Healthy
Conditions
Keywords
Rotavirus Vaccine
Brief summary
This is is a study of a parenteral trivalent rotavirus vaccine (P2-VP8 subunit rotavirus vaccine). The study examined the safety and immunogenicity of three dose levels of this vaccine in healthy South African adults, toddlers and infants. Progression from one dose level to another and to the next age group population was based on the assessment of safety information from the lowest dose and older age group. The primary safety hypothesis is that the P2-VP8 subunit rotavirus vaccine is safe and well-tolerated. The primary immunogenicity hypothesis is that the trivalent P2-VP8 subunit rotavirus vaccine is immunogenic in infant participants and will induce an immune response to at least 2 of the 3 strains in 60% or more of participants in at least one of the study groups.
Detailed description
The P2-VP8 vaccine tested in this study was developed by Dr. Taka Hoshino at National Institute of Allergy and Infectious Diseases (NIAID). The monovalent (P\[8\]) vaccine previously tested consisted of bacteria-expressed VP8 subunit from the Wa strain of human rotaviruses (G1\[P8\]). A deoxyribonucleic acid (DNA) segment encoding the sequence of P2 epitope from tetanus toxin was fused to the VP8 sequence, resulting in this chimeric protein vaccine (P2-VP8). Dr. Hoshino's laboratory demonstrated in preclinical testing that the immunogenicity of these VP8 proteins could be significantly enhanced when fused with the P2 epitope of tetanus toxin, which exerts a strong T cell helper function. Further, immunization of neonatal piglets with a P2-VP8-P\[8\] chimeric protein conferred significant protection against experimental rotavirus gastroenteritis. Based on results of the initial first-in-human testing of the monovalent (P\[8\]) vaccine, a trivalent vaccine that includes antigens from P\[4\], P\[6\] and P\[8\] strains (DS-1, 1076 and Wa, respectively) has been developed to broaden responses for these 3 P-types, which together are responsible for the vast majority of global disease burden. The trivalent vaccine was assessed in this study. The first clinical testing of the monovalent (P\[8\]) P2-VP8 subunit rotavirus vaccine was performed in 18-45 year old adults in North America. Overall, the vaccine was well-tolerated at all three dose levels, was associated with only mild transient local reactogenicity, and no safety concerns were identified. Almost all vaccine recipients demonstrated greater than 4-fold rise in IgG and IgA response to P2-VP8 antigen by enzyme-linked immunosorbent assay (ELISA) after three vaccinations: only one vaccine recipient did not demonstrate an immunoglobulin G (IgG) response (in the 30 µg group) and all vaccine recipients demonstrated immunoglobulin A (IgA) responses. Neutralizing antibody responses were also encouraging, with clear increases in geometric mean titers (GMTs) for all three dose levels at one month post-third study injection (Day 84) compared to pre-vaccination levels. Neutralizing antibody responses to heterologous rotavirus strains were most robust to P\[8\] strains, moderate to the P\[4\] strain and fairly limited to the P\[6\] strain. Clinical testing of the monovalent (P\[8\]) P2-VP8 subunit rotavirus vaccine was initiated in South African toddlers and infants in 2014. The vaccine was generally well-tolerated at all three dose levels. In both toddlers and infants, when local reactogenicity was reported, it was transient, rarely greater than mild, and never severe. When present, systemic reactogenicity was also transient and generally mild, without discernable dose effect. In the dose-escalation phase of the testing in the infant cohorts, the study injections were paused temporarily due to findings of severe neutropenia on post-vaccination laboratory monitoring in three participants (two infants and one toddler) but were later resumed after the Safety Review Committee assessed that the data did not support relation to the study vaccine. The primary serology results in the infant cohorts were close to universal responses, with substantial increases in titer as demonstrated by mean-fold increase in GMT. In infants receiving the 30 µg dose, the GMT rose from a baseline value of 107 to a post-vaccination value of 9,583. Although not as dramatic as the IgG responses, there were good IgA responses to P2-VP8, with the seroresponse rate over 80% in infants receiving 30 µg of vaccine. The 60 µg dose did not appear to provide any better response than the 30 µg dose, although this study was not powered for that comparison. In summary, the P2-VP8 monovalent vaccine was generally well-tolerated in healthy South African infants, and there was no evidence that the higher vaccine dose (60 µg) provided any benefit in serologic responses or impact on shedding of Rotarix compared to the lower dose (30 µg).
Interventions
BIOLOGICALTrivalent P2-VP8 Subunit Rotavirus Vaccine
Manufactured and supplied by the Walter Reed Army Institute of Research (WRAIR) Pilot Bioproduction Facility (BPF). The trivalent P2-VP8 vaccine was formulated as a sterile suspension containing a total of 360 µg of protein (120 µg of each P type) per mL adsorbed to aluminum hydroxide (1.125 mg of aluminum per mL in a phosphate buffer, pH 7).
BIOLOGICALPlacebo
Sodium Chloride 0.9%, USP for Injection
Sponsors
The Emmes Company, LLC
PATH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Weeks to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy adults (≥ 18 and ≤ 45 years), toddlers (≥ 2 and ≤ 3 years), and infants (≥ 6 and ≤ 8 weeks) * Participants will remain in the area during the study * Females of childbearing potential must not be pregnant or breastfeeding, and willing to use adequate method of contraception during the trial.
Exclusion criteria
* Presence of fever or other acute illness * concurrent participation in another clinical trial * Presence of malnutrition or other systemic disorder. * Infants with history of premature birth (\< 37 week gestational age) * History of congenital abdominal disorders or surgery * Suspected or known impairment of immune function * Infants who have received rotavirus vaccine in the past * Known sensitivity to any components of the vaccine * History of anaphylactic reaction * Major congenital or genetic defect * Unwillingness to follow study schedule * Receipt of immunoglobulin therapy or blood products in last 6 months * History of chronic immunosuppressive medications (with the exception of inhaled or topical steroids) * Any medical condition that, in the judgement of the investigator, would interfere with the protocol, or would interfere with participant's ability to adhere to the study protocol. * Clinically significant screening laboratory value * Human immunodeficiency virus (HIV) infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Experiencing Adverse Events (AE) Within 28 Days of Any Vaccination | Up to 28 days after any vaccination (up to Day 28 for toddlers and up to Day 84 for infants and adults) | Any symptom starting after 7 days post any study injection was recorded as an adverse event. A serious adverse event (SAE) is any event that occurred from the first dose of study drug that resulted in any of the following outcomes: 1. Death 2. Life-threatening AE 3. Inpatient hospitalization or prolongation of existing hospitalization 4. Persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions 5. Congenital abnormality or birth defect 6. Important medical event that may not result in one of the above outcomes but may jeopardize the health of the study participant or require medical or surgical intervention to prevent one of the outcomes listed above. The severity of adverse events was graded from Mild (grade 1) to Life Threatening (grade 4). AEs related to study drug were those events for which there was a reasonable possibility that the study drug caused the event In the opinion of the site investigator. |
| Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | 7 days following each vaccination | Reactogenicity data (solicited signs or symptoms) were assessed for 7 days after each injection. Participants and parents were instructed to assess and record daily local reactions (injection site pain/tenderness, redness, swelling, itching), as well as systemic signs and symptoms (fever, headache, vomiting, nausea, fatigue, chills and myalgia for adults; and fever, vomiting, decreased appetite, irritability, and decreased activity for toddlers and infants) in a participant memory aid. Reactions were graded on a scale from mild (Grade 1) to life-threatening (Grade 4). The overall number of participants who experienced any local or systemic reaction is reported. Grades are based on maximum severity per participant. |
| Number of Infants With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse 4 Weeks After the Third Vaccination, by Vaccine Antigen | Day 84 | Seroresponse was defined as a four-fold rise or greater in antibody titer between Baseline and 28 days after the third injection (Day 84). Measured by enzyme-linked immunosorbent assay (ELISA) and adjusted for decay in maternal IgG antibodies. The estimated maternal antibody half-life was derived from linear regression of Log2 transformed titers in placebo recipients from the combined infant cohorts. |
| Number of Infants With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse 4 Weeks After the Third Vaccination, by Vaccine Antigen | Day 84 | Seroresponse was defined as a four-fold rise or greater in antibody titer between Baseline and 28 days after the final injection (Day 84). Measured by enzyme-linked immunosorbent assay (ELISA) to whole viral lysate. |
| Number of Infants With Neutralizing Antibody Responses 4 Weeks After the Third Vaccination to Each Rotavirus Strain | Day 84 | Neutralizing antibody response was defined as a ≥ 2.7-fold rise in antibody titer between Baseline and 28 days after the final injection (Day 84). Neutralizing antibodies to each of the three rotavirus strains from which the vaccine antigens were derived (Wa, DS-1, and 1076) were measured using a validated assay. For infants, antibody titer was adjusted for decay in maternal antibodies. |
| Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Infants, by Vaccine Antigen | Baseline and Days 56 (pre-vaccination) and 84 | Measured by ELISA at Baseline, 28 days after the second injection (Day 56 pre-vaccination; secondary outcome) and 28 days after the third and final injection (Day 84; primary outcome). |
| Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Infants, by Vaccine Antigen | Baseline and Days 56 (pre-vaccination) and 84 | Measured by ELISA at Baseline, 28 days after the second injection (Day 56 pre-vaccination; secondary outcome) and 28 days after the third and final injection (Day 84; primary outcome). |
| Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Infants | Baseline and Days 56 (pre-vaccination) and 84 | Neutralizing antibodies to each of the three rotavirus strains from which the vaccine antigens were derived (Wa, DS-1, and 1076) were measured at Baseline and 28 days after the second injection (Day 56 pre-vaccination; secondary outcome) and third injection (Day 84; primary outcome). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen | Baseline and Day 28 for toddlers or Day 84 for adults | Measured at Baseline and 28 days after the final injection (Day 84 for adults; Day 28 for toddlers). |
| Number of Participants Experiencing Adverse Events (AE) Over the Entire Study Period | Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers) | Any symptom starting after 7 days post any study injection was recorded as an adverse event. A serious adverse event (SAE) is any event that occurred from the first dose of study drug that resulted in any of the following outcomes: * Death - Life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * Persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * Congenital abnormality or birth defect * Important medical event that may not result in one of the above outcomes but may jeopardize the health of the study participant or require medical or surgical intervention to prevent one of the outcomes listed in the above definition of serious event. AEs related to study drug were those events for which there was a reasonable possibility that the study drug caused the event In the opinion of the site investigator. |
| Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Adults and Toddlers | Baseline and Day 28 for toddlers or Day 84 for adults | Measured at Baseline and 28 days after the final injection (Day 84 for adults; Day 28 for toddlers). |
| Number of Infants With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse 4 Weeks After the Second Vaccination, by Vaccine Antigen | Day 56, pre-vaccination | Seroresponse was defined as a four-fold rise or greater in antibody titer between Baseline and 28 days after the 2nd injection (Day 56). Measured by enzyme-linked immunosorbent assay (ELISA) and adjusted for decay in maternal antibodies. The estimated maternal antibody half-life was derived from linear regression of Log2 transformed titers in placebo recipients from the combined infant cohorts. |
| Number of Infants With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse 4 Weeks After the Second Vaccination, by Vaccine Antigen | Day 56, pre-vaccination | Seroresponse was defined as a four-fold rise or greater in antibody titer between Baseline and 28 days after the second injection (Day 56). Measured by enzyme-linked immunosorbent assay (ELISA) to whole viral lysate. |
| Number of Infants With Neutralizing Antibody Responses 4 Weeks After the Second Vaccination | Day 56, prevaccination | Neutralizing antibody response was defined as a ≥ 2.7-fold rise in antibody titer between Baseline and 28 days after the second injection (Day 56). Neutralizing antibodies to each of the three rotavirus strains from which the vaccine antigens were derived (Wa, DS-1, and 1076) were measured using a validated assay. For infants, antibody titers were adjusted for decay in maternal antibodies. |
| Number of Adults and Toddlers With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse, by Vaccine Antigen | Day 84 for adults; Day 28 for toddlers | Seroresponse was defined as a four-fold rise or greater in IgG antibody titer between Baseline and 28 days after the final injection (Day 84 for adults and Day 28 for toddlers). Measured by enzyme-linked immunosorbent assay (ELISA). |
| Number of Adults and Toddlers With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse, by Vaccine Antigen | Day 84 for adults; Day 28 for toddlers | Seroresponse was defined as a four-fold rise or greater in IgA antibody titer between Baseline and 28 days after the final injection (Day 84 for adults and Day 28 for toddlers). Measured by enzyme-linked immunosorbent assay (ELISA). |
| Number of Adults and Toddlers With Neutralizing Antibody Responses to Each Rotavirus Strain | Day 84 for adults; Day 28 for toddlers | Neutralizing antibody response was defined as a ≥ 2.7-fold rise in antibody titer between Baseline and 28 days after the final injection (Day 84 for adults and Day 28 for toddlers) for each of the three rotavirus strains from which the vaccine antigens were derived (Wa, DS-1, and 1076). |
| Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen | Baseline and Day 28 for toddlers or Day 84 for adults | Measured at Baseline and 28 days after the final injection (Day 84 for adults; Day 28 for toddlers). |
Countries
South Africa
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Adults: Placebo Adults received three intramuscular injections of placebo four weeks apart on Days 0, 28, and 56. | 6 |
| Adults: 30 µg P2-VP8 Adults received three intramuscular injections of 30 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56. | 12 |
| Adults: 90 µg P2-VP8 Adults received three intramuscular injections of 90 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56. | 12 |
| Toddlers: Placebo Toddlers received one intramuscular injection of placebo on Day 0. | 6 |
| Toddlers: 30 µg P2-VP8 Toddlers received one intramuscular injection of 30 µg trivalent P2-VP8 subunit rotavirus vaccine on Day 0. | 12 |
| Toddlers: 90 µg P2-VP8 Toddlers received one intramuscular injection of 90 µg trivalent P2-VP8 subunit rotavirus vaccine on Day 0. | 12 |
| Infants: Placebo Infants received three intramuscular injections of placebo four weeks apart on Days 0, 28, and 56. | 139 |
| Infants: 15 µg P2-VP8 Infants received three intramuscular injections of 15 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56. | 140 |
| Infants: 30 µg P2-VP8 Infants received three intramuscular injections of 30 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56. | 140 |
| Infants: 90 µg P2-VP8 Infants received three intramuscular injections of 90 µg trivalent P2-VP8 subunit rotavirus vaccine four weeks apart on Days 0, 28, and 56. | 139 |
| Total | 618 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Death | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 0 |
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 2 | 2 | 2 |
| Overall Study | Protocol Violation | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 0 | 1 | 0 | 0 | 0 | 5 | 9 | 7 | 3 |
Baseline characteristics
| Characteristic | Adults: Placebo | Adults: 30 µg P2-VP8 | Adults: 90 µg P2-VP8 | Toddlers: Placebo | Toddlers: 30 µg P2-VP8 | Toddlers: 90 µg P2-VP8 | Infants: Placebo | Infants: 15 µg P2-VP8 | Infants: 30 µg P2-VP8 | Infants: 90 µg P2-VP8 | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 25.3 years STANDARD_DEVIATION 2.1 | 32.0 years STANDARD_DEVIATION 4.8 | 26.0 years STANDARD_DEVIATION 6 | 2.6 years STANDARD_DEVIATION 0.1 | 2.6 years STANDARD_DEVIATION 0.2 | 2.5 years STANDARD_DEVIATION 0.2 | 0.13 years STANDARD_DEVIATION 0.01 | 0.13 years STANDARD_DEVIATION 0.01 | 0.13 years STANDARD_DEVIATION 0.01 | 0.13 years STANDARD_DEVIATION 0.01 | 16.3 years STANDARD_DEVIATION 2.6 |
| Height | 167.0 centimeters STANDARD_DEVIATION 12.5 | 164.4 centimeters STANDARD_DEVIATION 10.6 | 160.6 centimeters STANDARD_DEVIATION 8.3 | 88.8 centimeters STANDARD_DEVIATION 6.8 | 86.4 centimeters STANDARD_DEVIATION 7.6 | 88.5 centimeters STANDARD_DEVIATION 4.3 | 55.4 centimeters STANDARD_DEVIATION 2.35 | 54.9 centimeters STANDARD_DEVIATION 2.48 | 55.1 centimeters STANDARD_DEVIATION 2.24 | 55.3 centimeters STANDARD_DEVIATION 1.98 | 62.0 centimeters STANDARD_DEVIATION 24.2 |
| Race/Ethnicity, Customized Black | 6 Participants | 12 Participants | 12 Participants | 6 Participants | 12 Participants | 12 Participants | 137 Participants | 138 Participants | 138 Participants | 136 Participants | 609 Participants |
| Race/Ethnicity, Customized Colored | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 2 Participants | 1 Participants | 3 Participants | 8 Participants |
| Race/Ethnicity, Customized Indian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Unspecified | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 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 | 3 Participants | 6 Participants | 9 Participants | 4 Participants | 7 Participants | 5 Participants | 67 Participants | 66 Participants | 76 Participants | 64 Participants | 307 Participants |
| Sex: Female, Male Male | 3 Participants | 6 Participants | 3 Participants | 2 Participants | 5 Participants | 7 Participants | 72 Participants | 74 Participants | 64 Participants | 75 Participants | 311 Participants |
| Weight | 62.7 kilograms STANDARD_DEVIATION 8.1 | 68.7 kilograms STANDARD_DEVIATION 10.4 | 61.2 kilograms STANDARD_DEVIATION 10.2 | 13.8 kilograms STANDARD_DEVIATION 2.4 | 12.6 kilograms STANDARD_DEVIATION 1.5 | 13.5 kilograms STANDARD_DEVIATION 2.3 | 4.9 kilograms STANDARD_DEVIATION 0.59 | 4.8 kilograms STANDARD_DEVIATION 0.66 | 4.8 kilograms STANDARD_DEVIATION 0.54 | 4.9 kilograms STANDARD_DEVIATION 0.58 | 8.1 kilograms STANDARD_DEVIATION 13 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 12 | 0 / 12 | 0 / 6 | 0 / 12 | 0 / 12 | 1 / 139 | 1 / 140 | 1 / 140 | 0 / 139 |
| other Total, other adverse events | 2 / 6 | 8 / 12 | 11 / 12 | 5 / 6 | 9 / 12 | 8 / 12 | 132 / 139 | 129 / 139 | 134 / 140 | 130 / 139 |
| serious Total, serious adverse events | 0 / 6 | 0 / 12 | 0 / 12 | 0 / 6 | 1 / 12 | 1 / 12 | 8 / 139 | 13 / 139 | 6 / 140 | 8 / 139 |
Outcome results
Primary
Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Infants, by Vaccine Antigen
Measured by ELISA at Baseline, 28 days after the second injection (Day 56 pre-vaccination; secondary outcome) and 28 days after the third and final injection (Day 84; primary outcome).
Time frame: Baseline and Days 56 (pre-vaccination) and 84
Population: Per-protocol population; participants with valid specimens at each time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Adults: Placebo | Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Infants, by Vaccine Antigen | P[6]: Day 56 | 6 titer |
| Adults: Placebo | Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Infants, by Vaccine Antigen | P[6]: Day 84 | 7 titer |
| Adults: Placebo | Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Infants, by Vaccine Antigen | P[4]: Day 56 | 6 titer |
| Adults: Placebo | Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Infants, by Vaccine Antigen | P[8]: Baseline | 5 titer |
| Adults: Placebo | Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Infants, by Vaccine Antigen | P[8]: Day 84 | 6 titer |
| Adults: Placebo | Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Infants, by Vaccine Antigen | P[4]: Day 84 | 7 titer |
| Adults: Placebo | Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Infants, by Vaccine Antigen | P[4]: Baseline | 5 titer |
| Adults: Placebo | Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Infants, by Vaccine Antigen | P[6]: Baseline | 5 titer |
| Adults: Placebo | Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Infants, by Vaccine Antigen | P[8]: Day 56 | 6 titer |
| Adults: 30 µg P2-VP8 | Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Infants, by Vaccine Antigen | P[6]: Baseline | 5 titer |
| Adults: 30 µg P2-VP8 | Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Infants, by Vaccine Antigen | P[8]: Baseline | 5 titer |
| Adults: 30 µg P2-VP8 | Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Infants, by Vaccine Antigen | P[4]: Day 84 | 13 titer |
| Adults: 30 µg P2-VP8 | Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Infants, by Vaccine Antigen | P[6]: Day 84 | 12 titer |
| Adults: 30 µg P2-VP8 | Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Infants, by Vaccine Antigen | P[8]: Day 84 | 11 titer |
| Adults: 30 µg P2-VP8 | Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Infants, by Vaccine Antigen | P[8]: Day 56 | 8 titer |
| Adults: 30 µg P2-VP8 | Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Infants, by Vaccine Antigen | P[4]: Day 56 | 9 titer |
| Adults: 30 µg P2-VP8 | Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Infants, by Vaccine Antigen | P[4]: Baseline | 5 titer |
| Adults: 30 µg P2-VP8 | Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Infants, by Vaccine Antigen | P[6]: Day 56 | 9 titer |
| Adults: 90 µg P2-VP8 | Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Infants, by Vaccine Antigen | P[6]: Day 56 | 10 titer |
| Adults: 90 µg P2-VP8 | Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Infants, by Vaccine Antigen | P[4]: Baseline | 5 titer |
| Adults: 90 µg P2-VP8 | Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Infants, by Vaccine Antigen | P[4]: Day 56 | 10 titer |
| Adults: 90 µg P2-VP8 | Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Infants, by Vaccine Antigen | P[4]: Day 84 | 12 titer |
| Adults: 90 µg P2-VP8 | Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Infants, by Vaccine Antigen | P[6]: Baseline | 5 titer |
| Adults: 90 µg P2-VP8 | Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Infants, by Vaccine Antigen | P[6]: Day 84 | 13 titer |
| Adults: 90 µg P2-VP8 | Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Infants, by Vaccine Antigen | P[8]: Baseline | 5 titer |
| Adults: 90 µg P2-VP8 | Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Infants, by Vaccine Antigen | P[8]: Day 56 | 8 titer |
| Adults: 90 µg P2-VP8 | Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Infants, by Vaccine Antigen | P[8]: Day 84 | 9 titer |
| Toddlers: Placebo | Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Infants, by Vaccine Antigen | P[8]: Baseline | 5 titer |
| Toddlers: Placebo | Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Infants, by Vaccine Antigen | P[6]: Baseline | 5 titer |
| Toddlers: Placebo | Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Infants, by Vaccine Antigen | P[4]: Day 84 | 10 titer |
| Toddlers: Placebo | Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Infants, by Vaccine Antigen | P[8]: Day 84 | 8 titer |
| Toddlers: Placebo | Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Infants, by Vaccine Antigen | P[8]: Day 56 | 7 titer |
| Toddlers: Placebo | Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Infants, by Vaccine Antigen | P[4]: Day 56 | 9 titer |
| Toddlers: Placebo | Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Infants, by Vaccine Antigen | P[6]: Day 84 | 12 titer |
| Toddlers: Placebo | Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Infants, by Vaccine Antigen | P[6]: Day 56 | 10 titer |
| Toddlers: Placebo | Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Infants, by Vaccine Antigen | P[4]: Baseline | 5 titer |
Primary
Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Infants, by Vaccine Antigen
Measured by ELISA at Baseline, 28 days after the second injection (Day 56 pre-vaccination; secondary outcome) and 28 days after the third and final injection (Day 84; primary outcome).
Time frame: Baseline and Days 56 (pre-vaccination) and 84
Population: Per-protocol population; participants with valid specimens at each time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Adults: Placebo | Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Infants, by Vaccine Antigen | P[8]: Baseline | 84 titer |
| Adults: Placebo | Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Infants, by Vaccine Antigen | P[6]: Day 84 | 50 titer |
| Adults: Placebo | Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Infants, by Vaccine Antigen | P[8]: Day 84 | 30 titer |
| Adults: Placebo | Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Infants, by Vaccine Antigen | P[6]: Baseline | 67 titer |
| Adults: Placebo | Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Infants, by Vaccine Antigen | P[4]: Day 84 | 28 titer |
| Adults: Placebo | Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Infants, by Vaccine Antigen | P[4]: Day 56 | 30 titer |
| Adults: Placebo | Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Infants, by Vaccine Antigen | P[8]: Day 56 | 35 titer |
| Adults: Placebo | Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Infants, by Vaccine Antigen | P[6]: Day 56 | 47 titer |
| Adults: Placebo | Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Infants, by Vaccine Antigen | P[4]: Baseline | 73 titer |
| Adults: 30 µg P2-VP8 | Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Infants, by Vaccine Antigen | P[6]: Day 56 | 5031 titer |
| Adults: 30 µg P2-VP8 | Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Infants, by Vaccine Antigen | P[8]: Baseline | 86 titer |
| Adults: 30 µg P2-VP8 | Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Infants, by Vaccine Antigen | P[6]: Day 84 | 14028 titer |
| Adults: 30 µg P2-VP8 | Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Infants, by Vaccine Antigen | P[4]: Day 56 | 1456 titer |
| Adults: 30 µg P2-VP8 | Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Infants, by Vaccine Antigen | P[4]: Baseline | 80 titer |
| Adults: 30 µg P2-VP8 | Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Infants, by Vaccine Antigen | P[4]: Day 84 | 3888 titer |
| Adults: 30 µg P2-VP8 | Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Infants, by Vaccine Antigen | P[8]: Day 84 | 5365 titer |
| Adults: 30 µg P2-VP8 | Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Infants, by Vaccine Antigen | P[8]: Day 56 | 1897 titer |
| Adults: 30 µg P2-VP8 | Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Infants, by Vaccine Antigen | P[6]: Baseline | 73 titer |
| Adults: 90 µg P2-VP8 | Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Infants, by Vaccine Antigen | P[6]: Day 56 | 5709 titer |
| Adults: 90 µg P2-VP8 | Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Infants, by Vaccine Antigen | P[4]: Baseline | 62 titer |
| Adults: 90 µg P2-VP8 | Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Infants, by Vaccine Antigen | P[4]: Day 56 | 1849 titer |
| Adults: 90 µg P2-VP8 | Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Infants, by Vaccine Antigen | P[4]: Day 84 | 4205 titer |
| Adults: 90 µg P2-VP8 | Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Infants, by Vaccine Antigen | P[6]: Baseline | 63 titer |
| Adults: 90 µg P2-VP8 | Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Infants, by Vaccine Antigen | P[6]: Day 84 | 14724 titer |
| Adults: 90 µg P2-VP8 | Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Infants, by Vaccine Antigen | P[8]: Baseline | 74 titer |
| Adults: 90 µg P2-VP8 | Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Infants, by Vaccine Antigen | P[8]: Day 56 | 2323 titer |
| Adults: 90 µg P2-VP8 | Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Infants, by Vaccine Antigen | P[8]: Day 84 | 5792 titer |
| Toddlers: Placebo | Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Infants, by Vaccine Antigen | P[8]: Baseline | 81 titer |
| Toddlers: Placebo | Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Infants, by Vaccine Antigen | P[6]: Baseline | 66 titer |
| Toddlers: Placebo | Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Infants, by Vaccine Antigen | P[4]: Day 84 | 5244 titer |
| Toddlers: Placebo | Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Infants, by Vaccine Antigen | P[8]: Day 84 | 7088 titer |
| Toddlers: Placebo | Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Infants, by Vaccine Antigen | P[8]: Day 56 | 3050 titer |
| Toddlers: Placebo | Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Infants, by Vaccine Antigen | P[4]: Day 56 | 2424 titer |
| Toddlers: Placebo | Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Infants, by Vaccine Antigen | P[6]: Day 84 | 17085 titer |
| Toddlers: Placebo | Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Infants, by Vaccine Antigen | P[6]: Day 56 | 7122 titer |
| Toddlers: Placebo | Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Infants, by Vaccine Antigen | P[4]: Baseline | 76 titer |
Primary
Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Infants
Neutralizing antibodies to each of the three rotavirus strains from which the vaccine antigens were derived (Wa, DS-1, and 1076) were measured at Baseline and 28 days after the second injection (Day 56 pre-vaccination; secondary outcome) and third injection (Day 84; primary outcome).
Time frame: Baseline and Days 56 (pre-vaccination) and 84
Population: Per-protocol population participants with valid specimens at each time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Adults: Placebo | Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Infants | Strain 1076: Baseline | 31 titer |
| Adults: Placebo | Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Infants | Strain DS-1: Day 84 | 11 titer |
| Adults: Placebo | Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Infants | Strain 1076: Day 84 | 10 titer |
| Adults: Placebo | Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Infants | Strain DS-1: Baseline | 54 titer |
| Adults: Placebo | Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Infants | Strain Wa: Day 84 | 42 titer |
| Adults: Placebo | Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Infants | Strain Wa: Day 56 | 42 titer |
| Adults: Placebo | Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Infants | Strain 1076: Day 56 | 12 titer |
| Adults: Placebo | Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Infants | Strain DS-1: Day 56 | 16 titer |
| Adults: Placebo | Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Infants | Strain Wa: Baseline | 118 titer |
| Adults: 30 µg P2-VP8 | Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Infants | Strain DS-1: Day 56 | 26 titer |
| Adults: 30 µg P2-VP8 | Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Infants | Strain 1076: Baseline | 37 titer |
| Adults: 30 µg P2-VP8 | Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Infants | Strain DS-1: Day 84 | 49 titer |
| Adults: 30 µg P2-VP8 | Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Infants | Strain Wa: Day 56 | 90 titer |
| Adults: 30 µg P2-VP8 | Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Infants | Strain Wa: Baseline | 154 titer |
| Adults: 30 µg P2-VP8 | Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Infants | Strain Wa: Day 84 | 90 titer |
| Adults: 30 µg P2-VP8 | Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Infants | Strain 1076: Day 84 | 34 titer |
| Adults: 30 µg P2-VP8 | Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Infants | Strain 1076: Day 56 | 18 titer |
| Adults: 30 µg P2-VP8 | Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Infants | Strain DS-1: Baseline | 51 titer |
| Adults: 90 µg P2-VP8 | Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Infants | Strain DS-1: Day 56 | 26 titer |
| Adults: 90 µg P2-VP8 | Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Infants | Strain Wa: Baseline | 128 titer |
| Adults: 90 µg P2-VP8 | Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Infants | Strain Wa: Day 56 | 85 titer |
| Adults: 90 µg P2-VP8 | Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Infants | Strain Wa: Day 84 | 85 titer |
| Adults: 90 µg P2-VP8 | Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Infants | Strain DS-1: Baseline | 44 titer |
| Adults: 90 µg P2-VP8 | Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Infants | Strain DS-1: Day 84 | 48 titer |
| Adults: 90 µg P2-VP8 | Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Infants | Strain 1076: Baseline | 30 titer |
| Adults: 90 µg P2-VP8 | Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Infants | Strain 1076: Day 56 | 18 titer |
| Adults: 90 µg P2-VP8 | Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Infants | Strain 1076: Day 84 | 35 titer |
| Toddlers: Placebo | Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Infants | Strain 1076: Baseline | 35 titer |
| Toddlers: Placebo | Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Infants | Strain DS-1: Baseline | 46 titer |
| Toddlers: Placebo | Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Infants | Strain Wa: Day 84 | 85 titer |
| Toddlers: Placebo | Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Infants | Strain 1076: Day 84 | 43 titer |
| Toddlers: Placebo | Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Infants | Strain 1076: Day 56 | 20 titer |
| Toddlers: Placebo | Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Infants | Strain Wa: Day 56 | 85 titer |
| Toddlers: Placebo | Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Infants | Strain DS-1: Day 84 | 53 titer |
| Toddlers: Placebo | Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Infants | Strain DS-1: Day 56 | 27 titer |
| Toddlers: Placebo | Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Infants | Strain Wa: Baseline | 130 titer |
Primary
Number of Infants With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse 4 Weeks After the Third Vaccination, by Vaccine Antigen
Seroresponse was defined as a four-fold rise or greater in antibody titer between Baseline and 28 days after the final injection (Day 84). Measured by enzyme-linked immunosorbent assay (ELISA) to whole viral lysate.
Time frame: Day 84
Population: Per-protocol population participants with available data
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Adults: Placebo | Number of Infants With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse 4 Weeks After the Third Vaccination, by Vaccine Antigen | P[6] | 13 Participants |
| Adults: Placebo | Number of Infants With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse 4 Weeks After the Third Vaccination, by Vaccine Antigen | P[4] | 13 Participants |
| Adults: Placebo | Number of Infants With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse 4 Weeks After the Third Vaccination, by Vaccine Antigen | P[8] | 11 Participants |
| Adults: Placebo | Number of Infants With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse 4 Weeks After the Third Vaccination, by Vaccine Antigen | All 3 antigens | 7 Participants |
| Adults: Placebo | Number of Infants With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse 4 Weeks After the Third Vaccination, by Vaccine Antigen | Any 2 antigens | 11 Participants |
| Adults: 30 µg P2-VP8 | Number of Infants With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse 4 Weeks After the Third Vaccination, by Vaccine Antigen | All 3 antigens | 19 Participants |
| Adults: 30 µg P2-VP8 | Number of Infants With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse 4 Weeks After the Third Vaccination, by Vaccine Antigen | P[4] | 35 Participants |
| Adults: 30 µg P2-VP8 | Number of Infants With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse 4 Weeks After the Third Vaccination, by Vaccine Antigen | P[6] | 37 Participants |
| Adults: 30 µg P2-VP8 | Number of Infants With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse 4 Weeks After the Third Vaccination, by Vaccine Antigen | P[8] | 36 Participants |
| Adults: 30 µg P2-VP8 | Number of Infants With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse 4 Weeks After the Third Vaccination, by Vaccine Antigen | Any 2 antigens | 34 Participants |
| Adults: 90 µg P2-VP8 | Number of Infants With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse 4 Weeks After the Third Vaccination, by Vaccine Antigen | P[6] | 44 Participants |
| Adults: 90 µg P2-VP8 | Number of Infants With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse 4 Weeks After the Third Vaccination, by Vaccine Antigen | P[8] | 26 Participants |
| Adults: 90 µg P2-VP8 | Number of Infants With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse 4 Weeks After the Third Vaccination, by Vaccine Antigen | Any 2 antigens | 35 Participants |
| Adults: 90 µg P2-VP8 | Number of Infants With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse 4 Weeks After the Third Vaccination, by Vaccine Antigen | P[4] | 40 Participants |
| Adults: 90 µg P2-VP8 | Number of Infants With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse 4 Weeks After the Third Vaccination, by Vaccine Antigen | All 3 antigens | 16 Participants |
| Toddlers: Placebo | Number of Infants With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse 4 Weeks After the Third Vaccination, by Vaccine Antigen | P[6] | 34 Participants |
| Toddlers: Placebo | Number of Infants With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse 4 Weeks After the Third Vaccination, by Vaccine Antigen | Any 2 antigens | 29 Participants |
| Toddlers: Placebo | Number of Infants With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse 4 Weeks After the Third Vaccination, by Vaccine Antigen | P[8] | 28 Participants |
| Toddlers: Placebo | Number of Infants With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse 4 Weeks After the Third Vaccination, by Vaccine Antigen | P[4] | 32 Participants |
| Toddlers: Placebo | Number of Infants With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse 4 Weeks After the Third Vaccination, by Vaccine Antigen | All 3 antigens | 16 Participants |
Primary
Number of Infants With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse 4 Weeks After the Third Vaccination, by Vaccine Antigen
Seroresponse was defined as a four-fold rise or greater in antibody titer between Baseline and 28 days after the third injection (Day 84). Measured by enzyme-linked immunosorbent assay (ELISA) and adjusted for decay in maternal IgG antibodies. The estimated maternal antibody half-life was derived from linear regression of Log2 transformed titers in placebo recipients from the combined infant cohorts.
Time frame: Day 84
Population: Per-protocol population included all randomized participants who adhered to the protocol, completed all their scheduled visits and vaccinations up to the analysis time point and presented no major protocol violations (defined as a protocol violation that was considered to have an impact on the immunogenicity results of the study).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Adults: Placebo | Number of Infants With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse 4 Weeks After the Third Vaccination, by Vaccine Antigen | Any 2 antigens | 16 Participants |
| Adults: Placebo | Number of Infants With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse 4 Weeks After the Third Vaccination, by Vaccine Antigen | P[6] | 38 Participants |
| Adults: Placebo | Number of Infants With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse 4 Weeks After the Third Vaccination, by Vaccine Antigen | All 3 antigens | 11 Participants |
| Adults: Placebo | Number of Infants With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse 4 Weeks After the Third Vaccination, by Vaccine Antigen | P[8] | 13 Participants |
| Adults: Placebo | Number of Infants With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse 4 Weeks After the Third Vaccination, by Vaccine Antigen | P[4] | 16 Participants |
| Adults: 30 µg P2-VP8 | Number of Infants With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse 4 Weeks After the Third Vaccination, by Vaccine Antigen | P[8] | 131 Participants |
| Adults: 30 µg P2-VP8 | Number of Infants With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse 4 Weeks After the Third Vaccination, by Vaccine Antigen | Any 2 antigens | 131 Participants |
| Adults: 30 µg P2-VP8 | Number of Infants With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse 4 Weeks After the Third Vaccination, by Vaccine Antigen | All 3 antigens | 131 Participants |
| Adults: 30 µg P2-VP8 | Number of Infants With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse 4 Weeks After the Third Vaccination, by Vaccine Antigen | P[6] | 131 Participants |
| Adults: 30 µg P2-VP8 | Number of Infants With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse 4 Weeks After the Third Vaccination, by Vaccine Antigen | P[4] | 131 Participants |
| Adults: 90 µg P2-VP8 | Number of Infants With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse 4 Weeks After the Third Vaccination, by Vaccine Antigen | P[8] | 130 Participants |
| Adults: 90 µg P2-VP8 | Number of Infants With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse 4 Weeks After the Third Vaccination, by Vaccine Antigen | P[4] | 130 Participants |
| Adults: 90 µg P2-VP8 | Number of Infants With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse 4 Weeks After the Third Vaccination, by Vaccine Antigen | P[6] | 132 Participants |
| Adults: 90 µg P2-VP8 | Number of Infants With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse 4 Weeks After the Third Vaccination, by Vaccine Antigen | Any 2 antigens | 130 Participants |
| Adults: 90 µg P2-VP8 | Number of Infants With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse 4 Weeks After the Third Vaccination, by Vaccine Antigen | All 3 antigens | 130 Participants |
| Toddlers: Placebo | Number of Infants With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse 4 Weeks After the Third Vaccination, by Vaccine Antigen | Any 2 antigens | 134 Participants |
| Toddlers: Placebo | Number of Infants With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse 4 Weeks After the Third Vaccination, by Vaccine Antigen | P[6] | 134 Participants |
| Toddlers: Placebo | Number of Infants With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse 4 Weeks After the Third Vaccination, by Vaccine Antigen | P[4] | 134 Participants |
| Toddlers: Placebo | Number of Infants With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse 4 Weeks After the Third Vaccination, by Vaccine Antigen | P[8] | 134 Participants |
| Toddlers: Placebo | Number of Infants With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse 4 Weeks After the Third Vaccination, by Vaccine Antigen | All 3 antigens | 134 Participants |
Primary
Number of Infants With Neutralizing Antibody Responses 4 Weeks After the Third Vaccination to Each Rotavirus Strain
Neutralizing antibody response was defined as a ≥ 2.7-fold rise in antibody titer between Baseline and 28 days after the final injection (Day 84). Neutralizing antibodies to each of the three rotavirus strains from which the vaccine antigens were derived (Wa, DS-1, and 1076) were measured using a validated assay. For infants, antibody titer was adjusted for decay in maternal antibodies.
Time frame: Day 84
Population: Per-protocol population participants with available data for each strain
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Adults: Placebo | Number of Infants With Neutralizing Antibody Responses 4 Weeks After the Third Vaccination to Each Rotavirus Strain | Any 2 strains | 15 Participants |
| Adults: Placebo | Number of Infants With Neutralizing Antibody Responses 4 Weeks After the Third Vaccination to Each Rotavirus Strain | Rotavirus strain DS-1 | 26 Participants |
| Adults: Placebo | Number of Infants With Neutralizing Antibody Responses 4 Weeks After the Third Vaccination to Each Rotavirus Strain | All 3 strains | 10 Participants |
| Adults: Placebo | Number of Infants With Neutralizing Antibody Responses 4 Weeks After the Third Vaccination to Each Rotavirus Strain | Rotavirus strain 1076 | 16 Participants |
| Adults: Placebo | Number of Infants With Neutralizing Antibody Responses 4 Weeks After the Third Vaccination to Each Rotavirus Strain | Rotavirus strain Wa | 26 Participants |
| Adults: 30 µg P2-VP8 | Number of Infants With Neutralizing Antibody Responses 4 Weeks After the Third Vaccination to Each Rotavirus Strain | Rotavirus strain 1076 | 90 Participants |
| Adults: 30 µg P2-VP8 | Number of Infants With Neutralizing Antibody Responses 4 Weeks After the Third Vaccination to Each Rotavirus Strain | Any 2 strains | 101 Participants |
| Adults: 30 µg P2-VP8 | Number of Infants With Neutralizing Antibody Responses 4 Weeks After the Third Vaccination to Each Rotavirus Strain | All 3 strains | 65 Participants |
| Adults: 30 µg P2-VP8 | Number of Infants With Neutralizing Antibody Responses 4 Weeks After the Third Vaccination to Each Rotavirus Strain | Rotavirus strain DS-1 | 100 Participants |
| Adults: 30 µg P2-VP8 | Number of Infants With Neutralizing Antibody Responses 4 Weeks After the Third Vaccination to Each Rotavirus Strain | Rotavirus strain Wa | 96 Participants |
| Adults: 90 µg P2-VP8 | Number of Infants With Neutralizing Antibody Responses 4 Weeks After the Third Vaccination to Each Rotavirus Strain | Rotavirus strain 1076 | 103 Participants |
| Adults: 90 µg P2-VP8 | Number of Infants With Neutralizing Antibody Responses 4 Weeks After the Third Vaccination to Each Rotavirus Strain | Rotavirus strain Wa | 107 Participants |
| Adults: 90 µg P2-VP8 | Number of Infants With Neutralizing Antibody Responses 4 Weeks After the Third Vaccination to Each Rotavirus Strain | Rotavirus strain DS-1 | 105 Participants |
| Adults: 90 µg P2-VP8 | Number of Infants With Neutralizing Antibody Responses 4 Weeks After the Third Vaccination to Each Rotavirus Strain | Any 2 strains | 108 Participants |
| Adults: 90 µg P2-VP8 | Number of Infants With Neutralizing Antibody Responses 4 Weeks After the Third Vaccination to Each Rotavirus Strain | All 3 strains | 81 Participants |
| Toddlers: Placebo | Number of Infants With Neutralizing Antibody Responses 4 Weeks After the Third Vaccination to Each Rotavirus Strain | Any 2 strains | 114 Participants |
| Toddlers: Placebo | Number of Infants With Neutralizing Antibody Responses 4 Weeks After the Third Vaccination to Each Rotavirus Strain | Rotavirus strain DS-1 | 108 Participants |
| Toddlers: Placebo | Number of Infants With Neutralizing Antibody Responses 4 Weeks After the Third Vaccination to Each Rotavirus Strain | Rotavirus strain Wa | 105 Participants |
| Toddlers: Placebo | Number of Infants With Neutralizing Antibody Responses 4 Weeks After the Third Vaccination to Each Rotavirus Strain | Rotavirus strain 1076 | 109 Participants |
| Toddlers: Placebo | Number of Infants With Neutralizing Antibody Responses 4 Weeks After the Third Vaccination to Each Rotavirus Strain | All 3 strains | 83 Participants |
Primary
Number of Participants Experiencing Adverse Events (AE) Within 28 Days of Any Vaccination
Any symptom starting after 7 days post any study injection was recorded as an adverse event. A serious adverse event (SAE) is any event that occurred from the first dose of study drug that resulted in any of the following outcomes: 1. Death 2. Life-threatening AE 3. Inpatient hospitalization or prolongation of existing hospitalization 4. Persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions 5. Congenital abnormality or birth defect 6. Important medical event that may not result in one of the above outcomes but may jeopardize the health of the study participant or require medical or surgical intervention to prevent one of the outcomes listed above. The severity of adverse events was graded from Mild (grade 1) to Life Threatening (grade 4). AEs related to study drug were those events for which there was a reasonable possibility that the study drug caused the event In the opinion of the site investigator.
Time frame: Up to 28 days after any vaccination (up to Day 28 for toddlers and up to Day 84 for infants and adults)
Population: Safety population included all participants who were randomized and received at least one injection of the study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Adults: Placebo | Number of Participants Experiencing Adverse Events (AE) Within 28 Days of Any Vaccination | Any serious adverse event | 0 Participants |
| Adults: Placebo | Number of Participants Experiencing Adverse Events (AE) Within 28 Days of Any Vaccination | Any AE related to study drug | 0 Participants |
| Adults: Placebo | Number of Participants Experiencing Adverse Events (AE) Within 28 Days of Any Vaccination | Any grade 2 or higher AE | 0 Participants |
| Adults: Placebo | Number of Participants Experiencing Adverse Events (AE) Within 28 Days of Any Vaccination | Any grade 2 or higher AE related to study drug | 0 Participants |
| Adults: Placebo | Number of Participants Experiencing Adverse Events (AE) Within 28 Days of Any Vaccination | Any AE | 2 Participants |
| Adults: 30 µg P2-VP8 | Number of Participants Experiencing Adverse Events (AE) Within 28 Days of Any Vaccination | Any AE | 8 Participants |
| Adults: 30 µg P2-VP8 | Number of Participants Experiencing Adverse Events (AE) Within 28 Days of Any Vaccination | Any grade 2 or higher AE related to study drug | 0 Participants |
| Adults: 30 µg P2-VP8 | Number of Participants Experiencing Adverse Events (AE) Within 28 Days of Any Vaccination | Any serious adverse event | 0 Participants |
| Adults: 30 µg P2-VP8 | Number of Participants Experiencing Adverse Events (AE) Within 28 Days of Any Vaccination | Any AE related to study drug | 0 Participants |
| Adults: 30 µg P2-VP8 | Number of Participants Experiencing Adverse Events (AE) Within 28 Days of Any Vaccination | Any grade 2 or higher AE | 2 Participants |
| Adults: 90 µg P2-VP8 | Number of Participants Experiencing Adverse Events (AE) Within 28 Days of Any Vaccination | Any AE related to study drug | 1 Participants |
| Adults: 90 µg P2-VP8 | Number of Participants Experiencing Adverse Events (AE) Within 28 Days of Any Vaccination | Any serious adverse event | 0 Participants |
| Adults: 90 µg P2-VP8 | Number of Participants Experiencing Adverse Events (AE) Within 28 Days of Any Vaccination | Any grade 2 or higher AE related to study drug | 0 Participants |
| Adults: 90 µg P2-VP8 | Number of Participants Experiencing Adverse Events (AE) Within 28 Days of Any Vaccination | Any AE | 9 Participants |
| Adults: 90 µg P2-VP8 | Number of Participants Experiencing Adverse Events (AE) Within 28 Days of Any Vaccination | Any grade 2 or higher AE | 1 Participants |
| Toddlers: Placebo | Number of Participants Experiencing Adverse Events (AE) Within 28 Days of Any Vaccination | Any serious adverse event | 0 Participants |
| Toddlers: Placebo | Number of Participants Experiencing Adverse Events (AE) Within 28 Days of Any Vaccination | Any grade 2 or higher AE | 0 Participants |
| Toddlers: Placebo | Number of Participants Experiencing Adverse Events (AE) Within 28 Days of Any Vaccination | Any grade 2 or higher AE related to study drug | 0 Participants |
| Toddlers: Placebo | Number of Participants Experiencing Adverse Events (AE) Within 28 Days of Any Vaccination | Any AE | 3 Participants |
| Toddlers: Placebo | Number of Participants Experiencing Adverse Events (AE) Within 28 Days of Any Vaccination | Any AE related to study drug | 0 Participants |
| Toddlers: 30 µg P2-VP8 | Number of Participants Experiencing Adverse Events (AE) Within 28 Days of Any Vaccination | Any serious adverse event | 1 Participants |
| Toddlers: 30 µg P2-VP8 | Number of Participants Experiencing Adverse Events (AE) Within 28 Days of Any Vaccination | Any AE related to study drug | 0 Participants |
| Toddlers: 30 µg P2-VP8 | Number of Participants Experiencing Adverse Events (AE) Within 28 Days of Any Vaccination | Any grade 2 or higher AE | 1 Participants |
| Toddlers: 30 µg P2-VP8 | Number of Participants Experiencing Adverse Events (AE) Within 28 Days of Any Vaccination | Any grade 2 or higher AE related to study drug | 0 Participants |
| Toddlers: 30 µg P2-VP8 | Number of Participants Experiencing Adverse Events (AE) Within 28 Days of Any Vaccination | Any AE | 8 Participants |
| Toddlers: 90 µg P2-VP8 | Number of Participants Experiencing Adverse Events (AE) Within 28 Days of Any Vaccination | Any grade 2 or higher AE related to study drug | 0 Participants |
| Toddlers: 90 µg P2-VP8 | Number of Participants Experiencing Adverse Events (AE) Within 28 Days of Any Vaccination | Any AE | 6 Participants |
| Toddlers: 90 µg P2-VP8 | Number of Participants Experiencing Adverse Events (AE) Within 28 Days of Any Vaccination | Any serious adverse event | 0 Participants |
| Toddlers: 90 µg P2-VP8 | Number of Participants Experiencing Adverse Events (AE) Within 28 Days of Any Vaccination | Any AE related to study drug | 0 Participants |
| Toddlers: 90 µg P2-VP8 | Number of Participants Experiencing Adverse Events (AE) Within 28 Days of Any Vaccination | Any grade 2 or higher AE | 1 Participants |
| Infants: Placebo | Number of Participants Experiencing Adverse Events (AE) Within 28 Days of Any Vaccination | Any AE | 119 Participants |
| Infants: Placebo | Number of Participants Experiencing Adverse Events (AE) Within 28 Days of Any Vaccination | Any serious adverse event | 4 Participants |
| Infants: Placebo | Number of Participants Experiencing Adverse Events (AE) Within 28 Days of Any Vaccination | Any grade 2 or higher AE | 19 Participants |
| Infants: Placebo | Number of Participants Experiencing Adverse Events (AE) Within 28 Days of Any Vaccination | Any AE related to study drug | 3 Participants |
| Infants: Placebo | Number of Participants Experiencing Adverse Events (AE) Within 28 Days of Any Vaccination | Any grade 2 or higher AE related to study drug | 1 Participants |
| Infants: 15 µg P2-VP8 | Number of Participants Experiencing Adverse Events (AE) Within 28 Days of Any Vaccination | Any AE related to study drug | 2 Participants |
| Infants: 15 µg P2-VP8 | Number of Participants Experiencing Adverse Events (AE) Within 28 Days of Any Vaccination | Any AE | 118 Participants |
| Infants: 15 µg P2-VP8 | Number of Participants Experiencing Adverse Events (AE) Within 28 Days of Any Vaccination | Any serious adverse event | 8 Participants |
| Infants: 15 µg P2-VP8 | Number of Participants Experiencing Adverse Events (AE) Within 28 Days of Any Vaccination | Any grade 2 or higher AE related to study drug | 0 Participants |
| Infants: 15 µg P2-VP8 | Number of Participants Experiencing Adverse Events (AE) Within 28 Days of Any Vaccination | Any grade 2 or higher AE | 24 Participants |
| Infants: 30 µg P2-VP8 | Number of Participants Experiencing Adverse Events (AE) Within 28 Days of Any Vaccination | Any grade 2 or higher AE | 18 Participants |
| Infants: 30 µg P2-VP8 | Number of Participants Experiencing Adverse Events (AE) Within 28 Days of Any Vaccination | Any AE | 122 Participants |
| Infants: 30 µg P2-VP8 | Number of Participants Experiencing Adverse Events (AE) Within 28 Days of Any Vaccination | Any grade 2 or higher AE related to study drug | 1 Participants |
| Infants: 30 µg P2-VP8 | Number of Participants Experiencing Adverse Events (AE) Within 28 Days of Any Vaccination | Any AE related to study drug | 3 Participants |
| Infants: 30 µg P2-VP8 | Number of Participants Experiencing Adverse Events (AE) Within 28 Days of Any Vaccination | Any serious adverse event | 4 Participants |
| Infants: 90 µg P2-VP8 | Number of Participants Experiencing Adverse Events (AE) Within 28 Days of Any Vaccination | Any AE | 124 Participants |
| Infants: 90 µg P2-VP8 | Number of Participants Experiencing Adverse Events (AE) Within 28 Days of Any Vaccination | Any AE related to study drug | 2 Participants |
| Infants: 90 µg P2-VP8 | Number of Participants Experiencing Adverse Events (AE) Within 28 Days of Any Vaccination | Any grade 2 or higher AE related to study drug | 1 Participants |
| Infants: 90 µg P2-VP8 | Number of Participants Experiencing Adverse Events (AE) Within 28 Days of Any Vaccination | Any grade 2 or higher AE | 20 Participants |
| Infants: 90 µg P2-VP8 | Number of Participants Experiencing Adverse Events (AE) Within 28 Days of Any Vaccination | Any serious adverse event | 4 Participants |
Primary
Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination
Reactogenicity data (solicited signs or symptoms) were assessed for 7 days after each injection. Participants and parents were instructed to assess and record daily local reactions (injection site pain/tenderness, redness, swelling, itching), as well as systemic signs and symptoms (fever, headache, vomiting, nausea, fatigue, chills and myalgia for adults; and fever, vomiting, decreased appetite, irritability, and decreased activity for toddlers and infants) in a participant memory aid. Reactions were graded on a scale from mild (Grade 1) to life-threatening (Grade 4). The overall number of participants who experienced any local or systemic reaction is reported. Grades are based on maximum severity per participant.
Time frame: 7 days following each vaccination
Population: Safety population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Adults: Placebo | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Systemic reaction: Grade 1 | 5 Participants |
| Adults: Placebo | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Local reaction: Grade 1 | 1 Participants |
| Adults: Placebo | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Systemic reaction : Grade 2 | 0 Participants |
| Adults: Placebo | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Any systemic reaction | 5 Participants |
| Adults: Placebo | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Local reaction: Grade 4 | 0 Participants |
| Adults: Placebo | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Systemic reaction: Grade 3 | 0 Participants |
| Adults: Placebo | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Any local reaction | 1 Participants |
| Adults: Placebo | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Local reaction: Grade 3 | 0 Participants |
| Adults: Placebo | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Local reaction: Grade 2 | 0 Participants |
| Adults: Placebo | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Systemic reaction: Grade 4 | 0 Participants |
| Adults: 30 µg P2-VP8 | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Local reaction: Grade 1 | 6 Participants |
| Adults: 30 µg P2-VP8 | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Systemic reaction: Grade 1 | 6 Participants |
| Adults: 30 µg P2-VP8 | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Systemic reaction: Grade 4 | 0 Participants |
| Adults: 30 µg P2-VP8 | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Local reaction: Grade 2 | 1 Participants |
| Adults: 30 µg P2-VP8 | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Local reaction: Grade 3 | 0 Participants |
| Adults: 30 µg P2-VP8 | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Systemic reaction: Grade 3 | 0 Participants |
| Adults: 30 µg P2-VP8 | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Local reaction: Grade 4 | 0 Participants |
| Adults: 30 µg P2-VP8 | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Any local reaction | 7 Participants |
| Adults: 30 µg P2-VP8 | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Any systemic reaction | 6 Participants |
| Adults: 30 µg P2-VP8 | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Systemic reaction : Grade 2 | 0 Participants |
| Adults: 90 µg P2-VP8 | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Systemic reaction: Grade 1 | 6 Participants |
| Adults: 90 µg P2-VP8 | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Any local reaction | 9 Participants |
| Adults: 90 µg P2-VP8 | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Local reaction: Grade 4 | 0 Participants |
| Adults: 90 µg P2-VP8 | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Systemic reaction : Grade 2 | 3 Participants |
| Adults: 90 µg P2-VP8 | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Local reaction: Grade 1 | 6 Participants |
| Adults: 90 µg P2-VP8 | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Local reaction: Grade 3 | 0 Participants |
| Adults: 90 µg P2-VP8 | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Local reaction: Grade 2 | 3 Participants |
| Adults: 90 µg P2-VP8 | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Systemic reaction: Grade 4 | 0 Participants |
| Adults: 90 µg P2-VP8 | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Systemic reaction: Grade 3 | 0 Participants |
| Adults: 90 µg P2-VP8 | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Any systemic reaction | 9 Participants |
| Toddlers: Placebo | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Any local reaction | 2 Participants |
| Toddlers: Placebo | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Any systemic reaction | 4 Participants |
| Toddlers: Placebo | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Local reaction: Grade 2 | 0 Participants |
| Toddlers: Placebo | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Local reaction: Grade 4 | 0 Participants |
| Toddlers: Placebo | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Local reaction: Grade 1 | 2 Participants |
| Toddlers: Placebo | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Systemic reaction: Grade 1 | 3 Participants |
| Toddlers: Placebo | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Local reaction: Grade 3 | 0 Participants |
| Toddlers: Placebo | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Systemic reaction : Grade 2 | 1 Participants |
| Toddlers: Placebo | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Systemic reaction: Grade 4 | 0 Participants |
| Toddlers: Placebo | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Systemic reaction: Grade 3 | 0 Participants |
| Toddlers: 30 µg P2-VP8 | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Systemic reaction: Grade 4 | 0 Participants |
| Toddlers: 30 µg P2-VP8 | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Systemic reaction: Grade 3 | 0 Participants |
| Toddlers: 30 µg P2-VP8 | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Local reaction: Grade 2 | 2 Participants |
| Toddlers: 30 µg P2-VP8 | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Any local reaction | 6 Participants |
| Toddlers: 30 µg P2-VP8 | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Any systemic reaction | 5 Participants |
| Toddlers: 30 µg P2-VP8 | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Local reaction: Grade 3 | 0 Participants |
| Toddlers: 30 µg P2-VP8 | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Systemic reaction: Grade 1 | 5 Participants |
| Toddlers: 30 µg P2-VP8 | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Local reaction: Grade 4 | 0 Participants |
| Toddlers: 30 µg P2-VP8 | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Systemic reaction : Grade 2 | 0 Participants |
| Toddlers: 30 µg P2-VP8 | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Local reaction: Grade 1 | 4 Participants |
| Toddlers: 90 µg P2-VP8 | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Local reaction: Grade 4 | 0 Participants |
| Toddlers: 90 µg P2-VP8 | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Systemic reaction: Grade 1 | 2 Participants |
| Toddlers: 90 µg P2-VP8 | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Any systemic reaction | 2 Participants |
| Toddlers: 90 µg P2-VP8 | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Local reaction: Grade 3 | 0 Participants |
| Toddlers: 90 µg P2-VP8 | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Local reaction: Grade 2 | 0 Participants |
| Toddlers: 90 µg P2-VP8 | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Any local reaction | 2 Participants |
| Toddlers: 90 µg P2-VP8 | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Systemic reaction: Grade 3 | 0 Participants |
| Toddlers: 90 µg P2-VP8 | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Systemic reaction: Grade 4 | 0 Participants |
| Toddlers: 90 µg P2-VP8 | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Local reaction: Grade 1 | 2 Participants |
| Toddlers: 90 µg P2-VP8 | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Systemic reaction : Grade 2 | 0 Participants |
| Infants: Placebo | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Local reaction: Grade 2 | 9 Participants |
| Infants: Placebo | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Any local reaction | 93 Participants |
| Infants: Placebo | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Local reaction: Grade 1 | 84 Participants |
| Infants: Placebo | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Local reaction: Grade 3 | 0 Participants |
| Infants: Placebo | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Local reaction: Grade 4 | 0 Participants |
| Infants: Placebo | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Any systemic reaction | 116 Participants |
| Infants: Placebo | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Systemic reaction: Grade 1 | 86 Participants |
| Infants: Placebo | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Systemic reaction : Grade 2 | 30 Participants |
| Infants: Placebo | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Systemic reaction: Grade 3 | 0 Participants |
| Infants: Placebo | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Systemic reaction: Grade 4 | 0 Participants |
| Infants: 15 µg P2-VP8 | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Local reaction: Grade 1 | 83 Participants |
| Infants: 15 µg P2-VP8 | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Systemic reaction : Grade 2 | 39 Participants |
| Infants: 15 µg P2-VP8 | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Any local reaction | 102 Participants |
| Infants: 15 µg P2-VP8 | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Local reaction: Grade 2 | 19 Participants |
| Infants: 15 µg P2-VP8 | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Systemic reaction: Grade 1 | 70 Participants |
| Infants: 15 µg P2-VP8 | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Any systemic reaction | 114 Participants |
| Infants: 15 µg P2-VP8 | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Local reaction: Grade 3 | 0 Participants |
| Infants: 15 µg P2-VP8 | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Local reaction: Grade 4 | 0 Participants |
| Infants: 15 µg P2-VP8 | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Systemic reaction: Grade 3 | 4 Participants |
| Infants: 15 µg P2-VP8 | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Systemic reaction: Grade 4 | 1 Participants |
| Infants: 30 µg P2-VP8 | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Any systemic reaction | 113 Participants |
| Infants: 30 µg P2-VP8 | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Local reaction: Grade 3 | 0 Participants |
| Infants: 30 µg P2-VP8 | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Any local reaction | 109 Participants |
| Infants: 30 µg P2-VP8 | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Systemic reaction: Grade 4 | 0 Participants |
| Infants: 30 µg P2-VP8 | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Local reaction: Grade 2 | 13 Participants |
| Infants: 30 µg P2-VP8 | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Local reaction: Grade 4 | 0 Participants |
| Infants: 30 µg P2-VP8 | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Systemic reaction : Grade 2 | 28 Participants |
| Infants: 30 µg P2-VP8 | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Systemic reaction: Grade 3 | 2 Participants |
| Infants: 30 µg P2-VP8 | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Systemic reaction: Grade 1 | 83 Participants |
| Infants: 30 µg P2-VP8 | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Local reaction: Grade 1 | 96 Participants |
| Infants: 90 µg P2-VP8 | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Systemic reaction: Grade 1 | 73 Participants |
| Infants: 90 µg P2-VP8 | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Local reaction: Grade 4 | 0 Participants |
| Infants: 90 µg P2-VP8 | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Systemic reaction : Grade 2 | 40 Participants |
| Infants: 90 µg P2-VP8 | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Local reaction: Grade 3 | 0 Participants |
| Infants: 90 µg P2-VP8 | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Local reaction: Grade 2 | 16 Participants |
| Infants: 90 µg P2-VP8 | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Local reaction: Grade 1 | 92 Participants |
| Infants: 90 µg P2-VP8 | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Systemic reaction: Grade 3 | 2 Participants |
| Infants: 90 µg P2-VP8 | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Any local reaction | 108 Participants |
| Infants: 90 µg P2-VP8 | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Systemic reaction: Grade 4 | 0 Participants |
| Infants: 90 µg P2-VP8 | Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination | Any systemic reaction | 115 Participants |
Secondary
Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen
Measured at Baseline and 28 days after the final injection (Day 84 for adults; Day 28 for toddlers).
Time frame: Baseline and Day 28 for toddlers or Day 84 for adults
Population: Per-protocol population participants with valid specimens at each time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Adults: Placebo | Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen | P[4]: Baseline | 151 titer |
| Adults: Placebo | Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen | P[4]: 28 days post-final vaccination | 202 titer |
| Adults: Placebo | Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen | P[6]: Baseline | 56 titer |
| Adults: Placebo | Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen | P[6]: 28 days post-final vaccination | 95 titer |
| Adults: Placebo | Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen | P[8]: Baseline | 119 titer |
| Adults: Placebo | Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen | P[8]: 28 days post-final vaccination | 194 titer |
| Adults: 30 µg P2-VP8 | Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen | P[4]: 28 days post-final vaccination | 4685 titer |
| Adults: 30 µg P2-VP8 | Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen | P[6]: 28 days post-final vaccination | 2470 titer |
| Adults: 30 µg P2-VP8 | Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen | P[8]: 28 days post-final vaccination | 3590 titer |
| Adults: 30 µg P2-VP8 | Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen | P[4]: Baseline | 186 titer |
| Adults: 30 µg P2-VP8 | Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen | P[6]: Baseline | 120 titer |
| Adults: 30 µg P2-VP8 | Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen | P[8]: Baseline | 151 titer |
| Adults: 90 µg P2-VP8 | Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen | P[8]: 28 days post-final vaccination | 2350 titer |
| Adults: 90 µg P2-VP8 | Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen | P[8]: Baseline | 89 titer |
| Adults: 90 µg P2-VP8 | Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen | P[6]: 28 days post-final vaccination | 1864 titer |
| Adults: 90 µg P2-VP8 | Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen | P[6]: Baseline | 113 titer |
| Adults: 90 µg P2-VP8 | Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen | P[4]: Baseline | 143 titer |
| Adults: 90 µg P2-VP8 | Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen | P[4]: 28 days post-final vaccination | 4533 titer |
| Toddlers: Placebo | Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen | P[6]: 28 days post-final vaccination | 15 titer |
| Toddlers: Placebo | Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen | P[4]: 28 days post-final vaccination | 221 titer |
| Toddlers: Placebo | Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen | P[6]: Baseline | 16 titer |
| Toddlers: Placebo | Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen | P[8]: 28 days post-final vaccination | 211 titer |
| Toddlers: Placebo | Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen | P[8]: Baseline | 136 titer |
| Toddlers: Placebo | Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen | P[4]: Baseline | 174 titer |
| Toddlers: 30 µg P2-VP8 | Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen | P[4]: Baseline | 124 titer |
| Toddlers: 30 µg P2-VP8 | Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen | P[8]: Baseline | 83 titer |
| Toddlers: 30 µg P2-VP8 | Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen | P[4]: 28 days post-final vaccination | 629 titer |
| Toddlers: 30 µg P2-VP8 | Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen | P[6]: Baseline | 55 titer |
| Toddlers: 30 µg P2-VP8 | Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen | P[6]: 28 days post-final vaccination | 198 titer |
| Toddlers: 30 µg P2-VP8 | Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen | P[8]: 28 days post-final vaccination | 928 titer |
| Toddlers: 90 µg P2-VP8 | Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen | P[6]: 28 days post-final vaccination | 101 titer |
| Toddlers: 90 µg P2-VP8 | Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen | P[6]: Baseline | 15 titer |
| Toddlers: 90 µg P2-VP8 | Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen | P[8]: Baseline | 41 titer |
| Toddlers: 90 µg P2-VP8 | Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen | P[8]: 28 days post-final vaccination | 530 titer |
| Toddlers: 90 µg P2-VP8 | Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen | P[4]: 28 days post-final vaccination | 443 titer |
| Toddlers: 90 µg P2-VP8 | Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen | P[4]: Baseline | 49 titer |
Secondary
Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen
Measured at Baseline and 28 days after the final injection (Day 84 for adults; Day 28 for toddlers).
Time frame: Baseline and Day 28 for toddlers or Day 84 for adults
Population: Per protocol population; participants with valid specimens at each time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Adults: Placebo | Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen | P[4]: Baseline | 425 titer |
| Adults: Placebo | Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen | P[4]: 28 days post-final vaccination | 311 titer |
| Adults: Placebo | Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen | P[6]: Baseline | 89 titer |
| Adults: Placebo | Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen | P[6]: 28 days post-final vaccination | 89 titer |
| Adults: Placebo | Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen | P[8]: Baseline | 140 titer |
| Adults: Placebo | Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen | P[8]: 28 days post-final vaccination | 113 titer |
| Adults: 30 µg P2-VP8 | Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen | P[4]: 28 days post-final vaccination | 11642 titer |
| Adults: 30 µg P2-VP8 | Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen | P[6]: 28 days post-final vaccination | 22120 titer |
| Adults: 30 µg P2-VP8 | Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen | P[8]: 28 days post-final vaccination | 11355 titer |
| Adults: 30 µg P2-VP8 | Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen | P[4]: Baseline | 358 titer |
| Adults: 30 µg P2-VP8 | Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen | P[6]: Baseline | 251 titer |
| Adults: 30 µg P2-VP8 | Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen | P[8]: Baseline | 205 titer |
| Adults: 90 µg P2-VP8 | Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen | P[8]: 28 days post-final vaccination | 14557 titer |
| Adults: 90 µg P2-VP8 | Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen | P[8]: Baseline | 220 titer |
| Adults: 90 µg P2-VP8 | Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen | P[6]: 28 days post-final vaccination | 29706 titer |
| Adults: 90 µg P2-VP8 | Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen | P[6]: Baseline | 234 titer |
| Adults: 90 µg P2-VP8 | Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen | P[4]: Baseline | 444 titer |
| Adults: 90 µg P2-VP8 | Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen | P[4]: 28 days post-final vaccination | 13337 titer |
| Toddlers: Placebo | Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen | P[6]: 28 days post-final vaccination | 72 titer |
| Toddlers: Placebo | Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen | P[4]: 28 days post-final vaccination | 174 titer |
| Toddlers: Placebo | Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen | P[6]: Baseline | 58 titer |
| Toddlers: Placebo | Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen | P[8]: 28 days post-final vaccination | 294 titer |
| Toddlers: Placebo | Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen | P[8]: Baseline | 229 titer |
| Toddlers: Placebo | Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen | P[4]: Baseline | 183 titer |
| Toddlers: 30 µg P2-VP8 | Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen | P[4]: Baseline | 195 titer |
| Toddlers: 30 µg P2-VP8 | Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen | P[8]: Baseline | 113 titer |
| Toddlers: 30 µg P2-VP8 | Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen | P[4]: 28 days post-final vaccination | 920 titer |
| Toddlers: 30 µg P2-VP8 | Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen | P[6]: Baseline | 172 titer |
| Toddlers: 30 µg P2-VP8 | Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen | P[6]: 28 days post-final vaccination | 1767 titer |
| Toddlers: 30 µg P2-VP8 | Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen | P[8]: 28 days post-final vaccination | 1207 titer |
| Toddlers: 90 µg P2-VP8 | Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen | P[6]: 28 days post-final vaccination | 2515 titer |
| Toddlers: 90 µg P2-VP8 | Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen | P[6]: Baseline | 150 titer |
| Toddlers: 90 µg P2-VP8 | Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen | P[8]: Baseline | 231 titer |
| Toddlers: 90 µg P2-VP8 | Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen | P[8]: 28 days post-final vaccination | 4059 titer |
| Toddlers: 90 µg P2-VP8 | Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen | P[4]: 28 days post-final vaccination | 2396 titer |
| Toddlers: 90 µg P2-VP8 | Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen | P[4]: Baseline | 282 titer |
Secondary
Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Adults and Toddlers
Measured at Baseline and 28 days after the final injection (Day 84 for adults; Day 28 for toddlers).
Time frame: Baseline and Day 28 for toddlers or Day 84 for adults
Population: Per-protocol population participants with valid specimens at each time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Adults: Placebo | Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Adults and Toddlers | Strain DS-1: 28 days post-final vaccination | 59 titer |
| Adults: Placebo | Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Adults and Toddlers | Strain Wa: Baseline | 317 titer |
| Adults: Placebo | Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Adults and Toddlers | Strain Wa: 28 days post-final vaccination | 244 titer |
| Adults: Placebo | Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Adults and Toddlers | Strain 1076: 28 days post-final vaccination | 43 titer |
| Adults: Placebo | Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Adults and Toddlers | Strain DS-1: Baseline | 76 titer |
| Adults: Placebo | Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Adults and Toddlers | Strain 1076: Baseline | 77 titer |
| Adults: 30 µg P2-VP8 | Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Adults and Toddlers | Strain DS-1: Baseline | 114 titer |
| Adults: 30 µg P2-VP8 | Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Adults and Toddlers | Strain DS-1: 28 days post-final vaccination | 390 titer |
| Adults: 30 µg P2-VP8 | Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Adults and Toddlers | Strain Wa: Baseline | 448 titer |
| Adults: 30 µg P2-VP8 | Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Adults and Toddlers | Strain Wa: 28 days post-final vaccination | 913 titer |
| Adults: 30 µg P2-VP8 | Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Adults and Toddlers | Strain 1076: Baseline | 175 titer |
| Adults: 30 µg P2-VP8 | Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Adults and Toddlers | Strain 1076: 28 days post-final vaccination | 354 titer |
| Adults: 90 µg P2-VP8 | Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Adults and Toddlers | Strain 1076: 28 days post-final vaccination | 284 titer |
| Adults: 90 µg P2-VP8 | Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Adults and Toddlers | Strain Wa: 28 days post-final vaccination | 815 titer |
| Adults: 90 µg P2-VP8 | Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Adults and Toddlers | Strain DS-1: Baseline | 119 titer |
| Adults: 90 µg P2-VP8 | Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Adults and Toddlers | Strain 1076: Baseline | 152 titer |
| Adults: 90 µg P2-VP8 | Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Adults and Toddlers | Strain DS-1: 28 days post-final vaccination | 317 titer |
| Adults: 90 µg P2-VP8 | Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Adults and Toddlers | Strain Wa: Baseline | 276 titer |
| Toddlers: Placebo | Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Adults and Toddlers | Strain DS-1: Baseline | 16 titer |
| Toddlers: Placebo | Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Adults and Toddlers | Strain Wa: Baseline | 77 titer |
| Toddlers: Placebo | Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Adults and Toddlers | Strain Wa: 28 days post-final vaccination | 78 titer |
| Toddlers: Placebo | Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Adults and Toddlers | Strain DS-1: 28 days post-final vaccination | 15 titer |
| Toddlers: Placebo | Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Adults and Toddlers | Strain 1076: Baseline | 13 titer |
| Toddlers: Placebo | Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Adults and Toddlers | Strain 1076: 28 days post-final vaccination | 15 titer |
| Toddlers: 30 µg P2-VP8 | Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Adults and Toddlers | Strain Wa: 28 days post-final vaccination | 147 titer |
| Toddlers: 30 µg P2-VP8 | Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Adults and Toddlers | Strain 1076: 28 days post-final vaccination | 30 titer |
| Toddlers: 30 µg P2-VP8 | Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Adults and Toddlers | Strain Wa: Baseline | 131 titer |
| Toddlers: 30 µg P2-VP8 | Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Adults and Toddlers | Strain 1076: Baseline | 28 titer |
| Toddlers: 30 µg P2-VP8 | Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Adults and Toddlers | Strain DS-1: 28 days post-final vaccination | 40 titer |
| Toddlers: 30 µg P2-VP8 | Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Adults and Toddlers | Strain DS-1: Baseline | 29 titer |
| Toddlers: 90 µg P2-VP8 | Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Adults and Toddlers | Strain DS-1: 28 days post-final vaccination | 60 titer |
| Toddlers: 90 µg P2-VP8 | Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Adults and Toddlers | Strain Wa: 28 days post-final vaccination | 253 titer |
| Toddlers: 90 µg P2-VP8 | Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Adults and Toddlers | Strain 1076: Baseline | 16 titer |
| Toddlers: 90 µg P2-VP8 | Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Adults and Toddlers | Strain Wa: Baseline | 67 titer |
| Toddlers: 90 µg P2-VP8 | Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Adults and Toddlers | Strain 1076: 28 days post-final vaccination | 25 titer |
| Toddlers: 90 µg P2-VP8 | Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Adults and Toddlers | Strain DS-1: Baseline | 20 titer |
Secondary
Number of Adults and Toddlers With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse, by Vaccine Antigen
Seroresponse was defined as a four-fold rise or greater in IgA antibody titer between Baseline and 28 days after the final injection (Day 84 for adults and Day 28 for toddlers). Measured by enzyme-linked immunosorbent assay (ELISA).
Time frame: Day 84 for adults; Day 28 for toddlers
Population: Per-protocol population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Adults: Placebo | Number of Adults and Toddlers With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse, by Vaccine Antigen | Any 2 antigens | 0 Participants |
| Adults: Placebo | Number of Adults and Toddlers With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse, by Vaccine Antigen | P[6] | 0 Participants |
| Adults: Placebo | Number of Adults and Toddlers With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse, by Vaccine Antigen | P[4] | 0 Participants |
| Adults: Placebo | Number of Adults and Toddlers With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse, by Vaccine Antigen | All 3 antigens | 0 Participants |
| Adults: Placebo | Number of Adults and Toddlers With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse, by Vaccine Antigen | P[8] | 0 Participants |
| Adults: 30 µg P2-VP8 | Number of Adults and Toddlers With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse, by Vaccine Antigen | P[6] | 9 Participants |
| Adults: 30 µg P2-VP8 | Number of Adults and Toddlers With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse, by Vaccine Antigen | Any 2 antigens | 11 Participants |
| Adults: 30 µg P2-VP8 | Number of Adults and Toddlers With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse, by Vaccine Antigen | P[4] | 11 Participants |
| Adults: 30 µg P2-VP8 | Number of Adults and Toddlers With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse, by Vaccine Antigen | All 3 antigens | 9 Participants |
| Adults: 30 µg P2-VP8 | Number of Adults and Toddlers With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse, by Vaccine Antigen | P[8] | 11 Participants |
| Adults: 90 µg P2-VP8 | Number of Adults and Toddlers With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse, by Vaccine Antigen | P[6] | 9 Participants |
| Adults: 90 µg P2-VP8 | Number of Adults and Toddlers With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse, by Vaccine Antigen | Any 2 antigens | 10 Participants |
| Adults: 90 µg P2-VP8 | Number of Adults and Toddlers With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse, by Vaccine Antigen | All 3 antigens | 9 Participants |
| Adults: 90 µg P2-VP8 | Number of Adults and Toddlers With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse, by Vaccine Antigen | P[8] | 10 Participants |
| Adults: 90 µg P2-VP8 | Number of Adults and Toddlers With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse, by Vaccine Antigen | P[4] | 11 Participants |
| Toddlers: Placebo | Number of Adults and Toddlers With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse, by Vaccine Antigen | P[8] | 0 Participants |
| Toddlers: Placebo | Number of Adults and Toddlers With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse, by Vaccine Antigen | P[4] | 0 Participants |
| Toddlers: Placebo | Number of Adults and Toddlers With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse, by Vaccine Antigen | P[6] | 0 Participants |
| Toddlers: Placebo | Number of Adults and Toddlers With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse, by Vaccine Antigen | Any 2 antigens | 0 Participants |
| Toddlers: Placebo | Number of Adults and Toddlers With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse, by Vaccine Antigen | All 3 antigens | 0 Participants |
| Toddlers: 30 µg P2-VP8 | Number of Adults and Toddlers With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse, by Vaccine Antigen | Any 2 antigens | 9 Participants |
| Toddlers: 30 µg P2-VP8 | Number of Adults and Toddlers With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse, by Vaccine Antigen | P[4] | 8 Participants |
| Toddlers: 30 µg P2-VP8 | Number of Adults and Toddlers With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse, by Vaccine Antigen | All 3 antigens | 5 Participants |
| Toddlers: 30 µg P2-VP8 | Number of Adults and Toddlers With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse, by Vaccine Antigen | P[6] | 6 Participants |
| Toddlers: 30 µg P2-VP8 | Number of Adults and Toddlers With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse, by Vaccine Antigen | P[8] | 10 Participants |
| Toddlers: 90 µg P2-VP8 | Number of Adults and Toddlers With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse, by Vaccine Antigen | P[4] | 11 Participants |
| Toddlers: 90 µg P2-VP8 | Number of Adults and Toddlers With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse, by Vaccine Antigen | Any 2 antigens | 10 Participants |
| Toddlers: 90 µg P2-VP8 | Number of Adults and Toddlers With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse, by Vaccine Antigen | P[6] | 8 Participants |
| Toddlers: 90 µg P2-VP8 | Number of Adults and Toddlers With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse, by Vaccine Antigen | All 3 antigens | 8 Participants |
| Toddlers: 90 µg P2-VP8 | Number of Adults and Toddlers With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse, by Vaccine Antigen | P[8] | 10 Participants |
Secondary
Number of Adults and Toddlers With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse, by Vaccine Antigen
Seroresponse was defined as a four-fold rise or greater in IgG antibody titer between Baseline and 28 days after the final injection (Day 84 for adults and Day 28 for toddlers). Measured by enzyme-linked immunosorbent assay (ELISA).
Time frame: Day 84 for adults; Day 28 for toddlers
Population: Per-protocol population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Adults: Placebo | Number of Adults and Toddlers With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse, by Vaccine Antigen | Any 2 antigens | 0 Participants |
| Adults: Placebo | Number of Adults and Toddlers With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse, by Vaccine Antigen | P[6] | 0 Participants |
| Adults: Placebo | Number of Adults and Toddlers With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse, by Vaccine Antigen | P[4] | 0 Participants |
| Adults: Placebo | Number of Adults and Toddlers With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse, by Vaccine Antigen | All 3 antigens | 0 Participants |
| Adults: Placebo | Number of Adults and Toddlers With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse, by Vaccine Antigen | P[8] | 0 Participants |
| Adults: 30 µg P2-VP8 | Number of Adults and Toddlers With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse, by Vaccine Antigen | P[6] | 10 Participants |
| Adults: 30 µg P2-VP8 | Number of Adults and Toddlers With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse, by Vaccine Antigen | Any 2 antigens | 11 Participants |
| Adults: 30 µg P2-VP8 | Number of Adults and Toddlers With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse, by Vaccine Antigen | P[4] | 11 Participants |
| Adults: 30 µg P2-VP8 | Number of Adults and Toddlers With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse, by Vaccine Antigen | All 3 antigens | 10 Participants |
| Adults: 30 µg P2-VP8 | Number of Adults and Toddlers With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse, by Vaccine Antigen | P[8] | 11 Participants |
| Adults: 90 µg P2-VP8 | Number of Adults and Toddlers With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse, by Vaccine Antigen | P[6] | 11 Participants |
| Adults: 90 µg P2-VP8 | Number of Adults and Toddlers With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse, by Vaccine Antigen | Any 2 antigens | 11 Participants |
| Adults: 90 µg P2-VP8 | Number of Adults and Toddlers With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse, by Vaccine Antigen | All 3 antigens | 11 Participants |
| Adults: 90 µg P2-VP8 | Number of Adults and Toddlers With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse, by Vaccine Antigen | P[8] | 11 Participants |
| Adults: 90 µg P2-VP8 | Number of Adults and Toddlers With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse, by Vaccine Antigen | P[4] | 11 Participants |
| Toddlers: Placebo | Number of Adults and Toddlers With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse, by Vaccine Antigen | P[8] | 0 Participants |
| Toddlers: Placebo | Number of Adults and Toddlers With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse, by Vaccine Antigen | P[4] | 0 Participants |
| Toddlers: Placebo | Number of Adults and Toddlers With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse, by Vaccine Antigen | P[6] | 0 Participants |
| Toddlers: Placebo | Number of Adults and Toddlers With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse, by Vaccine Antigen | Any 2 antigens | 0 Participants |
| Toddlers: Placebo | Number of Adults and Toddlers With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse, by Vaccine Antigen | All 3 antigens | 0 Participants |
| Toddlers: 30 µg P2-VP8 | Number of Adults and Toddlers With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse, by Vaccine Antigen | Any 2 antigens | 9 Participants |
| Toddlers: 30 µg P2-VP8 | Number of Adults and Toddlers With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse, by Vaccine Antigen | P[4] | 7 Participants |
| Toddlers: 30 µg P2-VP8 | Number of Adults and Toddlers With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse, by Vaccine Antigen | All 3 antigens | 6 Participants |
| Toddlers: 30 µg P2-VP8 | Number of Adults and Toddlers With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse, by Vaccine Antigen | P[6] | 9 Participants |
| Toddlers: 30 µg P2-VP8 | Number of Adults and Toddlers With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse, by Vaccine Antigen | P[8] | 10 Participants |
| Toddlers: 90 µg P2-VP8 | Number of Adults and Toddlers With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse, by Vaccine Antigen | P[4] | 11 Participants |
| Toddlers: 90 µg P2-VP8 | Number of Adults and Toddlers With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse, by Vaccine Antigen | Any 2 antigens | 12 Participants |
| Toddlers: 90 µg P2-VP8 | Number of Adults and Toddlers With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse, by Vaccine Antigen | P[6] | 11 Participants |
| Toddlers: 90 µg P2-VP8 | Number of Adults and Toddlers With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse, by Vaccine Antigen | All 3 antigens | 8 Participants |
| Toddlers: 90 µg P2-VP8 | Number of Adults and Toddlers With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse, by Vaccine Antigen | P[8] | 10 Participants |
Secondary
Number of Adults and Toddlers With Neutralizing Antibody Responses to Each Rotavirus Strain
Neutralizing antibody response was defined as a ≥ 2.7-fold rise in antibody titer between Baseline and 28 days after the final injection (Day 84 for adults and Day 28 for toddlers) for each of the three rotavirus strains from which the vaccine antigens were derived (Wa, DS-1, and 1076).
Time frame: Day 84 for adults; Day 28 for toddlers
Population: Per-protocol population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Adults: Placebo | Number of Adults and Toddlers With Neutralizing Antibody Responses to Each Rotavirus Strain | Any 2 strains | 0 Participants |
| Adults: Placebo | Number of Adults and Toddlers With Neutralizing Antibody Responses to Each Rotavirus Strain | Rotavirus strain DS-1 | 0 Participants |
| Adults: Placebo | Number of Adults and Toddlers With Neutralizing Antibody Responses to Each Rotavirus Strain | Rotavirus strain Wa | 0 Participants |
| Adults: Placebo | Number of Adults and Toddlers With Neutralizing Antibody Responses to Each Rotavirus Strain | All 3 strains | 0 Participants |
| Adults: Placebo | Number of Adults and Toddlers With Neutralizing Antibody Responses to Each Rotavirus Strain | Rotavirus strain 1076 | 0 Participants |
| Adults: 30 µg P2-VP8 | Number of Adults and Toddlers With Neutralizing Antibody Responses to Each Rotavirus Strain | Rotavirus strain DS-1 | 5 Participants |
| Adults: 30 µg P2-VP8 | Number of Adults and Toddlers With Neutralizing Antibody Responses to Each Rotavirus Strain | Any 2 strains | 3 Participants |
| Adults: 30 µg P2-VP8 | Number of Adults and Toddlers With Neutralizing Antibody Responses to Each Rotavirus Strain | Rotavirus strain Wa | 3 Participants |
| Adults: 30 µg P2-VP8 | Number of Adults and Toddlers With Neutralizing Antibody Responses to Each Rotavirus Strain | All 3 strains | 1 Participants |
| Adults: 30 µg P2-VP8 | Number of Adults and Toddlers With Neutralizing Antibody Responses to Each Rotavirus Strain | Rotavirus strain 1076 | 2 Participants |
| Adults: 90 µg P2-VP8 | Number of Adults and Toddlers With Neutralizing Antibody Responses to Each Rotavirus Strain | Rotavirus strain DS-1 | 4 Participants |
| Adults: 90 µg P2-VP8 | Number of Adults and Toddlers With Neutralizing Antibody Responses to Each Rotavirus Strain | Any 2 strains | 3 Participants |
| Adults: 90 µg P2-VP8 | Number of Adults and Toddlers With Neutralizing Antibody Responses to Each Rotavirus Strain | All 3 strains | 3 Participants |
| Adults: 90 µg P2-VP8 | Number of Adults and Toddlers With Neutralizing Antibody Responses to Each Rotavirus Strain | Rotavirus strain 1076 | 3 Participants |
| Adults: 90 µg P2-VP8 | Number of Adults and Toddlers With Neutralizing Antibody Responses to Each Rotavirus Strain | Rotavirus strain Wa | 8 Participants |
| Toddlers: Placebo | Number of Adults and Toddlers With Neutralizing Antibody Responses to Each Rotavirus Strain | Rotavirus strain 1076 | 0 Participants |
| Toddlers: Placebo | Number of Adults and Toddlers With Neutralizing Antibody Responses to Each Rotavirus Strain | Rotavirus strain Wa | 0 Participants |
| Toddlers: Placebo | Number of Adults and Toddlers With Neutralizing Antibody Responses to Each Rotavirus Strain | Rotavirus strain DS-1 | 0 Participants |
| Toddlers: Placebo | Number of Adults and Toddlers With Neutralizing Antibody Responses to Each Rotavirus Strain | Any 2 strains | 0 Participants |
| Toddlers: Placebo | Number of Adults and Toddlers With Neutralizing Antibody Responses to Each Rotavirus Strain | All 3 strains | 0 Participants |
| Toddlers: 30 µg P2-VP8 | Number of Adults and Toddlers With Neutralizing Antibody Responses to Each Rotavirus Strain | Any 2 strains | 0 Participants |
| Toddlers: 30 µg P2-VP8 | Number of Adults and Toddlers With Neutralizing Antibody Responses to Each Rotavirus Strain | Rotavirus strain Wa | 1 Participants |
| Toddlers: 30 µg P2-VP8 | Number of Adults and Toddlers With Neutralizing Antibody Responses to Each Rotavirus Strain | All 3 strains | 0 Participants |
| Toddlers: 30 µg P2-VP8 | Number of Adults and Toddlers With Neutralizing Antibody Responses to Each Rotavirus Strain | Rotavirus strain DS-1 | 1 Participants |
| Toddlers: 30 µg P2-VP8 | Number of Adults and Toddlers With Neutralizing Antibody Responses to Each Rotavirus Strain | Rotavirus strain 1076 | 0 Participants |
| Toddlers: 90 µg P2-VP8 | Number of Adults and Toddlers With Neutralizing Antibody Responses to Each Rotavirus Strain | Rotavirus strain Wa | 5 Participants |
| Toddlers: 90 µg P2-VP8 | Number of Adults and Toddlers With Neutralizing Antibody Responses to Each Rotavirus Strain | Any 2 strains | 2 Participants |
| Toddlers: 90 µg P2-VP8 | Number of Adults and Toddlers With Neutralizing Antibody Responses to Each Rotavirus Strain | Rotavirus strain DS-1 | 3 Participants |
| Toddlers: 90 µg P2-VP8 | Number of Adults and Toddlers With Neutralizing Antibody Responses to Each Rotavirus Strain | All 3 strains | 1 Participants |
| Toddlers: 90 µg P2-VP8 | Number of Adults and Toddlers With Neutralizing Antibody Responses to Each Rotavirus Strain | Rotavirus strain 1076 | 2 Participants |
Secondary
Number of Infants With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse 4 Weeks After the Second Vaccination, by Vaccine Antigen
Seroresponse was defined as a four-fold rise or greater in antibody titer between Baseline and 28 days after the second injection (Day 56). Measured by enzyme-linked immunosorbent assay (ELISA) to whole viral lysate.
Time frame: Day 56, pre-vaccination
Population: Per-protocol population; participants with available data for each antigen
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Adults: Placebo | Number of Infants With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse 4 Weeks After the Second Vaccination, by Vaccine Antigen | P[6] | 12 Participants |
| Adults: Placebo | Number of Infants With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse 4 Weeks After the Second Vaccination, by Vaccine Antigen | P[4] | 6 Participants |
| Adults: Placebo | Number of Infants With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse 4 Weeks After the Second Vaccination, by Vaccine Antigen | P[8] | 6 Participants |
| Adults: Placebo | Number of Infants With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse 4 Weeks After the Second Vaccination, by Vaccine Antigen | All 3 antigens | 4 Participants |
| Adults: Placebo | Number of Infants With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse 4 Weeks After the Second Vaccination, by Vaccine Antigen | Any 2 antigens | 7 Participants |
| Adults: 30 µg P2-VP8 | Number of Infants With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse 4 Weeks After the Second Vaccination, by Vaccine Antigen | Any 2 antigens | 19 Participants |
| Adults: 30 µg P2-VP8 | Number of Infants With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse 4 Weeks After the Second Vaccination, by Vaccine Antigen | P[4] | 22 Participants |
| Adults: 30 µg P2-VP8 | Number of Infants With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse 4 Weeks After the Second Vaccination, by Vaccine Antigen | P[6] | 22 Participants |
| Adults: 30 µg P2-VP8 | Number of Infants With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse 4 Weeks After the Second Vaccination, by Vaccine Antigen | P[8] | 19 Participants |
| Adults: 30 µg P2-VP8 | Number of Infants With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse 4 Weeks After the Second Vaccination, by Vaccine Antigen | All 3 antigens | 9 Participants |
| Adults: 90 µg P2-VP8 | Number of Infants With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse 4 Weeks After the Second Vaccination, by Vaccine Antigen | All 3 antigens | 16 Participants |
| Adults: 90 µg P2-VP8 | Number of Infants With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse 4 Weeks After the Second Vaccination, by Vaccine Antigen | P[8] | 22 Participants |
| Adults: 90 µg P2-VP8 | Number of Infants With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse 4 Weeks After the Second Vaccination, by Vaccine Antigen | Any 2 antigens | 25 Participants |
| Adults: 90 µg P2-VP8 | Number of Infants With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse 4 Weeks After the Second Vaccination, by Vaccine Antigen | P[4] | 29 Participants |
| Adults: 90 µg P2-VP8 | Number of Infants With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse 4 Weeks After the Second Vaccination, by Vaccine Antigen | P[6] | 33 Participants |
| Toddlers: Placebo | Number of Infants With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse 4 Weeks After the Second Vaccination, by Vaccine Antigen | Any 2 antigens | 21 Participants |
| Toddlers: Placebo | Number of Infants With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse 4 Weeks After the Second Vaccination, by Vaccine Antigen | P[6] | 27 Participants |
| Toddlers: Placebo | Number of Infants With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse 4 Weeks After the Second Vaccination, by Vaccine Antigen | P[8] | 18 Participants |
| Toddlers: Placebo | Number of Infants With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse 4 Weeks After the Second Vaccination, by Vaccine Antigen | P[4] | 20 Participants |
| Toddlers: Placebo | Number of Infants With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse 4 Weeks After the Second Vaccination, by Vaccine Antigen | All 3 antigens | 10 Participants |
Secondary
Number of Infants With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse 4 Weeks After the Second Vaccination, by Vaccine Antigen
Seroresponse was defined as a four-fold rise or greater in antibody titer between Baseline and 28 days after the 2nd injection (Day 56). Measured by enzyme-linked immunosorbent assay (ELISA) and adjusted for decay in maternal antibodies. The estimated maternal antibody half-life was derived from linear regression of Log2 transformed titers in placebo recipients from the combined infant cohorts.
Time frame: Day 56, pre-vaccination
Population: Per-protocol population; participants with available data for each antigen
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Adults: Placebo | Number of Infants With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse 4 Weeks After the Second Vaccination, by Vaccine Antigen | Any 2 antigens | 7 Participants |
| Adults: Placebo | Number of Infants With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse 4 Weeks After the Second Vaccination, by Vaccine Antigen | P[6] | 25 Participants |
| Adults: Placebo | Number of Infants With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse 4 Weeks After the Second Vaccination, by Vaccine Antigen | All 3 antigens | 4 Participants |
| Adults: Placebo | Number of Infants With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse 4 Weeks After the Second Vaccination, by Vaccine Antigen | P[8] | 7 Participants |
| Adults: Placebo | Number of Infants With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse 4 Weeks After the Second Vaccination, by Vaccine Antigen | P[4] | 7 Participants |
| Adults: 30 µg P2-VP8 | Number of Infants With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse 4 Weeks After the Second Vaccination, by Vaccine Antigen | P[8] | 126 Participants |
| Adults: 30 µg P2-VP8 | Number of Infants With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse 4 Weeks After the Second Vaccination, by Vaccine Antigen | Any 2 antigens | 126 Participants |
| Adults: 30 µg P2-VP8 | Number of Infants With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse 4 Weeks After the Second Vaccination, by Vaccine Antigen | All 3 antigens | 126 Participants |
| Adults: 30 µg P2-VP8 | Number of Infants With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse 4 Weeks After the Second Vaccination, by Vaccine Antigen | P[6] | 136 Participants |
| Adults: 30 µg P2-VP8 | Number of Infants With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse 4 Weeks After the Second Vaccination, by Vaccine Antigen | P[4] | 126 Participants |
| Adults: 90 µg P2-VP8 | Number of Infants With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse 4 Weeks After the Second Vaccination, by Vaccine Antigen | P[8] | 119 Participants |
| Adults: 90 µg P2-VP8 | Number of Infants With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse 4 Weeks After the Second Vaccination, by Vaccine Antigen | P[4] | 121 Participants |
| Adults: 90 µg P2-VP8 | Number of Infants With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse 4 Weeks After the Second Vaccination, by Vaccine Antigen | P[6] | 125 Participants |
| Adults: 90 µg P2-VP8 | Number of Infants With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse 4 Weeks After the Second Vaccination, by Vaccine Antigen | Any 2 antigens | 121 Participants |
| Adults: 90 µg P2-VP8 | Number of Infants With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse 4 Weeks After the Second Vaccination, by Vaccine Antigen | All 3 antigens | 114 Participants |
| Toddlers: Placebo | Number of Infants With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse 4 Weeks After the Second Vaccination, by Vaccine Antigen | Any 2 antigens | 132 Participants |
| Toddlers: Placebo | Number of Infants With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse 4 Weeks After the Second Vaccination, by Vaccine Antigen | P[6] | 133 Participants |
| Toddlers: Placebo | Number of Infants With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse 4 Weeks After the Second Vaccination, by Vaccine Antigen | P[4] | 131 Participants |
| Toddlers: Placebo | Number of Infants With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse 4 Weeks After the Second Vaccination, by Vaccine Antigen | P[8] | 131 Participants |
| Toddlers: Placebo | Number of Infants With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse 4 Weeks After the Second Vaccination, by Vaccine Antigen | All 3 antigens | 128 Participants |
Secondary
Number of Infants With Neutralizing Antibody Responses 4 Weeks After the Second Vaccination
Neutralizing antibody response was defined as a ≥ 2.7-fold rise in antibody titer between Baseline and 28 days after the second injection (Day 56). Neutralizing antibodies to each of the three rotavirus strains from which the vaccine antigens were derived (Wa, DS-1, and 1076) were measured using a validated assay. For infants, antibody titers were adjusted for decay in maternal antibodies.
Time frame: Day 56, prevaccination
Population: Per-protocol population, participants with available data for each strain
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Adults: Placebo | Number of Infants With Neutralizing Antibody Responses 4 Weeks After the Second Vaccination | Any 2 strains | 14 Participants |
| Adults: Placebo | Number of Infants With Neutralizing Antibody Responses 4 Weeks After the Second Vaccination | Rotavirus strain DS-1 | 19 Participants |
| Adults: Placebo | Number of Infants With Neutralizing Antibody Responses 4 Weeks After the Second Vaccination | All 3 strains | 4 Participants |
| Adults: Placebo | Number of Infants With Neutralizing Antibody Responses 4 Weeks After the Second Vaccination | Rotavirus strain 1076 | 13 Participants |
| Adults: Placebo | Number of Infants With Neutralizing Antibody Responses 4 Weeks After the Second Vaccination | Rotavirus strain Wa | 16 Participants |
| Adults: 30 µg P2-VP8 | Number of Infants With Neutralizing Antibody Responses 4 Weeks After the Second Vaccination | Rotavirus strain 1076 | 29 Participants |
| Adults: 30 µg P2-VP8 | Number of Infants With Neutralizing Antibody Responses 4 Weeks After the Second Vaccination | Any 2 strains | 35 Participants |
| Adults: 30 µg P2-VP8 | Number of Infants With Neutralizing Antibody Responses 4 Weeks After the Second Vaccination | All 3 strains | 12 Participants |
| Adults: 30 µg P2-VP8 | Number of Infants With Neutralizing Antibody Responses 4 Weeks After the Second Vaccination | Rotavirus strain DS-1 | 38 Participants |
| Adults: 30 µg P2-VP8 | Number of Infants With Neutralizing Antibody Responses 4 Weeks After the Second Vaccination | Rotavirus strain Wa | 49 Participants |
| Adults: 90 µg P2-VP8 | Number of Infants With Neutralizing Antibody Responses 4 Weeks After the Second Vaccination | Rotavirus strain 1076 | 33 Participants |
| Adults: 90 µg P2-VP8 | Number of Infants With Neutralizing Antibody Responses 4 Weeks After the Second Vaccination | Rotavirus strain Wa | 51 Participants |
| Adults: 90 µg P2-VP8 | Number of Infants With Neutralizing Antibody Responses 4 Weeks After the Second Vaccination | Rotavirus strain DS-1 | 44 Participants |
| Adults: 90 µg P2-VP8 | Number of Infants With Neutralizing Antibody Responses 4 Weeks After the Second Vaccination | Any 2 strains | 38 Participants |
| Adults: 90 µg P2-VP8 | Number of Infants With Neutralizing Antibody Responses 4 Weeks After the Second Vaccination | All 3 strains | 13 Participants |
| Toddlers: Placebo | Number of Infants With Neutralizing Antibody Responses 4 Weeks After the Second Vaccination | Any 2 strains | 37 Participants |
| Toddlers: Placebo | Number of Infants With Neutralizing Antibody Responses 4 Weeks After the Second Vaccination | Rotavirus strain DS-1 | 48 Participants |
| Toddlers: Placebo | Number of Infants With Neutralizing Antibody Responses 4 Weeks After the Second Vaccination | Rotavirus strain Wa | 49 Participants |
| Toddlers: Placebo | Number of Infants With Neutralizing Antibody Responses 4 Weeks After the Second Vaccination | Rotavirus strain 1076 | 32 Participants |
| Toddlers: Placebo | Number of Infants With Neutralizing Antibody Responses 4 Weeks After the Second Vaccination | All 3 strains | 13 Participants |
Secondary
Number of Participants Experiencing Adverse Events (AE) Over the Entire Study Period
Any symptom starting after 7 days post any study injection was recorded as an adverse event. A serious adverse event (SAE) is any event that occurred from the first dose of study drug that resulted in any of the following outcomes: * Death - Life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * Persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * Congenital abnormality or birth defect * Important medical event that may not result in one of the above outcomes but may jeopardize the health of the study participant or require medical or surgical intervention to prevent one of the outcomes listed in the above definition of serious event. AEs related to study drug were those events for which there was a reasonable possibility that the study drug caused the event In the opinion of the site investigator.
Time frame: Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)
Population: Safety population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Adults: Placebo | Number of Participants Experiencing Adverse Events (AE) Over the Entire Study Period | Any serious adverse event | 0 Participants |
| Adults: Placebo | Number of Participants Experiencing Adverse Events (AE) Over the Entire Study Period | Any adverse event | 2 Participants |
| Adults: Placebo | Number of Participants Experiencing Adverse Events (AE) Over the Entire Study Period | Any AE related to study drug | 0 Participants |
| Adults: Placebo | Number of Participants Experiencing Adverse Events (AE) Over the Entire Study Period | Any grade 2 or higher AE | 0 Participants |
| Adults: Placebo | Number of Participants Experiencing Adverse Events (AE) Over the Entire Study Period | Any grade 2 or higher AE related to study drug | 0 Participants |
| Adults: 30 µg P2-VP8 | Number of Participants Experiencing Adverse Events (AE) Over the Entire Study Period | Any grade 2 or higher AE | 2 Participants |
| Adults: 30 µg P2-VP8 | Number of Participants Experiencing Adverse Events (AE) Over the Entire Study Period | Any AE related to study drug | 0 Participants |
| Adults: 30 µg P2-VP8 | Number of Participants Experiencing Adverse Events (AE) Over the Entire Study Period | Any grade 2 or higher AE related to study drug | 0 Participants |
| Adults: 30 µg P2-VP8 | Number of Participants Experiencing Adverse Events (AE) Over the Entire Study Period | Any serious adverse event | 0 Participants |
| Adults: 30 µg P2-VP8 | Number of Participants Experiencing Adverse Events (AE) Over the Entire Study Period | Any adverse event | 8 Participants |
| Adults: 90 µg P2-VP8 | Number of Participants Experiencing Adverse Events (AE) Over the Entire Study Period | Any grade 2 or higher AE | 1 Participants |
| Adults: 90 µg P2-VP8 | Number of Participants Experiencing Adverse Events (AE) Over the Entire Study Period | Any serious adverse event | 0 Participants |
| Adults: 90 µg P2-VP8 | Number of Participants Experiencing Adverse Events (AE) Over the Entire Study Period | Any AE related to study drug | 1 Participants |
| Adults: 90 µg P2-VP8 | Number of Participants Experiencing Adverse Events (AE) Over the Entire Study Period | Any adverse event | 11 Participants |
| Adults: 90 µg P2-VP8 | Number of Participants Experiencing Adverse Events (AE) Over the Entire Study Period | Any grade 2 or higher AE related to study drug | 0 Participants |
| Toddlers: Placebo | Number of Participants Experiencing Adverse Events (AE) Over the Entire Study Period | Any adverse event | 5 Participants |
| Toddlers: Placebo | Number of Participants Experiencing Adverse Events (AE) Over the Entire Study Period | Any AE related to study drug | 0 Participants |
| Toddlers: Placebo | Number of Participants Experiencing Adverse Events (AE) Over the Entire Study Period | Any grade 2 or higher AE | 0 Participants |
| Toddlers: Placebo | Number of Participants Experiencing Adverse Events (AE) Over the Entire Study Period | Any grade 2 or higher AE related to study drug | 0 Participants |
| Toddlers: Placebo | Number of Participants Experiencing Adverse Events (AE) Over the Entire Study Period | Any serious adverse event | 0 Participants |
| Toddlers: 30 µg P2-VP8 | Number of Participants Experiencing Adverse Events (AE) Over the Entire Study Period | Any grade 2 or higher AE related to study drug | 0 Participants |
| Toddlers: 30 µg P2-VP8 | Number of Participants Experiencing Adverse Events (AE) Over the Entire Study Period | Any grade 2 or higher AE | 2 Participants |
| Toddlers: 30 µg P2-VP8 | Number of Participants Experiencing Adverse Events (AE) Over the Entire Study Period | Any AE related to study drug | 0 Participants |
| Toddlers: 30 µg P2-VP8 | Number of Participants Experiencing Adverse Events (AE) Over the Entire Study Period | Any serious adverse event | 1 Participants |
| Toddlers: 30 µg P2-VP8 | Number of Participants Experiencing Adverse Events (AE) Over the Entire Study Period | Any adverse event | 9 Participants |
| Toddlers: 90 µg P2-VP8 | Number of Participants Experiencing Adverse Events (AE) Over the Entire Study Period | Any grade 2 or higher AE | 2 Participants |
| Toddlers: 90 µg P2-VP8 | Number of Participants Experiencing Adverse Events (AE) Over the Entire Study Period | Any adverse event | 8 Participants |
| Toddlers: 90 µg P2-VP8 | Number of Participants Experiencing Adverse Events (AE) Over the Entire Study Period | Any serious adverse event | 1 Participants |
| Toddlers: 90 µg P2-VP8 | Number of Participants Experiencing Adverse Events (AE) Over the Entire Study Period | Any AE related to study drug | 0 Participants |
| Toddlers: 90 µg P2-VP8 | Number of Participants Experiencing Adverse Events (AE) Over the Entire Study Period | Any grade 2 or higher AE related to study drug | 0 Participants |
| Infants: Placebo | Number of Participants Experiencing Adverse Events (AE) Over the Entire Study Period | Any serious adverse event | 8 Participants |
| Infants: Placebo | Number of Participants Experiencing Adverse Events (AE) Over the Entire Study Period | Any AE related to study drug | 3 Participants |
| Infants: Placebo | Number of Participants Experiencing Adverse Events (AE) Over the Entire Study Period | Any grade 2 or higher AE related to study drug | 1 Participants |
| Infants: Placebo | Number of Participants Experiencing Adverse Events (AE) Over the Entire Study Period | Any adverse event | 132 Participants |
| Infants: Placebo | Number of Participants Experiencing Adverse Events (AE) Over the Entire Study Period | Any grade 2 or higher AE | 27 Participants |
| Infants: 15 µg P2-VP8 | Number of Participants Experiencing Adverse Events (AE) Over the Entire Study Period | Any grade 2 or higher AE | 43 Participants |
| Infants: 15 µg P2-VP8 | Number of Participants Experiencing Adverse Events (AE) Over the Entire Study Period | Any serious adverse event | 13 Participants |
| Infants: 15 µg P2-VP8 | Number of Participants Experiencing Adverse Events (AE) Over the Entire Study Period | Any AE related to study drug | 2 Participants |
| Infants: 15 µg P2-VP8 | Number of Participants Experiencing Adverse Events (AE) Over the Entire Study Period | Any adverse event | 129 Participants |
| Infants: 15 µg P2-VP8 | Number of Participants Experiencing Adverse Events (AE) Over the Entire Study Period | Any grade 2 or higher AE related to study drug | 0 Participants |
| Infants: 30 µg P2-VP8 | Number of Participants Experiencing Adverse Events (AE) Over the Entire Study Period | Any adverse event | 134 Participants |
| Infants: 30 µg P2-VP8 | Number of Participants Experiencing Adverse Events (AE) Over the Entire Study Period | Any grade 2 or higher AE | 28 Participants |
| Infants: 30 µg P2-VP8 | Number of Participants Experiencing Adverse Events (AE) Over the Entire Study Period | Any serious adverse event | 6 Participants |
| Infants: 30 µg P2-VP8 | Number of Participants Experiencing Adverse Events (AE) Over the Entire Study Period | Any AE related to study drug | 3 Participants |
| Infants: 30 µg P2-VP8 | Number of Participants Experiencing Adverse Events (AE) Over the Entire Study Period | Any grade 2 or higher AE related to study drug | 1 Participants |
| Infants: 90 µg P2-VP8 | Number of Participants Experiencing Adverse Events (AE) Over the Entire Study Period | Any AE related to study drug | 3 Participants |
| Infants: 90 µg P2-VP8 | Number of Participants Experiencing Adverse Events (AE) Over the Entire Study Period | Any adverse event | 130 Participants |
| Infants: 90 µg P2-VP8 | Number of Participants Experiencing Adverse Events (AE) Over the Entire Study Period | Any grade 2 or higher AE related to study drug | 1 Participants |
| Infants: 90 µg P2-VP8 | Number of Participants Experiencing Adverse Events (AE) Over the Entire Study Period | Any serious adverse event | 8 Participants |
| Infants: 90 µg P2-VP8 | Number of Participants Experiencing Adverse Events (AE) Over the Entire Study Period | Any grade 2 or higher AE | 36 Participants |
Post Hoc
Number of Adults and Infants With ≥ 4-fold Rise in Neutralizing Antibody Titer to Each Rotavirus Strain
The number of adults and infants with a 4-fold or greater increase from Baseline in neutralizing antibody titers to each of the three rotavirus strains from which the vaccine antigens were derived 4 weeks after the second (Day 56) and third (Day 84) vaccinations. For infants, antibody titer was adjusted for decay in maternal antibodies.
Time frame: Day 56 and Day 84
Population: Per-protocol population participants with valid specimens at each time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Adults: Placebo | Number of Adults and Infants With ≥ 4-fold Rise in Neutralizing Antibody Titer to Each Rotavirus Strain | Strain Wa: Day 84 | 0 Participants |
| Adults: Placebo | Number of Adults and Infants With ≥ 4-fold Rise in Neutralizing Antibody Titer to Each Rotavirus Strain | Strain DS-1: Day 84 | 0 Participants |
| Adults: Placebo | Number of Adults and Infants With ≥ 4-fold Rise in Neutralizing Antibody Titer to Each Rotavirus Strain | Strain 1076: Day 84 | 0 Participants |
| Adults: Placebo | Number of Adults and Infants With ≥ 4-fold Rise in Neutralizing Antibody Titer to Each Rotavirus Strain | Strain DS-1: Day 56 | 0 Participants |
| Adults: Placebo | Number of Adults and Infants With ≥ 4-fold Rise in Neutralizing Antibody Titer to Each Rotavirus Strain | Strain 1076: Day 56 | 0 Participants |
| Adults: Placebo | Number of Adults and Infants With ≥ 4-fold Rise in Neutralizing Antibody Titer to Each Rotavirus Strain | Strain Wa: Day 56 | 0 Participants |
| Adults: 30 µg P2-VP8 | Number of Adults and Infants With ≥ 4-fold Rise in Neutralizing Antibody Titer to Each Rotavirus Strain | Strain DS-1: Day 56 | 5 Participants |
| Adults: 30 µg P2-VP8 | Number of Adults and Infants With ≥ 4-fold Rise in Neutralizing Antibody Titer to Each Rotavirus Strain | Strain 1076: Day 84 | 2 Participants |
| Adults: 30 µg P2-VP8 | Number of Adults and Infants With ≥ 4-fold Rise in Neutralizing Antibody Titer to Each Rotavirus Strain | Strain Wa: Day 84 | 2 Participants |
| Adults: 30 µg P2-VP8 | Number of Adults and Infants With ≥ 4-fold Rise in Neutralizing Antibody Titer to Each Rotavirus Strain | Strain DS-1: Day 84 | 4 Participants |
| Adults: 30 µg P2-VP8 | Number of Adults and Infants With ≥ 4-fold Rise in Neutralizing Antibody Titer to Each Rotavirus Strain | Strain Wa: Day 56 | 0 Participants |
| Adults: 30 µg P2-VP8 | Number of Adults and Infants With ≥ 4-fold Rise in Neutralizing Antibody Titer to Each Rotavirus Strain | Strain 1076: Day 56 | 1 Participants |
| Adults: 90 µg P2-VP8 | Number of Adults and Infants With ≥ 4-fold Rise in Neutralizing Antibody Titer to Each Rotavirus Strain | Strain Wa: Day 56 | 4 Participants |
| Adults: 90 µg P2-VP8 | Number of Adults and Infants With ≥ 4-fold Rise in Neutralizing Antibody Titer to Each Rotavirus Strain | Strain 1076: Day 56 | 1 Participants |
| Adults: 90 µg P2-VP8 | Number of Adults and Infants With ≥ 4-fold Rise in Neutralizing Antibody Titer to Each Rotavirus Strain | Strain Wa: Day 84 | 3 Participants |
| Adults: 90 µg P2-VP8 | Number of Adults and Infants With ≥ 4-fold Rise in Neutralizing Antibody Titer to Each Rotavirus Strain | Strain 1076: Day 84 | 3 Participants |
| Adults: 90 µg P2-VP8 | Number of Adults and Infants With ≥ 4-fold Rise in Neutralizing Antibody Titer to Each Rotavirus Strain | Strain DS-1: Day 56 | 2 Participants |
| Adults: 90 µg P2-VP8 | Number of Adults and Infants With ≥ 4-fold Rise in Neutralizing Antibody Titer to Each Rotavirus Strain | Strain DS-1: Day 84 | 4 Participants |
| Toddlers: Placebo | Number of Adults and Infants With ≥ 4-fold Rise in Neutralizing Antibody Titer to Each Rotavirus Strain | Strain Wa: Day 56 | 9 Participants |
| Toddlers: Placebo | Number of Adults and Infants With ≥ 4-fold Rise in Neutralizing Antibody Titer to Each Rotavirus Strain | Strain DS-1: Day 56 | 11 Participants |
| Toddlers: Placebo | Number of Adults and Infants With ≥ 4-fold Rise in Neutralizing Antibody Titer to Each Rotavirus Strain | Strain DS-1: Day 84 | 17 Participants |
| Toddlers: Placebo | Number of Adults and Infants With ≥ 4-fold Rise in Neutralizing Antibody Titer to Each Rotavirus Strain | Strain 1076: Day 56 | 7 Participants |
| Toddlers: Placebo | Number of Adults and Infants With ≥ 4-fold Rise in Neutralizing Antibody Titer to Each Rotavirus Strain | Strain 1076: Day 84 | 13 Participants |
| Toddlers: Placebo | Number of Adults and Infants With ≥ 4-fold Rise in Neutralizing Antibody Titer to Each Rotavirus Strain | Strain Wa: Day 84 | 17 Participants |
| Toddlers: 30 µg P2-VP8 | Number of Adults and Infants With ≥ 4-fold Rise in Neutralizing Antibody Titer to Each Rotavirus Strain | Strain 1076: Day 84 | 73 Participants |
| Toddlers: 30 µg P2-VP8 | Number of Adults and Infants With ≥ 4-fold Rise in Neutralizing Antibody Titer to Each Rotavirus Strain | Strain DS-1: Day 84 | 85 Participants |
| Toddlers: 30 µg P2-VP8 | Number of Adults and Infants With ≥ 4-fold Rise in Neutralizing Antibody Titer to Each Rotavirus Strain | Strain Wa: Day 56 | 31 Participants |
| Toddlers: 30 µg P2-VP8 | Number of Adults and Infants With ≥ 4-fold Rise in Neutralizing Antibody Titer to Each Rotavirus Strain | Strain Wa: Day 84 | 73 Participants |
| Toddlers: 30 µg P2-VP8 | Number of Adults and Infants With ≥ 4-fold Rise in Neutralizing Antibody Titer to Each Rotavirus Strain | Strain 1076: Day 56 | 21 Participants |
| Toddlers: 30 µg P2-VP8 | Number of Adults and Infants With ≥ 4-fold Rise in Neutralizing Antibody Titer to Each Rotavirus Strain | Strain DS-1: Day 56 | 25 Participants |
| Toddlers: 90 µg P2-VP8 | Number of Adults and Infants With ≥ 4-fold Rise in Neutralizing Antibody Titer to Each Rotavirus Strain | Strain 1076: Day 56 | 20 Participants |
| Toddlers: 90 µg P2-VP8 | Number of Adults and Infants With ≥ 4-fold Rise in Neutralizing Antibody Titer to Each Rotavirus Strain | Strain 1076: Day 84 | 86 Participants |
| Toddlers: 90 µg P2-VP8 | Number of Adults and Infants With ≥ 4-fold Rise in Neutralizing Antibody Titer to Each Rotavirus Strain | Strain DS-1: Day 84 | 96 Participants |
| Toddlers: 90 µg P2-VP8 | Number of Adults and Infants With ≥ 4-fold Rise in Neutralizing Antibody Titer to Each Rotavirus Strain | Strain Wa: Day 56 | 29 Participants |
| Toddlers: 90 µg P2-VP8 | Number of Adults and Infants With ≥ 4-fold Rise in Neutralizing Antibody Titer to Each Rotavirus Strain | Strain DS-1: Day 56 | 30 Participants |
| Toddlers: 90 µg P2-VP8 | Number of Adults and Infants With ≥ 4-fold Rise in Neutralizing Antibody Titer to Each Rotavirus Strain | Strain Wa: Day 84 | 95 Participants |
| Infants: Placebo | Number of Adults and Infants With ≥ 4-fold Rise in Neutralizing Antibody Titer to Each Rotavirus Strain | Strain 1076: Day 56 | 18 Participants |
| Infants: Placebo | Number of Adults and Infants With ≥ 4-fold Rise in Neutralizing Antibody Titer to Each Rotavirus Strain | Strain DS-1: Day 84 | 93 Participants |
| Infants: Placebo | Number of Adults and Infants With ≥ 4-fold Rise in Neutralizing Antibody Titer to Each Rotavirus Strain | Strain Wa: Day 84 | 92 Participants |
| Infants: Placebo | Number of Adults and Infants With ≥ 4-fold Rise in Neutralizing Antibody Titer to Each Rotavirus Strain | Strain 1076: Day 84 | 98 Participants |
| Infants: Placebo | Number of Adults and Infants With ≥ 4-fold Rise in Neutralizing Antibody Titer to Each Rotavirus Strain | Strain Wa: Day 56 | 23 Participants |
| Infants: Placebo | Number of Adults and Infants With ≥ 4-fold Rise in Neutralizing Antibody Titer to Each Rotavirus Strain | Strain DS-1: Day 56 | 30 Participants |
Post Hoc
Number of Toddlers With ≥ 4-fold Rise in Neutralizing Antibody Titer to Each Rotavirus Strain
The number of toddlers with a 4-fold or greater increase from Baseline 4 weeks after vaccination in neutralizing antibody titers to each of the three rotavirus strains from which the vaccine antigens were derived.
Time frame: Day 28
Population: Per-protocol population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Adults: Placebo | Number of Toddlers With ≥ 4-fold Rise in Neutralizing Antibody Titer to Each Rotavirus Strain | Rotavirus strain DS-1 | 0 Participants |
| Adults: Placebo | Number of Toddlers With ≥ 4-fold Rise in Neutralizing Antibody Titer to Each Rotavirus Strain | Rotavirus strain Wa | 0 Participants |
| Adults: Placebo | Number of Toddlers With ≥ 4-fold Rise in Neutralizing Antibody Titer to Each Rotavirus Strain | Rotavirus strain 1076 | 0 Participants |
| Adults: 30 µg P2-VP8 | Number of Toddlers With ≥ 4-fold Rise in Neutralizing Antibody Titer to Each Rotavirus Strain | Rotavirus strain DS-1 | 1 Participants |
| Adults: 30 µg P2-VP8 | Number of Toddlers With ≥ 4-fold Rise in Neutralizing Antibody Titer to Each Rotavirus Strain | Rotavirus strain Wa | 0 Participants |
| Adults: 30 µg P2-VP8 | Number of Toddlers With ≥ 4-fold Rise in Neutralizing Antibody Titer to Each Rotavirus Strain | Rotavirus strain 1076 | 0 Participants |
| Adults: 90 µg P2-VP8 | Number of Toddlers With ≥ 4-fold Rise in Neutralizing Antibody Titer to Each Rotavirus Strain | Rotavirus strain Wa | 4 Participants |
| Adults: 90 µg P2-VP8 | Number of Toddlers With ≥ 4-fold Rise in Neutralizing Antibody Titer to Each Rotavirus Strain | Rotavirus strain 1076 | 1 Participants |
| Adults: 90 µg P2-VP8 | Number of Toddlers With ≥ 4-fold Rise in Neutralizing Antibody Titer to Each Rotavirus Strain | Rotavirus strain DS-1 | 3 Participants |