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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01206114

Enrollment

2351

Registered

2010-09-21

Start date

2010-09-30

Completion date

2014-09-30

Last updated

2014-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza Caused by the 2009 H1N1 Influenza Virus

Keywords

2009 H1N1 influenza, vaccination, pandemic, effectiveness

Brief summary

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.

Detailed description

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.

Interventions

OTHERFollow-up

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 76 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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	September 2010 to April 2011

Secondary

Measure	Time frame
To evaluate the incidence, severity and possible complications of laboratory-confirmed infection with the 2009 H1N1 influenza virus	September 2010 to April 2011
To explore the ability of different vaccination regimens to prevent 2009 H1N1 influenza	September 2010 to April 2011
To explore the effectiveness of the 2009 H1N1 vaccines in subgroups stratified by age	September 2010 to April 2011

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026