Clinical trial NCT01024725: Evaluation of Pandemic Vaccination Campaign
Official title: Evaluation of a Vaccination Campaign With A(H1N1)v Pandemic Vaccines: a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Influenza Caused by the Novel A(H1N1)v Influenza Virus
Keywords: A(H1N1)v influenza
vaccination
pandemic
Lead sponsor: Finnish Institute for Health and Welfare
Sponsor class: OTHER_GOV
First posted: 2009-12-03
Enrollment: 3518
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The subjects will be invited from the population assigned to use the services of Tampere health centre, according to the target groups for pandemic vaccination. Invitations will be distributed at the maternity clinics for pregnant women, at work places for health professionals, and letters will be sent home to random sample of subjects at age groups of 18-24 years, 25-64 years and potetially later at 65-75 years of age.

Brief summary: A cohort of 4000 community-dwelling adults is followed to evaluate the effectiveness of the Finnish national A(H1N1)v influenza vaccination campaign in preventing the first episode of laboratory-confirmed A(H1N1)v influenza. The safety of vaccination and the severity of the disease are followed primarily from health care registers. In a subgroup of 200 participants, the humoral and cellular immunogenicity of the vaccine will be studied.


Eligibility criteria: Inclusion Criteria:

* Full legal competence;
* Written informed consent obtained;
* Assigned to use the services of Tampere health centre and community-dwelling;
* At least 18 and no more than 75 years old, inclusive;
* Belongs to the target group of A(H1N1)v vaccination in the region during the pandemic vaccination campaign;
* Able to communicate fluently in Finnish or Swedish
* Able to adhere to all protocol required study procedures without any special burden or risk, as judged by the investigator or designate.

Exclusion Criteria:

* For the total study cohort, no specific exclusion criteria will be applied;
* For the subgroup for follow-up of immunogenicity of the vaccine (immunogenicity cohort), exclusion criteria comprise:

  * previous severe allergic reaction to influenza vaccines or known severe allergy to the ingredients of the vaccine
  * previous severe allergic reaction to eggs
  * significant immunological disorder

Primary outcomes:
measure: Effectiveness of vaccination in preventing the first episode of laboratory-confirmed A(H1N1)v infection in adults
timeFrame: 3 November 2009 to 30 April 2010
Secondary outcomes:
measure: Safety of vaccination with the A(H1N1)v vaccine
timeFrame: 3 November 2009 to 31 October-November 2010
measure: Severity and possible complications of the A(H1N1)v influenza
timeFrame: 3 November 2009 to 31 October-November 2010
measure: Humoral and cellular immune responses to the vaccine (subgroup of 200 adults)
timeFrame: 3 November 2009 to 31 October-November 2010
measure: Effectiveness of the vaccine in subgroups
timeFrame: 3 November 2009 to 31 October-November 2010
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: National Institute for Health and Welfare
Study officials:
affiliation: Finnish Institute for Health and Welfare
name: Terhi M Kilpi, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Syrjanen RK, Jokinen J, Ziegler T, Sundman J, Lahdenkari M, Julkunen I, Kilpi TM. Effectiveness of pandemic and seasonal influenza vaccines in preventing laboratory-confirmed influenza in adults: a clinical cohort study during epidemic seasons 2009-2010 and 2010-2011 in Finland. PLoS One. 2014 Sep 29;9(9):e108538. doi: 10.1371/journal.pone.0108538. eCollection 2014.