Gastroenteritis
Conditions
Brief summary
This is a phase 2, multi-country, randomized, double-blind, placebo-controlled trial to evaluate the immune response to routine pediatric vaccinations when co-administered with HIL-214 or placebo in healthy infants. This trial will also evaluate the safety profile of a 2-dose regimen of HIL-214 co-administered with routine pediatric vaccines.
Detailed description
Epidemiologic studies have shown that gastroenteritis in infants is associated with several viruses, including norovirus, sapovirus and rotavirus. These viruses together or individually can be associated with illness ranging from asymptomatic to serious. Asymptomatic infection can create a reservoir, allowing further spread of the virus, whereas serious illness can lead to death, particularly in the very young, very old or immunocompromised. As the burden of rotavirus in children decreases due to successful rotavirus vaccination programs in infants, norovirus infections are increasingly recognized as the primary cause of acute gastroenteritis (AGE) in many countries around the world. Currently, there is no available vaccine to counter the disease burden associated with norovirus. Vaccinating at an early age would reduce the severe illness in young children and also reduce the asymptomatic cases which act as a vehicle for transmission within the population. As infants already receive multiple vaccines during the first months of life, an additional vaccination must fit into the immunization scheme in a convenient way for compliance. It must also have an acceptable safety profile and be immunogenic without interfering with the immune response to routine childhood vaccines.
Interventions
BIOLOGICALHIL-214
2 injections - given at 4 months and the second at 6 months of age.
BIOLOGICALPlacebo
2 injections - given at 4 months and the second at 6 months of age.
Sponsors
HilleVax
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Months to 2 Months
Healthy volunteers
Yes
Inclusion criteria
* The subject is aged 2 months (+14 days). * Male or female. * Infants who are in good health at the time of entry into the trial as determined by medical history, physical examination (including vital signs) and clinical judgment of the investigator. * The subject's LAR signs and dates a written, informed consent form (ICF) and any required privacy authorization prior to the initiation of any trial procedures, after the nature of the trial has been explained according to local regulatory requirements. * Infants whose LARs can and are willing to comply with trial procedures and are available for the duration of follow-up.
Exclusion criteria
* Clinically significant abnormality in growth by height, weight, or head circumference (according to local guidelines). * Gastrointestinal abnormalities or any chronic gastrointestinal disease, including any uncorrected congenital malformation of the gastrointestinal tract according to medical history and/or physical examination. * Known hypersensitivity or allergy to any of the investigational vaccine components (including excipients). * Severe reaction to routine childhood vaccine(s) administered at Visit 1. * Any clinically significant active infection (as assessed by the investigator) or temperature ≥38.0°C (\>100.4°F), within 3 days of intended trial vaccination. * Any serious chronic or progressive disease according to the judgment of the investigator (e.g., cardiac, renal or hepatic disease). * Individuals with history of, e.g., convulsions/febrile convulsions, or any illness, that, in the opinion of the investigator, might interfere with the results of the trial or pose additional risk to the subjects due to participation in the trial. * Known or suspected impairment/alteration of immune function. * Subjects with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time. * Subjects who received or are scheduled to receive any licensed or authorized vaccines not planned in this trial within 14 days (for inactivated vaccines) or within 28 days (for live vaccines) before or after any dose of trial vaccine. Note: Flu and/or COVID vaccine can be administered per local guidelines at any time during the trial. * Subjects participating in any clinical trial with another investigational product 30 days prior to first trial visit or due to participate in another clinical trial at any time during the conduct of this trial. * Subjects known to be positive for or in evaluation for possible human immunodeficiency virus infection. * Subject's LAR or subject's first-degree relatives involved in the trial conduct.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immune Response to the Licensed Pediatric DTaP-Hib-IPV-HepB Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo. | 28 days post-dose 2 | Evaluate the immune response to the licensed pediatric DTaP-Hib-IPV-HepB vaccine co-administered with a 2-dose regimen of HIL-214 at 4 and 6 months of age, compared to that of the routine pediatric vaccine co-administered with placebo. Due to differing local availability of licensed DTaP-Hib-IPV-HepB vaccine, data are presented by country (Panama and USA). Outcome measures: * Binary (yes/no) variable indicating anti-DT immunoglobulin G (IgG) concentration ≥0.1 IU/mL. * Binary variable indicating anti-TT IgG concentration ≥0.1 IU/mL. * Anti-pertussis \[FHA\], \[PRN\] and \[PTX\]) IgG concentrations. * Binary variable indicating anti-poliovirus neutralizing antibody titers ≥1:8, * Binary variable indicating anti-Haemophilus influenzae type b * Binary variable indicating anti-hepatitis b surface antigen Geometric mean (geometric mean standard deviation) anti-FHA, anti-PRN, and anti-PTX are presented as a separate outcome. |
| Immune Response to the Licensed Pediatric Pneumococcal 13 Valent (PCV13) Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo. | 28 days post-dose 2 | The outcome was assessed using measurements of immune response to the concomitant anti-pneumococcal capsular polysaccharide IgG \[serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 19A, 19F, 18C, and 23F\]) at 28 days post-dose. Geometric mean concentrations are presented. |
| Immune Response to the Licensed Pediatric Rotavirus Vaccine (RV1) Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo. | 28 days post-dose 2 | This outcome was assessed using measurements of immune response to the concomitant RV1 vaccine (anti-RV1 IgA). Geometric mean concentrations at 28 days post-dose 2 are reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immunogenicity of a 2-dose Regimen of HIL-214 Co-administered With Routine Pediatric Vaccines at 4 and 6 Months of Age. | Pre-dose 1 and 28 days post-dose 2 | Anti-norovirus (GI.1 and GII.4c) HBGA-blocking antibodies were measured at prior to dose 1 (\ 4 months of age) and 28 days post-dose 2 (\ 6 months of age). Seroresponse was defined as a fold increase from baseline greater than or equal to 4. Seroresponse rates and 95% confidence intervals (CIs) are presented. Data are stratified by country (Panama and USA). |
| Evaluate the Safety Profile of a 2-dose Regimen of HIL-214 Co-administered With Routine Pediatric Vaccines at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo. | Day 1 to Day 7 post-dose 1 and Day 1 to Day 7 post-dose 2 | Percentage of participants with solicited local (injection site) reactions within 7 days of any vaccine administration. Assessed reactions included pain, redness, induration, and swelling. |
| Evaluate the Safety Profile of a 2-dose Regimen of HIL-214 Co-administered With Routine Pediatric Vaccines at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo | Day 1 to 12 months post-dose 1 | Percentage of participants with medically attended adverse events (AEs) at any point during the trial. |
Countries
Panama, Puerto Rico, United States
Participant flow
Recruitment details
Participants took part in the trial at 10 investigative sites in Panama and the United States from 10 June 2023 to 08 July 2024.
Pre-assignment details
Participants were enrolled in 1 of 2 treatment arms and received 2 doses of either HIL-214, a norovirus vaccine comprising 50 µg GI.1 virus-like particle (VLP) and 150 µg GII.4c VLP, adjuvanted with 500 µg of aluminum hydroxide, or placebo.
Participants by arm
| Arm | Count |
|---|---|
| Placebo 1 dose of placebo at 4 months of age and 1 dose of placebo at 6 months of age, and routine childhood vaccines according to schedule. | 164 |
| HIL-214 1 dose of HIL-214 at 4 months of age and 1 dose of HIL-214 at 6 months of age, and routine childhood vaccines according to schedule. | 165 |
| Total | 329 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Reason not included in pre-specified categories | 2 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 3 |
Baseline characteristics
| Characteristic | Placebo | HIL-214 | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 164 Participants | 165 Participants | 329 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 125.7 days STANDARD_DEVIATION 4.35 | 125.6 days STANDARD_DEVIATION 4.48 | 125.7 days STANDARD_DEVIATION 4.41 |
| Breastfeeding Status Breastfeeding | 143 Participants | 146 Participants | 289 Participants |
| Breastfeeding Status Not breastfeeding | 21 Participants | 19 Participants | 40 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 159 Participants | 160 Participants | 319 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 5 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Head Circumference | 41.24 cm STANDARD_DEVIATION 1.217 | 41.33 cm STANDARD_DEVIATION 1.29 | 41.29 cm STANDARD_DEVIATION 1.253 |
| Length | 61.84 cm STANDARD_DEVIATION 2.221 | 62.12 cm STANDARD_DEVIATION 2.219 | 61.98 cm STANDARD_DEVIATION 2.221 |
| Prior Vaccinations No | 1 Participants | 4 Participants | 5 Participants |
| Prior Vaccinations Yes | 163 Participants | 161 Participants | 324 Participants |
| Race/Ethnicity, Customized Race/Ethnicity American Indian or Alaskan Native | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Black or African American | 2 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Race/Ethnicity More than one race | 151 Participants | 154 Participants | 305 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Other | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Race/Ethnicity White | 9 Participants | 9 Participants | 18 Participants |
| Region of Enrollment Panama | 150 participants | 152 participants | 302 participants |
| Region of Enrollment United States | 14 participants | 13 participants | 27 participants |
| Sex: Female, Male Female | 82 Participants | 82 Participants | 164 Participants |
| Sex: Female, Male Male | 82 Participants | 83 Participants | 165 Participants |
| Weight | 7.00 kg STANDARD_DEVIATION 0.892 | 7.01 kg STANDARD_DEVIATION 0.877 | 7.00 kg STANDARD_DEVIATION 0.883 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 164 | 0 / 165 |
| other Total, other adverse events | 81 / 164 | 77 / 165 |
| serious Total, serious adverse events | 7 / 164 | 3 / 165 |
Outcome results
Primary
Immune Response to the Licensed Pediatric DTaP-Hib-IPV-HepB Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo.
Evaluate the immune response to the licensed pediatric DTaP-Hib-IPV-HepB vaccine co-administered with a 2-dose regimen of HIL-214 at 4 and 6 months of age, compared to that of the routine pediatric vaccine co-administered with placebo. Due to differing local availability of licensed DTaP-Hib-IPV-HepB vaccine, data are presented by country (Panama and USA). Outcome measures: * Binary (yes/no) variable indicating anti-DT immunoglobulin G (IgG) concentration ≥0.1 IU/mL. * Binary variable indicating anti-TT IgG concentration ≥0.1 IU/mL. * Anti-pertussis \[FHA\], \[PRN\] and \[PTX\]) IgG concentrations. * Binary variable indicating anti-poliovirus neutralizing antibody titers ≥1:8, * Binary variable indicating anti-Haemophilus influenzae type b * Binary variable indicating anti-hepatitis b surface antigen Geometric mean (geometric mean standard deviation) anti-FHA, anti-PRN, and anti-PTX are presented as a separate outcome.
Time frame: 28 days post-dose 2
Population: Immunology Evaluable Analysis Set; all participants in the randomized analysis set that received all doses of all study vaccines (routine and trial vaccines) within the required time window.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo (Panama) | Immune Response to the Licensed Pediatric DTaP-Hib-IPV-HepB Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo. | Anti-poliovirus type 3 neutralizing antibody titers ≥3 log2 | 99.3 percentage of participants |
| Placebo (Panama) | Immune Response to the Licensed Pediatric DTaP-Hib-IPV-HepB Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo. | Anti-poliovirus type 2 neutralizing antibody titers ≥3 log2 | 100 percentage of participants |
| Placebo (Panama) | Immune Response to the Licensed Pediatric DTaP-Hib-IPV-HepB Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo. | Anti-poliovirus type 1 neutralizing antibody titers ≥3 log2 | 100 percentage of participants |
| Placebo (Panama) | Immune Response to the Licensed Pediatric DTaP-Hib-IPV-HepB Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo. | Anti-HBsAg IgG concentration ≥10 mIU/mL | 100 percentage of participants |
| Placebo (Panama) | Immune Response to the Licensed Pediatric DTaP-Hib-IPV-HepB Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo. | Anti-PRP IgG concentration ≥ 0.15 ug/mL | 100 percentage of participants |
| Placebo (Panama) | Immune Response to the Licensed Pediatric DTaP-Hib-IPV-HepB Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo. | Anti-tetanus toxoid IgG concentration ≥0.1 IU/mL | 100 percentage of participants |
| Placebo (Panama) | Immune Response to the Licensed Pediatric DTaP-Hib-IPV-HepB Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo. | Anti-diphtheria toxoid IgG concentration ≥0.1 IU/mL. | 99.3 percentage of participants |
| HIL-214 (Panama) | Immune Response to the Licensed Pediatric DTaP-Hib-IPV-HepB Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo. | Anti-PRP IgG concentration ≥ 0.15 ug/mL | 100 percentage of participants |
| HIL-214 (Panama) | Immune Response to the Licensed Pediatric DTaP-Hib-IPV-HepB Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo. | Anti-diphtheria toxoid IgG concentration ≥0.1 IU/mL. | 100 percentage of participants |
| HIL-214 (Panama) | Immune Response to the Licensed Pediatric DTaP-Hib-IPV-HepB Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo. | Anti-tetanus toxoid IgG concentration ≥0.1 IU/mL | 100 percentage of participants |
| HIL-214 (Panama) | Immune Response to the Licensed Pediatric DTaP-Hib-IPV-HepB Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo. | Anti-poliovirus type 1 neutralizing antibody titers ≥3 log2 | 100 percentage of participants |
| HIL-214 (Panama) | Immune Response to the Licensed Pediatric DTaP-Hib-IPV-HepB Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo. | Anti-poliovirus type 2 neutralizing antibody titers ≥3 log2 | 100 percentage of participants |
| HIL-214 (Panama) | Immune Response to the Licensed Pediatric DTaP-Hib-IPV-HepB Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo. | Anti-poliovirus type 3 neutralizing antibody titers ≥3 log2 | 99.2 percentage of participants |
| HIL-214 (Panama) | Immune Response to the Licensed Pediatric DTaP-Hib-IPV-HepB Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo. | Anti-HBsAg IgG concentration ≥10 mIU/mL | 100 percentage of participants |
| Placebo (USA) | Immune Response to the Licensed Pediatric DTaP-Hib-IPV-HepB Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo. | Anti-tetanus toxoid IgG concentration ≥0.1 IU/mL | 100 percentage of participants |
| Placebo (USA) | Immune Response to the Licensed Pediatric DTaP-Hib-IPV-HepB Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo. | Anti-PRP IgG concentration ≥ 0.15 ug/mL | 100 percentage of participants |
| Placebo (USA) | Immune Response to the Licensed Pediatric DTaP-Hib-IPV-HepB Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo. | Anti-HBsAg IgG concentration ≥10 mIU/mL | 100 percentage of participants |
| Placebo (USA) | Immune Response to the Licensed Pediatric DTaP-Hib-IPV-HepB Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo. | Anti-diphtheria toxoid IgG concentration ≥0.1 IU/mL. | 100 percentage of participants |
| Placebo (USA) | Immune Response to the Licensed Pediatric DTaP-Hib-IPV-HepB Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo. | Anti-poliovirus type 1 neutralizing antibody titers ≥3 log2 | 100 percentage of participants |
| Placebo (USA) | Immune Response to the Licensed Pediatric DTaP-Hib-IPV-HepB Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo. | Anti-poliovirus type 3 neutralizing antibody titers ≥3 log2 | 100 percentage of participants |
| Placebo (USA) | Immune Response to the Licensed Pediatric DTaP-Hib-IPV-HepB Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo. | Anti-poliovirus type 2 neutralizing antibody titers ≥3 log2 | 100 percentage of participants |
| HIL-214 (USA) | Immune Response to the Licensed Pediatric DTaP-Hib-IPV-HepB Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo. | Anti-tetanus toxoid IgG concentration ≥0.1 IU/mL | 100 percentage of participants |
| HIL-214 (USA) | Immune Response to the Licensed Pediatric DTaP-Hib-IPV-HepB Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo. | Anti-poliovirus type 2 neutralizing antibody titers ≥3 log2 | 100 percentage of participants |
| HIL-214 (USA) | Immune Response to the Licensed Pediatric DTaP-Hib-IPV-HepB Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo. | Anti-poliovirus type 3 neutralizing antibody titers ≥3 log2 | 100 percentage of participants |
| HIL-214 (USA) | Immune Response to the Licensed Pediatric DTaP-Hib-IPV-HepB Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo. | Anti-diphtheria toxoid IgG concentration ≥0.1 IU/mL. | 100 percentage of participants |
| HIL-214 (USA) | Immune Response to the Licensed Pediatric DTaP-Hib-IPV-HepB Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo. | Anti-PRP IgG concentration ≥ 0.15 ug/mL | 100 percentage of participants |
| HIL-214 (USA) | Immune Response to the Licensed Pediatric DTaP-Hib-IPV-HepB Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo. | Anti-poliovirus type 1 neutralizing antibody titers ≥3 log2 | 83.3 percentage of participants |
| HIL-214 (USA) | Immune Response to the Licensed Pediatric DTaP-Hib-IPV-HepB Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo. | Anti-HBsAg IgG concentration ≥10 mIU/mL | 100 percentage of participants |
Primary
Immune Response to the Licensed Pediatric DTaP-Hib-IPV-HepB Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo.
Evaluate the immune response to the licensed pediatric DTaP-Hib-IPV-HepB vaccine co-administered with a 2-dose regimen of HIL-214 at 4 and 6 months of age, compared to that of the routine pediatric vaccine co-administered with placebo. Due to differing local availability of licensed DTaP-Hib-IPV-HepB vaccine, data are presented by country (Panama and USA). Outcome measures: Geometric mean anti-FHA, anti-PRN, and anti-PTX concentrations
Time frame: 28 days post-dose 2
Population: Immunology Evaluable Analysis Set; all participants in the randomized analysis set that receive all doses of all study vaccines (routine and trial vaccines) within the required time window.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (Panama) | Immune Response to the Licensed Pediatric DTaP-Hib-IPV-HepB Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo. | Anti-pertussis FHA concentration | 83.958 IU/mL | Standard Deviation 1.8338 |
| Placebo (Panama) | Immune Response to the Licensed Pediatric DTaP-Hib-IPV-HepB Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo. | Anti-pertussis toxin (PTX) concentration | 48.536 IU/mL | Standard Deviation 1.8552 |
| Placebo (Panama) | Immune Response to the Licensed Pediatric DTaP-Hib-IPV-HepB Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo. | Anti-pertactin (PRN) concentration | 92.605 IU/mL | Standard Deviation 2.1811 |
| HIL-214 (Panama) | Immune Response to the Licensed Pediatric DTaP-Hib-IPV-HepB Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo. | Anti-pertussis FHA concentration | 78.726 IU/mL | Standard Deviation 1.8566 |
| HIL-214 (Panama) | Immune Response to the Licensed Pediatric DTaP-Hib-IPV-HepB Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo. | Anti-pertussis toxin (PTX) concentration | 48.906 IU/mL | Standard Deviation 2.015 |
| HIL-214 (Panama) | Immune Response to the Licensed Pediatric DTaP-Hib-IPV-HepB Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo. | Anti-pertactin (PRN) concentration | 84.617 IU/mL | Standard Deviation 2.2496 |
| Placebo (USA) | Immune Response to the Licensed Pediatric DTaP-Hib-IPV-HepB Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo. | Anti-pertactin (PRN) concentration | 61.222 IU/mL | Standard Deviation 2.6526 |
| Placebo (USA) | Immune Response to the Licensed Pediatric DTaP-Hib-IPV-HepB Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo. | Anti-pertussis FHA concentration | 32.515 IU/mL | Standard Deviation 2.9346 |
| Placebo (USA) | Immune Response to the Licensed Pediatric DTaP-Hib-IPV-HepB Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo. | Anti-pertussis toxin (PTX) concentration | 80.713 IU/mL | Standard Deviation 2.2249 |
| HIL-214 (USA) | Immune Response to the Licensed Pediatric DTaP-Hib-IPV-HepB Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo. | Anti-pertussis FHA concentration | 26.358 IU/mL | Standard Deviation 2.7499 |
| HIL-214 (USA) | Immune Response to the Licensed Pediatric DTaP-Hib-IPV-HepB Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo. | Anti-pertussis toxin (PTX) concentration | 43.066 IU/mL | Standard Deviation 2.5144 |
| HIL-214 (USA) | Immune Response to the Licensed Pediatric DTaP-Hib-IPV-HepB Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo. | Anti-pertactin (PRN) concentration | 43.417 IU/mL | Standard Deviation 2.7743 |
Primary
Immune Response to the Licensed Pediatric Pneumococcal 13 Valent (PCV13) Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo.
The outcome was assessed using measurements of immune response to the concomitant anti-pneumococcal capsular polysaccharide IgG \[serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 19A, 19F, 18C, and 23F\]) at 28 days post-dose. Geometric mean concentrations are presented.
Time frame: 28 days post-dose 2
Population: Immunology Evaluable Analysis Set; all participants in the randomized analysis set that receive all doses of all study vaccines (routine and trial vaccines) within the required time window.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (Panama) | Immune Response to the Licensed Pediatric Pneumococcal 13 Valent (PCV13) Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo. | Anti-pneumococcal IgG concentration for serotype 6A | 7.660 ug/mL | Standard Deviation 2.0384 |
| Placebo (Panama) | Immune Response to the Licensed Pediatric Pneumococcal 13 Valent (PCV13) Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo. | Anti-pneumococcal IgG concentration for serotype 1 | 5.255 ug/mL | Standard Deviation 1.9827 |
| Placebo (Panama) | Immune Response to the Licensed Pediatric Pneumococcal 13 Valent (PCV13) Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo. | Anti-pneumococcal IgG concentration for serotype 14 | 11.819 ug/mL | Standard Deviation 2.3158 |
| Placebo (Panama) | Immune Response to the Licensed Pediatric Pneumococcal 13 Valent (PCV13) Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo. | Anti-pneumococcal IgG concentration for serotype 3 | 0.777 ug/mL | Standard Deviation 2.3728 |
| Placebo (Panama) | Immune Response to the Licensed Pediatric Pneumococcal 13 Valent (PCV13) Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo. | Anti-pneumococcal IgG concentration for serotype 9V | 3.881 ug/mL | Standard Deviation 1.9259 |
| Placebo (Panama) | Immune Response to the Licensed Pediatric Pneumococcal 13 Valent (PCV13) Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo. | Anti-pneumococcal IgG concentration for serotype 4 | 2.958 ug/mL | Standard Deviation 1.8468 |
| Placebo (Panama) | Immune Response to the Licensed Pediatric Pneumococcal 13 Valent (PCV13) Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo. | Anti-pneumococcal IgG concentration for serotype 6B | 6.419 ug/mL | Standard Deviation 2.3854 |
| Placebo (Panama) | Immune Response to the Licensed Pediatric Pneumococcal 13 Valent (PCV13) Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo. | Anti-pneumococcal IgG concentration for serotype 19A | 3.203 ug/mL | Standard Deviation 2.0635 |
| Placebo (Panama) | Immune Response to the Licensed Pediatric Pneumococcal 13 Valent (PCV13) Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo. | Anti-pneumococcal IgG concentration for serotype 19F | 5.822 ug/mL | Standard Deviation 2.003 |
| Placebo (Panama) | Immune Response to the Licensed Pediatric Pneumococcal 13 Valent (PCV13) Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo. | Anti-pneumococcal IgG concentration for serotype 5 | 2.378 ug/mL | Standard Deviation 1.9223 |
| Placebo (Panama) | Immune Response to the Licensed Pediatric Pneumococcal 13 Valent (PCV13) Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo. | Anti-pneumococcal IgG concentration for serotype 18C | 2.997 ug/mL | Standard Deviation 1.8435 |
| Placebo (Panama) | Immune Response to the Licensed Pediatric Pneumococcal 13 Valent (PCV13) Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo. | Anti-pneumococcal IgG concentration for serotype 23F | 2.885 ug/mL | Standard Deviation 2.5878 |
| Placebo (Panama) | Immune Response to the Licensed Pediatric Pneumococcal 13 Valent (PCV13) Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo. | Anti-pneumococcal IgG concentration for serotype 7F | 5.091 ug/mL | Standard Deviation 1.6726 |
| HIL-214 (Panama) | Immune Response to the Licensed Pediatric Pneumococcal 13 Valent (PCV13) Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo. | Anti-pneumococcal IgG concentration for serotype 23F | 2.543 ug/mL | Standard Deviation 2.7745 |
| HIL-214 (Panama) | Immune Response to the Licensed Pediatric Pneumococcal 13 Valent (PCV13) Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo. | Anti-pneumococcal IgG concentration for serotype 19A | 3.069 ug/mL | Standard Deviation 1.9742 |
| HIL-214 (Panama) | Immune Response to the Licensed Pediatric Pneumococcal 13 Valent (PCV13) Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo. | Anti-pneumococcal IgG concentration for serotype 18C | 3.040 ug/mL | Standard Deviation 1.9344 |
| HIL-214 (Panama) | Immune Response to the Licensed Pediatric Pneumococcal 13 Valent (PCV13) Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo. | Anti-pneumococcal IgG concentration for serotype 1 | 5.802 ug/mL | Standard Deviation 2.2008 |
| HIL-214 (Panama) | Immune Response to the Licensed Pediatric Pneumococcal 13 Valent (PCV13) Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo. | Anti-pneumococcal IgG concentration for serotype 4 | 2.773 ug/mL | Standard Deviation 2.0253 |
| HIL-214 (Panama) | Immune Response to the Licensed Pediatric Pneumococcal 13 Valent (PCV13) Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo. | Anti-pneumococcal IgG concentration for serotype 5 | 2.429 ug/mL | Standard Deviation 1.9277 |
| HIL-214 (Panama) | Immune Response to the Licensed Pediatric Pneumococcal 13 Valent (PCV13) Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo. | Anti-pneumococcal IgG concentration for serotype 6A | 7.414 ug/mL | Standard Deviation 2.2194 |
| HIL-214 (Panama) | Immune Response to the Licensed Pediatric Pneumococcal 13 Valent (PCV13) Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo. | Anti-pneumococcal IgG concentration for serotype 6B | 5.459 ug/mL | Standard Deviation 2.7604 |
| HIL-214 (Panama) | Immune Response to the Licensed Pediatric Pneumococcal 13 Valent (PCV13) Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo. | Anti-pneumococcal IgG concentration for serotype 7F | 5.063 ug/mL | Standard Deviation 1.7727 |
| HIL-214 (Panama) | Immune Response to the Licensed Pediatric Pneumococcal 13 Valent (PCV13) Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo. | Anti-pneumococcal IgG concentration for serotype 9V | 3.568 ug/mL | Standard Deviation 2.1651 |
| HIL-214 (Panama) | Immune Response to the Licensed Pediatric Pneumococcal 13 Valent (PCV13) Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo. | Anti-pneumococcal IgG concentration for serotype 14 | 12.017 ug/mL | Standard Deviation 2.3278 |
| HIL-214 (Panama) | Immune Response to the Licensed Pediatric Pneumococcal 13 Valent (PCV13) Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo. | Anti-pneumococcal IgG concentration for serotype 19F | 5.487 ug/mL | Standard Deviation 2.1713 |
| HIL-214 (Panama) | Immune Response to the Licensed Pediatric Pneumococcal 13 Valent (PCV13) Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo. | Anti-pneumococcal IgG concentration for serotype 3 | 0.747 ug/mL | Standard Deviation 2.2117 |
Primary
Immune Response to the Licensed Pediatric Rotavirus Vaccine (RV1) Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo.
This outcome was assessed using measurements of immune response to the concomitant RV1 vaccine (anti-RV1 IgA). Geometric mean concentrations at 28 days post-dose 2 are reported.
Time frame: 28 days post-dose 2
Population: Immunology Evaluable Analysis Set, all participants in the randomized analysis set that receive all doses of all study vaccines (routine and trial vaccines) within the required time window
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo (Panama) | Immune Response to the Licensed Pediatric Rotavirus Vaccine (RV1) Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo. | 67.772 U/mL | Standard Deviation 4.0633 |
| HIL-214 (Panama) | Immune Response to the Licensed Pediatric Rotavirus Vaccine (RV1) Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo. | 87.694 U/mL | Standard Deviation 4.2618 |
Secondary
Evaluate the Safety Profile of a 2-dose Regimen of HIL-214 Co-administered With Routine Pediatric Vaccines at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo
Percentage of participants with medically attended adverse events (AEs) at any point during the trial.
Time frame: Day 1 to 12 months post-dose 1
Population: Safety Analysis Set; all participants that received trial vaccine (HIL-214 or placebo)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo (Panama) | Evaluate the Safety Profile of a 2-dose Regimen of HIL-214 Co-administered With Routine Pediatric Vaccines at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo | 63.4 percentage of participants |
| HIL-214 (Panama) | Evaluate the Safety Profile of a 2-dose Regimen of HIL-214 Co-administered With Routine Pediatric Vaccines at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo | 65.5 percentage of participants |
Secondary
Evaluate the Safety Profile of a 2-dose Regimen of HIL-214 Co-administered With Routine Pediatric Vaccines at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo.
Percentage of participants with solicited local (injection site) reactions within 7 days of any vaccine administration. Assessed reactions included pain, redness, induration, and swelling.
Time frame: Day 1 to Day 7 post-dose 1 and Day 1 to Day 7 post-dose 2
Population: Safety Analysis Set, all participants that received trial vaccine (HIL-214 or placebo)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo (Panama) | Evaluate the Safety Profile of a 2-dose Regimen of HIL-214 Co-administered With Routine Pediatric Vaccines at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo. | 38.4 percentage of participants |
| HIL-214 (Panama) | Evaluate the Safety Profile of a 2-dose Regimen of HIL-214 Co-administered With Routine Pediatric Vaccines at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo. | 41.2 percentage of participants |
Secondary
Evaluate the Safety Profile of a 2-dose Regimen of HIL-214 Co-administered With Routine Pediatric Vaccines at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo.
Percentage of participants with solicited systemic adverse events (AEs) within 7 days of any vaccine administration. Assessed AEs included drowsiness, irritability/fussiness, loss of appetite, fever, vomiting, and diarrhea.
Time frame: Day 1 to Day 7 post-dose 1 and Day 1 to Day 7 post-dose 2
Population: Safety Analysis Set; all participants that received trial vaccine (HIL 214 or placebo).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo (Panama) | Evaluate the Safety Profile of a 2-dose Regimen of HIL-214 Co-administered With Routine Pediatric Vaccines at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo. | 54.9 percentage of participants |
| HIL-214 (Panama) | Evaluate the Safety Profile of a 2-dose Regimen of HIL-214 Co-administered With Routine Pediatric Vaccines at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo. | 46.1 percentage of participants |
Secondary
Evaluate the Safety Profile of a 2-dose Regimen of HIL-214 Co-administered With Routine Pediatric Vaccines at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo.
Percentage of participants with adverse events (AEs) leading to vaccine discontinuation or trial withdrawal.
Time frame: Day 1 to 28 days post-dose 1 (vaccine discontinuation); Day 1 to 12 months post-dose 1
Population: Safety Analysis Set; all participants that received trial vaccine (HIL-214 or placebo).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo (Panama) | Evaluate the Safety Profile of a 2-dose Regimen of HIL-214 Co-administered With Routine Pediatric Vaccines at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo. | AE leading to vaccine discontinuation | 0 percentage of participants |
| Placebo (Panama) | Evaluate the Safety Profile of a 2-dose Regimen of HIL-214 Co-administered With Routine Pediatric Vaccines at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo. | AE leading to trial withdrawal | 0 percentage of participants |
| HIL-214 (Panama) | Evaluate the Safety Profile of a 2-dose Regimen of HIL-214 Co-administered With Routine Pediatric Vaccines at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo. | AE leading to vaccine discontinuation | 0 percentage of participants |
| HIL-214 (Panama) | Evaluate the Safety Profile of a 2-dose Regimen of HIL-214 Co-administered With Routine Pediatric Vaccines at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo. | AE leading to trial withdrawal | 0 percentage of participants |
Secondary
Immunogenicity of a 2-dose Regimen of HIL-214 Co-administered With Routine Pediatric Vaccines at 4 and 6 Months of Age.
Anti-norovirus (GI.1 and GII.4c) HBGA-blocking antibodies were measured at prior to dose 1 (\ 4 months of age) and 28 days post-dose 2 (\ 6 months of age). Seroresponse was defined as a fold increase from baseline greater than or equal to 4. Seroresponse rates and 95% confidence intervals (CIs) are presented. Data are stratified by country (Panama and USA).
Time frame: Pre-dose 1 and 28 days post-dose 2
Population: Immunology Evaluable Analysis Set; all participants in the randomized analysis set that receive all doses of all study vaccines (routine and trial vaccines) within the required time window.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo (Panama) | Immunogenicity of a 2-dose Regimen of HIL-214 Co-administered With Routine Pediatric Vaccines at 4 and 6 Months of Age. | Anti-GI.1 seroresponse by HBGA-blocking assay at 28 days post-dose 2 | 4.1 percentage of participants |
| Placebo (Panama) | Immunogenicity of a 2-dose Regimen of HIL-214 Co-administered With Routine Pediatric Vaccines at 4 and 6 Months of Age. | Anti-GI.1 and GII.4c seroresponse by HBGA-blocking assay at 28 days post-dose 2 | 0.8 percentage of participants |
| Placebo (Panama) | Immunogenicity of a 2-dose Regimen of HIL-214 Co-administered With Routine Pediatric Vaccines at 4 and 6 Months of Age. | Anti-GII.4c seroresponse by HBGA-blocking assay at 28 days post-dose 2 | 1.6 percentage of participants |
| HIL-214 (Panama) | Immunogenicity of a 2-dose Regimen of HIL-214 Co-administered With Routine Pediatric Vaccines at 4 and 6 Months of Age. | Anti-GI.1 seroresponse by HBGA-blocking assay at 28 days post-dose 2 | 97.5 percentage of participants |
| HIL-214 (Panama) | Immunogenicity of a 2-dose Regimen of HIL-214 Co-administered With Routine Pediatric Vaccines at 4 and 6 Months of Age. | Anti-GI.1 and GII.4c seroresponse by HBGA-blocking assay at 28 days post-dose 2 | 53.0 percentage of participants |
| HIL-214 (Panama) | Immunogenicity of a 2-dose Regimen of HIL-214 Co-administered With Routine Pediatric Vaccines at 4 and 6 Months of Age. | Anti-GII.4c seroresponse by HBGA-blocking assay at 28 days post-dose 2 | 51.3 percentage of participants |
| Placebo (USA) | Immunogenicity of a 2-dose Regimen of HIL-214 Co-administered With Routine Pediatric Vaccines at 4 and 6 Months of Age. | Anti-GII.4c seroresponse by HBGA-blocking assay at 28 days post-dose 2 | 0 percentage of participants |
| Placebo (USA) | Immunogenicity of a 2-dose Regimen of HIL-214 Co-administered With Routine Pediatric Vaccines at 4 and 6 Months of Age. | Anti-GI.1 seroresponse by HBGA-blocking assay at 28 days post-dose 2 | 0 percentage of participants |
| Placebo (USA) | Immunogenicity of a 2-dose Regimen of HIL-214 Co-administered With Routine Pediatric Vaccines at 4 and 6 Months of Age. | Anti-GI.1 and GII.4c seroresponse by HBGA-blocking assay at 28 days post-dose 2 | 0 percentage of participants |
| HIL-214 (USA) | Immunogenicity of a 2-dose Regimen of HIL-214 Co-administered With Routine Pediatric Vaccines at 4 and 6 Months of Age. | Anti-GI.1 seroresponse by HBGA-blocking assay at 28 days post-dose 2 | 100 percentage of participants |
| HIL-214 (USA) | Immunogenicity of a 2-dose Regimen of HIL-214 Co-administered With Routine Pediatric Vaccines at 4 and 6 Months of Age. | Anti-GI.1 and GII.4c seroresponse by HBGA-blocking assay at 28 days post-dose 2 | 16.7 percentage of participants |
| HIL-214 (USA) | Immunogenicity of a 2-dose Regimen of HIL-214 Co-administered With Routine Pediatric Vaccines at 4 and 6 Months of Age. | Anti-GII.4c seroresponse by HBGA-blocking assay at 28 days post-dose 2 | 16.7 percentage of participants |