Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 4, and 11 to 12 Months (V419-008)

PHASE3CompletedINTERVENTIONAL
Enrollment

1,315

Participants

Timeline

Start Date

November 23, 2011

Primary Completion Date

October 9, 2013

Study Completion Date

October 9, 2013

Conditions
Bacterial InfectionsVirus Diseases
Interventions
BIOLOGICAL

PR5I

DTaP-HB-IPV-Hib (Diphtheria, tetanus, pertussis \[acellular, component\], hepatitis B \[recombinant DNA\], polio virus \[inactivated\], and Haemophilus influenza type b conjugate vaccine \[adsorbed\]) Vaccine 0.5 mL intramuscular injection at 2, 4, and 11 to 12 months of age. Injection is to be administered in the upper anterolateral thigh, separate limb from the concomitant vaccine. PR5I is a liquid suspension hexavalent vaccine.

BIOLOGICAL

Rotavirus vaccine

Rotarix™ 1.5 mL oral dose at 2 and 4 months of age (subset 1, Italy and Sweden) or RotaTeq™ 2 mL oral dose at 2, 4 and 5 months of age (subset 2, Finland)

BIOLOGICAL

Prevenar 13™

Prevenar 13™ 0.5 mL intramuscular injection at 2, 4, and 11 to 12 months of age. Injection is to be administered in the upper anterolateral thigh, separate limb from the concomitant vaccine.

BIOLOGICAL

INFANRIX™ hexa

Combined Diphtheria-Tetanus-acellular Pertussis \[DTaP\], Hepatitis B \[HepB\], Poliovirus \[IPV\] and Haemophilus influenzae type b \[Hib\] Vaccine 0.5 mL intramuscular injection at 2, 4 and 11 to 12 months of age. Injection is to be administered in the upper anterolateral thigh, separate limb from the concomitant vaccine. INFANRIX™ hexa is provided as 2 components (lyophilized Hib and liquid DTaP, IPV, and HepB). Prior to administration, the vaccine must be reconstituted by adding the liquid DTaP-HepB-IPV component to the vial containing the Hib pellet.

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

MCM Vaccines B.V.

INDUSTRY

NCT01480258 - Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 4, and 11 to 12 Months (V419-008) | Biotech Hunter | Biotech Hunter