21.1 fold change |
| 12-23 Months: ETVAX (1/2) | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | 9.24 fold change |
| 12-23 Months: ETVAX (1/2) | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | 3.67 fold change |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | 11.3 fold change |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | 2.96 fold change |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | 8.92 fold change |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | 5.83 fold change |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | 16.2 fold change |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | 1.56 fold change |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | 1.16 fold change |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | 1.47 fold change |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | 1.69 fold change |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | 1.33 fold change |
| 12-23 Months: Placebo | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | 3.67 fold change |
| 12-23 Months: Placebo | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | 4.85 fold change |
| 12-23 Months: Placebo | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | 4.26 fold change |
| 12-23 Months: Placebo | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | 1.3 fold change |
| 12-23 Months: Placebo | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | 2.52 fold change |
| 6-11 Months: ETVAX (1/8) | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | 2.96 fold change |
| 6-11 Months: ETVAX (1/8) | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | 1.38 fold change |
| 6-11 Months: ETVAX (1/8) | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | 8.8 fold change |
| 6-11 Months: ETVAX (1/8) | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | 1.54 fold change |
| 6-11 Months: ETVAX (1/8) | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | 3.39 fold change |
| 6-11 Months: ETVAX (1/4) | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | 2.95 fold change |
| 6-11 Months: ETVAX (1/4) | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | 1.58 fold change |
| 6-11 Months: ETVAX (1/4) | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | 1.5 fold change |
| 6-11 Months: ETVAX (1/4) | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | 4.75 fold change |
| 6-11 Months: ETVAX (1/4) | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | 7.55 fold change |
| 6-11 Months: ETVAX (1/2) | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | 1.48 fold change |
| 6-11 Months: ETVAX (1/2) | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | 2.81 fold change |
| 6-11 Months: ETVAX (1/2) | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | 3.67 fold change |
| 6-11 Months: ETVAX (1/2) | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | 1.03 fold change |
| 6-11 Months: ETVAX (1/2) | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | 12.6 fold change |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | 1.81 fold change |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | 1.38 fold change |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | 9.25 fold change |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | 1.29 fold change |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | 2.72 fold change |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | 1.62 fold change |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | 1.91 fold change |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | 1.24 fold change |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | 1.54 fold change |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | 1.37 fold change |
Secondary
Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects, by Antigen
Fecal secretion was measured on Day 7, Day 19, and Day 28; number in table is based on the maximum value for each subject. Antigen in ETVAX were: E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin
Time frame: 28 days
Population: Subjects who received both vaccinations and had valid baseline and endline immunologic samples.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Adult: ETVAX (Full) | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects, by Antigen | LTB | 3.74 fold change |
| Adult: ETVAX (Full) | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects, by Antigen | CFA/I | 3.59 fold change |
| Adult: ETVAX (Full) | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects, by Antigen | CS5 | 2.47 fold change |
| Adult: ETVAX (Full) | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects, by Antigen | CS6 | 1.76 fold change |
| Adult: ETVAX (Full) | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects, by Antigen | CS3 | 2.98 fold change |
| Adult: ETVAX (Full) + 10 ug dmLT | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects, by Antigen | CS6 | 2.85 fold change |
| Adult: ETVAX (Full) + 10 ug dmLT | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects, by Antigen | CS5 | 2.63 fold change |
| Adult: ETVAX (Full) + 10 ug dmLT | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects, by Antigen | LTB | 3.71 fold change |
| Adult: ETVAX (Full) + 10 ug dmLT | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects, by Antigen | CS3 | 2.57 fold change |
| Adult: ETVAX (Full) + 10 ug dmLT | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects, by Antigen | CFA/I | 3.36 fold change |
| Adult: Placebo | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects, by Antigen | CS5 | 3.96 fold change |
| Adult: Placebo | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects, by Antigen | CFA/I | 3.41 fold change |
| Adult: Placebo | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects, by Antigen | LTB | 8.3 fold change |
| Adult: Placebo | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects, by Antigen | CS3 | 2 fold change |
| Adult: Placebo | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects, by Antigen | CS6 | 1.4 fold change |
| 24-59 Months: ETVAX (1/4) | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects, by Antigen | CFA/I | 5.19 fold change |
| 24-59 Months: ETVAX (1/4) | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects, by Antigen | CS3 | 4.6 fold change |
| 24-59 Months: ETVAX (1/4) | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects, by Antigen | CS5 | 4.08 fold change |
| 24-59 Months: ETVAX (1/4) | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects, by Antigen | CS6 | 7.21 fold change |
| 24-59 Months: ETVAX (1/4) | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects, by Antigen | LTB | 8.8 fold change |
| 24-59 Months: ETVAX (1/2) | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects, by Antigen | CS6 | 1.72 fold change |
| 24-59 Months: ETVAX (1/2) | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects, by Antigen | LTB | 5.64 fold change |
| 24-59 Months: ETVAX (1/2) | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects, by Antigen | CS3 | 3.66 fold change |
| 24-59 Months: ETVAX (1/2) | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects, by Antigen | CFA/I | 2.7 fold change |
| 24-59 Months: ETVAX (1/2) | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects, by Antigen | CS5 | 1.78 fold change |
| 24-59 Months: ETVAX (Full) | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects, by Antigen | CS3 | 1.91 fold change |
| 24-59 Months: ETVAX (Full) | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects, by Antigen | CS5 | 1.79 fold change |
| 24-59 Months: ETVAX (Full) | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects, by Antigen | CS6 | 1.96 fold change |
| 24-59 Months: ETVAX (Full) | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects, by Antigen | LTB | 2.58 fold change |
| 24-59 Months: ETVAX (Full) | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects, by Antigen | CFA/I | 2.1 fold change |
Secondary
Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 19, by Antigen
Fecal secretion was measured on Day 0 and Day 19 (5 days after administration of second dose of vaccine). Antigen in ETVAX were: E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin
Time frame: 19 days
Population: Subjects who received both vaccinations and had valid baseline and endline immunologic samples.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Adult: ETVAX (Full) | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 19, by Antigen | CS6 | 0.896 fold change |
| Adult: ETVAX (Full) | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 19, by Antigen | CS3 | 1.36 fold change |
| Adult: ETVAX (Full) | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 19, by Antigen | CFA/I | 1.81 fold change |
| Adult: ETVAX (Full) | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 19, by Antigen | LTB | 1.75 fold change |
| Adult: ETVAX (Full) | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 19, by Antigen | CS5 | 1.44 fold change |
| Adult: ETVAX (Full) + 10 ug dmLT | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 19, by Antigen | CS3 | 1.19 fold change |
| Adult: ETVAX (Full) + 10 ug dmLT | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 19, by Antigen | CS6 | 1.42 fold change |
| Adult: ETVAX (Full) + 10 ug dmLT | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 19, by Antigen | CFA/I | 1.18 fold change |
| Adult: ETVAX (Full) + 10 ug dmLT | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 19, by Antigen | LTB | 1.99 fold change |
| Adult: ETVAX (Full) + 10 ug dmLT | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 19, by Antigen | CS5 | 1.24 fold change |
| Adult: Placebo | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 19, by Antigen | CS3 | 0.97 fold change |
| Adult: Placebo | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 19, by Antigen | CS6 | 0.457 fold change |
| Adult: Placebo | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 19, by Antigen | LTB | 3.25 fold change |
| Adult: Placebo | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 19, by Antigen | CS5 | 1.37 fold change |
| Adult: Placebo | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 19, by Antigen | CFA/I | 0.975 fold change |
| 24-59 Months: ETVAX (1/4) | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 19, by Antigen | CS5 | 1.92 fold change |
| 24-59 Months: ETVAX (1/4) | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 19, by Antigen | CFA/I | 2.31 fold change |
| 24-59 Months: ETVAX (1/4) | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 19, by Antigen | CS3 | 1.88 fold change |
| 24-59 Months: ETVAX (1/4) | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 19, by Antigen | CS6 | 2.41 fold change |
| 24-59 Months: ETVAX (1/4) | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 19, by Antigen | LTB | 3.19 fold change |
| 24-59 Months: ETVAX (1/2) | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 19, by Antigen | CS6 | 0.96 fold change |
| 24-59 Months: ETVAX (1/2) | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 19, by Antigen | CFA/I | 1.08 fold change |
| 24-59 Months: ETVAX (1/2) | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 19, by Antigen | LTB | 3.64 fold change |
| 24-59 Months: ETVAX (1/2) | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 19, by Antigen | CS3 | 1.52 fold change |
| 24-59 Months: ETVAX (1/2) | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 19, by Antigen | CS5 | 0.888 fold change |
| 24-59 Months: ETVAX (Full) | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 19, by Antigen | CFA/I | 1.23 fold change |
| 24-59 Months: ETVAX (Full) | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 19, by Antigen | CS6 | 1.2 fold change |
| 24-59 Months: ETVAX (Full) | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 19, by Antigen | CS3 | 1.1 fold change |
| 24-59 Months: ETVAX (Full) | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 19, by Antigen | LTB | 1.64 fold change |
| 24-59 Months: ETVAX (Full) | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 19, by Antigen | CS5 | 1.1 fold change |
Secondary
Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 28, by Antigen
Fecal secretion was measured on Day 0 and Day 28 (2 weeks after administration of second dose of vaccine). Antigen in ETVAX were: E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin
Time frame: 28 days
Population: Subjects who received both vaccinations and had valid baseline and endline immunologic samples.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Adult: ETVAX (Full) | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 28, by Antigen | CS6 | 0.882 fold change |
| Adult: ETVAX (Full) | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 28, by Antigen | CS3 | 1.28 fold change |
| Adult: ETVAX (Full) | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 28, by Antigen | CFA/I | 2.74 fold change |
| Adult: ETVAX (Full) | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 28, by Antigen | LTB | 2.14 fold change |
| Adult: ETVAX (Full) | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 28, by Antigen | CS5 | 1.63 fold change |
| Adult: ETVAX (Full) + 10 ug dmLT | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 28, by Antigen | CS3 | 1.59 fold change |
| Adult: ETVAX (Full) + 10 ug dmLT | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 28, by Antigen | CS6 | 1.5 fold change |
| Adult: ETVAX (Full) + 10 ug dmLT | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 28, by Antigen | CFA/I | 2.35 fold change |
| Adult: ETVAX (Full) + 10 ug dmLT | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 28, by Antigen | LTB | 1.92 fold change |
| Adult: ETVAX (Full) + 10 ug dmLT | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 28, by Antigen | CS5 | 1.61 fold change |
| Adult: Placebo | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 28, by Antigen | CS3 | 1.02 fold change |
| Adult: Placebo | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 28, by Antigen | CS6 | 0.709 fold change |
| Adult: Placebo | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 28, by Antigen | LTB | 4.58 fold change |
| Adult: Placebo | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 28, by Antigen | CS5 | 1.42 fold change |
| Adult: Placebo | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 28, by Antigen | CFA/I | 1.46 fold change |
| 24-59 Months: ETVAX (1/4) | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 28, by Antigen | CS5 | 1.85 fold change |
| 24-59 Months: ETVAX (1/4) | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 28, by Antigen | CFA/I | 2.73 fold change |
| 24-59 Months: ETVAX (1/4) | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 28, by Antigen | CS3 | 2.83 fold change |
| 24-59 Months: ETVAX (1/4) | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 28, by Antigen | CS6 | 2.6 fold change |
| 24-59 Months: ETVAX (1/4) | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 28, by Antigen | LTB | 5.33 fold change |
| 24-59 Months: ETVAX (1/2) | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 28, by Antigen | CS6 | 1.39 fold change |
| 24-59 Months: ETVAX (1/2) | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 28, by Antigen | CFA/I | 2.35 fold change |
| 24-59 Months: ETVAX (1/2) | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 28, by Antigen | LTB | 4.65 fold change |
| 24-59 Months: ETVAX (1/2) | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 28, by Antigen | CS3 | 3.08 fold change |
| 24-59 Months: ETVAX (1/2) | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 28, by Antigen | CS5 | 1.18 fold change |
| 24-59 Months: ETVAX (Full) | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 28, by Antigen | CFA/I | 1.32 fold change |
| 24-59 Months: ETVAX (Full) | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 28, by Antigen | CS6 | 1.05 fold change |
| 24-59 Months: ETVAX (Full) | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 28, by Antigen | CS3 | 1.71 fold change |
| 24-59 Months: ETVAX (Full) | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 28, by Antigen | LTB | 1.19 fold change |
| 24-59 Months: ETVAX (Full) | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 28, by Antigen | CS5 | 1.16 fold change |
Secondary
Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 7, by Antigen
Fecal secretion was measured on Day 0 and Day 7 (7 days after administration of first dose of vaccine). Antigen in ETVAX were: E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin
Time frame: 7 days
Population: Subjects who received both vaccinations and had valid baseline and endline immunologic samples.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Adult: ETVAX (Full) | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 7, by Antigen | CS6 | 1.09 fold change |
| Adult: ETVAX (Full) | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 7, by Antigen | CS3 | 1.32 fold change |
| Adult: ETVAX (Full) | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 7, by Antigen | CFA/I | 2.05 fold change |
| Adult: ETVAX (Full) | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 7, by Antigen | LTB | 1.63 fold change |
| Adult: ETVAX (Full) | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 7, by Antigen | CS5 | 1.37 fold change |
| Adult: ETVAX (Full) + 10 ug dmLT | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 7, by Antigen | CS3 | 0.587 fold change |
| Adult: ETVAX (Full) + 10 ug dmLT | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 7, by Antigen | CS6 | 0.718 fold change |
| Adult: ETVAX (Full) + 10 ug dmLT | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 7, by Antigen | CFA/I | 0.98 fold change |
| Adult: ETVAX (Full) + 10 ug dmLT | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 7, by Antigen | LTB | 0.937 fold change |
| Adult: ETVAX (Full) + 10 ug dmLT | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 7, by Antigen | CS5 | 0.981 fold change |
| Adult: Placebo | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 7, by Antigen | CS3 | 0.884 fold change |
| Adult: Placebo | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 7, by Antigen | CS6 | 0.529 fold change |
| Adult: Placebo | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 7, by Antigen | LTB | 1.76 fold change |
| Adult: Placebo | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 7, by Antigen | CS5 | 1.19 fold change |
| Adult: Placebo | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 7, by Antigen | CFA/I | 1.12 fold change |
| 24-59 Months: ETVAX (1/4) | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 7, by Antigen | CS5 | 2.22 fold change |
| 24-59 Months: ETVAX (1/4) | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 7, by Antigen | CFA/I | 2.92 fold change |
| 24-59 Months: ETVAX (1/4) | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 7, by Antigen | CS3 | 2.71 fold change |
| 24-59 Months: ETVAX (1/4) | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 7, by Antigen | CS6 | 3.75 fold change |
| 24-59 Months: ETVAX (1/4) | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 7, by Antigen | LTB | 2.54 fold change |
| 24-59 Months: ETVAX (1/2) | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 7, by Antigen | CS6 | 1.02 fold change |
| 24-59 Months: ETVAX (1/2) | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 7, by Antigen | CFA/I | 1.53 fold change |
| 24-59 Months: ETVAX (1/2) | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 7, by Antigen | LTB | 2.01 fold change |
| 24-59 Months: ETVAX (1/2) | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 7, by Antigen | CS3 | 1.73 fold change |
| 24-59 Months: ETVAX (1/2) | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 7, by Antigen | CS5 | 0.793 fold change |
| 24-59 Months: ETVAX (Full) | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 7, by Antigen | CFA/I | 1.07 fold change |
| 24-59 Months: ETVAX (Full) | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 7, by Antigen | CS6 | 1.09 fold change |
| 24-59 Months: ETVAX (Full) | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 7, by Antigen | CS3 | 0.989 fold change |
| 24-59 Months: ETVAX (Full) | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 7, by Antigen | LTB | 1.1 fold change |
| 24-59 Months: ETVAX (Full) | Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 7, by Antigen | CS5 | 0.841 fold change |
Secondary
Geometric Mean Fold Change of Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose
Between baseline and after vaccination (measured 7 days after the first dose and 5 days after the second). B-subunit of the E. coli heat-labile enterotoxin (LTB) was one of the antigens in the ETVAX vaccine.
Time frame: 19 days
Population: Subjects who received both vaccinations and had valid baseline and endline immunologic samples.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Adult: ETVAX (Full) | Geometric Mean Fold Change of Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | 6.53 fold change |
| Adult: ETVAX (Full) + 10 ug dmLT | Geometric Mean Fold Change of Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | 10.3 fold change |
| Adult: Placebo | Geometric Mean Fold Change of Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | 1.11 fold change |
| 24-59 Months: ETVAX (1/4) | Geometric Mean Fold Change of Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | 3.53 fold change |
| 24-59 Months: ETVAX (1/2) | Geometric Mean Fold Change of Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | 7.57 fold change |
| 24-59 Months: ETVAX (Full) | Geometric Mean Fold Change of Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | 6.39 fold change |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Geometric Mean Fold Change of Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | 5.02 fold change |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Geometric Mean Fold Change of Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | 4.69 fold change |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Geometric Mean Fold Change of Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | 1.23 fold change |
| 24-59 Months: Placebo | Geometric Mean Fold Change of Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | 3.56 fold change |
| 12-23 Months: ETVAX (1/4) | Geometric Mean Fold Change of Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | 2.21 fold change |
| 12-23 Months: ETVAX (1/2) | Geometric Mean Fold Change of Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | 4.73 fold change |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Geometric Mean Fold Change of Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | 8.77 fold change |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Geometric Mean Fold Change of Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | 0.996 fold change |
| 12-23 Months: Placebo | Geometric Mean Fold Change of Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | 4.3 fold change |
| 6-11 Months: ETVAX (1/8) | Geometric Mean Fold Change of Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | 5.64 fold change |
| 6-11 Months: ETVAX (1/4) | Geometric Mean Fold Change of Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | 5.47 fold change |
| 6-11 Months: ETVAX (1/2) | Geometric Mean Fold Change of Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | 5.19 fold change |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Geometric Mean Fold Change of Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | 5.67 fold change |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Geometric Mean Fold Change of Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | 1.74 fold change |
Secondary
Geometric Mean Titer (GMT) for Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for O78 Antigen, Among Adults
Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second).
Time frame: 19 days
Population: Subjects who received both vaccinations and had valid baseline and endline immunologic samples.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Adult: ETVAX (Full) | Geometric Mean Titer (GMT) for Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for O78 Antigen, Among Adults | 177 titer |
| Adult: ETVAX (Full) + 10 ug dmLT | Geometric Mean Titer (GMT) for Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for O78 Antigen, Among Adults | 166 titer |
| Adult: Placebo | Geometric Mean Titer (GMT) for Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for O78 Antigen, Among Adults | 30.9 titer |
Secondary
Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen
Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second). Antigen in ETVAX were: E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin
Time frame: 19 days
Population: Subjects who received both vaccinations and had valid baseline and endline immunologic samples.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Adult: ETVAX (Full) | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | 3184 titer |
| Adult: ETVAX (Full) | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | 11354 titer |
| Adult: ETVAX (Full) | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | 5535 titer |
| Adult: ETVAX (Full) | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | 9991 titer |
| Adult: ETVAX (Full) | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | 4405 titer |
| Adult: ETVAX (Full) + 10 ug dmLT | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | 6732 titer |
| Adult: ETVAX (Full) + 10 ug dmLT | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | 4795 titer |
| Adult: ETVAX (Full) + 10 ug dmLT | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | 3450 titer |
| Adult: ETVAX (Full) + 10 ug dmLT | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | 5198 titer |
| Adult: ETVAX (Full) + 10 ug dmLT | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | 7658 titer |
| Adult: Placebo | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | 115 titer |
| Adult: Placebo | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | 221 titer |
| Adult: Placebo | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | 82.1 titer |
| Adult: Placebo | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | 126 titer |
| Adult: Placebo | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | 101 titer |
| 24-59 Months: ETVAX (1/4) | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | 7298 titer |
| 24-59 Months: ETVAX (1/4) | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | 2545 titer |
| 24-59 Months: ETVAX (1/4) | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | 4869 titer |
| 24-59 Months: ETVAX (1/4) | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | 727 titer |
| 24-59 Months: ETVAX (1/4) | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | 9277 titer |
| 24-59 Months: ETVAX (1/2) | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | 440 titer |
| 24-59 Months: ETVAX (1/2) | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | 2067 titer |
| 24-59 Months: ETVAX (1/2) | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | 2913 titer |
| 24-59 Months: ETVAX (1/2) | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | 2283 titer |
| 24-59 Months: ETVAX (1/2) | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | 1473 titer |
| 24-59 Months: ETVAX (Full) | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | 4868 titer |
| 24-59 Months: ETVAX (Full) | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | 6417 titer |
| 24-59 Months: ETVAX (Full) | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | 990 titer |
| 24-59 Months: ETVAX (Full) | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | 1921 titer |
| 24-59 Months: ETVAX (Full) | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | 7819 titer |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | 2239 titer |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | 876 titer |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | 1435 titer |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | 468 titer |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | 1400 titer |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | 2475 titer |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | 3164 titer |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | 4076 titer |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | 913 titer |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | 255 titer |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | 71.5 titer |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | 96.3 titer |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | 149 titer |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | 76.1 titer |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | 190 titer |
| 24-59 Months: Placebo | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | 210 titer |
| 24-59 Months: Placebo | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | 1490 titer |
| 24-59 Months: Placebo | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | 369 titer |
| 24-59 Months: Placebo | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | 914 titer |
| 24-59 Months: Placebo | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | 600 titer |
| 12-23 Months: ETVAX (1/4) | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | 187 titer |
| 12-23 Months: ETVAX (1/4) | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | 1322 titer |
| 12-23 Months: ETVAX (1/4) | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | 1883 titer |
| 12-23 Months: ETVAX (1/4) | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | 394 titer |
| 12-23 Months: ETVAX (1/4) | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | 2937 titer |
| 12-23 Months: ETVAX (1/2) | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | 577 titer |
| 12-23 Months: ETVAX (1/2) | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | 225 titer |
| 12-23 Months: ETVAX (1/2) | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | 2242 titer |
| 12-23 Months: ETVAX (1/2) | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | 1346 titer |
| 12-23 Months: ETVAX (1/2) | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | 229 titer |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | 325 titer |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | 862 titer |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | 700 titer |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | 616 titer |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | 1584 titer |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | 83.3 titer |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | 155 titer |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | 134 titer |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | 91.7 titer |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | 93.9 titer |
| 12-23 Months: Placebo | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | 318 titer |
| 12-23 Months: Placebo | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | 396 titer |
| 12-23 Months: Placebo | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | 163 titer |
| 12-23 Months: Placebo | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | 110 titer |
| 12-23 Months: Placebo | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | 355 titer |
| 6-11 Months: ETVAX (1/8) | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | 89.6 titer |
| 6-11 Months: ETVAX (1/8) | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | 228 titer |
| 6-11 Months: ETVAX (1/8) | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | 100 titer |
| 6-11 Months: ETVAX (1/8) | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | 704 titer |
| 6-11 Months: ETVAX (1/8) | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | 263 titer |
| 6-11 Months: ETVAX (1/4) | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | 212 titer |
| 6-11 Months: ETVAX (1/4) | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | 82.7 titer |
| 6-11 Months: ETVAX (1/4) | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | 190 titer |
| 6-11 Months: ETVAX (1/4) | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | 506 titer |
| 6-11 Months: ETVAX (1/4) | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | 328 titer |
| 6-11 Months: ETVAX (1/2) | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | 771 titer |
| 6-11 Months: ETVAX (1/2) | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | 202 titer |
| 6-11 Months: ETVAX (1/2) | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | 60.9 titer |
| 6-11 Months: ETVAX (1/2) | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | 186 titer |
| 6-11 Months: ETVAX (1/2) | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | 90.4 titer |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | 81.5 titer |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | 196 titer |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | 60.9 titer |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | 123 titer |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | 509 titer |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | 104 titer |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | 96.3 titer |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | 123 titer |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | 99.9 titer |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | 129 titer |
Secondary
Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects, by Antigen
Fecal secretion was measured on Day 7, Day 19, and Day 28; number in table is based on the maximum value for each subject. Antigen in ETVAX were: E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin
Time frame: 28 days
Population: Subjects who received both vaccinations and had valid baseline and endline immunologic samples.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Adult: ETVAX (Full) | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects, by Antigen | CS5 | 47.7 titer |
| Adult: ETVAX (Full) | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects, by Antigen | CFA/I | 74.3 titer |
| Adult: ETVAX (Full) | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects, by Antigen | LTB | 655 titer |
| Adult: ETVAX (Full) | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects, by Antigen | CS6 | 122 titer |
| Adult: ETVAX (Full) | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects, by Antigen | CS3 | 236 titer |
| Adult: ETVAX (Full) + 10 ug dmLT | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects, by Antigen | CS6 | 272 titer |
| Adult: ETVAX (Full) + 10 ug dmLT | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects, by Antigen | CS5 | 153 titer |
| Adult: ETVAX (Full) + 10 ug dmLT | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects, by Antigen | LTB | 2330 titer |
| Adult: ETVAX (Full) + 10 ug dmLT | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects, by Antigen | CS3 | 340 titer |
| Adult: ETVAX (Full) + 10 ug dmLT | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects, by Antigen | CFA/I | 281 titer |
| Adult: Placebo | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects, by Antigen | LTB | 1500 titer |
| Adult: Placebo | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects, by Antigen | CS5 | 63.9 titer |
| Adult: Placebo | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects, by Antigen | CS3 | 101 titer |
| Adult: Placebo | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects, by Antigen | CFA/I | 141 titer |
| Adult: Placebo | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects, by Antigen | CS6 | 90.3 titer |
| 24-59 Months: ETVAX (1/4) | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects, by Antigen | LTB | 4159 titer |
| 24-59 Months: ETVAX (1/4) | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects, by Antigen | CFA/I | 230 titer |
| 24-59 Months: ETVAX (1/4) | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects, by Antigen | CS5 | 107 titer |
| 24-59 Months: ETVAX (1/4) | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects, by Antigen | CS3 | 332 titer |
| 24-59 Months: ETVAX (1/4) | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects, by Antigen | CS6 | 361 titer |
| 24-59 Months: ETVAX (1/2) | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects, by Antigen | CS3 | 402 titer |
| 24-59 Months: ETVAX (1/2) | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects, by Antigen | CFA/I | 122 titer |
| 24-59 Months: ETVAX (1/2) | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects, by Antigen | CS5 | 127 titer |
| 24-59 Months: ETVAX (1/2) | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects, by Antigen | LTB | 1299 titer |
| 24-59 Months: ETVAX (1/2) | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects, by Antigen | CS6 | 170 titer |
| 24-59 Months: ETVAX (Full) | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects, by Antigen | CS5 | 74 titer |
| 24-59 Months: ETVAX (Full) | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects, by Antigen | CFA/I | 113 titer |
| 24-59 Months: ETVAX (Full) | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects, by Antigen | CS6 | 181 titer |
| 24-59 Months: ETVAX (Full) | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects, by Antigen | LTB | 839 titer |
| 24-59 Months: ETVAX (Full) | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects, by Antigen | CS3 | 204 titer |
Secondary
Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 19, by Antigen
Fecal secretion was measured on Day 19 (5 days after administration of second dose of vaccine). Antigen in ETVAX were: E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin
Time frame: 19 days
Population: Subjects who received both vaccinations and had valid baseline and endline immunologic samples.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Adult: ETVAX (Full) | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 19, by Antigen | CS6 | 62.2 titer |
| Adult: ETVAX (Full) | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 19, by Antigen | CS3 | 107 titer |
| Adult: ETVAX (Full) | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 19, by Antigen | CFA/I | 37.3 titer |
| Adult: ETVAX (Full) | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 19, by Antigen | LTB | 306 titer |
| Adult: ETVAX (Full) | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 19, by Antigen | CS5 | 27.8 titer |
| Adult: ETVAX (Full) + 10 ug dmLT | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 19, by Antigen | CS3 | 158 titer |
| Adult: ETVAX (Full) + 10 ug dmLT | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 19, by Antigen | CS6 | 135 titer |
| Adult: ETVAX (Full) + 10 ug dmLT | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 19, by Antigen | CFA/I | 99.1 titer |
| Adult: ETVAX (Full) + 10 ug dmLT | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 19, by Antigen | LTB | 1246 titer |
| Adult: ETVAX (Full) + 10 ug dmLT | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 19, by Antigen | CS5 | 72.7 titer |
| Adult: Placebo | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 19, by Antigen | CS3 | 48.7 titer |
| Adult: Placebo | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 19, by Antigen | CS6 | 29.8 titer |
| Adult: Placebo | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 19, by Antigen | LTB | 587 titer |
| Adult: Placebo | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 19, by Antigen | CS5 | 22.1 titer |
| Adult: Placebo | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 19, by Antigen | CFA/I | 40.2 titer |
| 24-59 Months: ETVAX (1/4) | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 19, by Antigen | CS5 | 50.5 titer |
| 24-59 Months: ETVAX (1/4) | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 19, by Antigen | CFA/I | 102 titer |
| 24-59 Months: ETVAX (1/4) | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 19, by Antigen | CS3 | 136 titer |
| 24-59 Months: ETVAX (1/4) | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 19, by Antigen | CS6 | 121 titer |
| 24-59 Months: ETVAX (1/4) | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 19, by Antigen | LTB | 1507 titer |
| 24-59 Months: ETVAX (1/2) | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 19, by Antigen | CS6 | 94.8 titer |
| 24-59 Months: ETVAX (1/2) | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 19, by Antigen | CFA/I | 48.9 titer |
| 24-59 Months: ETVAX (1/2) | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 19, by Antigen | LTB | 838 titer |
| 24-59 Months: ETVAX (1/2) | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 19, by Antigen | CS3 | 166 titer |
| 24-59 Months: ETVAX (1/2) | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 19, by Antigen | CS5 | 63.5 titer |
| 24-59 Months: ETVAX (Full) | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 19, by Antigen | CFA/I | 66.3 titer |
| 24-59 Months: ETVAX (Full) | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 19, by Antigen | CS6 | 110 titer |
| 24-59 Months: ETVAX (Full) | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 19, by Antigen | CS3 | 118 titer |
| 24-59 Months: ETVAX (Full) | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 19, by Antigen | LTB | 533 titer |
| 24-59 Months: ETVAX (Full) | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 19, by Antigen | CS5 | 45.8 titer |
Secondary
Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 28, by Antigen
Fecal secretion was measured on Day 28 (2 weeks after administration of second dose of vaccine). Antigen in ETVAX were: E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin
Time frame: 28 days
Population: Subjects who received both vaccinations and had valid baseline and endline immunologic samples.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Adult: ETVAX (Full) | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 28, by Antigen | CS6 | 57.8 titer |
| Adult: ETVAX (Full) | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 28, by Antigen | CS5 | 28.8 titer |
| Adult: ETVAX (Full) | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 28, by Antigen | CFA/I | 52.4 titer |
| Adult: ETVAX (Full) | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 28, by Antigen | LTB | 517 titer |
| Adult: ETVAX (Full) | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 28, by Antigen | CS3 | 106 titer |
| Adult: ETVAX (Full) + 10 ug dmLT | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 28, by Antigen | CS3 | 271 titer |
| Adult: ETVAX (Full) + 10 ug dmLT | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 28, by Antigen | CS5 | 271 titer |
| Adult: ETVAX (Full) + 10 ug dmLT | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 28, by Antigen | CS6 | 145 titer |
| Adult: ETVAX (Full) + 10 ug dmLT | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 28, by Antigen | CFA/I | 178 titer |
| Adult: ETVAX (Full) + 10 ug dmLT | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 28, by Antigen | LTB | 2151 titer |
| Adult: Placebo | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 28, by Antigen | CS5 | 57.5 titer |
| Adult: Placebo | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 28, by Antigen | CFA/I | 72.6 titer |
| Adult: Placebo | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 28, by Antigen | CS3 | 57.5 titer |
| Adult: Placebo | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 28, by Antigen | CS6 | 44.2 titer |
| Adult: Placebo | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 28, by Antigen | LTB | 911 titer |
| 24-59 Months: ETVAX (1/4) | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 28, by Antigen | CS5 | 223 titer |
| 24-59 Months: ETVAX (1/4) | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 28, by Antigen | CS6 | 138 titer |
| 24-59 Months: ETVAX (1/4) | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 28, by Antigen | CS3 | 223 titer |
| 24-59 Months: ETVAX (1/4) | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 28, by Antigen | CFA/I | 126 titer |
| 24-59 Months: ETVAX (1/4) | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 28, by Antigen | LTB | 2231 titer |
| 24-59 Months: ETVAX (1/2) | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 28, by Antigen | CS3 | 373 titer |
| 24-59 Months: ETVAX (1/2) | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 28, by Antigen | CS5 | 373 titer |
| 24-59 Months: ETVAX (1/2) | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 28, by Antigen | LTB | 1128 titer |
| 24-59 Months: ETVAX (1/2) | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 28, by Antigen | CS6 | 163 titer |
| 24-59 Months: ETVAX (1/2) | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 28, by Antigen | CFA/I | 136 titer |
| 24-59 Months: ETVAX (Full) | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 28, by Antigen | CS6 | 86.1 titer |
| 24-59 Months: ETVAX (Full) | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 28, by Antigen | LTB | 391 titer |
| 24-59 Months: ETVAX (Full) | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 28, by Antigen | CFA/I | 61.8 titer |
| 24-59 Months: ETVAX (Full) | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 28, by Antigen | CS3 | 181 titer |
| 24-59 Months: ETVAX (Full) | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 28, by Antigen | CS5 | 181 titer |
Secondary
Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 7, by Antigen
Fecal secretion was measured on Day 7 (7 days after administration of first dose of vaccine). Antigen in ETVAX were: E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin
Time frame: 7 days
Population: Subjects who received both vaccinations and had valid baseline and endline immunologic samples.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Adult: ETVAX (Full) | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 7, by Antigen | CS6 | 72 titer |
| Adult: ETVAX (Full) | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 7, by Antigen | CS3 | 111 titer |
| Adult: ETVAX (Full) | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 7, by Antigen | CFA/I | 49.6 titer |
| Adult: ETVAX (Full) | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 7, by Antigen | LTB | 281 titer |
| Adult: ETVAX (Full) | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 7, by Antigen | CS5 | 27.8 titer |
| Adult: ETVAX (Full) + 10 ug dmLT | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 7, by Antigen | CS3 | 94.7 titer |
| Adult: ETVAX (Full) + 10 ug dmLT | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 7, by Antigen | CS6 | 80.7 titer |
| Adult: ETVAX (Full) + 10 ug dmLT | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 7, by Antigen | CFA/I | 94.7 titer |
| Adult: ETVAX (Full) + 10 ug dmLT | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 7, by Antigen | LTB | 474 titer |
| Adult: ETVAX (Full) + 10 ug dmLT | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 7, by Antigen | CS5 | 65 titer |
| Adult: Placebo | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 7, by Antigen | CS3 | 53.8 titer |
| Adult: Placebo | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 7, by Antigen | CS6 | 36.3 titer |
| Adult: Placebo | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 7, by Antigen | LTB | 345 titer |
| Adult: Placebo | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 7, by Antigen | CS5 | 19.5 titer |
| Adult: Placebo | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 7, by Antigen | CFA/I | 53.8 titer |
| 24-59 Months: ETVAX (1/4) | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 7, by Antigen | CS5 | 60.7 titer |
| 24-59 Months: ETVAX (1/4) | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 7, by Antigen | CFA/I | 125 titer |
| 24-59 Months: ETVAX (1/4) | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 7, by Antigen | CS3 | 125 titer |
| 24-59 Months: ETVAX (1/4) | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 7, by Antigen | CS6 | 187 titer |
| 24-59 Months: ETVAX (1/4) | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 7, by Antigen | LTB | 1249 titer |
| 24-59 Months: ETVAX (1/2) | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 7, by Antigen | CS6 | 101 titer |
| 24-59 Months: ETVAX (1/2) | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 7, by Antigen | CFA/I | 70.6 titer |
| 24-59 Months: ETVAX (1/2) | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 7, by Antigen | LTB | 536 titer |
| 24-59 Months: ETVAX (1/2) | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 7, by Antigen | CS3 | 70.6 titer |
| 24-59 Months: ETVAX (1/2) | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 7, by Antigen | CS5 | 59.8 titer |
| 24-59 Months: ETVAX (Full) | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 7, by Antigen | CFA/I | 57.1 titer |
| 24-59 Months: ETVAX (Full) | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 7, by Antigen | CS6 | 101 titer |
| 24-59 Months: ETVAX (Full) | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 7, by Antigen | CS3 | 57.1 titer |
| 24-59 Months: ETVAX (Full) | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 7, by Antigen | LTB | 448 titer |
| 24-59 Months: ETVAX (Full) | Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 7, by Antigen | CS5 | 35.6 titer |
Secondary
Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX
Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second). Antigen in ETVAX were: E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin
Time frame: 19 days
Population: Subjects who received both vaccinations and had valid baseline and endline immunologic samples.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Adult: ETVAX (Full) | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | 243 titer |
| Adult: ETVAX (Full) | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | 84.8 titer |
| Adult: ETVAX (Full) | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | 35.3 titer |
| Adult: ETVAX (Full) | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | 277 titer |
| Adult: ETVAX (Full) | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | 74.4 titer |
| Adult: ETVAX (Full) + 10 ug dmLT | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | 72.1 titer |
| Adult: ETVAX (Full) + 10 ug dmLT | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | 57.8 titer |
| Adult: ETVAX (Full) + 10 ug dmLT | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | 229 titer |
| Adult: ETVAX (Full) + 10 ug dmLT | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | 390 titer |
| Adult: ETVAX (Full) + 10 ug dmLT | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | 42.1 titer |
| Adult: Placebo | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | 20.7 titer |
| Adult: Placebo | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | 53.1 titer |
| Adult: Placebo | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | 10.1 titer |
| Adult: Placebo | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | 20 titer |
| Adult: Placebo | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | 13.6 titer |
| 24-59 Months: ETVAX (1/4) | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | 147 titer |
| 24-59 Months: ETVAX (1/4) | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | 531 titer |
| 24-59 Months: ETVAX (1/4) | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | 991 titer |
| 24-59 Months: ETVAX (1/4) | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | 791 titer |
| 24-59 Months: ETVAX (1/4) | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | 665 titer |
| 24-59 Months: ETVAX (1/2) | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | 131 titer |
| 24-59 Months: ETVAX (1/2) | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | 694 titer |
| 24-59 Months: ETVAX (1/2) | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | 529 titer |
| 24-59 Months: ETVAX (1/2) | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | 940 titer |
| 24-59 Months: ETVAX (1/2) | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | 692 titer |
| 24-59 Months: ETVAX (Full) | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | 1036 titer |
| 24-59 Months: ETVAX (Full) | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | 475 titer |
| 24-59 Months: ETVAX (Full) | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | 508 titer |
| 24-59 Months: ETVAX (Full) | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | 568 titer |
| 24-59 Months: ETVAX (Full) | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | 402 titer |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | 386 titer |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | 317 titer |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | 483 titer |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | 424 titer |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | 669 titer |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | 1299 titer |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | 469 titer |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | 677 titer |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | 194 titer |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | 450 titer |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | 237 titer |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | 265 titer |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | 371 titer |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | 67.3 titer |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | 123 titer |
| 24-59 Months: Placebo | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | 368 titer |
| 24-59 Months: Placebo | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | 430 titer |
| 24-59 Months: Placebo | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | 76.1 titer |
| 24-59 Months: Placebo | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | 318 titer |
| 24-59 Months: Placebo | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | 518 titer |
| 12-23 Months: ETVAX (1/4) | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | 269 titer |
| 12-23 Months: ETVAX (1/4) | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | 532 titer |
| 12-23 Months: ETVAX (1/4) | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | 590 titer |
| 12-23 Months: ETVAX (1/4) | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | 352 titer |
| 12-23 Months: ETVAX (1/4) | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | 191 titer |
| 12-23 Months: ETVAX (1/2) | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | 915 titer |
| 12-23 Months: ETVAX (1/2) | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | 298 titer |
| 12-23 Months: ETVAX (1/2) | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | 163 titer |
| 12-23 Months: ETVAX (1/2) | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | 230 titer |
| 12-23 Months: ETVAX (1/2) | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | 245 titer |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | 297 titer |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | 260 titer |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | 189 titer |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | 203 titer |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | 1439 titer |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | 115 titer |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | 141 titer |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | 96.6 titer |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | 89.3 titer |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | 231 titer |
| 12-23 Months: Placebo | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | 67.3 titer |
| 12-23 Months: Placebo | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | 105 titer |
| 12-23 Months: Placebo | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | 253 titer |
| 12-23 Months: Placebo | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | 111 titer |
| 12-23 Months: Placebo | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | 110 titer |
| 6-11 Months: ETVAX (1/8) | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | 78.9 titer |
| 6-11 Months: ETVAX (1/8) | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | 137 titer |
| 6-11 Months: ETVAX (1/8) | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | 1165 titer |
| 6-11 Months: ETVAX (1/8) | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | 133 titer |
| 6-11 Months: ETVAX (1/8) | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | 140 titer |
| 6-11 Months: ETVAX (1/4) | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | 162 titer |
| 6-11 Months: ETVAX (1/4) | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | 164 titer |
| 6-11 Months: ETVAX (1/4) | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | 77.6 titer |
| 6-11 Months: ETVAX (1/4) | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | 67 titer |
| 6-11 Months: ETVAX (1/4) | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | 723 titer |
| 6-11 Months: ETVAX (1/2) | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | 57.2 titer |
| 6-11 Months: ETVAX (1/2) | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | 63.4 titer |
| 6-11 Months: ETVAX (1/2) | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | 74 titer |
| 6-11 Months: ETVAX (1/2) | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | 45.1 titer |
| 6-11 Months: ETVAX (1/2) | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | 442 titer |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | 129 titer |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | 111 titer |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | 124 titer |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | 98.4 titer |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | 403 titer |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | 59.2 titer |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | 53.8 titer |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | 58.9 titer |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | 90.8 titer |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | 93.8 titer |
Secondary
Geometric Mean Titer (GMT) of Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose
Measured 7 days after the first dose and 5 days after the second). B-subunit of the E. coli heat-labile enterotoxin (LTB) was one of the antigens in the ETVAX vaccine.
Time frame: 19 days
Population: Subjects who received both vaccinations and had valid baseline and endline immunologic samples.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Adult: ETVAX (Full) | Geometric Mean Titer (GMT) of Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | 1582 titer |
| Adult: ETVAX (Full) + 10 ug dmLT | Geometric Mean Titer (GMT) of Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | 1125 titer |
| Adult: Placebo | Geometric Mean Titer (GMT) of Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | 85.1 titer |
| 24-59 Months: ETVAX (1/4) | Geometric Mean Titer (GMT) of Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | 5700 titer |
| 24-59 Months: ETVAX (1/2) | Geometric Mean Titer (GMT) of Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | 5047 titer |
| 24-59 Months: ETVAX (Full) | Geometric Mean Titer (GMT) of Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | 3784 titer |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Geometric Mean Titer (GMT) of Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | 3006 titer |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Geometric Mean Titer (GMT) of Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | 2470 titer |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Geometric Mean Titer (GMT) of Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | 721 titer |
| 24-59 Months: Placebo | Geometric Mean Titer (GMT) of Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | 3644 titer |
| 12-23 Months: ETVAX (1/4) | Geometric Mean Titer (GMT) of Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | 2401 titer |
| 12-23 Months: ETVAX (1/2) | Geometric Mean Titer (GMT) of Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | 1565 titer |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Geometric Mean Titer (GMT) of Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | 5163 titer |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Geometric Mean Titer (GMT) of Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | 788 titer |
| 12-23 Months: Placebo | Geometric Mean Titer (GMT) of Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | 1314 titer |
| 6-11 Months: ETVAX (1/8) | Geometric Mean Titer (GMT) of Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | 3561 titer |
| 6-11 Months: ETVAX (1/4) | Geometric Mean Titer (GMT) of Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | 3935 titer |
| 6-11 Months: ETVAX (1/2) | Geometric Mean Titer (GMT) of Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | 1488 titer |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Geometric Mean Titer (GMT) of Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | 1521 titer |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Geometric Mean Titer (GMT) of Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | 513 titer |
Secondary
Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen
Fecal secretion was measured on Day 7, Day 19, and Day 28; number in table is subjects experiencing a four-fold rise at any of these time points. Antigens in ETVAX were: E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin
Time frame: 28 days
Population: Subjects who received both vaccinations and had valid baseline and endline immunologic samples.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Adult: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CS3 | No | 15 Participants |
| Adult: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CS5 | No | 14 Participants |
| Adult: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | LTB | Yes | 11 Participants |
| Adult: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CFA/I | No | 12 Participants |
| Adult: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | LTB | No | 11 Participants |
| Adult: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CS5 | Yes | 6 Participants |
| Adult: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CFA/I | Yes | 8 Participants |
| Adult: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CS6 | No | 15 Participants |
| Adult: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CS3 | Yes | 6 Participants |
| Adult: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CS6 | Yes | 5 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CS3 | No | 16 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CFA/I | No | 14 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CS6 | No | 15 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CS6 | Yes | 7 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CS5 | No | 16 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | LTB | No | 11 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CS5 | Yes | 5 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CFA/I | Yes | 6 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | LTB | Yes | 11 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CS3 | Yes | 6 Participants |
| Adult: Placebo | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CS3 | Yes | 4 Participants |
| Adult: Placebo | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | LTB | Yes | 10 Participants |
| Adult: Placebo | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | LTB | No | 6 Participants |
| Adult: Placebo | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CFA/I | Yes | 7 Participants |
| Adult: Placebo | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CFA/I | No | 8 Participants |
| Adult: Placebo | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CS3 | No | 12 Participants |
| Adult: Placebo | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CS5 | Yes | 9 Participants |
| Adult: Placebo | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CS5 | No | 7 Participants |
| Adult: Placebo | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CS6 | Yes | 5 Participants |
| Adult: Placebo | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CS6 | No | 9 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | LTB | Yes | 13 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CS3 | No | 12 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CS5 | No | 9 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CFA/I | Yes | 10 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CS5 | Yes | 10 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CS6 | No | 7 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CFA/I | No | 9 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | LTB | No | 7 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CS6 | Yes | 12 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CS3 | Yes | 8 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CFA/I | Yes | 6 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CS3 | Yes | 8 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CS6 | Yes | 3 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CS5 | No | 13 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CS5 | Yes | 2 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | LTB | No | 11 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CS3 | No | 10 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CS6 | No | 15 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | LTB | Yes | 10 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CFA/I | No | 8 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CFA/I | No | 24 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CS6 | No | 24 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CS5 | No | 25 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CS3 | Yes | 9 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CFA/I | Yes | 8 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CS5 | Yes | 5 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CS3 | No | 26 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | LTB | Yes | 10 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | LTB | No | 26 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CS6 | Yes | 9 Participants |
Secondary
Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen
Fecal secretion was measured on Day 0 and Day 19 (5 days after administration of second dose of vaccine). Antigens in ETVAX were: E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin
Time frame: 19 days
Population: Subjects who received both vaccinations and had valid baseline and endline immunologic samples.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Adult: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CS3 | No | 19 Participants |
| Adult: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CS3 | Yes | 2 Participants |
| Adult: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | LTB | No | 17 Participants |
| Adult: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | LTB | Yes | 5 Participants |
| Adult: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CS6 | No | 20 Participants |
| Adult: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CS6 | Yes | 0 Participants |
| Adult: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CFA/I | No | 15 Participants |
| Adult: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CFA/I | Yes | 5 Participants |
| Adult: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CS5 | No | 17 Participants |
| Adult: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CS5 | Yes | 3 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CFA/I | No | 18 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CFA/I | Yes | 2 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CS3 | Yes | 4 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CS3 | No | 18 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CS5 | Yes | 3 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CS5 | No | 18 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CS6 | Yes | 5 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CS6 | No | 17 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | LTB | Yes | 5 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | LTB | No | 17 Participants |
| Adult: Placebo | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CS3 | No | 13 Participants |
| Adult: Placebo | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CS6 | No | 12 Participants |
| Adult: Placebo | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CFA/I | Yes | 4 Participants |
| Adult: Placebo | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CS5 | Yes | 4 Participants |
| Adult: Placebo | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CS3 | Yes | 3 Participants |
| Adult: Placebo | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CFA/I | No | 11 Participants |
| Adult: Placebo | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CS5 | No | 12 Participants |
| Adult: Placebo | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | LTB | Yes | 8 Participants |
| Adult: Placebo | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | LTB | No | 8 Participants |
| Adult: Placebo | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CS6 | Yes | 2 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CS6 | Yes | 6 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CS6 | No | 13 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CFA/I | No | 13 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | LTB | No | 13 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | LTB | Yes | 7 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CFA/I | Yes | 6 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CS5 | No | 13 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CS5 | Yes | 6 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CS3 | No | 15 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CS3 | Yes | 5 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CS6 | Yes | 1 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CS3 | No | 15 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CS5 | Yes | 1 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CS5 | No | 14 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CFA/I | Yes | 4 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CS6 | No | 17 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | LTB | No | 12 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | LTB | Yes | 9 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CS3 | Yes | 3 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CFA/I | No | 10 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CS5 | No | 27 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | LTB | No | 28 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CFA/I | No | 28 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CS3 | Yes | 3 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CS5 | Yes | 3 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CS6 | Yes | 7 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CS3 | No | 32 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CS6 | No | 26 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CFA/I | Yes | 4 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | LTB | Yes | 8 Participants |
Secondary
Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen
Fecal secretion was measured on Day 0 and Day 28 (2 weeks after administration of second dose of vaccine). Antigens in ETVAX were: E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin
Time frame: 28 days
Population: Subjects who received both vaccinations and had valid baseline and endline immunologic samples.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Adult: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CFA/I | Yes | 4 Participants |
| Adult: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CS5 | No | 10 Participants |
| Adult: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CS5 | Yes | 3 Participants |
| Adult: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | LTB | No | 9 Participants |
| Adult: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CFA/I | No | 8 Participants |
| Adult: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | LTB | Yes | 7 Participants |
| Adult: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CS3 | Yes | 2 Participants |
| Adult: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CS6 | No | 11 Participants |
| Adult: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CS6 | Yes | 3 Participants |
| Adult: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CS3 | No | 13 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CS6 | Yes | 4 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CS6 | No | 12 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CS5 | Yes | 3 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CS3 | No | 12 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | LTB | No | 10 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CS3 | Yes | 4 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | LTB | Yes | 5 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CS5 | No | 13 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CFA/I | No | 12 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CFA/I | Yes | 4 Participants |
| Adult: Placebo | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CS3 | Yes | 1 Participants |
| Adult: Placebo | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CFA/I | Yes | 4 Participants |
| Adult: Placebo | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CFA/I | No | 7 Participants |
| Adult: Placebo | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CS3 | No | 11 Participants |
| Adult: Placebo | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CS5 | Yes | 4 Participants |
| Adult: Placebo | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CS5 | No | 8 Participants |
| Adult: Placebo | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CS6 | Yes | 2 Participants |
| Adult: Placebo | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CS6 | No | 8 Participants |
| Adult: Placebo | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | LTB | Yes | 6 Participants |
| Adult: Placebo | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | LTB | No | 6 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CS3 | No | 13 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CFA/I | Yes | 6 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CS5 | No | 11 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CS3 | Yes | 6 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CS6 | Yes | 7 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | LTB | No | 8 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CS6 | No | 11 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CFA/I | No | 12 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | LTB | Yes | 11 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CS5 | Yes | 7 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CS6 | Yes | 2 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CFA/I | No | 4 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CS3 | No | 7 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CFA/I | Yes | 5 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CS6 | No | 7 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | LTB | No | 7 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CS5 | Yes | 1 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | LTB | Yes | 7 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CS5 | No | 7 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CS3 | Yes | 5 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CS5 | No | 20 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CS6 | Yes | 4 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CS3 | Yes | 8 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CFA/I | No | 22 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CS3 | No | 19 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | LTB | Yes | 7 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | LTB | No | 21 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CS6 | No | 21 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CS5 | Yes | 3 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CFA/I | Yes | 4 Participants |
Secondary
Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen
Fecal secretion was measured on Day 0 and Day 7 (7 days after administration of first dose of vaccine). Antigens in ETVAX were: E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin
Time frame: 7 days
Population: Subjects who received both vaccinations and had valid baseline and endline immunologic samples.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Adult: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CS3 | No | 15 Participants |
| Adult: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CS3 | Yes | 2 Participants |
| Adult: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | LTB | No | 14 Participants |
| Adult: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | LTB | Yes | 4 Participants |
| Adult: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CS6 | No | 14 Participants |
| Adult: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CS6 | Yes | 3 Participants |
| Adult: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CFA/I | No | 12 Participants |
| Adult: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CFA/I | Yes | 4 Participants |
| Adult: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CS5 | No | 14 Participants |
| Adult: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CS5 | Yes | 1 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CFA/I | No | 12 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CFA/I | Yes | 1 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CS3 | Yes | 0 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CS3 | No | 15 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CS5 | Yes | 1 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CS5 | No | 13 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CS6 | Yes | 0 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CS6 | No | 14 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | LTB | Yes | 2 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | LTB | No | 11 Participants |
| Adult: Placebo | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CS3 | No | 11 Participants |
| Adult: Placebo | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CS6 | No | 9 Participants |
| Adult: Placebo | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CFA/I | Yes | 1 Participants |
| Adult: Placebo | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CS5 | Yes | 4 Participants |
| Adult: Placebo | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CS3 | Yes | 1 Participants |
| Adult: Placebo | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CFA/I | No | 10 Participants |
| Adult: Placebo | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CS5 | No | 8 Participants |
| Adult: Placebo | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | LTB | Yes | 3 Participants |
| Adult: Placebo | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | LTB | No | 9 Participants |
| Adult: Placebo | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CS6 | Yes | 1 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CS6 | Yes | 7 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CS6 | No | 9 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CFA/I | No | 9 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | LTB | No | 10 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | LTB | Yes | 7 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CFA/I | Yes | 7 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CS5 | No | 12 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CS5 | Yes | 4 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CS3 | No | 11 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CS3 | Yes | 6 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CS6 | Yes | 1 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CS3 | No | 14 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CS5 | Yes | 0 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CS5 | No | 14 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CFA/I | Yes | 3 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CS6 | No | 16 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | LTB | No | 13 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | LTB | Yes | 5 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CS3 | Yes | 2 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CFA/I | No | 10 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CS5 | No | 17 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | LTB | No | 22 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CFA/I | No | 17 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CS3 | Yes | 2 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CS5 | Yes | 2 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CS6 | Yes | 5 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CS3 | No | 24 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CS6 | No | 18 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CFA/I | Yes | 4 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | LTB | Yes | 5 Participants |
Secondary
Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen
Fecal secretion was measured on Day 7, Day 19, and Day 28; number in table is subjects experiencing a two-fold rise at any of these time points. Antigen in ETVAX were: E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin
Time frame: 28 days
Population: Subjects who received both vaccinations and had valid baseline and endline immunologic samples.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Adult: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CS6 | Yes | 11 Participants |
| Adult: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CS6 | No | 9 Participants |
| Adult: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CS3 | No | 9 Participants |
| Adult: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CFA/I | Yes | 15 Participants |
| Adult: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | LTB | No | 8 Participants |
| Adult: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CS3 | Yes | 12 Participants |
| Adult: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CS5 | Yes | 12 Participants |
| Adult: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | LTB | Yes | 14 Participants |
| Adult: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CS5 | No | 8 Participants |
| Adult: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CFA/I | No | 5 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | LTB | Yes | 15 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CS3 | No | 12 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CFA/I | Yes | 10 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CFA/I | No | 10 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CS5 | No | 11 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CS6 | No | 9 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CS5 | Yes | 10 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CS3 | Yes | 10 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CS6 | Yes | 13 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | LTB | No | 7 Participants |
| Adult: Placebo | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CS6 | Yes | 8 Participants |
| Adult: Placebo | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | LTB | Yes | 14 Participants |
| Adult: Placebo | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CS6 | No | 6 Participants |
| Adult: Placebo | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CFA/I | No | 6 Participants |
| Adult: Placebo | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CS5 | Yes | 9 Participants |
| Adult: Placebo | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | LTB | No | 2 Participants |
| Adult: Placebo | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CS3 | Yes | 9 Participants |
| Adult: Placebo | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CS3 | No | 7 Participants |
| Adult: Placebo | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CS5 | No | 7 Participants |
| Adult: Placebo | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CFA/I | Yes | 9 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CFA/I | Yes | 13 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CS3 | Yes | 14 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CFA/I | No | 6 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CS6 | No | 4 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CS5 | No | 7 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CS6 | Yes | 15 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | LTB | Yes | 15 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | LTB | No | 5 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CS5 | Yes | 12 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CS3 | No | 6 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | LTB | Yes | 14 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CFA/I | Yes | 8 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CFA/I | No | 6 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CS3 | Yes | 14 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CS3 | No | 4 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CS5 | Yes | 7 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CS5 | No | 8 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CS6 | Yes | 6 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CS6 | No | 12 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | LTB | No | 7 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CS6 | Yes | 10 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CS5 | No | 19 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CS5 | Yes | 11 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | LTB | Yes | 20 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CS3 | No | 16 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CS3 | Yes | 19 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CFA/I | No | 16 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CFA/I | Yes | 16 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | LTB | No | 16 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen | CS6 | No | 23 Participants |
Secondary
Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen
Fecal secretion was measured on Day 0 and Day 19 (5 days after administration of second dose of vaccine). Antigen in ETVAX were: E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin
Time frame: Day 19
Population: Subjects who received both vaccinations and had valid baseline and endline immunologic samples.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Adult: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CS3 | No | 16 Participants |
| Adult: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CS3 | Yes | 5 Participants |
| Adult: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | LTB | No | 10 Participants |
| Adult: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | LTB | Yes | 12 Participants |
| Adult: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CS6 | No | 14 Participants |
| Adult: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CS6 | Yes | 6 Participants |
| Adult: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CFA/I | No | 12 Participants |
| Adult: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CFA/I | Yes | 8 Participants |
| Adult: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CS5 | No | 14 Participants |
| Adult: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CS5 | Yes | 6 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CFA/I | No | 13 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CFA/I | Yes | 7 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CS3 | Yes | 7 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CS3 | No | 15 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CS5 | Yes | 8 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CS5 | No | 13 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CS6 | Yes | 7 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CS6 | No | 15 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | LTB | Yes | 11 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | LTB | No | 11 Participants |
| Adult: Placebo | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CS3 | No | 11 Participants |
| Adult: Placebo | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CS6 | No | 10 Participants |
| Adult: Placebo | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CFA/I | Yes | 4 Participants |
| Adult: Placebo | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CS5 | Yes | 6 Participants |
| Adult: Placebo | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CS3 | Yes | 5 Participants |
| Adult: Placebo | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CFA/I | No | 11 Participants |
| Adult: Placebo | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CS5 | No | 10 Participants |
| Adult: Placebo | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | LTB | Yes | 11 Participants |
| Adult: Placebo | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | LTB | No | 5 Participants |
| Adult: Placebo | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CS6 | Yes | 4 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CS6 | Yes | 8 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CS6 | No | 11 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CFA/I | No | 11 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | LTB | No | 7 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | LTB | Yes | 13 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CFA/I | Yes | 8 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CS5 | No | 11 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CS5 | Yes | 8 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CS3 | No | 13 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CS3 | Yes | 7 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CS6 | Yes | 5 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CS3 | No | 10 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CS5 | Yes | 4 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CS5 | No | 11 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CFA/I | Yes | 5 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CS6 | No | 13 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | LTB | No | 10 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | LTB | Yes | 11 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CS3 | Yes | 8 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CFA/I | No | 9 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CS5 | No | 22 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | LTB | No | 21 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CFA/I | No | 22 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CS3 | Yes | 9 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CS5 | Yes | 8 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CS6 | Yes | 8 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CS3 | No | 26 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CS6 | No | 25 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | CFA/I | Yes | 10 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen | LTB | Yes | 15 Participants |
Secondary
Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen
Fecal secretion was measured on Day 0 and Day 28 (2 weeks after administration of second dose of vaccine). Antigen in ETVAX were: E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin
Time frame: 28 days
Population: Subjects who received both vaccinations and had valid baseline and endline immunologic samples.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Adult: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CS3 | No | 10 Participants |
| Adult: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CS3 | Yes | 5 Participants |
| Adult: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | LTB | No | 8 Participants |
| Adult: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | LTB | Yes | 8 Participants |
| Adult: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CS6 | No | 9 Participants |
| Adult: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CS6 | Yes | 5 Participants |
| Adult: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CFA/I | No | 5 Participants |
| Adult: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CFA/I | Yes | 7 Participants |
| Adult: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CS5 | No | 8 Participants |
| Adult: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CS5 | Yes | 5 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CFA/I | No | 10 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CFA/I | Yes | 6 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CS3 | Yes | 4 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CS3 | No | 12 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CS5 | Yes | 4 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CS5 | No | 12 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CS6 | Yes | 7 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CS6 | No | 9 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | LTB | Yes | 8 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | LTB | No | 7 Participants |
| Adult: Placebo | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CS3 | No | 7 Participants |
| Adult: Placebo | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CS6 | No | 7 Participants |
| Adult: Placebo | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CFA/I | Yes | 5 Participants |
| Adult: Placebo | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CS5 | Yes | 4 Participants |
| Adult: Placebo | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CS3 | Yes | 5 Participants |
| Adult: Placebo | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CFA/I | No | 6 Participants |
| Adult: Placebo | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CS5 | No | 8 Participants |
| Adult: Placebo | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | LTB | Yes | 10 Participants |
| Adult: Placebo | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | LTB | No | 2 Participants |
| Adult: Placebo | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CS6 | Yes | 3 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CS6 | Yes | 10 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CS6 | No | 8 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CFA/I | No | 8 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | LTB | No | 7 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | LTB | Yes | 12 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CFA/I | Yes | 10 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CS5 | No | 9 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CS5 | Yes | 9 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CS3 | No | 8 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CS3 | Yes | 11 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CS6 | Yes | 4 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CS3 | No | 4 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CS5 | Yes | 3 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CS5 | No | 5 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CFA/I | Yes | 5 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CS6 | No | 5 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | LTB | No | 5 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | LTB | Yes | 9 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CS3 | Yes | 8 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CFA/I | No | 4 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CS5 | No | 18 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | LTB | No | 18 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CFA/I | No | 16 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CS3 | Yes | 14 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CS5 | Yes | 5 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CS6 | Yes | 6 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CS3 | No | 13 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CS6 | No | 19 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | CFA/I | Yes | 10 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen | LTB | Yes | 10 Participants |
Secondary
Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen
Fecal secretion was measured on Day 0 and Day 7 (7 days after administration of first dose of vaccine). Antigens in ETVAX were: E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin
Time frame: 7 days
Population: Subjects who received both vaccinations and had valid baseline and endline immunologic samples.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Adult: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | LTB | No | 10 Participants |
| Adult: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CS6 | No | 11 Participants |
| Adult: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CS3 | Yes | 4 Participants |
| Adult: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CS5 | Yes | 5 Participants |
| Adult: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CFA/I | No | 8 Participants |
| Adult: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CS5 | No | 10 Participants |
| Adult: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CS6 | Yes | 6 Participants |
| Adult: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | LTB | Yes | 8 Participants |
| Adult: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CS3 | No | 13 Participants |
| Adult: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CFA/I | Yes | 8 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CS3 | No | 13 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CS5 | Yes | 2 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | LTB | No | 10 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | LTB | Yes | 3 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CFA/I | No | 11 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CS6 | No | 11 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CS3 | Yes | 2 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CFA/I | Yes | 2 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CS6 | Yes | 3 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CS5 | No | 12 Participants |
| Adult: Placebo | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CS3 | Yes | 4 Participants |
| Adult: Placebo | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CFA/I | Yes | 3 Participants |
| Adult: Placebo | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CFA/I | No | 8 Participants |
| Adult: Placebo | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CS3 | No | 8 Participants |
| Adult: Placebo | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CS5 | Yes | 4 Participants |
| Adult: Placebo | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CS5 | No | 8 Participants |
| Adult: Placebo | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CS6 | Yes | 1 Participants |
| Adult: Placebo | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CS6 | No | 9 Participants |
| Adult: Placebo | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | LTB | Yes | 5 Participants |
| Adult: Placebo | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | LTB | No | 7 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CS3 | No | 7 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CFA/I | Yes | 10 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CS5 | No | 8 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CS3 | Yes | 10 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CS6 | Yes | 10 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | LTB | No | 7 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CS6 | No | 6 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CFA/I | No | 6 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | LTB | Yes | 10 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CS5 | Yes | 8 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CS6 | Yes | 4 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CFA/I | No | 6 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CS3 | No | 7 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CFA/I | Yes | 7 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CS6 | No | 13 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | LTB | No | 9 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CS5 | Yes | 5 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | LTB | Yes | 9 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CS5 | No | 9 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CS3 | Yes | 9 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CS5 | No | 15 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CS6 | Yes | 6 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CFA/I | No | 15 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CS3 | Yes | 8 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CS3 | No | 18 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | LTB | Yes | 7 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | LTB | No | 20 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CS6 | No | 17 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CS5 | Yes | 4 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen | CFA/I | Yes | 6 Participants |
Secondary
Number and Percentage of Adult Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for O78 Antigen
Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second).
Time frame: 19 days
Population: Subjects who received both vaccinations and had valid baseline and endline immunologic samples.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Adult: ETVAX (Full) | Number and Percentage of Adult Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for O78 Antigen | ≥Two-fold | Yes | 11 Participants |
| Adult: ETVAX (Full) | Number and Percentage of Adult Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for O78 Antigen | ≥Two-fold | No | 4 Participants |
| Adult: ETVAX (Full) | Number and Percentage of Adult Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for O78 Antigen | ≥Four-fold | Yes | 5 Participants |
| Adult: ETVAX (Full) | Number and Percentage of Adult Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for O78 Antigen | ≥Four-fold | No | 10 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of Adult Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for O78 Antigen | ≥Four-fold | No | 7 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of Adult Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for O78 Antigen | ≥Two-fold | Yes | 10 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of Adult Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for O78 Antigen | ≥Four-fold | Yes | 8 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of Adult Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for O78 Antigen | ≥Two-fold | No | 5 Participants |
| Adult: Placebo | Number and Percentage of Adult Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for O78 Antigen | ≥Four-fold | No | 13 Participants |
| Adult: Placebo | Number and Percentage of Adult Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for O78 Antigen | ≥Two-fold | No | 13 Participants |
| Adult: Placebo | Number and Percentage of Adult Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for O78 Antigen | ≥Four-fold | Yes | 1 Participants |
| Adult: Placebo | Number and Percentage of Adult Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for O78 Antigen | ≥Two-fold | Yes | 1 Participants |
Secondary
Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen
Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second). Antigen in ETVAX were: E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin
Time frame: 19 days
Population: Subjects who received both vaccinations and had valid baseline and endline immunologic samples.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Adult: ETVAX (Full) | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | Yes | 15 Participants |
| Adult: ETVAX (Full) | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | No | 0 Participants |
| Adult: ETVAX (Full) | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | Yes | 15 Participants |
| Adult: ETVAX (Full) | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | No | 0 Participants |
| Adult: ETVAX (Full) | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | Yes | 15 Participants |
| Adult: ETVAX (Full) | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | No | 0 Participants |
| Adult: ETVAX (Full) | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | Yes | 15 Participants |
| Adult: ETVAX (Full) | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | No | 0 Participants |
| Adult: ETVAX (Full) | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | Yes | 15 Participants |
| Adult: ETVAX (Full) | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | No | 0 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | No | 0 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | Yes | 15 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | No | 0 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | Yes | 15 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | Yes | 15 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | No | 0 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | Yes | 15 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | No | 0 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | No | 0 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | Yes | 15 Participants |
| Adult: Placebo | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | Yes | 0 Participants |
| Adult: Placebo | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | No | 13 Participants |
| Adult: Placebo | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | No | 14 Participants |
| Adult: Placebo | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | No | 11 Participants |
| Adult: Placebo | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | Yes | 0 Participants |
| Adult: Placebo | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | No | 14 Participants |
| Adult: Placebo | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | No | 14 Participants |
| Adult: Placebo | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | Yes | 1 Participants |
| Adult: Placebo | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | Yes | 0 Participants |
| Adult: Placebo | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | Yes | 3 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | No | 0 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | Yes | 11 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | No | 0 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | Yes | 15 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | No | 0 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | Yes | 15 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | Yes | 15 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | Yes | 14 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | No | 1 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | No | 4 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | No | 2 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | No | 8 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | Yes | 13 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | No | 0 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | Yes | 12 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | Yes | 7 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | No | 3 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | Yes | 13 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | Yes | 15 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | No | 2 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | Yes | 14 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | Yes | 12 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | Yes | 15 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | No | 0 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | No | 1 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | No | 0 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | No | 3 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | Yes | 12 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | Yes | 15 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | No | 3 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | No | 4 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | Yes | 14 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | No | 4 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | Yes | 8 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | No | 1 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | Yes | 15 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | No | 0 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | No | 7 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | Yes | 11 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | Yes | 11 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | No | 1 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | No | 3 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | Yes | 12 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | Yes | 15 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | Yes | 14 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | No | 6 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | Yes | 9 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | No | 0 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | No | 6 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | Yes | 9 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | No | 48 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | Yes | 2 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | No | 47 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | No | 43 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | No | 48 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | Yes | 6 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | Yes | 1 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | No | 49 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | Yes | 1 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | Yes | 0 Participants |
| 24-59 Months: Placebo | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | No | 9 Participants |
| 24-59 Months: Placebo | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | Yes | 10 Participants |
| 24-59 Months: Placebo | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | Yes | 11 Participants |
| 24-59 Months: Placebo | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | Yes | 3 Participants |
| 24-59 Months: Placebo | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | No | 3 Participants |
| 24-59 Months: Placebo | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | Yes | 7 Participants |
| 24-59 Months: Placebo | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | No | 6 Participants |
| 24-59 Months: Placebo | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | Yes | 6 Participants |
| 24-59 Months: Placebo | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | No | 7 Participants |
| 24-59 Months: Placebo | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | No | 2 Participants |
| 12-23 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | Yes | 7 Participants |
| 12-23 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | Yes | 15 Participants |
| 12-23 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | No | 8 Participants |
| 12-23 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | No | 4 Participants |
| 12-23 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | No | 0 Participants |
| 12-23 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | Yes | 4 Participants |
| 12-23 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | Yes | 10 Participants |
| 12-23 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | Yes | 11 Participants |
| 12-23 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | No | 5 Participants |
| 12-23 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | No | 11 Participants |
| 12-23 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | No | 6 Participants |
| 12-23 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | Yes | 5 Participants |
| 12-23 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | Yes | 8 Participants |
| 12-23 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | Yes | 7 Participants |
| 12-23 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | No | 0 Participants |
| 12-23 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | No | 5 Participants |
| 12-23 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | Yes | 11 Participants |
| 12-23 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | No | 2 Participants |
| 12-23 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | Yes | 13 Participants |
| 12-23 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | No | 8 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | No | 10 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | No | 7 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | Yes | 6 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | Yes | 7 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | Yes | 8 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | Yes | 3 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | No | 6 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | No | 5 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | No | 2 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | Yes | 11 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | No | 38 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | Yes | 3 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | Yes | 3 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | No | 36 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | Yes | 3 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | No | 38 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | Yes | 1 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | No | 36 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | Yes | 1 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | No | 36 Participants |
| 12-23 Months: Placebo | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | Yes | 2 Participants |
| 12-23 Months: Placebo | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | No | 15 Participants |
| 12-23 Months: Placebo | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | Yes | 10 Participants |
| 12-23 Months: Placebo | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | No | 20 Participants |
| 12-23 Months: Placebo | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | Yes | 10 Participants |
| 12-23 Months: Placebo | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | No | 20 Participants |
| 12-23 Months: Placebo | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | Yes | 8 Participants |
| 12-23 Months: Placebo | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | No | 22 Participants |
| 12-23 Months: Placebo | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | No | 28 Participants |
| 12-23 Months: Placebo | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | Yes | 15 Participants |
| 6-11 Months: ETVAX (1/8) | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | No | 10 Participants |
| 6-11 Months: ETVAX (1/8) | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | Yes | 20 Participants |
| 6-11 Months: ETVAX (1/8) | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | No | 28 Participants |
| 6-11 Months: ETVAX (1/8) | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | Yes | 7 Participants |
| 6-11 Months: ETVAX (1/8) | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | Yes | 2 Participants |
| 6-11 Months: ETVAX (1/8) | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | No | 23 Participants |
| 6-11 Months: ETVAX (1/8) | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | No | 23 Participants |
| 6-11 Months: ETVAX (1/8) | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | Yes | 1 Participants |
| 6-11 Months: ETVAX (1/8) | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | No | 29 Participants |
| 6-11 Months: ETVAX (1/8) | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | Yes | 7 Participants |
| 6-11 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | Yes | 0 Participants |
| 6-11 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | Yes | 18 Participants |
| 6-11 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | Yes | 9 Participants |
| 6-11 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | Yes | 3 Participants |
| 6-11 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | No | 15 Participants |
| 6-11 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | No | 21 Participants |
| 6-11 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | No | 24 Participants |
| 6-11 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | No | 17 Participants |
| 6-11 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | Yes | 7 Participants |
| 6-11 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | No | 6 Participants |
| 6-11 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | No | 17 Participants |
| 6-11 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | No | 23 Participants |
| 6-11 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | Yes | 3 Participants |
| 6-11 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | No | 19 Participants |
| 6-11 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | Yes | 7 Participants |
| 6-11 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | Yes | 0 Participants |
| 6-11 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | Yes | 9 Participants |
| 6-11 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | Yes | 15 Participants |
| 6-11 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | No | 26 Participants |
| 6-11 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | No | 11 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | No | 10 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | No | 21 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | Yes | 19 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | Yes | 2 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | Yes | 1 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | No | 27 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | No | 25 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | Yes | 8 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | Yes | 4 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | No | 28 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | No | 41 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | Yes | 8 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | Yes | 0 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | Yes | 6 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | No | 49 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | No | 46 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | No | 43 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | Yes | 3 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | Yes | 4 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | No | 45 Participants |
Secondary
Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX
Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second). Antigen in ETVAX were: E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin
Time frame: 19 days
Population: Subjects who received both vaccinations and had valid baseline and endline immunologic samples.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Adult: ETVAX (Full) | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | Yes | 11 Participants |
| Adult: ETVAX (Full) | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | Yes | 4 Participants |
| Adult: ETVAX (Full) | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | Yes | 7 Participants |
| Adult: ETVAX (Full) | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | No | 2 Participants |
| Adult: ETVAX (Full) | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | Yes | 13 Participants |
| Adult: ETVAX (Full) | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | Yes | 6 Participants |
| Adult: ETVAX (Full) | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | No | 8 Participants |
| Adult: ETVAX (Full) | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | No | 8 Participants |
| Adult: ETVAX (Full) | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | No | 4 Participants |
| Adult: ETVAX (Full) | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | No | 9 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | Yes | 6 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | Yes | 10 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | Yes | 6 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | No | 4 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | Yes | 5 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | No | 8 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | No | 1 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | Yes | 14 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | No | 9 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | No | 10 Participants |
| Adult: Placebo | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | No | 12 Participants |
| Adult: Placebo | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | Yes | 0 Participants |
| Adult: Placebo | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | No | 14 Participants |
| Adult: Placebo | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | No | 14 Participants |
| Adult: Placebo | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | No | 13 Participants |
| Adult: Placebo | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | Yes | 0 Participants |
| Adult: Placebo | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | Yes | 0 Participants |
| Adult: Placebo | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | Yes | 2 Participants |
| Adult: Placebo | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | No | 13 Participants |
| Adult: Placebo | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | Yes | 0 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | No | 3 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | No | 12 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | Yes | 12 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | Yes | 6 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | Yes | 4 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | Yes | 11 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | No | 11 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | Yes | 3 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | No | 9 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | No | 4 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | No | 10 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | Yes | 5 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | Yes | 8 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | No | 9 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | No | 7 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | No | 9 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | Yes | 6 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | No | 1 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | Yes | 14 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | Yes | 6 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | No | 10 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | No | 1 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | Yes | 6 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | No | 9 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | Yes | 3 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | No | 12 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | Yes | 4 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | No | 11 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | Yes | 5 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | Yes | 14 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | Yes | 10 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | No | 3 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | No | 15 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | No | 5 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | No | 13 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | Yes | 12 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | Yes | 3 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | No | 12 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | Yes | 2 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | Yes | 0 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | Yes | 2 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | Yes | 4 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | No | 8 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | No | 11 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | Yes | 11 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | Yes | 7 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | No | 1 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | No | 4 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | No | 13 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | Yes | 14 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | No | 48 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | No | 48 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | No | 49 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | Yes | 0 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | No | 43 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | No | 47 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | Yes | 1 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | Yes | 2 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | Yes | 1 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | Yes | 6 Participants |
| 24-59 Months: Placebo | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | No | 11 Participants |
| 24-59 Months: Placebo | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | Yes | 5 Participants |
| 24-59 Months: Placebo | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | Yes | 9 Participants |
| 24-59 Months: Placebo | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | No | 10 Participants |
| 24-59 Months: Placebo | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | No | 4 Participants |
| 24-59 Months: Placebo | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | No | 10 Participants |
| 24-59 Months: Placebo | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | Yes | 2 Participants |
| 24-59 Months: Placebo | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | Yes | 3 Participants |
| 24-59 Months: Placebo | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | Yes | 3 Participants |
| 24-59 Months: Placebo | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | No | 8 Participants |
| 12-23 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | No | 4 Participants |
| 12-23 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | No | 12 Participants |
| 12-23 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | No | 12 Participants |
| 12-23 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | Yes | 3 Participants |
| 12-23 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | Yes | 3 Participants |
| 12-23 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | No | 11 Participants |
| 12-23 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | Yes | 11 Participants |
| 12-23 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | Yes | 1 Participants |
| 12-23 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | Yes | 4 Participants |
| 12-23 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | No | 14 Participants |
| 12-23 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | Yes | 2 Participants |
| 12-23 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | No | 10 Participants |
| 12-23 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | No | 9 Participants |
| 12-23 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | No | 12 Participants |
| 12-23 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | Yes | 1 Participants |
| 12-23 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | Yes | 3 Participants |
| 12-23 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | No | 11 Participants |
| 12-23 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | No | 3 Participants |
| 12-23 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | Yes | 10 Participants |
| 12-23 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | Yes | 4 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | Yes | 4 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | No | 9 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | Yes | 2 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | Yes | 3 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | Yes | 13 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | No | 0 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | Yes | 4 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | No | 10 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | No | 9 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | No | 11 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | No | 35 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | Yes | 4 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | No | 35 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | Yes | 4 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | Yes | 4 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | No | 35 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | No | 37 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | Yes | 2 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | Yes | 4 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | No | 35 Participants |
| 12-23 Months: Placebo | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | No | 21 Participants |
| 12-23 Months: Placebo | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | Yes | 8 Participants |
| 12-23 Months: Placebo | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | No | 22 Participants |
| 12-23 Months: Placebo | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | Yes | 3 Participants |
| 12-23 Months: Placebo | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | No | 27 Participants |
| 12-23 Months: Placebo | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | Yes | 4 Participants |
| 12-23 Months: Placebo | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | No | 26 Participants |
| 12-23 Months: Placebo | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | Yes | 17 Participants |
| 12-23 Months: Placebo | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | No | 13 Participants |
| 12-23 Months: Placebo | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | Yes | 9 Participants |
| 6-11 Months: ETVAX (1/8) | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | Yes | 8 Participants |
| 6-11 Months: ETVAX (1/8) | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | Yes | 9 Participants |
| 6-11 Months: ETVAX (1/8) | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | Yes | 2 Participants |
| 6-11 Months: ETVAX (1/8) | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | No | 21 Participants |
| 6-11 Months: ETVAX (1/8) | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | No | 9 Participants |
| 6-11 Months: ETVAX (1/8) | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | Yes | 21 Participants |
| 6-11 Months: ETVAX (1/8) | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | No | 28 Participants |
| 6-11 Months: ETVAX (1/8) | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | Yes | 10 Participants |
| 6-11 Months: ETVAX (1/8) | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | No | 22 Participants |
| 6-11 Months: ETVAX (1/8) | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | No | 20 Participants |
| 6-11 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | Yes | 17 Participants |
| 6-11 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | Yes | 6 Participants |
| 6-11 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | No | 21 Participants |
| 6-11 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | No | 18 Participants |
| 6-11 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | No | 20 Participants |
| 6-11 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | Yes | 4 Participants |
| 6-11 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | Yes | 5 Participants |
| 6-11 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | No | 19 Participants |
| 6-11 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | Yes | 7 Participants |
| 6-11 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | No | 8 Participants |
| 6-11 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | No | 8 Participants |
| 6-11 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | No | 21 Participants |
| 6-11 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | Yes | 7 Participants |
| 6-11 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | No | 17 Participants |
| 6-11 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | Yes | 7 Participants |
| 6-11 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | Yes | 18 Participants |
| 6-11 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | Yes | 9 Participants |
| 6-11 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | No | 19 Participants |
| 6-11 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | Yes | 5 Participants |
| 6-11 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | No | 19 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | Yes | 6 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | No | 24 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | Yes | 5 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | No | 7 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | No | 23 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | Yes | 7 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | No | 19 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | Yes | 10 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | No | 22 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | Yes | 22 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | No | 42 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | Yes | 10 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | No | 44 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | No | 36 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | No | 39 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | Yes | 13 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | Yes | 7 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | No | 44 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | Yes | 5 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | Yes | 5 Participants |
Secondary
Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose
Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second). B-subunit of the E. coli heat-labile enterotoxin (LTB) was one of the antigens in the ETVAX vaccine.
Time frame: 19 days
Population: Subjects who received both vaccinations and had valid baseline and endline immunologic samples.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Adult: ETVAX (Full) | Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | ≥Two-fold | No | 1 Participants |
| Adult: ETVAX (Full) | Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | ≥Four-fold | No | 4 Participants |
| Adult: ETVAX (Full) | Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | ≥Two-fold | Yes | 14 Participants |
| Adult: ETVAX (Full) | Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | ≥Four-fold | Yes | 11 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | ≥Four-fold | Yes | 13 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | ≥Two-fold | Yes | 13 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | ≥Four-fold | No | 2 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | ≥Two-fold | No | 2 Participants |
| Adult: Placebo | Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | ≥Four-fold | Yes | 0 Participants |
| Adult: Placebo | Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | ≥Two-fold | Yes | 2 Participants |
| Adult: Placebo | Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | ≥Four-fold | No | 14 Participants |
| Adult: Placebo | Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | ≥Two-fold | No | 12 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | ≥Two-fold | No | 4 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | ≥Four-fold | No | 9 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | ≥Two-fold | Yes | 11 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | ≥Four-fold | Yes | 6 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | ≥Four-fold | Yes | 10 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | ≥Two-fold | Yes | 14 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | ≥Four-fold | No | 5 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | ≥Two-fold | No | 1 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | ≥Two-fold | Yes | 15 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | ≥Four-fold | No | 4 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | ≥Two-fold | No | 0 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | ≥Four-fold | Yes | 11 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | ≥Two-fold | Yes | 12 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | ≥Four-fold | No | 6 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | ≥Two-fold | No | 3 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | ≥Four-fold | Yes | 9 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | ≥Two-fold | No | 0 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | ≥Two-fold | Yes | 15 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | ≥Four-fold | Yes | 8 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | ≥Four-fold | No | 7 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | ≥Four-fold | Yes | 2 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | ≥Two-fold | Yes | 5 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | ≥Two-fold | No | 44 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | ≥Four-fold | No | 47 Participants |
| 24-59 Months: Placebo | Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | ≥Two-fold | Yes | 8 Participants |
| 24-59 Months: Placebo | Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | ≥Two-fold | No | 5 Participants |
| 24-59 Months: Placebo | Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | ≥Four-fold | Yes | 3 Participants |
| 24-59 Months: Placebo | Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | ≥Four-fold | No | 10 Participants |
| 12-23 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | ≥Two-fold | No | 7 Participants |
| 12-23 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | ≥Four-fold | No | 12 Participants |
| 12-23 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | ≥Two-fold | Yes | 8 Participants |
| 12-23 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | ≥Four-fold | Yes | 3 Participants |
| 12-23 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | ≥Four-fold | No | 7 Participants |
| 12-23 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | ≥Two-fold | No | 0 Participants |
| 12-23 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | ≥Four-fold | Yes | 6 Participants |
| 12-23 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | ≥Two-fold | Yes | 13 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | ≥Two-fold | Yes | 13 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | ≥Four-fold | Yes | 10 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | ≥Two-fold | No | 0 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | ≥Four-fold | No | 3 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | ≥Two-fold | No | 38 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | ≥Four-fold | Yes | 0 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | ≥Four-fold | No | 39 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | ≥Two-fold | Yes | 1 Participants |
| 12-23 Months: Placebo | Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | ≥Two-fold | No | 11 Participants |
| 12-23 Months: Placebo | Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | ≥Two-fold | Yes | 19 Participants |
| 12-23 Months: Placebo | Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | ≥Four-fold | Yes | 14 Participants |
| 12-23 Months: Placebo | Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | ≥Four-fold | No | 16 Participants |
| 6-11 Months: ETVAX (1/8) | Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | ≥Four-fold | No | 15 Participants |
| 6-11 Months: ETVAX (1/8) | Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | ≥Four-fold | Yes | 15 Participants |
| 6-11 Months: ETVAX (1/8) | Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | ≥Two-fold | No | 6 Participants |
| 6-11 Months: ETVAX (1/8) | Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | ≥Two-fold | Yes | 24 Participants |
| 6-11 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | ≥Two-fold | Yes | 21 Participants |
| 6-11 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | ≥Two-fold | No | 4 Participants |
| 6-11 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | ≥Four-fold | Yes | 16 Participants |
| 6-11 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | ≥Four-fold | No | 9 Participants |
| 6-11 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | ≥Two-fold | Yes | 19 Participants |
| 6-11 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | ≥Four-fold | Yes | 12 Participants |
| 6-11 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | ≥Four-fold | No | 14 Participants |
| 6-11 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | ≥Two-fold | No | 7 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | ≥Four-fold | Yes | 13 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | ≥Four-fold | No | 16 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | ≥Two-fold | Yes | 23 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | ≥Two-fold | No | 6 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | ≥Two-fold | Yes | 13 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | ≥Four-fold | Yes | 7 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | ≥Two-fold | No | 36 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose | ≥Four-fold | No | 42 Participants |
Secondary
Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen
Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second). Antigen in ETVAX were: E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin
Time frame: 19 days
Population: Subjects who received both vaccinations and had valid baseline and endline immunologic samples.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Adult: ETVAX (Full) | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | No | 0 Participants |
| Adult: ETVAX (Full) | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | Yes | 15 Participants |
| Adult: ETVAX (Full) | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | No | 0 Participants |
| Adult: ETVAX (Full) | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | No | 0 Participants |
| Adult: ETVAX (Full) | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | No | 0 Participants |
| Adult: ETVAX (Full) | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | Yes | 15 Participants |
| Adult: ETVAX (Full) | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | Yes | 15 Participants |
| Adult: ETVAX (Full) | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | No | 0 Participants |
| Adult: ETVAX (Full) | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | Yes | 15 Participants |
| Adult: ETVAX (Full) | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | Yes | 15 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | No | 0 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | No | 0 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | Yes | 15 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | Yes | 15 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | Yes | 15 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | No | 0 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | No | 0 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | Yes | 15 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | No | 0 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | Yes | 15 Participants |
| Adult: Placebo | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | Yes | 0 Participants |
| Adult: Placebo | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | No | 10 Participants |
| Adult: Placebo | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | No | 14 Participants |
| Adult: Placebo | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | Yes | 4 Participants |
| Adult: Placebo | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | No | 13 Participants |
| Adult: Placebo | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | No | 14 Participants |
| Adult: Placebo | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | No | 14 Participants |
| Adult: Placebo | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | Yes | 1 Participants |
| Adult: Placebo | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | Yes | 0 Participants |
| Adult: Placebo | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | Yes | 0 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | No | 0 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | Yes | 15 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | No | 0 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | No | 3 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | Yes | 15 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | No | 1 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | Yes | 14 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | Yes | 15 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | No | 0 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | Yes | 12 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | Yes | 15 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | No | 0 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | No | 1 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | Yes | 12 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | No | 1 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | Yes | 14 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | Yes | 14 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | Yes | 13 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | No | 2 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | No | 3 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | No | 0 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | Yes | 15 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | Yes | 15 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | No | 0 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | No | 0 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | Yes | 14 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | No | 3 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | Yes | 15 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | Yes | 12 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | No | 1 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | No | 2 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | No | 1 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | Yes | 12 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | No | 3 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | No | 0 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | Yes | 15 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | Yes | 13 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | Yes | 14 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | Yes | 12 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | No | 3 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | Yes | 13 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | Yes | 15 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | Yes | 10 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | Yes | 11 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | No | 4 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | Yes | 15 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | No | 5 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | No | 2 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | No | 0 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | No | 0 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | Yes | 1 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | No | 46 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | No | 47 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | Yes | 2 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | Yes | 7 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | No | 45 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | Yes | 3 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | No | 42 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | Yes | 4 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | No | 48 Participants |
| 24-59 Months: Placebo | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | Yes | 6 Participants |
| 24-59 Months: Placebo | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | Yes | 11 Participants |
| 24-59 Months: Placebo | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | No | 2 Participants |
| 24-59 Months: Placebo | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | Yes | 13 Participants |
| 24-59 Months: Placebo | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | No | 2 Participants |
| 24-59 Months: Placebo | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | No | 5 Participants |
| 24-59 Months: Placebo | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | No | 0 Participants |
| 24-59 Months: Placebo | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | Yes | 8 Participants |
| 24-59 Months: Placebo | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | No | 6 Participants |
| 24-59 Months: Placebo | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | Yes | 11 Participants |
| 12-23 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | No | 2 Participants |
| 12-23 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | No | 4 Participants |
| 12-23 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | Yes | 7 Participants |
| 12-23 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | No | 8 Participants |
| 12-23 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | Yes | 5 Participants |
| 12-23 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | No | 10 Participants |
| 12-23 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | Yes | 15 Participants |
| 12-23 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | Yes | 11 Participants |
| 12-23 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | Yes | 13 Participants |
| 12-23 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | No | 0 Participants |
| 12-23 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | No | 0 Participants |
| 12-23 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | Yes | 13 Participants |
| 12-23 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | No | 7 Participants |
| 12-23 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | Yes | 12 Participants |
| 12-23 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | No | 1 Participants |
| 12-23 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | No | 4 Participants |
| 12-23 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | Yes | 9 Participants |
| 12-23 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | No | 4 Participants |
| 12-23 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | Yes | 9 Participants |
| 12-23 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | Yes | 6 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | Yes | 5 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | Yes | 8 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | No | 2 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | Yes | 9 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | No | 4 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | No | 8 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | Yes | 7 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | Yes | 11 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | No | 5 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | No | 6 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | Yes | 5 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | No | 36 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | No | 34 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | Yes | 3 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | Yes | 6 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | No | 33 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | Yes | 6 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | No | 36 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | Yes | 3 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | No | 33 Participants |
| 12-23 Months: Placebo | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | No | 19 Participants |
| 12-23 Months: Placebo | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | No | 15 Participants |
| 12-23 Months: Placebo | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | Yes | 19 Participants |
| 12-23 Months: Placebo | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | Yes | 3 Participants |
| 12-23 Months: Placebo | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | Yes | 11 Participants |
| 12-23 Months: Placebo | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | Yes | 15 Participants |
| 12-23 Months: Placebo | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | No | 15 Participants |
| 12-23 Months: Placebo | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | No | 27 Participants |
| 12-23 Months: Placebo | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | Yes | 15 Participants |
| 12-23 Months: Placebo | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | No | 11 Participants |
| 6-11 Months: ETVAX (1/8) | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | No | 25 Participants |
| 6-11 Months: ETVAX (1/8) | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | Yes | 24 Participants |
| 6-11 Months: ETVAX (1/8) | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | No | 17 Participants |
| 6-11 Months: ETVAX (1/8) | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | No | 6 Participants |
| 6-11 Months: ETVAX (1/8) | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | Yes | 13 Participants |
| 6-11 Months: ETVAX (1/8) | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | No | 24 Participants |
| 6-11 Months: ETVAX (1/8) | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | No | 21 Participants |
| 6-11 Months: ETVAX (1/8) | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | Yes | 9 Participants |
| 6-11 Months: ETVAX (1/8) | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | Yes | 5 Participants |
| 6-11 Months: ETVAX (1/8) | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | Yes | 6 Participants |
| 6-11 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | No | 4 Participants |
| 6-11 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | Yes | 12 Participants |
| 6-11 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | Yes | 13 Participants |
| 6-11 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | No | 19 Participants |
| 6-11 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | Yes | 20 Participants |
| 6-11 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | No | 11 Participants |
| 6-11 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | No | 12 Participants |
| 6-11 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | Yes | 5 Participants |
| 6-11 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | Yes | 5 Participants |
| 6-11 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | No | 19 Participants |
| 6-11 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | No | 8 Participants |
| 6-11 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | No | 21 Participants |
| 6-11 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | Yes | 18 Participants |
| 6-11 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | No | 13 Participants |
| 6-11 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | Yes | 10 Participants |
| 6-11 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | No | 16 Participants |
| 6-11 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | No | 26 Participants |
| 6-11 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | Yes | 13 Participants |
| 6-11 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | Yes | 0 Participants |
| 6-11 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | Yes | 5 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | Yes | 3 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | Yes | 11 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | No | 8 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | No | 18 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | No | 29 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | Yes | 21 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | Yes | 7 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | Yes | 0 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | No | 22 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | No | 26 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | No | 34 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | No | 42 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | No | 42 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | No | 47 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | No | 41 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS5 | Yes | 7 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS3 | Yes | 8 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CFA/I | Yes | 7 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | LTB | Yes | 15 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen | CS6 | Yes | 2 Participants |
Secondary
Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX
Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second). Antigen in ETVAX were: E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin
Time frame: 19 days
Population: Subjects who received both vaccinations and had valid baseline and endline immunologic samples.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Adult: ETVAX (Full) | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | Yes | 14 Participants |
| Adult: ETVAX (Full) | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | No | 0 Participants |
| Adult: ETVAX (Full) | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | Yes | 9 Participants |
| Adult: ETVAX (Full) | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | No | 5 Participants |
| Adult: ETVAX (Full) | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | Yes | 12 Participants |
| Adult: ETVAX (Full) | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | No | 5 Participants |
| Adult: ETVAX (Full) | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | No | 3 Participants |
| Adult: ETVAX (Full) | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | Yes | 8 Participants |
| Adult: ETVAX (Full) | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | No | 1 Participants |
| Adult: ETVAX (Full) | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | Yes | 15 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | Yes | 11 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | No | 1 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | No | 0 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | Yes | 13 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | Yes | 15 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | Yes | 12 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | No | 1 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | Yes | 14 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | No | 4 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | No | 3 Participants |
| Adult: Placebo | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | No | 14 Participants |
| Adult: Placebo | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | Yes | 0 Participants |
| Adult: Placebo | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | No | 11 Participants |
| Adult: Placebo | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | No | 13 Participants |
| Adult: Placebo | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | Yes | 1 Participants |
| Adult: Placebo | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | Yes | 3 Participants |
| Adult: Placebo | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | Yes | 0 Participants |
| Adult: Placebo | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | No | 13 Participants |
| Adult: Placebo | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | No | 13 Participants |
| Adult: Placebo | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | Yes | 0 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | Yes | 14 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | Yes | 14 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | No | 2 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | Yes | 11 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | Yes | 13 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | Yes | 5 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | No | 1 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | No | 10 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | No | 4 Participants |
| 24-59 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | No | 1 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | No | 8 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | Yes | 12 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | Yes | 7 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | No | 1 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | Yes | 12 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | No | 5 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | Yes | 10 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | No | 3 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | No | 3 Participants |
| 24-59 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | Yes | 14 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | Yes | 11 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | Yes | 15 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | Yes | 7 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | No | 8 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | Yes | 8 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | No | 7 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | No | 3 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | Yes | 12 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | No | 0 Participants |
| 24-59 Months: ETVAX (Full) | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | No | 4 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | Yes | 12 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | Yes | 7 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | No | 7 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | Yes | 10 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | Yes | 14 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | Yes | 8 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | No | 1 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | No | 3 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | No | 8 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | No | 5 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | No | 3 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | No | 1 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | Yes | 13 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | No | 2 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | Yes | 5 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | Yes | 12 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | Yes | 8 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | Yes | 14 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | No | 10 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | No | 7 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | Yes | 3 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | No | 44 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | No | 46 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | No | 46 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | Yes | 3 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | Yes | 5 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | Yes | 9 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | No | 40 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | No | 46 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | Yes | 3 Participants |
| 24-59 Months: Placebo | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | Yes | 5 Participants |
| 24-59 Months: Placebo | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | No | 6 Participants |
| 24-59 Months: Placebo | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | No | 8 Participants |
| 24-59 Months: Placebo | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | Yes | 12 Participants |
| 24-59 Months: Placebo | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | No | 1 Participants |
| 24-59 Months: Placebo | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | Yes | 6 Participants |
| 24-59 Months: Placebo | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | Yes | 7 Participants |
| 24-59 Months: Placebo | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | No | 7 Participants |
| 24-59 Months: Placebo | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | Yes | 7 Participants |
| 24-59 Months: Placebo | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | No | 6 Participants |
| 12-23 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | Yes | 5 Participants |
| 12-23 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | No | 10 Participants |
| 12-23 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | No | 4 Participants |
| 12-23 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | No | 3 Participants |
| 12-23 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | Yes | 11 Participants |
| 12-23 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | No | 9 Participants |
| 12-23 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | Yes | 12 Participants |
| 12-23 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | No | 10 Participants |
| 12-23 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | Yes | 6 Participants |
| 12-23 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | Yes | 5 Participants |
| 12-23 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | No | 10 Participants |
| 12-23 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | No | 10 Participants |
| 12-23 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | Yes | 3 Participants |
| 12-23 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | Yes | 12 Participants |
| 12-23 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | No | 1 Participants |
| 12-23 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | Yes | 5 Participants |
| 12-23 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | No | 8 Participants |
| 12-23 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | Yes | 5 Participants |
| 12-23 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | No | 8 Participants |
| 12-23 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | Yes | 3 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | No | 7 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | Yes | 8 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | Yes | 7 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | Yes | 13 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | No | 8 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | Yes | 5 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | Yes | 6 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | No | 5 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | No | 6 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | No | 0 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | Yes | 6 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | No | 31 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | No | 31 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | No | 31 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | Yes | 8 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | Yes | 8 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | Yes | 8 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | Yes | 7 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | No | 32 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | No | 33 Participants |
| 12-23 Months: Placebo | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | No | 19 Participants |
| 12-23 Months: Placebo | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | No | 18 Participants |
| 12-23 Months: Placebo | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | No | 15 Participants |
| 12-23 Months: Placebo | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | Yes | 15 Participants |
| 12-23 Months: Placebo | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | Yes | 11 Participants |
| 12-23 Months: Placebo | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | No | 20 Participants |
| 12-23 Months: Placebo | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | Yes | 10 Participants |
| 12-23 Months: Placebo | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | Yes | 12 Participants |
| 12-23 Months: Placebo | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | No | 8 Participants |
| 12-23 Months: Placebo | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | Yes | 22 Participants |
| 6-11 Months: ETVAX (1/8) | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | No | 13 Participants |
| 6-11 Months: ETVAX (1/8) | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | Yes | 17 Participants |
| 6-11 Months: ETVAX (1/8) | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | No | 4 Participants |
| 6-11 Months: ETVAX (1/8) | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | Yes | 14 Participants |
| 6-11 Months: ETVAX (1/8) | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | No | 21 Participants |
| 6-11 Months: ETVAX (1/8) | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | Yes | 9 Participants |
| 6-11 Months: ETVAX (1/8) | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | No | 16 Participants |
| 6-11 Months: ETVAX (1/8) | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | Yes | 26 Participants |
| 6-11 Months: ETVAX (1/8) | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | Yes | 13 Participants |
| 6-11 Months: ETVAX (1/8) | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | No | 17 Participants |
| 6-11 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | No | 4 Participants |
| 6-11 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | No | 15 Participants |
| 6-11 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | Yes | 21 Participants |
| 6-11 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | Yes | 13 Participants |
| 6-11 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | No | 16 Participants |
| 6-11 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | Yes | 9 Participants |
| 6-11 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | No | 12 Participants |
| 6-11 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | Yes | 11 Participants |
| 6-11 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | Yes | 10 Participants |
| 6-11 Months: ETVAX (1/4) | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | No | 14 Participants |
| 6-11 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | Yes | 11 Participants |
| 6-11 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | No | 13 Participants |
| 6-11 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | Yes | 12 Participants |
| 6-11 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | No | 5 Participants |
| 6-11 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | No | 15 Participants |
| 6-11 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | Yes | 12 Participants |
| 6-11 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | Yes | 21 Participants |
| 6-11 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | Yes | 13 Participants |
| 6-11 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | No | 14 Participants |
| 6-11 Months: ETVAX (1/2) | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | No | 14 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | No | 20 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | No | 5 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | Yes | 24 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | No | 17 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | Yes | 14 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | Yes | 12 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | No | 15 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | Yes | 14 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | Yes | 9 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | No | 15 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | No | 28 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | No | 39 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | No | 35 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | LTB | Yes | 21 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | Yes | 15 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | Yes | 14 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS3 | Yes | 14 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS6 | No | 35 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CFA/I | No | 34 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX | CS5 | Yes | 10 Participants |
Secondary
Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects
Time frame: 19 days
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Adult: ETVAX (Full) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 2 antigens | 0 Participants |
| Adult: ETVAX (Full) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 0 antigens | 10 Participants |
| Adult: ETVAX (Full) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 2 antigens | 0 Participants |
| Adult: ETVAX (Full) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 4 antigens | 0 Participants |
| Adult: ETVAX (Full) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 1 antigen | 5 Participants |
| Adult: ETVAX (Full) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 3 antigens | 0 Participants |
| Adult: ETVAX (Full) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 3 antigens | 0 Participants |
| Adult: ETVAX (Full) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 0 antigens | 9 Participants |
| Adult: ETVAX (Full) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 4 antigens | 0 Participants |
| Adult: ETVAX (Full) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 5 antigens | 0 Participants |
| Adult: ETVAX (Full) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 5 antigens | 0 Participants |
| Adult: ETVAX (Full) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 1 antigen | 4 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 1 antigen | 0 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 3 antigens | 0 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 5 antigens | 15 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 2 antigens | 0 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 5 antigens | 15 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 4 antigens | 0 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 0 antigens | 0 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 2 antigens | 0 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 0 antigens | 0 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 3 antigens | 0 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 1 antigen | 0 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 4 antigens | 0 Participants |
| Adult: Placebo | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 3 antigens | 0 Participants |
| Adult: Placebo | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 0 antigens | 0 Participants |
| Adult: Placebo | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 1 antigen | 0 Participants |
| Adult: Placebo | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 1 antigen | 0 Participants |
| Adult: Placebo | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 0 antigens | 0 Participants |
| Adult: Placebo | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 2 antigens | 0 Participants |
| Adult: Placebo | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 2 antigens | 0 Participants |
| Adult: Placebo | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 3 antigens | 0 Participants |
| Adult: Placebo | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 5 antigens | 15 Participants |
| Adult: Placebo | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 4 antigens | 0 Participants |
| Adult: Placebo | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 4 antigens | 0 Participants |
| Adult: Placebo | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 5 antigens | 15 Participants |
| 24-59 Months: ETVAX (1/4) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 4 antigens | 0 Participants |
| 24-59 Months: ETVAX (1/4) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 0 antigens | 37 Participants |
| 24-59 Months: ETVAX (1/4) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 3 antigens | 1 Participants |
| 24-59 Months: ETVAX (1/4) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 5 antigens | 0 Participants |
| 24-59 Months: ETVAX (1/4) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 4 antigens | 1 Participants |
| 24-59 Months: ETVAX (1/4) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 1 antigen | 7 Participants |
| 24-59 Months: ETVAX (1/4) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 2 antigens | 0 Participants |
| 24-59 Months: ETVAX (1/4) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 3 antigens | 0 Participants |
| 24-59 Months: ETVAX (1/4) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 1 antigen | 9 Participants |
| 24-59 Months: ETVAX (1/4) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 2 antigens | 2 Participants |
| 24-59 Months: ETVAX (1/4) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 0 antigens | 41 Participants |
| 24-59 Months: ETVAX (1/4) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 5 antigens | 0 Participants |
| 24-59 Months: ETVAX (1/2) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 0 antigens | 0 Participants |
| 24-59 Months: ETVAX (1/2) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 4 antigens | 3 Participants |
| 24-59 Months: ETVAX (1/2) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 1 antigen | 0 Participants |
| 24-59 Months: ETVAX (1/2) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 5 antigens | 11 Participants |
| 24-59 Months: ETVAX (1/2) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 0 antigens | 0 Participants |
| 24-59 Months: ETVAX (1/2) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 2 antigens | 0 Participants |
| 24-59 Months: ETVAX (1/2) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 5 antigens | 12 Participants |
| 24-59 Months: ETVAX (1/2) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 1 antigen | 0 Participants |
| 24-59 Months: ETVAX (1/2) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 4 antigens | 2 Participants |
| 24-59 Months: ETVAX (1/2) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 3 antigens | 1 Participants |
| 24-59 Months: ETVAX (1/2) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 2 antigens | 0 Participants |
| 24-59 Months: ETVAX (1/2) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 3 antigens | 1 Participants |
| 24-59 Months: ETVAX (Full) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 0 antigens | 0 Participants |
| 24-59 Months: ETVAX (Full) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 5 antigens | 4 Participants |
| 24-59 Months: ETVAX (Full) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 2 antigens | 2 Participants |
| 24-59 Months: ETVAX (Full) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 4 antigens | 9 Participants |
| 24-59 Months: ETVAX (Full) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 4 antigens | 5 Participants |
| 24-59 Months: ETVAX (Full) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 5 antigens | 9 Participants |
| 24-59 Months: ETVAX (Full) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 1 antigen | 0 Participants |
| 24-59 Months: ETVAX (Full) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 1 antigen | 0 Participants |
| 24-59 Months: ETVAX (Full) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 0 antigens | 0 Participants |
| 24-59 Months: ETVAX (Full) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 3 antigens | 0 Participants |
| 24-59 Months: ETVAX (Full) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 3 antigens | 0 Participants |
| 24-59 Months: ETVAX (Full) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 2 antigens | 1 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 4 antigens | 4 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 1 antigen | 0 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 3 antigens | 0 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 0 antigens | 0 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 5 antigens | 11 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 2 antigens | 1 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 5 antigens | 10 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 3 antigens | 0 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 4 antigens | 4 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 0 antigens | 0 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 1 antigen | 0 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 2 antigens | 0 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 4 antigens | 3 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 1 antigen | 0 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 0 antigens | 0 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 2 antigens | 2 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 0 antigens | 0 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 3 antigens | 2 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 4 antigens | 6 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 3 antigens | 0 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 1 antigen | 0 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 2 antigens | 2 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 5 antigens | 5 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 5 antigens | 10 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 0 antigens | 0 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 4 antigens | 5 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 1 antigen | 0 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 2 antigens | 1 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 0 antigens | 0 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 5 antigens | 7 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 4 antigens | 5 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 3 antigens | 3 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 3 antigens | 4 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 2 antigens | 0 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 1 antigen | 0 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 5 antigens | 5 Participants |
| 24-59 Months: Placebo | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 2 antigens | 3 Participants |
| 24-59 Months: Placebo | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 3 antigens | 1 Participants |
| 24-59 Months: Placebo | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 5 antigens | 0 Participants |
| 24-59 Months: Placebo | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 4 antigens | 2 Participants |
| 24-59 Months: Placebo | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 3 antigens | 0 Participants |
| 24-59 Months: Placebo | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 5 antigens | 0 Participants |
| 24-59 Months: Placebo | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 1 antigen | 4 Participants |
| 24-59 Months: Placebo | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 0 antigens | 26 Participants |
| 24-59 Months: Placebo | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 4 antigens | 0 Participants |
| 24-59 Months: Placebo | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 2 antigens | 3 Participants |
| 24-59 Months: Placebo | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 0 antigens | 30 Participants |
| 24-59 Months: Placebo | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 1 antigen | 5 Participants |
| 12-23 Months: ETVAX (1/4) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 2 antigens | 2 Participants |
| 12-23 Months: ETVAX (1/4) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 3 antigens | 1 Participants |
| 12-23 Months: ETVAX (1/4) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 3 antigens | 4 Participants |
| 12-23 Months: ETVAX (1/4) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 2 antigens | 3 Participants |
| 12-23 Months: ETVAX (1/4) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 4 antigens | 3 Participants |
| 12-23 Months: ETVAX (1/4) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 5 antigens | 5 Participants |
| 12-23 Months: ETVAX (1/4) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 1 antigen | 0 Participants |
| 12-23 Months: ETVAX (1/4) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 0 antigens | 0 Participants |
| 12-23 Months: ETVAX (1/4) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 0 antigens | 0 Participants |
| 12-23 Months: ETVAX (1/4) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 4 antigens | 3 Participants |
| 12-23 Months: ETVAX (1/4) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 1 antigen | 2 Participants |
| 12-23 Months: ETVAX (1/4) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 5 antigens | 1 Participants |
| 12-23 Months: ETVAX (1/2) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 2 antigens | 1 Participants |
| 12-23 Months: ETVAX (1/2) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 4 antigens | 3 Participants |
| 12-23 Months: ETVAX (1/2) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 2 antigens | 3 Participants |
| 12-23 Months: ETVAX (1/2) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 0 antigens | 0 Participants |
| 12-23 Months: ETVAX (1/2) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 5 antigens | 3 Participants |
| 12-23 Months: ETVAX (1/2) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 3 antigens | 4 Participants |
| 12-23 Months: ETVAX (1/2) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 4 antigens | 3 Participants |
| 12-23 Months: ETVAX (1/2) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 3 antigens | 5 Participants |
| 12-23 Months: ETVAX (1/2) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 5 antigens | 4 Participants |
| 12-23 Months: ETVAX (1/2) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 0 antigens | 0 Participants |
| 12-23 Months: ETVAX (1/2) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 1 antigen | 2 Participants |
| 12-23 Months: ETVAX (1/2) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 1 antigen | 2 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 0 antigens | 0 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 2 antigens | 2 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 0 antigens | 0 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 5 antigens | 5 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 4 antigens | 3 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 1 antigen | 0 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 3 antigens | 4 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 2 antigens | 2 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 4 antigens | 2 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 5 antigens | 3 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 3 antigens | 4 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 1 antigen | 1 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 0 antigens | 2 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 0 antigens | 2 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 5 antigens | 2 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 1 antigen | 1 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 4 antigens | 2 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 4 antigens | 6 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 1 antigen | 2 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 3 antigens | 5 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 3 antigens | 1 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 2 antigens | 0 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 2 antigens | 1 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 5 antigens | 2 Participants |
| 12-23 Months: Placebo | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 4 antigens | 1 Participants |
| 12-23 Months: Placebo | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 1 antigen | 13 Participants |
| 12-23 Months: Placebo | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 4 antigens | 1 Participants |
| 12-23 Months: Placebo | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 2 antigens | 2 Participants |
| 12-23 Months: Placebo | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 5 antigens | 0 Participants |
| 12-23 Months: Placebo | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 2 antigens | 7 Participants |
| 12-23 Months: Placebo | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 1 antigen | 18 Participants |
| 12-23 Months: Placebo | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 5 antigens | 0 Participants |
| 12-23 Months: Placebo | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 0 antigens | 33 Participants |
| 12-23 Months: Placebo | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 3 antigens | 0 Participants |
| 12-23 Months: Placebo | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 0 antigens | 22 Participants |
| 12-23 Months: Placebo | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 3 antigens | 1 Participants |
| 6-11 Months: ETVAX (1/8) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 2 antigens | 4 Participants |
| 6-11 Months: ETVAX (1/8) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 1 antigen | 6 Participants |
| 6-11 Months: ETVAX (1/8) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 0 antigens | 11 Participants |
| 6-11 Months: ETVAX (1/8) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 5 antigens | 2 Participants |
| 6-11 Months: ETVAX (1/8) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 4 antigens | 5 Participants |
| 6-11 Months: ETVAX (1/8) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 3 antigens | 5 Participants |
| 6-11 Months: ETVAX (1/8) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 2 antigens | 7 Participants |
| 6-11 Months: ETVAX (1/8) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 1 antigen | 4 Participants |
| 6-11 Months: ETVAX (1/8) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 0 antigens | 7 Participants |
| 6-11 Months: ETVAX (1/8) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 5 antigens | 1 Participants |
| 6-11 Months: ETVAX (1/8) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 4 antigens | 2 Participants |
| 6-11 Months: ETVAX (1/8) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 3 antigens | 6 Participants |
| 6-11 Months: ETVAX (1/4) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 5 antigens | 2 Participants |
| 6-11 Months: ETVAX (1/4) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 1 antigen | 10 Participants |
| 6-11 Months: ETVAX (1/4) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 1 antigen | 16 Participants |
| 6-11 Months: ETVAX (1/4) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 0 antigens | 3 Participants |
| 6-11 Months: ETVAX (1/4) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 4 antigens | 1 Participants |
| 6-11 Months: ETVAX (1/4) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 2 antigens | 8 Participants |
| 6-11 Months: ETVAX (1/4) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 3 antigens | 3 Participants |
| 6-11 Months: ETVAX (1/4) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 4 antigens | 0 Participants |
| 6-11 Months: ETVAX (1/4) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 2 antigens | 4 Participants |
| 6-11 Months: ETVAX (1/4) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 3 antigens | 7 Participants |
| 6-11 Months: ETVAX (1/4) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 0 antigens | 6 Participants |
| 6-11 Months: ETVAX (1/4) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 5 antigens | 0 Participants |
| 6-11 Months: ETVAX (1/2) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 1 antigen | 3 Participants |
| 6-11 Months: ETVAX (1/2) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 0 antigens | 3 Participants |
| 6-11 Months: ETVAX (1/2) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 3 antigens | 5 Participants |
| 6-11 Months: ETVAX (1/2) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 5 antigens | 1 Participants |
| 6-11 Months: ETVAX (1/2) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 4 antigens | 0 Participants |
| 6-11 Months: ETVAX (1/2) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 0 antigens | 2 Participants |
| 6-11 Months: ETVAX (1/2) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 2 antigens | 6 Participants |
| 6-11 Months: ETVAX (1/2) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 4 antigens | 3 Participants |
| 6-11 Months: ETVAX (1/2) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 2 antigens | 10 Participants |
| 6-11 Months: ETVAX (1/2) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 1 antigen | 10 Participants |
| 6-11 Months: ETVAX (1/2) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 5 antigens | 0 Participants |
| 6-11 Months: ETVAX (1/2) | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 3 antigens | 5 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 5 antigens | 0 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 0 antigens | 4 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 1 antigen | 9 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 4 antigens | 0 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 2 antigens | 4 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 3 antigens | 7 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 4 antigens | 2 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 3 antigens | 5 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 5 antigens | 0 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 0 antigens | 7 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 1 antigen | 9 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 2 antigens | 5 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 4 antigens | 0 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 5 antigens | 0 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 4 antigens | 2 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 1 antigen | 14 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 5 antigens | 0 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 3 antigens | 4 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 2 antigens | 6 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 2 antigens | 7 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 1 antigen | 13 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 3 antigens | 2 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 0 antigens | 4 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 0 antigens | 6 Participants |
Secondary
Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects
Time frame: 19 days
Population: Participants with results for all antigens (CFA/I, CS3, CS5, CS6, LTB) tested for.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Adult: ETVAX (Full) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 3 antigens | 0 Participants |
| Adult: ETVAX (Full) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 4 antigens | 0 Participants |
| Adult: ETVAX (Full) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 0 antigens | 11 Participants |
| Adult: ETVAX (Full) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 1 antigen | 2 Participants |
| Adult: ETVAX (Full) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 2 antigens | 0 Participants |
| Adult: ETVAX (Full) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 3 antigens | 0 Participants |
| Adult: ETVAX (Full) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 4 antigens | 0 Participants |
| Adult: ETVAX (Full) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 5 antigens | 0 Participants |
| Adult: ETVAX (Full) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 0 antigens | 10 Participants |
| Adult: ETVAX (Full) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 1 antigen | 2 Participants |
| Adult: ETVAX (Full) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 5 antigens | 0 Participants |
| Adult: ETVAX (Full) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 2 antigens | 1 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 3 antigens | 2 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 4 antigens | 4 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 0 antigens | 0 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 5 antigens | 1 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 2 antigens | 0 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 0 antigens | 0 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 1 antigen | 1 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 4 antigens | 4 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 1 antigen | 5 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 3 antigens | 3 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 2 antigens | 1 Participants |
| Adult: ETVAX (Full) + 10 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 5 antigens | 5 Participants |
| Adult: Placebo | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 5 antigens | 8 Participants |
| Adult: Placebo | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 4 antigens | 2 Participants |
| Adult: Placebo | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 2 antigens | 6 Participants |
| Adult: Placebo | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 3 antigens | 0 Participants |
| Adult: Placebo | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 5 antigens | 1 Participants |
| Adult: Placebo | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 2 antigens | 0 Participants |
| Adult: Placebo | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 1 antigen | 0 Participants |
| Adult: Placebo | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 0 antigens | 0 Participants |
| Adult: Placebo | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 3 antigens | 4 Participants |
| Adult: Placebo | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 4 antigens | 5 Participants |
| Adult: Placebo | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 1 antigen | 1 Participants |
| Adult: Placebo | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 0 antigens | 1 Participants |
| 24-59 Months: ETVAX (1/4) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 3 antigens | 1 Participants |
| 24-59 Months: ETVAX (1/4) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 0 antigens | 43 Participants |
| 24-59 Months: ETVAX (1/4) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 5 antigens | 1 Participants |
| 24-59 Months: ETVAX (1/4) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 4 antigens | 0 Participants |
| 24-59 Months: ETVAX (1/4) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 2 antigens | 4 Participants |
| 24-59 Months: ETVAX (1/4) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 1 antigen | 7 Participants |
| 24-59 Months: ETVAX (1/4) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 0 antigens | 36 Participants |
| 24-59 Months: ETVAX (1/4) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 5 antigens | 0 Participants |
| 24-59 Months: ETVAX (1/4) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 4 antigens | 0 Participants |
| 24-59 Months: ETVAX (1/4) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 3 antigens | 1 Participants |
| 24-59 Months: ETVAX (1/4) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 2 antigens | 2 Participants |
| 24-59 Months: ETVAX (1/4) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 1 antigen | 3 Participants |
| 24-59 Months: ETVAX (1/2) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 2 antigens | 0 Participants |
| 24-59 Months: ETVAX (1/2) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 3 antigens | 4 Participants |
| 24-59 Months: ETVAX (1/2) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 5 antigens | 4 Participants |
| 24-59 Months: ETVAX (1/2) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 0 antigens | 0 Participants |
| 24-59 Months: ETVAX (1/2) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 1 antigen | 1 Participants |
| 24-59 Months: ETVAX (1/2) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 0 antigens | 0 Participants |
| 24-59 Months: ETVAX (1/2) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 3 antigens | 4 Participants |
| 24-59 Months: ETVAX (1/2) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 4 antigens | 6 Participants |
| 24-59 Months: ETVAX (1/2) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 5 antigens | 1 Participants |
| 24-59 Months: ETVAX (1/2) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 1 antigen | 1 Participants |
| 24-59 Months: ETVAX (1/2) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 2 antigens | 9 Participants |
| 24-59 Months: ETVAX (1/2) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 4 antigens | 0 Participants |
| 24-59 Months: ETVAX (Full) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 4 antigens | 3 Participants |
| 24-59 Months: ETVAX (Full) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 4 antigens | 4 Participants |
| 24-59 Months: ETVAX (Full) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 2 antigens | 2 Participants |
| 24-59 Months: ETVAX (Full) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 0 antigens | 0 Participants |
| 24-59 Months: ETVAX (Full) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 1 antigen | 4 Participants |
| 24-59 Months: ETVAX (Full) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 5 antigens | 5 Participants |
| 24-59 Months: ETVAX (Full) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 3 antigens | 5 Participants |
| 24-59 Months: ETVAX (Full) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 1 antigen | 1 Participants |
| 24-59 Months: ETVAX (Full) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 5 antigens | 0 Participants |
| 24-59 Months: ETVAX (Full) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 3 antigens | 5 Participants |
| 24-59 Months: ETVAX (Full) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 2 antigens | 1 Participants |
| 24-59 Months: ETVAX (Full) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 0 antigens | 0 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 1 antigen | 7 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 3 antigens | 2 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 5 antigens | 5 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 3 antigens | 5 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 4 antigens | 2 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 0 antigens | 0 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 5 antigens | 1 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 2 antigens | 2 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 4 antigens | 2 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 1 antigen | 1 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 2 antigens | 3 Participants |
| 24-59 Months: ETVAX (1/2) + 2.5 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 0 antigens | 0 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 0 antigens | 1 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 4 antigens | 6 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 2 antigens | 5 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 3 antigens | 4 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 0 antigens | 1 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 5 antigens | 0 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 2 antigens | 1 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 3 antigens | 3 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 4 antigens | 0 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 5 antigens | 3 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 1 antigen | 5 Participants |
| 24-59 Months: ETVAX (1/2) + 5 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 1 antigen | 1 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 3 antigens | 5 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 4 antigens | 1 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 3 antigens | 7 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 2 antigens | 6 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 0 antigens | 0 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 2 antigens | 2 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 5 antigens | 3 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 1 antigen | 2 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 0 antigens | 0 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 1 antigen | 0 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 5 antigens | 1 Participants |
| 24-59 Months: ETVAX (1/2) + 10 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 4 antigens | 3 Participants |
| 24-59 Months: Placebo | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 0 antigens | 22 Participants |
| 24-59 Months: Placebo | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 2 antigens | 2 Participants |
| 24-59 Months: Placebo | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 1 antigen | 4 Participants |
| 24-59 Months: Placebo | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 3 antigens | 2 Participants |
| 24-59 Months: Placebo | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 5 antigens | 0 Participants |
| 24-59 Months: Placebo | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 5 antigens | 2 Participants |
| 24-59 Months: Placebo | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 3 antigens | 2 Participants |
| 24-59 Months: Placebo | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 4 antigens | 2 Participants |
| 24-59 Months: Placebo | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 4 antigens | 2 Participants |
| 24-59 Months: Placebo | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 1 antigen | 9 Participants |
| 24-59 Months: Placebo | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 0 antigens | 31 Participants |
| 24-59 Months: Placebo | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 2 antigens | 0 Participants |
| 12-23 Months: ETVAX (1/4) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 3 antigens | 1 Participants |
| 12-23 Months: ETVAX (1/4) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 4 antigens | 2 Participants |
| 12-23 Months: ETVAX (1/4) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 3 antigens | 3 Participants |
| 12-23 Months: ETVAX (1/4) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 5 antigens | 2 Participants |
| 12-23 Months: ETVAX (1/4) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 1 antigen | 3 Participants |
| 12-23 Months: ETVAX (1/4) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 0 antigens | 3 Participants |
| 12-23 Months: ETVAX (1/4) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 2 antigens | 4 Participants |
| 12-23 Months: ETVAX (1/4) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 2 antigens | 4 Participants |
| 12-23 Months: ETVAX (1/4) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 1 antigen | 2 Participants |
| 12-23 Months: ETVAX (1/4) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 0 antigens | 0 Participants |
| 12-23 Months: ETVAX (1/4) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 4 antigens | 2 Participants |
| 12-23 Months: ETVAX (1/4) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 5 antigens | 0 Participants |
| 12-23 Months: ETVAX (1/2) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 1 antigen | 3 Participants |
| 12-23 Months: ETVAX (1/2) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 4 antigens | 2 Participants |
| 12-23 Months: ETVAX (1/2) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 5 antigens | 0 Participants |
| 12-23 Months: ETVAX (1/2) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 0 antigens | 3 Participants |
| 12-23 Months: ETVAX (1/2) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 2 antigens | 2 Participants |
| 12-23 Months: ETVAX (1/2) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 2 antigens | 4 Participants |
| 12-23 Months: ETVAX (1/2) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 1 antigen | 7 Participants |
| 12-23 Months: ETVAX (1/2) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 5 antigens | 2 Participants |
| 12-23 Months: ETVAX (1/2) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 3 antigens | 2 Participants |
| 12-23 Months: ETVAX (1/2) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 4 antigens | 3 Participants |
| 12-23 Months: ETVAX (1/2) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 0 antigens | 1 Participants |
| 12-23 Months: ETVAX (1/2) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 3 antigens | 1 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 5 antigens | 1 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 3 antigens | 3 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 2 antigens | 3 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 1 antigen | 4 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 0 antigens | 3 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 0 antigens | 1 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 4 antigens | 1 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 3 antigens | 0 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 2 antigens | 3 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 1 antigen | 5 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 4 antigens | 1 Participants |
| 12-23 Months: ETVAX (1/2) + 2.5 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 5 antigens | 1 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 2 antigens | 2 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 4 antigens | 2 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 2 antigens | 2 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 5 antigens | 4 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 1 antigen | 7 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 0 antigens | 0 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 1 antigen | 4 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 3 antigens | 1 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 0 antigens | 0 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 3 antigens | 2 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 4 antigens | 1 Participants |
| 12-23 Months: ETVAX (1/2) + 5 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 5 antigens | 1 Participants |
| 12-23 Months: Placebo | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 0 antigens | 28 Participants |
| 12-23 Months: Placebo | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 2 antigens | 7 Participants |
| 12-23 Months: Placebo | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 3 antigens | 5 Participants |
| 12-23 Months: Placebo | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 4 antigens | 2 Participants |
| 12-23 Months: Placebo | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 4 antigens | 4 Participants |
| 12-23 Months: Placebo | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 0 antigens | 20 Participants |
| 12-23 Months: Placebo | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 1 antigen | 9 Participants |
| 12-23 Months: Placebo | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 5 antigens | 1 Participants |
| 12-23 Months: Placebo | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 5 antigens | 4 Participants |
| 12-23 Months: Placebo | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 2 antigens | 5 Participants |
| 12-23 Months: Placebo | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 1 antigen | 11 Participants |
| 12-23 Months: Placebo | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 3 antigens | 2 Participants |
| 6-11 Months: ETVAX (1/8) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 1 antigen | 7 Participants |
| 6-11 Months: ETVAX (1/8) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 4 antigens | 6 Participants |
| 6-11 Months: ETVAX (1/8) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 2 antigens | 5 Participants |
| 6-11 Months: ETVAX (1/8) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 5 antigens | 2 Participants |
| 6-11 Months: ETVAX (1/8) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 0 antigens | 6 Participants |
| 6-11 Months: ETVAX (1/8) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 0 antigens | 9 Participants |
| 6-11 Months: ETVAX (1/8) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 3 antigens | 2 Participants |
| 6-11 Months: ETVAX (1/8) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 1 antigen | 11 Participants |
| 6-11 Months: ETVAX (1/8) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 3 antigens | 2 Participants |
| 6-11 Months: ETVAX (1/8) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 5 antigens | 5 Participants |
| 6-11 Months: ETVAX (1/8) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 2 antigens | 4 Participants |
| 6-11 Months: ETVAX (1/8) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 4 antigens | 1 Participants |
| 6-11 Months: ETVAX (1/4) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 5 antigens | 6 Participants |
| 6-11 Months: ETVAX (1/4) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 5 antigens | 1 Participants |
| 6-11 Months: ETVAX (1/4) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 4 antigens | 2 Participants |
| 6-11 Months: ETVAX (1/4) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 3 antigens | 5 Participants |
| 6-11 Months: ETVAX (1/4) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 4 antigens | 2 Participants |
| 6-11 Months: ETVAX (1/4) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 0 antigens | 7 Participants |
| 6-11 Months: ETVAX (1/4) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 1 antigen | 7 Participants |
| 6-11 Months: ETVAX (1/4) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 2 antigens | 7 Participants |
| 6-11 Months: ETVAX (1/4) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 2 antigens | 5 Participants |
| 6-11 Months: ETVAX (1/4) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 1 antigen | 8 Participants |
| 6-11 Months: ETVAX (1/4) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 3 antigens | 8 Participants |
| 6-11 Months: ETVAX (1/4) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 0 antigens | 2 Participants |
| 6-11 Months: ETVAX (1/2) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 2 antigens | 6 Participants |
| 6-11 Months: ETVAX (1/2) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 3 antigens | 2 Participants |
| 6-11 Months: ETVAX (1/2) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 3 antigens | 2 Participants |
| 6-11 Months: ETVAX (1/2) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 4 antigens | 0 Participants |
| 6-11 Months: ETVAX (1/2) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 4 antigens | 2 Participants |
| 6-11 Months: ETVAX (1/2) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 1 antigen | 13 Participants |
| 6-11 Months: ETVAX (1/2) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 0 antigens | 3 Participants |
| 6-11 Months: ETVAX (1/2) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 5 antigens | 6 Participants |
| 6-11 Months: ETVAX (1/2) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 2 antigens | 5 Participants |
| 6-11 Months: ETVAX (1/2) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 5 antigens | 2 Participants |
| 6-11 Months: ETVAX (1/2) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 1 antigen | 8 Participants |
| 6-11 Months: ETVAX (1/2) | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 0 antigens | 1 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 1 antigen | 5 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 1 antigen | 4 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 2 antigens | 8 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 4 antigens | 1 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 0 antigens | 8 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 3 antigens | 4 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 5 antigens | 3 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 4 antigens | 1 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 5 antigens | 9 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 3 antigens | 0 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 0 antigens | 4 Participants |
| 6-11 Months: ETVAX (1/4) + 2.5 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 2 antigens | 5 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 1 antigen | 9 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 5 antigens | 3 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 3 antigens | 5 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 4 antigens | 2 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 2 antigens | 3 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 0 antigens | 3 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 3 antigens | 2 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 2 antigens | 3 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 1 antigen | 15 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Two-fold | 5 antigens | 7 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 4 antigens | 2 Participants |
| 6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT | Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects | ≥Four-fold | 0 antigens | 4 Participants |