1,315
Participants
Start Date
November 23, 2011
Primary Completion Date
October 9, 2013
Study Completion Date
October 9, 2013
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.
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)
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.
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.
Lead Sponsor
Merck Sharp & Dohme LLC
INDUSTRY
MCM Vaccines B.V.
INDUSTRY