Trials / Completed
CompletedNCT01340937
A Study of V419 Given Concomitantly With Prevnar 13™ and RotaTeq™ (V419-006)
A Phase III Randomized, Partially Double-Blind, Active-Comparator-Controlled, Lot-to-Lot Consistency Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 4, and 6 Months Concomitantly With Prevnar 13™ and RotaTeq ™
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 2,808 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 46 Days – 89 Days
- Healthy volunteers
- Accepted
Summary
This study will determine whether three manufacturing lots of V419 (PR5I) induce similar immune responses to all of the antigens contained in V419 when given concomitantly with Prevnar13™ and RotaTeq™.
Detailed description
This study is partially Double-Blinded in that the participants' parents/guardians, investigator/study site personnel, and Sponsor's representatives will be blinded to the lot of V419 the participant is randomized to receive, but not to the participant's treatment group (V419 or control).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | V419 | V419 (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate \[Meningococcal Outer Membrane Protein Complex\], and Hepatitis B \[Recombinant\] Vaccine) (from one of three lots) 0.5 mL intramuscular injection at 2, 4, and 6 months of age. |
| BIOLOGICAL | PENTACEL™ | PENTACEL™ 0.5 mL intramuscular injection at 15 months of age in the V419 groups and at 2, 4, 6, and 15 months of age in the control group |
| BIOLOGICAL | Prevnar 13™ | Prevnar 13™ 0.5 mL intramuscular injection at 2, 4, 6, and 15 months of age |
| BIOLOGICAL | RotaTeq™ | RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age |
| BIOLOGICAL | Recombivax HB vaccine | Recombivax HB vaccine 0.5 mL intramuscular injection at 2 and 6 months of age |
Timeline
- Start date
- 2011-05-10
- Primary completion
- 2012-12-18
- Completion
- 2013-07-26
- First posted
- 2011-04-25
- Last updated
- 2018-11-15
- Results posted
- 2016-05-02
Source: ClinicalTrials.gov record NCT01340937. Inclusion in this directory is not an endorsement.