Antibody Persistence at Age 3.5 and 4.5 Years After Primary and Booster DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccination
Condition: Diphtheria; Tetanus; Whooping Cough; Hepatitis B; Poliomyelitis; Haemophilus Influenzae Type b
MeSH terms: Hepatitis B; Tetanus; Diphtheria; Poliomyelitis; Whooping Cough; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a follow-up of the primary series vaccination schedule in Study A3L24 (NCT01177722)
      and booster vaccination in Study A3L27 (NCT01444781).

      Study Objective:

        -  To describe the long-term antibody persistence at 3.5 and 4.5 years of age following a
           3-dose primary series vaccination of either DTaP-IPV-Hep B-PRP-T+Prevenar™ (PCV7)
           +Rotarix™ or Infanrix hexa™+Prevenar™ (PCV7) +Rotarix™ vaccination at 2, 4, 6 months of
           age and a booster vaccination of DTaP-IPV-Hep B-PRP-T+Prevenar™ (PCV7) or Infanrix
           hexa™+Prevenar™ (PCV7) at 12 to 24 months of age.

      Observational Objectives:

        -  To describe the long-term antibody persistence by group and by stratification on the age
           at inclusion of the A3L27 booster study.

        -  To describe the effect of one additional oral dose of stand alone poliovirus isotypes 1,
           2 and 3 vaccine* on the antibody persistence immune response for poliovirus isotypes (4
           vs 5 doses of poliovirus administered).
    

Detailed description: 
      No investigational vaccine will be administered in the study. Subjects who were previously
      randomized and completed the primary series, Study A3L24 and the booster study A3L27 will be
      invited to take part in this study.

      Any serious adverse events (SAEs) related to the vaccines administered during the preceding
      trial (A3L27;) and SAEs related to A3L28 study procedures will be collected throughout the
      trial.

      No vaccine will be administered as part of this study.
    

Intervention name(s): DTaP-IPV-Hep B- PRP~T + Prevenar + Rotarix vaccine; DTaP- IPV-Hep B-PRP~T + Prevenar + Rotarix + Infanrix hexa vaccine; Infanrix hexa + Prevenar + Rotarix vaccine
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 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; 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.; 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.
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Diphtheria; Tetanus; Whooping Cough; Hepatitis B; Poliomyelitis; Pediatric combined vaccine