title: Health benefit for the child and promotion of the common good were the two most important reasons for participation in the FinIP vaccine trial.
abstract: OBJECTIVE
  The Finnish Invasive Pneumococcal disease (FinIP) vaccine trial was a nationwide cluster-randomised double-blind trial designed to demonstrate the effectiveness of pneumococcal conjugate vaccine in vaccinated children and indirect effects in unvaccinated populations. Together with the parallel carriage/AOM trial, over 47,000 children were enrolled, 52% of the initial target. We conducted a questionnaire study to find out which factors affected parents' decision on their child's study participation.
  
  
  METHODS
  A questionnaire designed to evaluate parents' attitudes to vaccine trial participation in general and the FinIP trial in particular was mailed after the trial enrolment period had ended to parents of randomly selected children: 1484 who participated in the trial and 1485 who did not participate.
  
  
  RESULTS
  Altogether 1438 parents (48%) responded to the questionnaire. The response rate was higher among FinIP participants (65%, 965/1484) than among FinIP non-participants (32%, 473/1485). The two most important reasons for giving consent to the FinIP trial were the potential benefit of immunisation against pneumococcal diseases (75% of consenters) and the promotion of the common good and public health (11%). The reasons reported as most important for declining consent were suspicions of vaccine safety (36%) and the double-blind trial design (12%). Up to 65% of the non-consenters declared that drug and vaccine trials should not be conducted in children at all.
  
  
  CONCLUSIONS
  The expected health benefit for the child was by far the most important reason for consenting to the vaccine trial. Safety concern was the main reason for decline. Importance and necessity of clinical drug and vaccine trials among children and the rationale of the blinded studies should be thoroughly explained to the public. This may increase participation in future vaccine trials.
authors.affiliation: National Institute for Health and Welfare, Department of Health Protection, FinnMedi 1, Biokatu 6, FI-33520 Tampere, Finland. Electronic address: heta.nieminen@thl.fi.
authors.forename: Heta
authors.initials: H
authors.lastname: Nieminen
authors.affiliation: National Institute for Health and Welfare, Department of Health Protection, FinnMedi 1, Biokatu 6, FI-33520 Tampere, Finland.
authors.forename: Ritva K
authors.initials: RK
authors.lastname: Syrjänen
authors.affiliation: National Institute for Health and Welfare, Department of Health Protection, PO Box 30, FI-00271 Helsinki, Finland.
authors.forename: Taneli
authors.initials: T
authors.lastname: Puumalainen
authors.affiliation: National Institute for Health and Welfare, Department of Health Protection, FinnMedi 1, Biokatu 6, FI-33520 Tampere, Finland.
authors.forename: Päivi
authors.initials: P
authors.lastname: Sirén
authors.affiliation: National Institute for Health and Welfare, Department of Health Protection, FinnMedi 1, Biokatu 6, FI-33520 Tampere, Finland.
authors.forename: Arto A
authors.initials: AA
authors.lastname: Palmu
mesh_terms: D000328:Adult; D001290:Attitude; D003256:Community Participation / Q000523:psychology*; D064420:Drug-Related Side Effects and Adverse Reactions / Q000523:psychology; D005260:Female; D005387:Finland / Q000453:epidemiology; D006801:Humans; D007223:Infant; D007342:Insurance Benefits; D008297:Male; D008875:Middle Aged; D011008:Pneumococcal Infections / Q000453:epidemiology / Q000517:prevention & control*; D022242:Pneumococcal Vaccines / Q000008:administration & dosage / Q000276:immunology*; D011897:Random Allocation; D016032:Randomized Controlled Trials as Topic; D012935:Social Justice; D011795:Surveys and Questionnaires; D014611:Vaccination / Q000523:psychology*; D055815:Young Adult
chemical_list: D022242:Pneumococcal Vaccines
keywords: Clinical trial; Consent; Questionnaire; Vaccine trial