Phase 4
N=1,271
Concomitant Use of Hepatitis A Vaccine, Inactivated With Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed Given to Healthy Children 15 Months of Age (V251-068)
Hepatitis A Virus
Bottom Line
View on ClinicalTrials.gov: NCT00289913 ↗Enrolled (actual)
1,271
Serious AEs
0.5%
Results posted
Jul 2011
Primary outcome: Primary: Seropositivity Rate (SPR) to Hepatitis A — 100; 100; 100; 100 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Comparator: VAQTA™ (Biological); Comparator: Infanrix™ (Biological); Comparator: PedvaxHIB™ (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Jun 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Seropositivity Rate (SPR) to Hepatitis A |
100; 100; 100; 100 | — |
| PRIMARY Antibody Response Rate to Haemophilus Influenzae Type b (Hib) |
98.1; 97.0; 97.3; 97.2 | — |
| PRIMARY Number of Participants With Adverse Events (AE) |
63; 86; 181; 239; 170; 466 | — |
| PRIMARY Geometric Mean Titers (GMTs) to Antibodies for the Pertussis Toxin (PT), Pertussis Filamentous Hemagglutinin Antibody (FHA), and Pertactin (PRN) Components of Infanrix™ |
69.2; 51.7; 253.8; 249.2; 333.5; 358.5 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00289913). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.