Trials / Completed
CompletedNCT00289913
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)
An Open, Randomized, Multicenter Study of the Safety, Tolerability, and Immunogenicity of VAQTA™ Given Concomitantly With PedvaxHIB™ and Infanrix™ in Healthy Children 15 Months of Age
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 1,274 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 12 Months – 17 Months
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Comparator: 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. |
| BIOLOGICAL | Comparator: 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. |
| BIOLOGICAL | Comparator: PedvaxHIB™ | PedvaxHIB™ (Haemophilus B Conjugate Vaccine \[Meningococcal Protein Conjugate\]). One intramuscular 0.5-mL injection of PedvaxHIB™ was administered at the first study visit. |
Timeline
- Start date
- 2006-04-01
- Primary completion
- 2010-06-01
- Completion
- 2010-06-01
- First posted
- 2006-02-10
- Last updated
- 2017-04-13
- Results posted
- 2011-07-07
Source: ClinicalTrials.gov record NCT00289913. Inclusion in this directory is not an endorsement.