title: Immunogenicity and safety of 3-dose primary vaccination with combined DTPa-HBV-IPV/Hib in Indian infants.
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.
authors.affiliation: a Bharati Vidyapeeth Deemed University Medical College , Pune , India.
authors.forename: Sanjay K
authors.initials: SK
authors.lastname: Lalwani
authors.affiliation: b Dr D Y Patil Medical College , Pune , India.
authors.forename: Sharad
authors.initials: S
authors.lastname: Agarkhedkar
authors.affiliation: c Kanchi Kamakoti Childs Trust Hospital and CHILDS Trust Medical Research Foundation , Chennai , India.
authors.forename: Balasubramanian
authors.initials: B
authors.lastname: Sundaram
authors.affiliation: d KLE University's J.N. Medical College , Belgaum , India.
authors.forename: Niranjana S
authors.initials: NS
authors.lastname: Mahantashetti
authors.affiliation: a Bharati Vidyapeeth Deemed University Medical College , Pune , India.
authors.forename: Nandini
authors.initials: N
authors.lastname: Malshe
authors.affiliation: b Dr D Y Patil Medical College , Pune , India.
authors.forename: Shalaka
authors.initials: S
authors.lastname: Agarkhedkar
authors.affiliation: e GSK Vaccines , Wavre , Belgium.
authors.forename: Olivier
authors.initials: O
authors.lastname: Van Der Meeren
authors.affiliation: e GSK Vaccines , Wavre , Belgium.
authors.forename: Shailesh
authors.initials: S
authors.lastname: Mehta
authors.affiliation: f GSK Pharmaceuticals , Bangalore , India.
authors.forename: Naveen
authors.initials: N
authors.lastname: Karkada
authors.affiliation: g GSK Vaccines , King of Prussia , USA.
authors.forename: Htay Htay
authors.initials: HH
authors.lastname: Han
authors.affiliation: e GSK Vaccines , Wavre , Belgium.
authors.forename: Narcisa
authors.initials: N
authors.lastname: Mesaros
mesh_terms: D000907:Antibodies, Bacterial / Q000097:blood*; D000914:Antibodies, Viral / Q000097:blood*; D015721:Diphtheria-Tetanus-Pertussis Vaccine / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology / Q000473:pathology; D005334:Fever / Q000453:epidemiology; D018073:Haemophilus Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D064368:Healthy Volunteers; D017325:Hepatitis B Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D006801:Humans; D007115:Immunization Schedule; D007194:India; D007223:Infant; D010146:Pain / Q000453:epidemiology; D011054:Poliovirus Vaccine, Inactivated / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D017778:Vaccines, Combined / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology
chemical_list: D000907:Antibodies, Bacterial; D000914:Antibodies, Viral; D015721:Diphtheria-Tetanus-Pertussis Vaccine; D018073:Haemophilus Vaccines; D017325:Hepatitis B Vaccines; D011054:Poliovirus Vaccine, Inactivated; D017778:Vaccines, Combined; C541235:diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine
keywords: combination vaccines; recombinant DTPa-HBV-IPV/Hib; seropositive; seroprotection; vaccine associated paralytic polio