title: Immunogenicity and Safety of a Liquid Hexavalent Vaccine in Indian Infants.
abstract: 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.
  
  
  METHODS
  Phase III, single-arm study.
  
  
  METHODS
  Two tertiary care hospitals.
  
  
  METHODS
  177 healthy, 6-week-old infants.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Pediatrics Department, CMC and Hospital, Brown Road, Ludhiana, Punjab; #Pediatrics Department, Bharati Vidyapeeth University Medical College, Pune; India; and *Sanofi Pasteur, Lyon, France. Correspondence to: Emmanuel Vidor, Sanofi Pasteur, 2 avenue Pont Pasteur, 69367 Lyon, France. Emmanuel.Vidor@sanofipasteur.com.
authors.forename: Jugesh
authors.initials: J
authors.lastname: Chhatwal
authors.forename: Sanjay
authors.initials: S
authors.lastname: Lalwani
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Vidor
mesh_terms: D015721:Diphtheria-Tetanus-Pertussis Vaccine / Q000009:adverse effects* / Q000276:immunology*; D018073:Haemophilus Vaccines / Q000009:adverse effects* / Q000276:immunology*; D017325:Hepatitis B Vaccines / Q000009:adverse effects* / Q000276:immunology*; D006801:Humans; D007114:Immunization; D007115:Immunization Schedule; D007194:India; D007223:Infant
chemical_list: D015721:Diphtheria-Tetanus-Pertussis Vaccine; D018073:Haemophilus Vaccines; D017325:Hepatitis B Vaccines; C122182:diphtheria-tetanus-acellular pertussis-Hib-hepatitis B vaccine