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

• Published in: Human vaccines & immunotherapeutics Vol. 13; no. 1; pp. 120 - 127
• Main Authors: Lalwani, Sanjay K., Agarkhedkar, Sharad, Sundaram, Balasubramanian, Mahantashetti, Niranjana S., Malshe, Nandini, Agarkhedkar, Shalaka, Van Der Meeren, Olivier, Mehta, Shailesh, Karkada, Naveen, Han, Htay Htay, Mesaros, Narcisa
• Format: Journal Article
• Language: English
• Published: United States Taylor & Francis 02.01.2017; Taylor & Francis Group
• Subjects: Antibodies, Bacterial - blood; Antibodies, Viral - blood; combination vaccines; Diphtheria-Tetanus-Pertussis Vaccine - administration & dosage; Diphtheria-Tetanus-Pertussis Vaccine - adverse effects; Diphtheria-Tetanus-Pertussis Vaccine - immunology; Drug-Related Side Effects and Adverse Reactions - epidemiology; Drug-Related Side Effects and Adverse Reactions - pathology; Fever - epidemiology; Haemophilus Vaccines - administration & dosage; Haemophilus Vaccines - adverse effects; Haemophilus Vaccines - immunology; Healthy Volunteers; Hepatitis B Vaccines - administration & dosage; Hepatitis B Vaccines - adverse effects; Hepatitis B Vaccines - immunology; Humans; Immunization Schedule; India; Infant; Pain - epidemiology; Poliovirus Vaccine, Inactivated - administration & dosage; Poliovirus Vaccine, Inactivated - adverse effects; Poliovirus Vaccine, Inactivated - immunology; recombinant DTPa-HBV-IPV/Hib; Research Papers; seropositive; seroprotection; vaccine associated paralytic polio; Vaccines, Combined - administration & dosage; Vaccines, Combined - adverse effects; Vaccines, Combined - immunology; seropositive; combination vaccines; seroprotection; recombinant DTPa-HBV-IPV/Hib; vaccine associated paralytic polio
• ISSN: 2164-5515; 2164-554X; 2164-554X
• DOI: 10.1080/21645515.2016.1225639

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.