† A booster response for each antigen was defined as a four-fold rise in antibody concentration if the pre-vaccination concentration was below the cut-off value and a two-fold rise in antibody concentration if the pre-vaccination concentration was above the cut-off value. The cut-off values for pertussis antigens were established based on antibody data from both adolescents and adults in previous clinical trials. The cut-off values were 85 EU/mL for PT, 170 EU/mL for FHA, 115 EU/mL for PRN and 258 EU/mL for FIM

Hepatitis B Vaccine

The concomitant use of ADACEL vaccine and hepatitis B (Hep B) vaccine (Recombivax HB®, 10 µg per dose using a two-dose regimen, manufactured by Merck and Co., Inc) was evaluated in a multi-center, open-labeled, randomized, controlled study that enrolled 410 adolescents, 11-14 years of age inclusive. One group received ADACEL and Hep B vaccines concurrently (N = 206). The other group (N = 204) received ADACEL vaccine at the first visit, then 4-6 weeks later received Hep B vaccine. The second dose of Hep B vaccine was given 4-6 weeks after the first dose. Serum samples were obtained prior to and 4-6 weeks after ADACEL vaccine administration, as well as 4-6 weeks after the 2nd dose of Hep B for all subjects. No interference was observed in the immune responses to any of the vaccine antigens when ADACEL and Hep B vaccines were given concurrently or separately. ⁽¹²⁾ (See DOSAGE AND ADMINISTRATION, Concomitant Vaccine Administration.)

Trivalent Inactivated Influenza Vaccine

The concomitant use of ADACEL vaccine and trivalent inactivated influenza vaccine (TIV, Fluzone®, manufactured by Aventis Pasteur Inc., Swiftwater, PA) was evaluated in a multi-center, open-labeled, randomized, controlled study conducted in 720 adults, 19-64 years of age inclusive. In one group, subjects received ADACEL and TIV vaccines concurrently (N = 359). The other group received TIV at the first visit, then 4-6 weeks later received ADACEL vaccine (N = 361). Sera were obtained prior to and 4-6 weeks after ADACEL vaccine, as well as 4-6 weeks after the TIV. The immune responses were comparable for concurrent and separate administration of ADACEL and TIV vaccines for diphtheria (percent of subjects with seroprotective concentration ≥ 0.1 IU/mL and booster responses), tetanus (percent of subjects with seroprotective concentration ≥0.1 IU/mL), pertussis antigens (booster responses and GMCs except lower PRN GMC in the concomitant group, lower bound of the 90% CI was 0.61 and the pre-specified criterion was ≥0.67) and influenza antigens (seroprotection and seroconversion rates). Although tetanus booster response rates were significantly lower in the group receiving the vaccines concurrently versus separately, greater than 98% of subjects in both groups achieved seroprotective levels of ≥ 0.1 IU/mL. ⁽¹²⁾ (See DOSAGE AND ADMINISTRATION, Concomitant Vaccine Administration.)

REFERENCES

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