Immunogenicity and safety of 3-dose primary vaccination with combined DTPa-HBV-IPV/Hib in Indian infants

Sanjay K Lalwani, Sharad Agarkhedkar, Balasubramanian Sundaram, Niranjana S Mahantashetti, Nandini Malshe, Shalaka Agarkhedkar, Olivier Van Der Meeren, Shailesh Mehta, Naveen Karkada, Htay Htay Han, Narcisa Mesaros, Sanjay K Lalwani, Sharad Agarkhedkar, Balasubramanian Sundaram, Niranjana S Mahantashetti, Nandini Malshe, Shalaka Agarkhedkar, Olivier Van Der Meeren, Shailesh Mehta, Naveen Karkada, Htay Htay Han, Narcisa Mesaros

Abstract

Multivalent combination vaccines have reduced the number of injections and therefore improved vaccine acceptance, timeliness of administration and global coverage. The hexavalent diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliovirus/Haemophilus influenzae type b (DTPa-HBV-IPV/Hib; Infanrix hexa™) vaccine, administered according to various schedules, is widely used for the primary vaccination of infants worldwide. In the current publication, we are presenting the immunogenicity and safety of 3 doses of DTPa-HBV-IPV/Hib vaccine when administered to Indian infants. 224 healthy infants (mean age 6.8 weeks) were vaccinated at 6-10-14 weeks (W) of age (n = 112) or 2-4-6 months (M) of age (n = 112). One month after the third vaccine dose, the seroprotection/seropositivity status against diphtheria, pertussis, tetanus, polio, hepatitis B and Hib antigens ranged from 98.6% to 100% in both groups. The vaccine response rate to the pertussis antigens ranged from 97% to 100%. Pain (6-10-14W group: 25.2%; 2-4-6M group: 13.4%) and fever (15.3% and; 15.2%, respectively) were the most frequently reported solicited local and general symptoms. Unsolicited adverse events were reported for 35.7% (6-10-14W group) and 22.3% (2-4-6M group) of subjects. No vaccine related serious adverse events were reported. In conclusion, the hexavalent DTPa-HBV-IPV/Hib vaccine was immunogenic and well tolerated, irrespective of the dosing schedule.

Keywords: combination vaccines; recombinant DTPa-HBV-IPV/Hib; seropositive; seroprotection; vaccine associated paralytic polio.

Figures

Figure 1.
Figure 1.
Study flow chart.
Figure 2.
Figure 2.
Overall incidence of solicited local and general symptoms for 4 d after primary vaccination (Total vaccinated cohort).

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