CompletedPhase 2

A Study of the Immunogenicity of Swine-origin A/H1N1 Influenza Vaccine in Healthy Adults

France202 participantsStarted 2010-03

Plain-language summary

This study is designed to describe the immunogenicity of a pandemic A/H1N1 influenza vaccine in healthy adults given a lower vaccine dose and in a similar group given a full dose of the vaccine. The primary objective is to describe describe the immune response of the inactivated, split-virion swine-origin A/H1N1 influenza vaccine without adjuvant.

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria : * Aged 18 to 60 years on the day of inclusion * Informed consent form has been signed and dated * Able to attend all scheduled visits and to comply with all trial procedures * For a woman of childbearing potential, use of an effective method of contraception from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination * Entitled to national social security Exclusion Criteria : * Known pregnancy, or a positive urine pregnancy test * Currently breastfeeding a child * Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the trial vaccination * Planned participation in another clinical trial during the present trial period * Receipt of any vaccine in the 4 weeks preceding the trial vaccination * Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response * Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months) * Self-reported seropositivity for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C * Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To provide information concerning the immunogenicity in terms of anti-hemagglutinin (HA) antibody titers against non-adjuvanted pandemic A/H1N1 influenza vaccine.

Timeframe: 21 days post-vaccination

Trial details

NCT IDNCT01089660

SponsorSanofi Pasteur, a Sanofi Company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2010-09

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