13vPnC Multidose Vial Safety, Tolerability and Immunogenicity Study in Healthy Infants.

PHASE3CompletedINTERVENTIONAL
Enrollment

500

Participants

Timeline

Start Date

January 31, 2014

Primary Completion Date

September 30, 2014

Study Completion Date

September 30, 2014

Conditions
Pneumococcal Vaccines
Interventions
BIOLOGICAL

13-valent pneumococcal conjugate vaccine

Subjects will receive three doses (0.5 mL each) of 13-valent pneumococcal conjugate vaccine (multidose vial formulation) in the anterolateral thigh muscle of the left leg. Dose 1 is administered between 42 and 70 days of age, dose 2 is administered 28 to 42 days after dose 1, dose 3 is administered 28 to 42 days after dose 2.

BIOLOGICAL

13-valent pneumococcal conjugate vaccine

Subjects will receive three doses (0.5 mL each) of 13-valent pneumococcal conjugate vaccine (single-dose syringe formulation) in the anterolateral thigh muscle of the left leg. Dose 1 is administered between 42 and 70 days of age, dose 2 is administered 28 to 42 days after dose 1, dose 3 is administered 28 to 42 days after dose 2.

Trial Locations (2)

000273

Medical Research Council Unit, The Gambia, Fajara

Unknown

Fajikunda Major Health Centre, Ksmd

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY