title: Comparison of the reactogenicity and immunogenicity of a combined diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated polio (DTPa-HBV-IPV) vaccine, mixed with the Haemophilus influenzae type b (Hib) conjugate vaccine and administered as a single injection, with the DTPa-IPV/Hib and hepatitis B vaccines administered in two simultaneous injections to infants at 2, 4 and 6 months of age.
abstract: An open, randomised, multicentre trial was performed to compare the reactogenicity and safety profile of the administration of a hexavalent diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated polio (DTPa-HBV-IPV) vaccine administered in one injection mixed with Haemophilus influenzae type b (Hib) conjugate vaccine (Group 1) with that of a pentavalent DTPa-IPV vaccine mixed with a Hib vaccine (DTPa-IPV/Hib), simultaneously administered with HBV (Group 2) in two injections in opposite thighs, as a primary vaccination course, to healthy infants at 2, 4 and 6 months of age. A total of 235 completed the study, 120 from Group 1 and 115 from Group 2. Blood samples (pre-vaccination and 1 month after the third dose) were obtained from a subset of infants (Group 1: 40; Group 2: 31) to assess the immune response to vaccination. Local and general solicited symptoms were recorded by parents on diary cards. Seven hundred and five diary cards (Group 1: 360; Group 2: 345) were collected. The clinically relevant and most commonly reported local reaction was pain (infant cried when the limb was moved) in 2.5% (Group 1) and 1.2% (Group 2) of diary cards. Fever was more frequently reported in Group 1 (21% of diary cards) than in Group 2 (12% of diary cards). However only 3 and 2% of doses in Groups 1 and 2, respectively, were responsible for a rectal temperature between 38.6 and 39.5 degrees C and only one case (Group 2) had > or =39.5 degrees C. Other clinically relevant general symptoms were rarely recorded: irritability (2-2.8%), loss of appetite (0.3-0.6%) and drowsiness (0.3-0.3%). All subjects included in the immunogenicity analysis had seroprotective titres to diphtheria, tetanus, polio virus types 1 and 3, Hib. Almost all subjects were seroprotected for anti-polio type 2 and hepatitis B (with the exception of 1 subject in Group 1 for each antigen). The vaccines response rates to pertussis antigens were over 97 and 90% in Groups 1 and 2, respectively. This study shows that, from a clinical perspective, the DTPa-HBV-IPV/Hib vaccine given in a single injection has a similar reactogenicity and safety profile to that of two licensed vaccines (DTPa-IPV/Hib, HBV) given in two simultaneous injections to infants at 2, 4 and 6 months of age. This is a valuable advantage, since in some countries, such as Spain and the UK, an additional injection (for the administration of meningococcal C conjugate vaccine) has been recently included in the infants' vaccination calendars.
authors.affiliation: Department of Paediatrics, Basurto Hospital, Bilbao, Spain.
authors.forename: J
authors.initials: J
authors.lastname: Arístegui
authors.forename: R
authors.initials: R
authors.lastname: Dal-Ré
authors.forename: J
authors.initials: J
authors.lastname: Díez-Delgado
authors.forename: J
authors.initials: J
authors.lastname: Marés
authors.forename: J M
authors.initials: JM
authors.lastname: Casanovas
authors.forename: P
authors.initials: P
authors.lastname: García-Corbeira
authors.forename: E
authors.initials: E
authors.lastname: De Frutos
authors.forename: D
authors.initials: D
authors.lastname: Van Esso
authors.forename: J
authors.initials: J
authors.lastname: Verdaguer
authors.forename: J
authors.initials: J
authors.lastname: De la Flor
authors.forename: F
authors.initials: F
authors.lastname: Moraga
authors.forename: R
authors.initials: R
authors.lastname: Boceta
authors.forename: J A
authors.initials: JA
authors.lastname: García-Martínez
mesh_terms: D000907:Antibodies, Bacterial / Q000032:analysis / Q000096:biosynthesis; D000914:Antibodies, Viral / Q000032:analysis / Q000096:biosynthesis; D015721:Diphtheria-Tetanus-Pertussis Vaccine / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D004306:Dose-Response Relationship, Immunologic; D005260:Female; D018073:Haemophilus Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D017325:Hepatitis B Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D006801:Humans; D007115:Immunization Schedule; D007223:Infant; D008297:Male; D011054:Poliovirus Vaccine, Inactivated / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D018401:Sample Size; D017778:Vaccines, Combined / Q000009:adverse effects / Q000276:immunology; D018074:Vaccines, Conjugate / 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; D018074:Vaccines, Conjugate