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

• Published in: Vaccine Vol. 23; no. 9; pp. 1135 - 1143
• Main Authors: Saenger, R., Maechler, G., Potreck, M., Zepp, F., Knuf, M., Habermehl, P., Schuerman, L.
• Format: Journal Article
• Language: English
• Published: Oxford Elsevier Ltd 19.01.2005; Elsevier; Elsevier Limited
• Subjects: Antigens; Applied microbiology; Biological and medical sciences; Booster dose; Children & youth; Combination paediatric vaccines; Confidence Intervals; Diphtheria; Diphtheria-Tetanus-Pertussis Vaccine - administration & dosage; Diphtheria-Tetanus-Pertussis Vaccine - adverse effects; DTPa; Female; Fever - chemically induced; Fundamental and applied biological sciences. Psychology; Haemophilus influenzae; Haemophilus Vaccines; Hepatitis B Vaccines - administration & dosage; Hepatitis B Vaccines - adverse effects; Hepatitis B virus; Hexavalent DTPa-HBV-IPV/Hib vaccine; Humans; Immunization; Immunization Schedule; Immunization, Secondary - adverse effects; Immunization, Secondary - methods; Infant; Injection; Licenses; Male; Microbiology; Miscellaneous; Multicenter Studies as Topic - methods; Multicenter Studies as Topic - statistics & numerical data; Pain; Poliovirus Vaccine, Inactivated; Randomized Controlled Trials as Topic - methods; Randomized Controlled Trials as Topic - statistics & numerical data; Studies; Tetanus; Vaccines; Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects); Vaccines, Combined - administration & dosage; Vaccines, Combined - adverse effects; Virology; Whooping cough; DTPa; Booster dose; Combination paediatric vaccines; Hexavalent DTPa-HBV-IPV/Hib vaccine; Virus; Hepadnaviridae; Booster vaccination; Orthohepadnavirus; Vaccine; Hepatitis B virus
• ISSN: 0264-410X; 1873-2518
• DOI: 10.1016/j.vaccine.2004.08.030

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 ≥39.5 °C was observed in 2.5% and 2.8% of the subjects, respectively. Fever ≥40.0 °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.