Safety, Tolerability, and Immunogenicity of V419 Given Concomitantly With Prevnar 13™ and RotaTeq™ (V419-005)

PHASE3CompletedINTERVENTIONAL
Enrollment

1,473

Participants

Timeline

Start Date

April 19, 2011

Primary Completion Date

May 9, 2013

Study Completion Date

May 9, 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) 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

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

MCM Vaccines B.V.

INDUSTRY

lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT01337167 - Safety, Tolerability, and Immunogenicity of V419 Given Concomitantly With Prevnar 13™ and RotaTeq™ (V419-005) | Biotech Hunter | Biotech Hunter