Antibody Persistence at Age 3.5 and 4.5 Years After Primary and Booster DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccination

PHASE3CompletedINTERVENTIONAL
Enrollment

558

Participants

Timeline

Start Date

October 31, 2013

Primary Completion Date

June 30, 2015

Study Completion Date

December 31, 2015

Conditions
DiphtheriaTetanusWhooping CoughHepatitis BPoliomyelitisHaemophilus Influenzae Type b
Interventions
BIOLOGICAL

DTaP-IPV-Hep B- PRP~T + Prevenar + Rotarix vaccine

DTaP-IPV-Hep B-PRP\~T vaccine at 2, 4, 6 months of age concomitantly with Prevenar and Rotarix (2 doses at 2 and 4 months of age), and a booster of the same investigational vaccine concomitantly with Prevenar (PCV7) at 12 to 24 months of age in a previous study

BIOLOGICAL

DTaP- IPV-Hep B-PRP~T + Prevenar + Rotarix + Infanrix hexa vaccine

DTaP-IPV-Hep B-PRP\~T vaccine at 2, 4, 6 months of age concomitantly with Prevenar and Rotarix (2 doses at 2 and 4 months of age) and a booster dose of Infanrix hexa vaccine with Prevnar at 12 to 24 months of age in a previous study.

BIOLOGICAL

Infanrix hexa + Prevenar + Rotarix vaccine

Infanrix hexa vaccine at 2, 4, 6 months of age concomitantly with Prevenar and Rotarix (2 doses at 2 and 4 months of age), and a booster dose of DTaP-IPV-Hep B-PRP\~T vaccine concomitantly with Prevenar vaccine concomitantly with Prevenar at 12 to 24 months of age in a previous study.

Trial Locations (2)

Unknown

Santiago de Cali

San José

All Listed Sponsors
lead

Sanofi Pasteur, a Sanofi Company

INDUSTRY

NCT01983540 - Antibody Persistence at Age 3.5 and 4.5 Years After Primary and Booster DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccination | Biotech Hunter | Biotech Hunter