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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Institute for Health and Welfare, Finland
ClinicalTrials.gov Identifier:
NCT01206114
First received: September 20, 2010
Last updated: August 13, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Influenza Caused by the 2009 H1N1 Influenza Virus
Other: Follow-up

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of the Effectiveness of Vaccination With 2009 H1N1 Vaccines During Influenza Season 2010-11

Resource links provided by NLM:


Further study details as provided by National Institute for Health and Welfare, Finland:

Primary Outcome Measures:
  • 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 [ Time Frame: September 2010 to April 2011 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To explore the ability of different vaccination regimens to prevent 2009 H1N1 influenza [ Time Frame: September 2010 to April 2011 ] [ Designated as safety issue: No ]
  • To explore the effectiveness of the 2009 H1N1 vaccines in subgroups stratified by age [ Time Frame: September 2010 to April 2011 ] [ Designated as safety issue: No ]
  • To evaluate the incidence, severity and possible complications of laboratory-confirmed infection with the 2009 H1N1 influenza virus [ Time Frame: September 2010 to April 2011 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

nasal/oral swabs, serum samples


Estimated Enrollment: 3000
Study Start Date: September 2010
Estimated Study Completion Date: January 2014
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 76 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01206114

Locations
Finland
National Institute for Health and Welfare
Tampere, Finland, 33520
Sponsors and Collaborators
National Institute for Health and Welfare, Finland
Investigators
Principal Investigator: Terhi M Kilpi, MD, PhD National Institute for Health and Welfare, Finland
  More Information

No publications provided

Responsible Party: National Institute for Health and Welfare, Finland
ClinicalTrials.gov Identifier: NCT01206114     History of Changes
Other Study ID Numbers: H1N1-495-10THL, 2010-021033-30, R10075M, 81/2010
Study First Received: September 20, 2010
Last Updated: August 13, 2013
Health Authority: Finland: Finnish Medicines Agency

Keywords provided by National Institute for Health and Welfare, Finland:
2009 H1N1 influenza
vaccination
pandemic
effectiveness

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 16, 2014