SAFETY OF COMBINED OLIGOSACCHARIDE CONJUGATE HAEMOPHILUS-INFLUENZAE TYPE-B (HBOC) AND WHOLE-CELL DIPHTHERIA-TETANUS TOXOIDS-PERTUSSIS VACCINE IN INFANCY

The safety of the combined oligosaccharide conjugate Haemophilus influenzae (Hib) type b (HbOC) and whole cell diphtheria-tetanus toxoids-pertussis (DTP) vaccine (Tetramune(R), HbOC-DTP; Lederle) in infancy was evaluated in 6644 recipients of this vaccine and compared with 3914 recipients of separate injections of whole cell DTP and HbOC vaccines when given as a three dose regimen to infants at 2, 4 and 6 months of age in each group. Of the total number of infants in the study, a subset of 1435 were enrolled into the study and then randomly assigned to receive either the Hib-DPT combined vaccine or the separate components. This subset was used to assess local and systemic side effects which were evaluated utilizing telephone interviews 48 to 72 hours after vaccine. The remaining children in the study population were enrolled in a nonrandomized manner. For these children parents were offered the experimental Hib-DPT vaccine and refusers were given HbOC and DTP. Both of these groups of children as well as the randomized subset described above were used to assess rates of episodes of hospitalization, emergency room utilization and sudden infant death syndrome in HbOC-DTP recipients and children who received HbOC and DTP separately. Immunogenicity was evaluated in 123 children by collection of a single serum sample 30 days after the third dose of HbOC-DTP. The observed immunogenicity was comparable to that observed in other recent studies for HbOC and DTP component antigens. The profile of local and systemic side effects observed was virtually identical to that observed after DTP plus HbOC given separately. In initial analyses the Hib-DPT children appeared to have a higher rate of hospitalization for pneumonia than the children with separate shots. After further analyses including chart review, review of chest radiographs, and adjustment for age and season, this initial association was believed most probably to be a result of chance alone. The HbOC-DTP vaccine offers the convenience of a single combined vaccine offering protection against diphtheria, pertussis, Hib and tetanus without any substantial or significant change in safety or immunogenicity profile.