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

Influenza Caused by the 2009 H1N1 Influenza Virus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01206114
• Other study ID #: H1N1-495-10THL
• Secondary ID: 2010-021033-30R1
• Status: Completed
• Phase: N/A
• First received: September 20, 2010
• Last updated: September 24, 2014
• Start date: September 2010
• Est. completion date: September 2014

Study information

• Verified date: September 2014
• Source: National Institute for Health and Welfare, Finland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines Agency
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2351
• Est. completion date: September 2014
• Est. primary completion date: April 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 76 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Influenza Caused by the 2009 H1N1 Influenza Virus
• Influenza, Human

Intervention

Other:
• Follow-up
Questionnaires, interviews, nasal/oral and serum samples, register data
• Follow-up
Questionnaires, interviews, nasal/oral and serum samples, register data

Locations

Country	Name	City	State
Finland	National Institute for Health and Welfare	Tampere

Sponsors (1)

Lead Sponsor	Collaborator
National Institute for Health and Welfare, Finland

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	To explore the ability of different vaccination regimens to prevent 2009 H1N1 influenza		September 2010 to April 2011	No
Secondary	To explore the effectiveness of the 2009 H1N1 vaccines in subgroups stratified by age		September 2010 to April 2011	No
Secondary	To evaluate the incidence, severity and possible complications of laboratory-confirmed infection with the 2009 H1N1 influenza virus		September 2010 to April 2011	No