CompletedPhase 3

Study of Swine-Origin A/H1N1 Influenza Non-Adjuvanted Vaccine in Healthy Adults in India

India100 participantsStarted 2010-01

Plain-language summary

The purpose of this study is to assess the safety and immunogenicity of one dose of A/H1N1 non-adjuvanted pandemic vaccine to support registration of the vaccine in India. Primary Objective: * To describe the safety profile (injection site reactions and systemic events) of the vaccine within 21 days following vaccination, and serious adverse events throughout the study in all subjects Secondary Objectives: * To describe the immune response to the vaccine 21 days after vaccination by hemagglutination inhibition (HAI) testing in all subjects * To describe the antibody persistence 6 months after vaccination by HAI testing in all subjects.

Who can participate

Age range

18 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 : * 18 years of age and above on the day of inclusion * Provision of informed consent form signed by the participant. If the participant is illiterate, an independent witness is required to sign the consent form. * Participant able to attend all scheduled visits and comply with all trial procedures * For a female, if sexually active, use of an effective method of contraception or abstinence for at least 4 weeks prior to the first vaccination, until at least 4 weeks after the last vaccination. Exclusion Criteria : * 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 * Planned receipt of any vaccine during the study period (except 6 months follow up) * 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) * Known seropositivity for human immunodeficiency virus, hepatitis B, or hepatitis C as reported by the participant /…

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 safety profile in terms of solicited injection site reactions, systemic events, and serious adverse events after administration of A/H1N1 pandemic influenza vaccine.

Timeframe: 7 days post-vaccination and entire study duration

Trial details

NCT IDNCT01053143

SponsorSanofi Pasteur, a Sanofi Company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2010-08

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