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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2351 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-09-30

Study Completion Date

2014-09-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Influenza Caused by the 2009 H1N1 Influenza Virus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Vaccinated persons

The participants have taken one or more doses of 2009 H1N1 vaccine, either as a monovalent vaccine or as a part of a trivalent seasonal 2010-2011 influenza vaccine

Follow-up

Intervention Type OTHER

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

Not (yet) vaccinated persons

The participants do not want to take any 2009 H1N1 vaccine or have not received any yet

Follow-up

Intervention Type OTHER

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

Interventions

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Follow-up

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

Intervention Type OTHER

Follow-up

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

76 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes