Immunogenicity and Safety of a Liquid Hexavalent Vaccine in Indian Infants.

OBJECTIVE

To evaluate the immunogenicity and safety of a fully liquid, hexavalent diphtheria-tetanus-acellular pertussis-inactivated poliovirus-hepatitis B-Haemophilus influenzae type b (DTaP-IPV- HB-PRP~T) vaccine in Indian infants.

DESIGN

Phase III, single-arm study.

SETTING

Two tertiary care hospitals.

PARTICIPANTS

177 healthy, 6-week-old infants.

INTERVENTION

All participants received hepatitis B vaccine and Oral polio vaccine (OPV) at birth and DTaP-IPV-HB-PRP~T at 6, 10, 14 weeks of age.

MAIN OUTCOME MEASURES

Serum was analyzed for immune responses to all antigens 1 month post- 3rd dose; safety was assessed for 30 minutes post-vaccination, and for 7 days (solicited reactions) and 30 days (unsolicited events).

RESULTS

Seroprotection rates were 100% for anti-HB (>10 mIU/mL), anti-PRP (>0.15 ug/mL), anti-T (>0.01 IU/mL), anti-polio 1, 2, and 3 (>8 [1/dil]), and 99.3% for diphtheria (>0.01 IU/mL). For the pertussis antigens, vaccine response rate was 93.8% for anti-PT and 99.3% for anti-FHA. 37.9% and 54.6% of participants experienced at least one solicited injection site and systemic reaction, respectively, and 20.3% of participants experienced at least one unsolicited event (none of which was related to the vaccination). Four serious adverse events (including one death) were reported, but none was related to the vaccination.

CONCLUSION

The fully liquid DTaP-IPV-HB-PRP~T vaccine is highly immunogenic in infants in India when administered in a 6, 10, 14 week schedule along with HB and OPV administered at birth, and was well tolerated.