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

Phase 4

Completed

Conditions: flu
influenza
10047438

Registration Number: NL-OMON35537

Lead Sponsor: Registratie en Medische Unit

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 375

Inclusion Criteria

* good self-reported health according to the investigator
* willingness and ability to adhere to the study regimen
* having a signed informed consent form
* age 18 * 52 years

Exclusion Criteria

The exclusion criteria with regard to contra-indications for receiving the pandemic influenza vaccine are:
* 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 with regard to 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

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary: pandemic influenza virus identification after reporting of<br /><br>influenza-like symptoms by the participants.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary:<br /><br>- The humoral immune response against pandemic influenza vaccine at each of the<br /><br>specified time points.<br /><br>- The cellular immune response against pandemic influenza vaccine at each of<br /><br>the specified time points.<br /><br>- The humoral and cellular, cross-specific and specific immune responses<br /><br>against the pandemic influenza virus in the pre-vaccination samples and in the<br /><br>unvaccinated group.<br /><br><br /><br>Added with reference to the extension:<br /><br>* the humoral and cellular immune responses against influenza A (H3N2) vaccine.</p><br>