Hepatitis B Clinical Trial
Official title:
Evaluation of Antibody Persistence Following a Primary Series at 2, 4, and 6 Months on Trial A3L24 and Booster Effect of the DTaP-IPV-Hep B-PRP~T Combined Vaccine or Infanrix Hexa™ Concomitantly Administered With Prevenar™ at 12 to 24 Months of Age in Healthy Latin American Infants
This is a follow-up of the primary series vaccination schedule in Study A3L24 (NCT01177722).
The objectives are:
- To describe the antibody persistence to any antigen contained in the investigational
DTaP-IPV-Hep B-PRP-T vaccine and Infanrix hexa™ prior to the booster dose
- To describe the safety and immunogenicity of the booster dose of either DTaP-IPV-Hep
B-PRP-T or Infanrix hexa™ vaccine.
- To describe the immunogenicity of a booster dose of Prevenar™ given at 12 to 24 months.
All participants who completed trial A3L24 (NCT01177722) will be recruited to participate in
this trial. Those who received DTaP-IPV-Hep B-PRP-T combined vaccine will be randomized to
receive either a booster dose of DTaP-IPV-Hep B-PRP-T or Infanrix hexa™ vaccine.
Those who received Infanrix hexa™ will receive a booster dose of DTaP-IPV-Hep B-PRP-T
combined vaccine. All participants will receive a booster dose of Prevenar™ concomitantly.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
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