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Objective. To evaluate the safety and immunogenicity of the recombinant acellular pertussis-diphtheria-tetanus (aPDT) vaccine (C-aPDT, Chiron/Biocine®). Study design. This is a randomized blinded trial evaluating the safety and immunogenicity of the recombinant aPDT vaccine (C-aPDT, Chiron/Biocine®) in 2000 infant recipients compared with 498 controls who received whole cell diphtheria-pertussis-tetanus (wDPT; Connaught) vaccine at 2, 4 and 6 months of age. In addition the safety and immunogenicity of the same C-aPDT vaccine were evaluated as a booster dose in a subset of the same population when given at 15 to 18 months of age and compared with licensed Lederle aPDT vaccine. Results. The C-aPDT vaccine was associated with very few local or systemic reactions when compared with wDPT. In toddlers the local and systemic side effects observed were similar after either acellular vaccine. When the immunogenicity of the C-aPDT vaccine was compared with the wDPT (Connaught) in infancy, the vaccines were equivalent for anti-diphtheria response, the wDPT developed higher anti-tetanus response and the C-aPDT vaccine was significantly more immunogenic for all other antigens tested. In toddlers the C-aPDT acellular vaccine exhibited equal or improved immunogenicity for antigens tested as compared with Lederle aPDT except for a higher anti-filamentous hemagglutinin response with the Lederle aPDT vaccine. Conclusion. The Chiron/Biocine® aPDT vaccine offers an improved safety profile as well as improved immunogenicity when compared with a licensed wDPT product.

Healthy children (N=609) 12 months to 23 months old were randomly assigned to one group(A) receiving MMRII, Tetramune and Varivax given separately and concomitantly and another group (B) receiving MMRII and Tetramune separately and concomitantly with Varivax given 6 weeks later. Subjects were followed for 42 days after each vaccination for local and systemic reactions. Serology was determined at day 42 for Group A and day 84 for Group B. No significant differences were noted between groups for local reactions, injection site rashes, fever≥102° F, or other systemic reactions as a group. There was a significant difference observed in GMTs for varicella(p=