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OpenTrials
Completed

NCT Number: NCT01206114

Evaluation of the Effectiveness of Vaccination With 2009 H1N1 Vaccines During Influenza Season 2010-11

A cohort of 3000 adults is followed to evaluate the effectiveness of the monovalent 2009 H1N1 vaccines used 2009-2010 and seasonal influenza vaccines used 2010-2011 in preventing the first laboratory-confirmed 2009 H1N1 influenza during the influenza season 2010-11.

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Key information

Age range

18 year–76 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Institute for Health and Welfare

Tampere, 33520, Finland

About this study

In the beginning of the study, changes in the background information collected in the original study (conducted 2009-2010) are asked with a questionnaire. Information on influenza vaccinations is collected with vaccination cards and monthly short message service (SMS), and verified in registers, if needed. If an epidemic caused by the 2009 H1N1 virus starts in Finland, the participants are asked to actively report symptoms of influenza like illnesses (ILI). The symptoms are also monitored by weekly SMS. In case of ILI, nasal and oral swabs are collected to verify the 2009 H1N1 influenza cases. Paired serum samples are collected at the acute on convalescence phase of the disease. The occurrence of laboratory-confirmed 2009 H1N1 influenza cases is compared between vaccinated and not (yet) vaccinated persons.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for the interview follow-up:

  • Participating in the study "Evaluation of a vaccination campaign with A(H1N1)v pandemic vaccines: a prospective cohort study" (AH1N1-483-09THL)
  • Assigned to use the services of Tampere health care centre;
  • Written consent for the interview follow-up phase obtained by mail;
  • Able to adhere to all protocol-required study procedures without any special burden or risk, as judged by the participant himself/herself

Inclusion criteria

for the confirmation of 2009 H1N1 influenza cases:

  • Participating in the study interview follow-up of the current study 'Evaluation the effectiveness of vaccination with 2009 H1N1 vaccines during influenza season 2010-11 (H1N1-495-10THL)
  • Assigned to use the services of Tampere health care centre
  • Written informed consent for the confirmation phase obtained at the first study visit
  • Able to adhere to all protocol required study procedures without any special burden or risk, as judged by the investigator or designate

Exclusion criteria

  • No specific exclusion criteria will be applied

Treatment and study plan

Follow-up

Other

Questionnaires, interviews, nasal/oral and serum samples, register data

Primary outcomes

  1. To determine the effectiveness of 2009 H1N1 influenza vaccination in preventing the first episode of laboratory-confirmed influenza caused by the 2009 H1N1 virus during the season 2010-11 among vaccinated adults as compared to unvaccinated adults

    Time frame: September 2010 to April 2011

Secondary outcomes

  1. To explore the ability of different vaccination regimens to prevent 2009 H1N1 influenza

    Time frame: September 2010 to April 2011

  2. To explore the effectiveness of the 2009 H1N1 vaccines in subgroups stratified by age

    Time frame: September 2010 to April 2011

  3. To evaluate the incidence, severity and possible complications of laboratory-confirmed infection with the 2009 H1N1 influenza virus

    Time frame: September 2010 to April 2011

Sponsors and collaborators

Lead sponsor

Finnish Institute for Health and Welfare

Other Gov

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2014
First posted
Sep 21, 2010
Registry last updated
Sep 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.