At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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™
In Brief
A Phase 3 clinical trial evaluating V419, DAPTACEL™, and 6 other interventions for Bacterial Infections and Virus Diseases. Completed, enrolled 1,473 participants.
Detailed 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.
Study Details
Timeline
Interventions
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
DAPTACEL™ 0.5 mL intramuscular injection at 15 months of age
PedvaxHIB™ 0.5 mL intramuscular injection at 15 months of age
Prevnar 13™ 0.5 mL intramuscular injection at 2, 4, 6, and 15 months of age
RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age
PENTACEL™ 0.5 mL intramuscular injection at 2, 4, and 6 months of age
Recombivax HB vaccine 0.5 mL intramuscular injection at 2 and 6 months of age
ActHIB™ 0.5 mL intramuscular injection at 15 months of age