ew influenza A (H1N1) disease incidence and immunogenicity of the pandemic influenza A (H1N1) vaccine in healthy adults

Phase 1

• Conditions: influenza A (H1N1) virus infection

• Registration Number: EUCTR2009-014770-17-NL
• Lead Sponsor: etherlands Vaccine Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-10-23
• Study Completion: 2011-04-12
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 375

Inclusion Criteria

Subjects have to fulfill all of the following criteria:
- age 18 – 52 years
- good self-reported health according to the investigator
- willingness and ability to adhere to the study regimen
- having a signed informed consent (IC) form

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

The contra-indications for receiving the pandemic influenza vaccine are exclusion criteria: allergy to any of the components of the vaccine or trace residues of eggs, chicken proteins, kanamycin and neomycin sulphate, formaldehyde and cetyltrimethylammonium bromide (CTAB).
The exclusion criteria for blood collection and the immunological analysis are:
- immune deficiencies
- haematological disorders
- bleeding disorders
- usage of anticoagulants, corticosteroids, NSAIDs and/or statins
- diabetes mellitus
- having had an infectious disease with fever within the last two weeks
- previously diagnosed with pandemic H1N1 influenza

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluate new influenza A (H1N1) disease (pandemic influenza) incidence of vaccinated compared to unvaccinated individuals. ;Secondary Objective: Secondary: <br>• Obtain data on immunogenicity of pandemic influenza vaccination:<br>- Evaluation of the humoral immune response to the vaccine and correlate this to protection against the virus.<br>- Evaluation of the cellular response to the vaccines and correlate this to protection against the virus.<br>- Evaluation of the response to the second dose of the pandemic influenza vaccine.<br><br>•Evaluation of cross-specific immune responses to pandemic H1N1 virus in the pre-vaccination samples. <br>•Evaluation of specific immune responses against pandemic H1N1 virus in infected, unvaccinated controls.<br>;Primary end point(s): pandemic influenza virus identification after reporting of influenza-like symptoms by the participants.