SAFETY AND IMMUNOGENICITY OF CONCOMITANT SEPARATE ADMINISTRATION OF MMR_II, TETRAMUNE (WYETH LEDERLE DPT & HbOC) AND VARIVAX (OKA/MERCK VARICELLA VACCINE) VS. CONCOMITANT INJECTIONS OF MMR_II AND TETRAMUNE• 660

Healthy children (N=609) 12 months to 23 months old were randomly assigned to one group(A) receiving MMR_II, Tetramune and Varivax given separately and concomitantly and another group (B) receiving MMR_II 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=<0.001) as well as varicella gpELISA titers ≥5.0 (p≤0.013). PRP titers were similar in both groups. TableTable

Table 1

These data demonstrate statistical significant differences in varicella antibody levels when Varivax is administered concomitantly with MMR and Tetramune. Whether this is clinically important remains to be determined.(Funded by a Merck Research Laboratories Grant)

Table 2