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.

Study Overview

• Status: Completed
• Conditions: Influenza Caused by the 2009 H1N1 Influenza Virus
• Intervention / Treatment: Other: Follow-up

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.

• Study Type: Observational
• Enrollment (Actual): 2351

Contacts and Locations

Study Locations

• Finland
  • Tampere, Finland, 33520
    • National Institute for Health and Welfare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participation in the study will be offered to all participants of the cohort study "Evaluation of a vaccination campaign with A(H1N1)v pandemic vaccines: a prospective cohort study" AH1N1-483-09THL, who still live in the study area (city of Tampere) and who have complied to the SMS or phone follow-up. The eligibility criteria of the original study AH1N1-483-09THL were: full legal competence; community-dwelling; age 18 to 75 years, written informed consent obtained; able to communicate fluently in Finnish or Swedish and able to adhere to all protocol required study procedures without any special burden or risk. Originally, 3500 persons participated in the study

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Other: Follow-up; 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	Other: Follow-up; Questionnaires, interviews, nasal/oral and serum samples, register data

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Time Frame
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
To evaluate the incidence, severity and possible complications of laboratory-confirmed infection with the 2009 H1N1 influenza virus	September 2010 to April 2011

Collaborators and Investigators

• Sponsor: Finnish Institute for Health and Welfare
• Investigators: Principal Investigator: Terhi M Kilpi, MD, PhD, Finnish Institute for Health and Welfare

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): April 1, 2011
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: September 20, 2010
• First Submitted That Met QC Criteria: September 20, 2010
• First Posted (Estimate): September 21, 2010

Study Record Updates

• Last Update Posted (Estimate): September 25, 2014
• Last Update Submitted That Met QC Criteria: September 24, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: effectiveness; vaccination; pandemic; 2009 H1N1 influenza
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: H1N1-495-10THL; 2010-021033-30 (EudraCT Number); R10075M (Other Identifier: The ethics committee of the Pirkanmaa Hospital District (PSHP)); 81/2010 (Other Identifier: Finnish Medicines Agency)