Hepatitis A Virus
Conditions
Keywords
Hepatitis A virus
Brief summary
This two-stage study evaluates the immunogenicity, safety, and tolerability of the administration of VAQTA™ (Hepatitis A Vaccine, Inactivated) concomitantly with PedvaxHIB™ (Haemophilus B Conjugate Vaccine \[Meningococcal Protein Conjugate\]) and Infanrix™ (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, GlaxoSmithKline) versus the administration of VAQTA™ in healthy children 15 months of age at study entry.
Detailed description
In stage I, VAQTA™ given concomitantly with Infanrix™ and/or PedvaxHIB™ was evaluated. In stage 2: Two (2) doses of the VAQTA™ vaccine were administered at least 6 months apart. Safety data was collected after each dose.
Interventions
BIOLOGICALComparator: VAQTA™
VAQTA™ (Hepatitis A Vaccine, Inactivated). Two intramuscular 0.5-mL doses of VAQTA™ were administered 24 weeks apart, with the second dose being administered prior to 24 months of age.
BIOLOGICALComparator: Infanrix™
Infanrix™ (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, GlaxoSmithKline). One intramuscular 0.5-mL injection of Infanrix™ was administered at the first study visit.
BIOLOGICALComparator: PedvaxHIB™
PedvaxHIB™ (Haemophilus B Conjugate Vaccine \[Meningococcal Protein Conjugate\]). One intramuscular 0.5-mL injection of PedvaxHIB™ was administered at the first study visit.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Months to 17 Months
Healthy volunteers
Yes
Inclusion criteria
* Stage 1) Healthy males and females 15 months of age with no active liver disease and a negative history of hepatitis A who have been vaccinated against Haemophilus influenzae type b (Hib), diphtheria, tetanus, and pertussis diseases * Stage 2) Healthy males and females 12 to 17 months of age with no active liver disease and a negative history of hepatitis A
Exclusion criteria
* Stage 1) Males and females previously vaccinated with hepatitis A vaccine, any immune deficiency, a history of allergy to any of the vaccine components, a history of seizure disorder or a neurologic disorder that would contraindicate pertussis vaccine, or a bleeding disorder * Stage 2) Males and females previously vaccinated with hepatitis A vaccine, any immune deficiency, a history of allergy to any of the vaccine components, or a history of bleeding disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Seropositivity Rate (SPR) to Hepatitis A | 4 weeks after dose 2 of VAQTA™ | SPR is the percent of participants with Hepatitis A antibody titers \>= 10 milli-International Units/milliliter (mIU/mL), 4 weeks after dose 2 of VAQTA™ regardless of their initial serostatus. Antibody titers to Hepatitis A virus (HAV) were detected in participants' serum samples using an Enzyme Immunoassay (EIA). |
| Antibody Response Rate to Haemophilus Influenzae Type b (Hib) | 4 weeks postvaccination with PedvaxHIB™ | Antibodies to the Hib capsular polysaccharide (polyribosylribitol phosphate \[PRP\]) are assessed in participants serum using radioimmunoassay (RIA). The limit of detection (LOD) for the RIA is 6.60 ng/mL. The antibody response rate is defined as the percentage of participants with anti-PRP titers \>1.0 mcg/mL, 4 weeks postvaccination with PedvaxHIB™. |
| Number of Participants With Adverse Events (AE) | Days 1 to 14 after any dose of VAQTA™ for systemic AEs, and Days 1 to 5 after any dose of VAQTA™ for injection-site AEs | Systemic and injection site AEs were collected from participants receiving * VAQTA™ concomitantly with Infanrix™ and PedvaxHIB™ or PedvaxHIB™ (Stage I) * VAQTA™ non-concomitantly with Infanrix™ and PedvaxHIB™ or PedvaxHIB™ (Stage I) * VAQTA™ administered alone (Stage II) Safety data was collected on a standardized Vaccination Report Card (VRC) following each dose. Participants returned the VRC after the safety follow-up period for each dose of VAQTA™. AEs determined by the investigator to be possibly, probably or definitely related to the vaccine are reported as Vaccine-related AE. |
| Geometric Mean Titers (GMTs) to Antibodies for the Pertussis Toxin (PT), Pertussis Filamentous Hemagglutinin Antibody (FHA), and Pertactin (PRN) Components of Infanrix™ | 4 weeks postvaccination with Infanrix™ | GMTs for antibodies to PT, FHA, and PRN were measured in serum samples of participants vaccinated with Infanrix™. IgG antibodies to PT were assessed using the anti-pertussis toxin enzyme-linked immunosorbent assay (anti-PT ELISA), with the LOD of 2.4 ELU/mL. IgG antibodies to FHA were assessed using the anti-pertussis filamentous hemagglutinin enzyme-linked immunosorbent assay (anti-FHA ELISA), with the LOD of 2.0 ELU/mL. IgG antibodies to PRN were assessed using the anti-pertussis pertactin enzyme-linked immunosorbent assay (anti-PRN ELISA), with the LOD of 3.3 ELU/mL. |
Participant flow
Recruitment details
In Stage I, a total of 620 participants were randomized to receive study vaccinations. However for 3 participants, the Health Insurance Portability and Accountability Act (HIPAA) and/or Informed Consent Form was not signed by the parents in error. Therefore a total of 617 participants were included in Stage I. 654 participants started Stage II.
Pre-assignment details
For this study: Visit 1 was on Day 1 (for Stage I and Stage II). Visit 2 was at Week 4 (Stage I) and Week 2 (Stage II). Visit 3 was at Week 24/Week 28 (Stage I) and Week 24 (Stage II). Visit 4 was at Week 28/Week 32 (Stage I) and Week 26 (Stage II). For safety, participants were followed for 14 days after each vaccination (safety follow-up \[F/U\]).
Participants by arm
| Arm | Count |
|---|---|
| VAQTA™, PedvaxHIB™ and Infanrix™/ VAQTA™ (Stage 1) Day 1: VAQTA™ (first dose), PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites.
Week 24: The second dose of VAQTA™ was administered. | 155 |
| PedvaxHIB™ and Infanrix™/ VAQTA™/ VAQTA™ (Stage 1) Day 1: PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites.
Week 4: The first dose of VAQTA™ was administered.
Week 28: The second dose of VAQTA™ was administered. | 151 |
| VAQTA™, PedvaxHIB™/ VAQTA™ (Stage 1) Day 1: VAQTA™ (first dose) and PedvaxHIB™ were administered concomitantly at different injection sites.
Week 24: The second dose of VAQTA™ was administered. | 159 |
| PedvaxHIB™/ VAQTA™/ VAQTA™ (Stage 1) Day 1: PedvaxHIB™ was administered.
Week 4: The first dose of VAQTA™ was administered.
Week 28: The second dose of VAQTA™ was administered. | 152 |
| VAQTA™/ VAQTA™ (Stage 2) Day 1: The first dose of VAQTA™ was administered.
Week 24: The second dose of VAQTA™ was administered. | 654 |
| Total | 1,271 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Visit 1 (Stage I and Stage II) | Lost after safety F/U | 2 | 1 | 0 | 0 | 5 |
| Visit 1 (Stage I and Stage II) | Lost during safety F/U | 3 | 2 | 2 | 2 | 1 |
| Visit 1 (Stage I and Stage II) | Moved during safety F/U | 0 | 0 | 0 | 0 | 1 |
| Visit 1 (Stage I and Stage II) | Other reasons after safety F/U | 1 | 0 | 2 | 0 | 0 |
| Visit 1 (Stage I and Stage II) | Other reasons during safety F/U | 0 | 0 | 0 | 1 | 0 |
| Visit 1 (Stage I and Stage II) | Protocol deviation after safety F/U | 1 | 2 | 0 | 0 | 0 |
| Visit 1 (Stage I and Stage II) | Protocol deviation during safety F/U | 0 | 1 | 0 | 0 | 0 |
| Visit 1 (Stage I and Stage II) | Withdrew consent after safety F/U] | 0 | 8 | 5 | 6 | 0 |
| Visit 1 (Stage I and Stage II) | Withdrew consent during safety F/U | 2 | 2 | 0 | 2 | 2 |
| Visit 2 (Stage I and Stage II) | Lost after safety F/U | 2 | 5 | 0 | 3 | 0 |
| Visit 2 (Stage I and Stage II) | Lost during safety F/U | 8 | 11 | 2 | 2 | 0 |
| Visit 2 (Stage I and Stage II) | Lost (Stage II) | 0 | 0 | 0 | 0 | 11 |
| Visit 2 (Stage I and Stage II) | Moved (Stage II) | 0 | 0 | 0 | 0 | 6 |
| Visit 2 (Stage I and Stage II) | Other reasons after safety F/U] | 1 | 0 | 0 | 0 | 0 |
| Visit 2 (Stage I and Stage II) | Other reasons during safety F/U | 1 | 0 | 1 | 0 | 0 |
| Visit 2 (Stage I and Stage II) | Other reasons (Stage II) | 0 | 0 | 0 | 0 | 9 |
| Visit 2 (Stage I and Stage II) | Protocol deviation after safety F/U | 0 | 1 | 3 | 1 | 0 |
| Visit 2 (Stage I and Stage II) | Protocol deviation during safety F/U | 0 | 0 | 1 | 0 | 0 |
| Visit 2 (Stage I and Stage II) | Protocol deviation (Stage II) | 0 | 0 | 0 | 0 | 7 |
| Visit 2 (Stage I and Stage II) | Subject moved during safety F/U | 0 | 1 | 0 | 0 | 0 |
| Visit 2 (Stage I and Stage II) | Withdrew consent after safety F/U | 0 | 1 | 2 | 0 | 0 |
| Visit 2 (Stage I and Stage II) | Withdrew consent during safety F/U | 3 | 2 | 1 | 0 | 0 |
| Visit 2 (Stage I and Stage II) | Withdrew consent (Stage II) | 0 | 0 | 0 | 0 | 7 |
| Visit 3 (Stage I and Stage II) | Lost after safety F/U | 1 | 2 | 0 | 1 | 4 |
| Visit 3 (Stage I and Stage II) | Lost during safety F/U | 8 | 3 | 1 | 2 | 2 |
| Visit 3 (Stage I and Stage II) | Moved after safety F/U | 0 | 0 | 0 | 0 | 1 |
| Visit 3 (Stage I and Stage II) | Other reasons after safety F/U | 0 | 1 | 0 | 0 | 0 |
| Visit 3 (Stage I and Stage II) | Other reasons during safety F/U | 0 | 0 | 0 | 0 | 1 |
| Visit 3 (Stage I and Stage II) | Protocol deviation during safety F/U | 0 | 1 | 0 | 0 | 0 |
| Visit 3 (Stage I and Stage II) | Withdrew consent after safety F/U] | 0 | 1 | 1 | 0 | 0 |
| Visit 3 (Stage I and Stage II) | Withdrew consent during safety F/U | 0 | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | VAQTA™, PedvaxHIB™ and Infanrix™/ VAQTA™ (Stage 1) | PedvaxHIB™ and Infanrix™/ VAQTA™/ VAQTA™ (Stage 1) | VAQTA™, PedvaxHIB™/ VAQTA™ (Stage 1) | PedvaxHIB™/ VAQTA™/ VAQTA™ (Stage 1) | VAQTA™/ VAQTA™ (Stage 2) | Total |
|---|---|---|---|---|---|---|
| Age, Customized Between 12 and 18 months | 155 participants | 151 participants | 159 participants | 152 participants | 654 participants | 1271 participants |
| Sex: Female, Male Female | 74 Participants | 67 Participants | 70 Participants | 73 Participants | 319 Participants | 603 Participants |
| Sex: Female, Male Male | 81 Participants | 84 Participants | 89 Participants | 79 Participants | 335 Participants | 668 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 116 / 150 | 74 / 145 | 123 / 152 | 88 / 146 | 426 / 641 |
| serious Total, serious adverse events | 0 / 150 | 2 / 145 | 0 / 152 | 2 / 146 | 2 / 641 |
Outcome results
Primary
Antibody Response Rate to Haemophilus Influenzae Type b (Hib)
Antibodies to the Hib capsular polysaccharide (polyribosylribitol phosphate \[PRP\]) are assessed in participants serum using radioimmunoassay (RIA). The limit of detection (LOD) for the RIA is 6.60 ng/mL. The antibody response rate is defined as the percentage of participants with anti-PRP titers \>1.0 mcg/mL, 4 weeks postvaccination with PedvaxHIB™.
Time frame: 4 weeks postvaccination with PedvaxHIB™
Population: The per-protocol population, which consisted of all Stage I participants who received vaccinations within the specified day ranges, completed appropriate follow-up, and were without any pre-specified protocol violations.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VAQTA™, PedvaxHIB™ and Infanrix™/ VAQTA™ (Stage 1) | Antibody Response Rate to Haemophilus Influenzae Type b (Hib) | 98.1 Percentage of participants |
| PedvaxHIB™ and Infanrix™/ VAQTA™/ VAQTA™ (Stage 1) | Antibody Response Rate to Haemophilus Influenzae Type b (Hib) | 97.0 Percentage of participants |
| VAQTA™, PedvaxHIB™/ VAQTA™ (Stage 1) | Antibody Response Rate to Haemophilus Influenzae Type b (Hib) | 97.3 Percentage of participants |
| PedvaxHIB™/ VAQTA™/ VAQTA™ (Stage 1) | Antibody Response Rate to Haemophilus Influenzae Type b (Hib) | 97.2 Percentage of participants |
Primary
Geometric Mean Titers (GMTs) to Antibodies for the Pertussis Toxin (PT), Pertussis Filamentous Hemagglutinin Antibody (FHA), and Pertactin (PRN) Components of Infanrix™
GMTs for antibodies to PT, FHA, and PRN were measured in serum samples of participants vaccinated with Infanrix™. IgG antibodies to PT were assessed using the anti-pertussis toxin enzyme-linked immunosorbent assay (anti-PT ELISA), with the LOD of 2.4 ELU/mL. IgG antibodies to FHA were assessed using the anti-pertussis filamentous hemagglutinin enzyme-linked immunosorbent assay (anti-FHA ELISA), with the LOD of 2.0 ELU/mL. IgG antibodies to PRN were assessed using the anti-pertussis pertactin enzyme-linked immunosorbent assay (anti-PRN ELISA), with the LOD of 3.3 ELU/mL.
Time frame: 4 weeks postvaccination with Infanrix™
Population: The per-protocol population, which consisted of all Stage I participants who received vaccinations within the specified day ranges, completed appropriate follow-up, and were without any pre-specified protocol violations.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| VAQTA™, PedvaxHIB™ and Infanrix™/ VAQTA™ (Stage 1) | Geometric Mean Titers (GMTs) to Antibodies for the Pertussis Toxin (PT), Pertussis Filamentous Hemagglutinin Antibody (FHA), and Pertactin (PRN) Components of Infanrix™ | Pertussis PT | 69.2 ELISA units per mL (ELU/mL) |
| VAQTA™, PedvaxHIB™ and Infanrix™/ VAQTA™ (Stage 1) | Geometric Mean Titers (GMTs) to Antibodies for the Pertussis Toxin (PT), Pertussis Filamentous Hemagglutinin Antibody (FHA), and Pertactin (PRN) Components of Infanrix™ | Pertussis FHA | 253.8 ELISA units per mL (ELU/mL) |
| VAQTA™, PedvaxHIB™ and Infanrix™/ VAQTA™ (Stage 1) | Geometric Mean Titers (GMTs) to Antibodies for the Pertussis Toxin (PT), Pertussis Filamentous Hemagglutinin Antibody (FHA), and Pertactin (PRN) Components of Infanrix™ | PRN | 333.5 ELISA units per mL (ELU/mL) |
| PedvaxHIB™ and Infanrix™/ VAQTA™/ VAQTA™ (Stage 1) | Geometric Mean Titers (GMTs) to Antibodies for the Pertussis Toxin (PT), Pertussis Filamentous Hemagglutinin Antibody (FHA), and Pertactin (PRN) Components of Infanrix™ | Pertussis PT | 51.7 ELISA units per mL (ELU/mL) |
| PedvaxHIB™ and Infanrix™/ VAQTA™/ VAQTA™ (Stage 1) | Geometric Mean Titers (GMTs) to Antibodies for the Pertussis Toxin (PT), Pertussis Filamentous Hemagglutinin Antibody (FHA), and Pertactin (PRN) Components of Infanrix™ | Pertussis FHA | 249.2 ELISA units per mL (ELU/mL) |
| PedvaxHIB™ and Infanrix™/ VAQTA™/ VAQTA™ (Stage 1) | Geometric Mean Titers (GMTs) to Antibodies for the Pertussis Toxin (PT), Pertussis Filamentous Hemagglutinin Antibody (FHA), and Pertactin (PRN) Components of Infanrix™ | PRN | 358.5 ELISA units per mL (ELU/mL) |
Primary
Number of Participants With Adverse Events (AE)
Systemic and injection site AEs were collected from participants receiving * VAQTA™ concomitantly with Infanrix™ and PedvaxHIB™ or PedvaxHIB™ (Stage I) * VAQTA™ non-concomitantly with Infanrix™ and PedvaxHIB™ or PedvaxHIB™ (Stage I) * VAQTA™ administered alone (Stage II) Safety data was collected on a standardized Vaccination Report Card (VRC) following each dose. Participants returned the VRC after the safety follow-up period for each dose of VAQTA™. AEs determined by the investigator to be possibly, probably or definitely related to the vaccine are reported as Vaccine-related AE.
Time frame: Days 1 to 14 after any dose of VAQTA™ for systemic AEs, and Days 1 to 5 after any dose of VAQTA™ for injection-site AEs
Population: Participants administered at least one dose of vaccine, for whom follow-up was available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| VAQTA™, PedvaxHIB™ and Infanrix™/ VAQTA™ (Stage 1) | Number of Participants With Adverse Events (AE) | With vaccine-related (VR) AE | 192 Participants |
| VAQTA™, PedvaxHIB™ and Infanrix™/ VAQTA™ (Stage 1) | Number of Participants With Adverse Events (AE) | ---injection-site AE (VR) | 164 Participants |
| VAQTA™, PedvaxHIB™ and Infanrix™/ VAQTA™ (Stage 1) | Number of Participants With Adverse Events (AE) | ---sytemic AE (VR) | 91 Participants |
| VAQTA™, PedvaxHIB™ and Infanrix™/ VAQTA™ (Stage 1) | Number of Participants With Adverse Events (AE) | With serious AE | 0 Participants |
| VAQTA™, PedvaxHIB™ and Infanrix™/ VAQTA™ (Stage 1) | Number of Participants With Adverse Events (AE) | With serious AE (VR) | 0 Participants |
| VAQTA™, PedvaxHIB™ and Infanrix™/ VAQTA™ (Stage 1) | Number of Participants With Adverse Events (AE) | Who died | 0 Participants |
| VAQTA™, PedvaxHIB™ and Infanrix™/ VAQTA™ (Stage 1) | Number of Participants With Adverse Events (AE) | Who discontinued due to AE | 0 Participants |
| VAQTA™, PedvaxHIB™ and Infanrix™/ VAQTA™ (Stage 1) | Number of Participants With Adverse Events (AE) | Who discontinued due to serious AE | 0 Participants |
| VAQTA™, PedvaxHIB™ and Infanrix™/ VAQTA™ (Stage 1) | Number of Participants With Adverse Events (AE) | With no AE | 63 Participants |
| VAQTA™, PedvaxHIB™ and Infanrix™/ VAQTA™ (Stage 1) | Number of Participants With Adverse Events (AE) | With one or more AE | 239 Participants |
| VAQTA™, PedvaxHIB™ and Infanrix™/ VAQTA™ (Stage 1) | Number of Participants With Adverse Events (AE) | ---injection-site AE | 167 Participants |
| VAQTA™, PedvaxHIB™ and Infanrix™/ VAQTA™ (Stage 1) | Number of Participants With Adverse Events (AE) | ---sytemic AE | 183 Participants |
| PedvaxHIB™ and Infanrix™/ VAQTA™/ VAQTA™ (Stage 1) | Number of Participants With Adverse Events (AE) | ---sytemic AE | 119 Participants |
| PedvaxHIB™ and Infanrix™/ VAQTA™/ VAQTA™ (Stage 1) | Number of Participants With Adverse Events (AE) | With vaccine-related (VR) AE | 129 Participants |
| PedvaxHIB™ and Infanrix™/ VAQTA™/ VAQTA™ (Stage 1) | Number of Participants With Adverse Events (AE) | Who discontinued due to AE | 0 Participants |
| PedvaxHIB™ and Infanrix™/ VAQTA™/ VAQTA™ (Stage 1) | Number of Participants With Adverse Events (AE) | With no AE | 86 Participants |
| PedvaxHIB™ and Infanrix™/ VAQTA™/ VAQTA™ (Stage 1) | Number of Participants With Adverse Events (AE) | ---injection-site AE (VR) | 116 Participants |
| PedvaxHIB™ and Infanrix™/ VAQTA™/ VAQTA™ (Stage 1) | Number of Participants With Adverse Events (AE) | Who died | 0 Participants |
| PedvaxHIB™ and Infanrix™/ VAQTA™/ VAQTA™ (Stage 1) | Number of Participants With Adverse Events (AE) | ---injection-site AE | 116 Participants |
| PedvaxHIB™ and Infanrix™/ VAQTA™/ VAQTA™ (Stage 1) | Number of Participants With Adverse Events (AE) | ---sytemic AE (VR) | 42 Participants |
| PedvaxHIB™ and Infanrix™/ VAQTA™/ VAQTA™ (Stage 1) | Number of Participants With Adverse Events (AE) | Who discontinued due to serious AE | 0 Participants |
| PedvaxHIB™ and Infanrix™/ VAQTA™/ VAQTA™ (Stage 1) | Number of Participants With Adverse Events (AE) | With serious AE (VR) | 0 Participants |
| PedvaxHIB™ and Infanrix™/ VAQTA™/ VAQTA™ (Stage 1) | Number of Participants With Adverse Events (AE) | With serious AE | 1 Participants |
| PedvaxHIB™ and Infanrix™/ VAQTA™/ VAQTA™ (Stage 1) | Number of Participants With Adverse Events (AE) | With one or more AE | 170 Participants |
| VAQTA™, PedvaxHIB™/ VAQTA™ (Stage 1) | Number of Participants With Adverse Events (AE) | With serious AE | 2 Participants |
| VAQTA™, PedvaxHIB™/ VAQTA™ (Stage 1) | Number of Participants With Adverse Events (AE) | With serious AE (VR) | 0 Participants |
| VAQTA™, PedvaxHIB™/ VAQTA™ (Stage 1) | Number of Participants With Adverse Events (AE) | With one or more AE | 466 Participants |
| VAQTA™, PedvaxHIB™/ VAQTA™ (Stage 1) | Number of Participants With Adverse Events (AE) | Who died | 0 Participants |
| VAQTA™, PedvaxHIB™/ VAQTA™ (Stage 1) | Number of Participants With Adverse Events (AE) | Who discontinued due to AE | 0 Participants |
| VAQTA™, PedvaxHIB™/ VAQTA™ (Stage 1) | Number of Participants With Adverse Events (AE) | Who discontinued due to serious AE | 0 Participants |
| VAQTA™, PedvaxHIB™/ VAQTA™ (Stage 1) | Number of Participants With Adverse Events (AE) | ---injection-site AE | 249 Participants |
| VAQTA™, PedvaxHIB™/ VAQTA™ (Stage 1) | Number of Participants With Adverse Events (AE) | With vaccine-related (VR) AE | 328 Participants |
| VAQTA™, PedvaxHIB™/ VAQTA™ (Stage 1) | Number of Participants With Adverse Events (AE) | ---injection-site AE (VR) | 249 Participants |
| VAQTA™, PedvaxHIB™/ VAQTA™ (Stage 1) | Number of Participants With Adverse Events (AE) | With no AE | 181 Participants |
| VAQTA™, PedvaxHIB™/ VAQTA™ (Stage 1) | Number of Participants With Adverse Events (AE) | ---sytemic AE (VR) | 147 Participants |
| VAQTA™, PedvaxHIB™/ VAQTA™ (Stage 1) | Number of Participants With Adverse Events (AE) | ---sytemic AE | 395 Participants |
Primary
Seropositivity Rate (SPR) to Hepatitis A
SPR is the percent of participants with Hepatitis A antibody titers \>= 10 milli-International Units/milliliter (mIU/mL), 4 weeks after dose 2 of VAQTA™ regardless of their initial serostatus. Antibody titers to Hepatitis A virus (HAV) were detected in participants' serum samples using an Enzyme Immunoassay (EIA).
Time frame: 4 weeks after dose 2 of VAQTA™
Population: The per-protocol population, which consisted of all Stage I participants who received vaccinations within the specified day ranges, completed appropriate follow-up, and were without any pre-specified protocol violations.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VAQTA™, PedvaxHIB™ and Infanrix™/ VAQTA™ (Stage 1) | Seropositivity Rate (SPR) to Hepatitis A | 100 Percentage of participants |
| PedvaxHIB™ and Infanrix™/ VAQTA™/ VAQTA™ (Stage 1) | Seropositivity Rate (SPR) to Hepatitis A | 100 Percentage of participants |
| VAQTA™, PedvaxHIB™/ VAQTA™ (Stage 1) | Seropositivity Rate (SPR) to Hepatitis A | 100 Percentage of participants |
| PedvaxHIB™/ VAQTA™/ VAQTA™ (Stage 1) | Seropositivity Rate (SPR) to Hepatitis A | 100 Percentage of participants |