Incidence of pandemic influenza and the immunogenicity of the pandemic vaccin.

New Influenza A (H1N1) disease incidence and immunogenicity of the pandemic influenza A (H1N1) vaccin in healthy adults.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON29324

Enrollment

375

Registered

2009-08-04

Start date

2009-10-26

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza, pandemic (H1N1) 2009, flu Influenza, pandemische griep, griep

Interventions

Healthy adults will be vaccinated 2 times with a 3 week interval with the pandemic influenza vaccin Focetria (Novartis). At the described timepoints blood sampling will take place for immunological an

Eligibility

Inclusion criteria

Inclusion criteria: 1. Good self-reported health according to the investigator; 2. Willingness and ability to adhere to the study regimen; 3. Having a signed informed consent (IC) form; 4. Age 18 – 65 years.

Exclusion criteria

Exclusion criteria: The exclusion criteria with regard to contra-indications for receiving the pandemic influenza vaccine are: 1. 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: 1. Immune deficiencies; 2. Haematological disorders; 3. Bleeding disorders; 4. Usage of anticoagulants, corticosteroids, NSAIDs and/or statins; 5. Diabetes mellitus; 6. Having had an infectious disease with fever within the last two weeks; 7. Previously diagnosed with pandemic H1N1 influenza.

Design outcomes

Primary

Measure	Time frame
Evaluation of pandemic influenza incidence of vaccinated subjects compared to unvaccinated subjects.	—

Secondary

Measure	Time frame
1. Obtain data on immunogenicity of pandemic influenza vaccination; a. Evaluation of the humoral immune response to the vaccine and correlate this to protection against the virus; b. Evaluation of the cellular response to the vaccines and correlate this to protection against the virus; c. Evaluation of the response to the second dose of the pandemic influenza vaccine. 2. Evaluation of cross-specific immune responses to pandemic H1N1 virus in the pre-vaccination samples; 3. Evaluation of specific immune responses against pandemic H1N1 virus in infected, unvaccinated controls; 4. Obtain data on immunogenicity of adjuvanted pandemic influenza A (H1N1) vaccination more than one year after vaccination; 5. Evaluation of the boosting capacity of unadjuvanted seasonal influenza A (H1N1) vaccination; 6. Evaluation of humoral and cellular immune responses against influenza A (H3N2) vaccine.	—

Measure

Time frame

1. Obtain data on immunogenicity of pandemic influenza vaccination; a. Evaluation of the humoral immune response to the vaccine and correlate this to protection against the virus; b. Evaluation of the cellular response to the vaccines and correlate this to protection against the virus; c. Evaluation of the response to the second dose of the pandemic influenza vaccine. 2. Evaluation of cross-specific immune responses to pandemic H1N1 virus in the pre-vaccination samples; 3. Evaluation of specific immune responses against pandemic H1N1 virus in infected, unvaccinated controls; 4. Obtain data on immunogenicity of adjuvanted pandemic influenza A (H1N1) vaccination more than one year after vaccination; 5. Evaluation of the boosting capacity of unadjuvanted seasonal influenza A (H1N1) vaccination; 6. Evaluation of humoral and cellular immune responses against influenza A (H3N2) vaccine.

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Contacts

Public ContactJ. Beek, van

Nederlands Vaccin Instituut Postbus 457

josine.van.beek@nvi-vaccin.nl+31 (0)30-2743184

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)