Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 3, 4 and 12 Months (V419-007)

PHASE3CompletedINTERVENTIONAL
Enrollment

1,250

Participants

Timeline

Start Date

May 26, 2011

Primary Completion Date

March 13, 2013

Study Completion Date

March 13, 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, 3, 4, and 12 months of age.

BIOLOGICAL

INFANRIX™ hexa

INFANRIX™ hexa 0.5 mL intramuscular injection at 2, 3, 4, and 12 months of age.

BIOLOGICAL

RotaTeq

RotaTeq (pentavalent combination live vaccine of 5 human-bovine reassortant rotavirus strains) 2 mL oral dose at 2, 3, and 4 months of age

BIOLOGICAL

Prevenar 13

Prevenar 13 0.5 mL intramuscular injection at 2, 3, 4,and 13 months of age

BIOLOGICAL

ProQuad™

ProQuad™ 0.5 mL subcutaneous injection at 12 and 13 months of age

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

MCM Vaccines B.V.

INDUSTRY

NCT01341639 - Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 3, 4 and 12 Months (V419-007) | Biotech Hunter | Biotech Hunter