Evaluation of Pandemic Vaccination Campaign

Evaluation of a Vaccination Campaign With A(H1N1)v Pandemic Vaccines: a Prospective Cohort Study

A cohort of 4000 community-dwelling adults is followed to evaluate the effectiveness of the Finnish national A(H1N1)v influenza vaccination campaign in preventing the first episode of laboratory-confirmed A(H1N1)v influenza. The safety of vaccination and the severity of the disease are followed primarily from health care registers. In a subgroup of 200 participants, the humoral and cellular immunogenicity of the vaccine will be studied.

Study Overview

• Status: Completed
• Conditions: Influenza Caused by the Novel A(H1N1)v Influenza Virus
• Intervention / Treatment: Other: Follow-up

• Study Type: Observational
• Enrollment (Actual): 3518

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 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The subjects will be invited from the population assigned to use the services of Tampere health centre, according to the target groups for pandemic vaccination. Invitations will be distributed at the maternity clinics for pregnant women, at work places for health professionals, and letters will be sent home to random sample of subjects at age groups of 18-24 years, 25-64 years and potetially later at 65-75 years of age.

Description

Inclusion Criteria:

• Full legal competence;
• Written informed consent obtained;
• Assigned to use the services of Tampere health centre and community-dwelling;
• At least 18 and no more than 75 years old, inclusive;
• Belongs to the target group of A(H1N1)v vaccination in the region during the pandemic vaccination campaign;
• Able to communicate fluently in Finnish or Swedish
• Able to adhere to all protocol required study procedures without any special burden or risk, as judged by the investigator or designate.

Exclusion Criteria:

• For the total study cohort, no specific exclusion criteria will be applied;

• For the subgroup for follow-up of immunogenicity of the vaccine (immunogenicity cohort), exclusion criteria comprise:

  • previous severe allergic reaction to influenza vaccines or known severe allergy to the ingredients of the vaccine
  • previous severe allergic reaction to eggs
  • significant immunological disorder

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Not (yet) vaccinated persons; The participants do not want to take the vaccine (available only in the national vaccination campaign) or have not received it yet	Other: Follow-up; Nasopharyngeal/oropharyngeal and blood samples, interviews, questionnaires, register data
Vaccinated persons; The participants have taken the vaccine according to the national vaccination campaign	Other: Follow-up; Nasopharyngeal/oropharyngeal and blood samples, interviews, questionnaires, register data

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Effectiveness of vaccination in preventing the first episode of laboratory-confirmed A(H1N1)v infection in adults	3 November 2009 to 30 April 2010

Secondary Outcome Measures

Outcome Measure	Time Frame
Safety of vaccination with the A(H1N1)v vaccine	3 November 2009 to 31 October-November 2010
Severity and possible complications of the A(H1N1)v influenza	3 November 2009 to 31 October-November 2010
Humoral and cellular immune responses to the vaccine (subgroup of 200 adults)	3 November 2009 to 31 October-November 2010
Effectiveness of the vaccine in subgroups	3 November 2009 to 31 October-November 2010

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: November 1, 2009
• Primary Completion (Actual): April 1, 2010
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: November 2, 2009
• First Submitted That Met QC Criteria: December 2, 2009
• First Posted (Estimate): December 3, 2009

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: vaccination; pandemic; A(H1N1)v 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: AH1N1-483-09THL; EudraCT 2009-015700-26 (Other Identifier: NAM Finland); ETL R09152M