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

Evaluation of Antibody Persistence at 3.5 and 4.5 Years of Age in Healthy Children After Primary Series and Booster Vaccination With Investigational (DTaP-IPV-Hep B-PRP~T) or Infanrix Hexa™ Vaccines in Latin America

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 558 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 42 Months – 54 Months
• Healthy volunteers: Accepted

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.

Conditions

• Diphtheria
• Tetanus
• Whooping Cough
• Hepatitis B
• Poliomyelitis
• Haemophilus Influenzae Type b

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2013-10-01
• Primary completion: 2015-06-01
• Completion: 2015-12-01
• First posted: 2013-11-14
• Last updated: 2016-01-05

Locations

2 sites across 2 countries: Colombia, Costa Rica