A Study of V419 Given Concomitantly With Prevnar 13™ and RotaTeq™ (V419-006)

PHASE3CompletedINTERVENTIONAL
Enrollment

2,808

Participants

Timeline

Start Date

May 10, 2011

Primary Completion Date

December 18, 2012

Study Completion Date

July 26, 2013

Conditions
Bacterial InfectionsVirus Diseases
Interventions
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

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

MCM Vaccines B.V.

INDUSTRY

lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT01340937 - A Study of V419 Given Concomitantly With Prevnar 13™ and RotaTeq™ (V419-006) | Biotech Hunter | Biotech Hunter