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Be Part of Research - Trial Details - Safety and Immunogenicity of an Intramuscular Pandemic Influenza Vaccine in Adults and the Elderly

Safety and Immunogenicity of an Intramuscular Pandemic Influenza Vaccine in Adults and the Elderly

Completed

Open to: ALL

Age: 18.0 - N/A

Medical Conditions

Influenza, Human
Orthomyxoviridae Infections


This information is provided directly by researchers and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information.


Based on the results from a previous formulation/dosage ranging trial, this phase II multicenter, open trial was designed to determine the safety and immunogenicity of two vaccine formulation/dosages with and without adjuvant 21 days after each vaccination in adults (18 to 60 years and in the elderly (\> 60 years) as required by the European Medicines Agency (EMEA) guideline. The antibody persistence until the booster vaccination at 6 or 12 months will also be evaluated.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Jun 2006 Dec 2008

Publications

"Lazarus R, Kelly S, Snape MD, Vandermeulen C, Voysey M, Hoppenbrouwers K, Hens A, Van Damme P, Pepin S, Leroux-Roels I, Leroux-Roels G, Pollard AJ. Antibody Persistence and Booster Responses to Split-Virion H5N1 Avian Influenza Vaccine in Young and Elderly Adults. PLoS One. 2016 Nov 4;11(11):e0165384. doi: 10.1371/journal.pone.0165384. eCollection 2016."; "27814377"; "Leroux-Roels I, Van der Wielen M, Kafeja F, Vandermeulen C, Lazarus R, Snape MD, John T, Carre C, Nougarede N, Pepin S, Leroux-Roels G, Hoppenbrouwers K, Pollard AJ, Van Damme P. Humoral and cellular immune responses to split-virion H5N1 influenza vaccine in young and elderly adults. Vaccine. 2009 Nov 16;27(49):6918-25. doi: 10.1016/j.vaccine.2009.08.110. Epub 2009 Sep 15."; "19761837"

INTERVENTIONAL

Intervention Type : BIOLOGICAL
Intervention Description : 0.5mL, Intramuscular

Intervention Arm Group : Study Group 1;

Intervention Type : BIOLOGICAL
Intervention Description : 0.5mL, Intramuscular

Intervention Arm Group : Study Group 2;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Oxford


The study is sponsored by Sanofi Pasteur, a Sanofi Company




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Read full details for Trial ID: NCT00415129
Last updated 10 January 2014

This page is to help you find out about a research study and if you may be able to take part

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