NCT01206114

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,351 (actual)
• Sponsor: Finnish Institute for Health and Welfare · Other Government
• Sex: All
• Age: 18 Years – 76 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Influenza Caused by the 2009 H1N1 Influenza Virus

Interventions

Type	Name	Description
OTHER	Follow-up	Questionnaires, interviews, nasal/oral and serum samples, register data
OTHER	Follow-up	Questionnaires, interviews, nasal/oral and serum samples, register data

Timeline

• Start date: 2010-09-01
• Primary completion: 2011-04-01
• Completion: 2014-09-01
• First posted: 2010-09-21
• Last updated: 2014-09-25

Locations

1 site across 1 country: Finland