NCT01206114

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,351

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

September 20, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 21, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

September 25, 2014

Status Verified

September 1, 2014

Enrollment Period

7 months

First QC Date

September 20, 2010

Last Update Submit

September 24, 2014

Conditions

Influenza Caused by the 2009 H1N1 Influenza Virus

Keywords

2009 H1N1 influenzavaccinationpandemiceffectiveness

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

Study Arms (2)

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

Not (yet) vaccinated persons

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

Other: Follow-up

Interventions

Follow-upOTHER

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

Vaccinated persons

Eligibility Criteria

Age18 Years - 76 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute for Health and Welfare

Tampere, 33520, Finland

Location

Related Publications (1)

  • 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.

    PMID: 25265186DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

nasal/oral swabs, serum samples

Study Officials

  • Terhi M Kilpi, MD, PhD

    Finnish Institute for Health and Welfare

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2010

First Posted

September 21, 2010

Study Start

September 1, 2010

Primary Completion

April 1, 2011

Study Completion

September 1, 2014

Last Updated

September 25, 2014

Record last verified: 2014-09

Locations

FI(1)