title: Booster vaccination with hexavalent DTPa-HBV-IPV/Hib vaccine in the second year of life is as safe as concomitant DTPa-IPV/Hib + HBV administered separately.
abstract: The safety and reactogenicity of a booster dose of GSK Biologicals' hexavalent DTPa-HBV-IPV/Hib vaccine (N=4725) was compared with the separate administration of GSK Biologicals' DTPa-IPV/Hib and HBV vaccines (N=4474) in two open, randomized multicenter studies (A and B). Solicited symptoms occurring within 4 days of vaccination were recorded on diary cards and serious adverse events (SAEs) were collected throughout the study period. In Study A (N=1149), incidences of solicited symptoms were similar in both groups; there were no SAEs either reported within 4 days of vaccination or considered to be causally related to vaccination. In study B (N=8050), where fever was the only solicited symptom, rectal temperature > or =39.5 degrees C was observed in 2.5% and 2.8% of the subjects, respectively. Fever > or =40.0 degrees C was rare (0.6%), and only two cases of febrile convulsions were recorded during the 4 days following vaccination both in the control group. Large swelling reactions (defined as local injection site swelling with diameter >50 mm, noticeable diffuse injection site swelling or noticeable increased circumference of the injected limb) were reported following 2.3% of the booster vaccine doses, regardless of the vaccine used. Extensive swelling reactions involving an adjacent joint were reported in 0.1% of the subjects. Two SAEs, both reported after booster doses of DTPa-IPV/Hib and HBV vaccines administered separately, were considered by the investigators to be related to vaccination. Both resolved completely without sequelae. The hexavalent DTPa-HBV-IPV/Hib vaccine and the DTPa-IPV/Hib and HBV vaccines administered separately have similar good reactogenicity and safety profiles when given as booster doses in the second year of life.
authors.affiliation: GlaxoSmithKline GmbH & Co. KG, Theresienhoehe 11, 80339, Munich, Germany. roland.saenger@gsk.com
authors.forename: R
authors.initials: R
authors.lastname: Saenger
authors.forename: G
authors.initials: G
authors.lastname: Maechler
authors.forename: M
authors.initials: M
authors.lastname: Potreck
authors.forename: F
authors.initials: F
authors.lastname: Zepp
authors.forename: M
authors.initials: M
authors.lastname: Knuf
authors.forename: P
authors.initials: P
authors.lastname: Habermehl
authors.forename: L
authors.initials: L
authors.lastname: Schuerman
mesh_terms: D016001:Confidence Intervals; D015721:Diphtheria-Tetanus-Pertussis Vaccine / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D005334:Fever / Q000139:chemically induced; D018073:Haemophilus Vaccines; D017325:Hepatitis B Vaccines / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D007115:Immunization Schedule; D007117:Immunization, Secondary / Q000009:adverse effects / Q000379:methods*; D007223:Infant; D008297:Male; D015337:Multicenter Studies as Topic / Q000379:methods* / Q000706:statistics & numerical data; D011054:Poliovirus Vaccine, Inactivated; D016032:Randomized Controlled Trials as Topic / Q000379:methods* / Q000706:statistics & numerical data; D017778:Vaccines, Combined / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: C451839:DTPa-HBV-IPV combined vaccine; D015721:Diphtheria-Tetanus-Pertussis Vaccine; D018073:Haemophilus Vaccines; D017325:Hepatitis B Vaccines; D011054:Poliovirus Vaccine, Inactivated; D017778:Vaccines, Combined