Trials / Completed
CompletedNCT01337167
Safety, Tolerability, and Immunogenicity of V419 Given Concomitantly With Prevnar 13™ and RotaTeq™ (V419-005)
A Phase III Randomized, Open-Label, Active-Comparator Controlled Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V419 in Infants When Given at 2, 4, and 6 Months Concomitantly With Prevnar 13™ and RotaTeq™
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,473 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 46 Days – 89 Days
- Healthy volunteers
- Accepted
Summary
This is a study to assess the safety, tolerability, and immunogenicity of V419 (PR5I) when administered as an infant series at 2, 4, and 6 months of age followed by a toddler dose of DAPTACEL™, Prevnar 13™ and PedvaxHIB™ at 15 months of age. The study will determine whether subjects who receive V419 have a similar immune response to the vaccine compared to subjects who receive licensed component vaccine controls.
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) 0.5 mL intramuscular injection at 2, 4, and 6 months of age |
| BIOLOGICAL | DAPTACEL™ | DAPTACEL™ 0.5 mL intramuscular injection at 15 months of age |
| BIOLOGICAL | PedvaxHIB™ | PedvaxHIB™ 0.5 mL intramuscular injection at 15 months of age |
| 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 | PENTACEL™ | PENTACEL™ 0.5 mL intramuscular injection 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 |
| BIOLOGICAL | ActHIB™ | ActHIB™ 0.5 mL intramuscular injection at 15 months of age |
Timeline
- Start date
- 2011-04-19
- Primary completion
- 2013-05-09
- Completion
- 2013-05-09
- First posted
- 2011-04-18
- Last updated
- 2018-11-15
- Results posted
- 2016-03-16
Source: ClinicalTrials.gov record NCT01337167. Inclusion in this directory is not an endorsement.