title: Reactogenicity profile of a combined hepatitis A and B vaccine in clinical practice: a naturalistic study in adult travellers.
abstract: A prospective observational naturalistic study was conducted to assess the reactogenicity of the combined hepatitis A and hepatitis B (HAB) vaccine in a real-life setting. All healthy candidates for HAB vaccination attending an adult vaccination centre between October 1998 and February 2000 were invited to participate in the study. A follow-up diary card was provided to subjects to record local and general symptoms during a 4-day follow-up. Intensity was graded from 1 to 3. Redness was recorded as presence or absence. Fever was defined as axillar temperature > or =37.5 degrees C and grade 3 >39.0 degrees C. For all other symptoms, grade 3 was defined as an adverse reaction preventing normal everyday activities; 998 subjects (74% females), mean age (+/-S.D.) of 23 years (+/-4.5) (range: 11-54 years) agreed to participate. At first immunization 92% were <30 years old. Grade 3 pain and swelling was recorded in 1.2% and 0.3% of local symptom sheets completed, respectively; 438 subjects received the HAB vaccine alone (group 1) whereas 560 received at least one concomitant vaccine (group 2). In 45%, 27%, 18% and 10% of subjects the HAB vaccine was coadministered with 1, 2, 3 or 4 to 6 vaccines (mainly Td adult-type, typhoid, MMR and IPV vaccine). Grade 3 pain and swelling were recorded in 1.2% & 0.3% of symptom sheets (SS), respectively. In group 1, any fever and grade 3 fever was recorded in 3.5% and 0.1% of SS. Group 1 versus 2 had a lower risk for any fatigue (p=0.0002; OR=0.617) and any malaise (p=0.0076; OR=0.693) but not for grade 3 symptoms. In conclusion, our study showed that the HAB vaccine is well tolerated in adults either alone or coadministered with other vaccines in the routine clinical practice.
authors.affiliation: Adult Vaccination Centre, Preventive Medicine Department, Hospital Clinic, Barcelona, Spain.
authors.forename: Anna
authors.initials: A
authors.lastname: Vilella
authors.forename: Rafael
authors.initials: R
authors.lastname: Dal-Ré
authors.forename: Dulcis
authors.initials: D
authors.lastname: Simó
authors.forename: Jesús
authors.initials: J
authors.lastname: Puente
authors.forename: Consolación
authors.initials: C
authors.lastname: Díez
authors.forename: Pilar
authors.initials: P
authors.lastname: García-Corbeira
authors.forename: José María
authors.initials: JM
authors.lastname: Bayas
mesh_terms: D000293:Adolescent; D000328:Adult; D002648:Child; D005260:Female; D022362:Hepatitis A Vaccines / Q000009:adverse effects* / Q000276:immunology; D017325:Hepatitis B Vaccines / Q000009:adverse effects* / Q000276:immunology; D006801:Humans; D008297:Male; D008875:Middle Aged; D019370:Observation; D011446:Prospective Studies; D017778:Vaccines, Combined / Q000009:adverse effects / Q000276:immunology
chemical_list: D022362:Hepatitis A Vaccines; D017325:Hepatitis B Vaccines; D017778:Vaccines, Combined