OBJECTIVE: To evaluate the immunogenicity of the Hepatitis B and Haemophilus influenzae type b components and the overall safety and reactogenicity of the DTPw-HBV/Hib vaccine when given as primary vaccination to Indian infants. DESIGN AND METHODS: At 3 centers in India, 225 healthy infants (who had received HBV at birth) received three doses of DTPw-HBV/Hib vaccine at 6, 10 and 14 weeks of age. Serum anti-HBs and anti-PRP antibody levels were measured prior to vaccination and one month post dose 3. Solicited local and general symptoms reported during the 4-day follow-up period and unsolicited adverse event reported during the 30-day follow-up period after each dose were recorded. Serious adverse events were recorded throughout the study. RESULTS: A total of 219 subjects completed the study. 2.7% and 11.5% of all administered doses led to redness and swelling >20 mm, respectively; only 3.6% of doses were followed by severe pain (cried when limb was moved, spontaneously painful) within 4 days after vaccination. Fever exceeding 39.5C was recorded following only one dose in one subject. The percentage of doses followed by severe solicited general symptoms (symptoms that prevented normal activity) did not exceed 0.8%. Two SAEs were reported, neither of which were considered as related to vaccination. One month post-dose 3, all subjects had seroprotective antiPRP antibody concentrations (> or =0.15 microgram/mL) and 98.6% had concentrations > or =1 microgram/mL; 99% were seropositive for antiHBs (concentrations > or = 3 mIU/mL) and 99% were seroprotected (concentrations > or = 10 mIU/mL). CONCLUSION: The combination DTPw-HBV/Hib vaccine is immunogenic (for the antigens tested), safe and well tolerated in Indian infants.
OBJECTIVE: To evaluate the immunogenicity of the Hepatitis B and Haemophilus influenzae type b components and the overall safety and reactogenicity of the DTPw-HBV/Hib vaccine when given as primary vaccination to Indian infants. DESIGN AND METHODS: At 3 centers in India, 225 healthy infants (who had received HBV at birth) received three doses of DTPw-HBV/Hib vaccine at 6, 10 and 14 weeks of age. Serum anti-HBs and anti-PRP antibody levels were measured prior to vaccination and one month post dose 3. Solicited local and general symptoms reported during the 4-day follow-up period and unsolicited adverse event reported during the 30-day follow-up period after each dose were recorded. Serious adverse events were recorded throughout the study. RESULTS: A total of 219 subjects completed the study. 2.7% and 11.5% of all administered doses led to redness and swelling >20 mm, respectively; only 3.6% of doses were followed by severe pain (cried when limb was moved, spontaneously painful) within 4 days after vaccination. Fever exceeding 39.5C was recorded following only one dose in one subject. The percentage of doses followed by severe solicited general symptoms (symptoms that prevented normal activity) did not exceed 0.8%. Two SAEs were reported, neither of which were considered as related to vaccination. One month post-dose 3, all subjects had seroprotective antiPRP antibody concentrations (> or =0.15 microgram/mL) and 98.6% had concentrations > or =1 microgram/mL; 99% were seropositive for antiHBs (concentrations > or = 3 mIU/mL) and 99% were seroprotected (concentrations > or = 10 mIU/mL). CONCLUSION: The combination DTPw-HBV/Hib vaccine is immunogenic (for the antigens tested), safe and well tolerated in Indian infants.