A Study of Inactivated Swine-Origin A/H1N1 Influenza Vaccines in Healthy European Subjects Aged 3… (NCT00956202) | Clinical Trial Compass
CompletedPhase 2
A Study of Inactivated Swine-Origin A/H1N1 Influenza Vaccines in Healthy European Subjects Aged 3 to 17 Years
Finland303 participantsStarted 2009-08
Plain-language summary
The purpose of this study is to generate data on immunogenicity and safety of the monovalent H1N1 vaccine in support of the development and registration.
Primary objectives:
* To describe the immune response to vaccines 21 days after each vaccination in all participants.
* To describe the antibody persistence eight months after the first vaccine administration using HAI method, in a subset of participants who received two injections.
* To describe the immune response against the A/H1N1 strain using HAI method 21 days after a vaccination with the 2010-2011 NH seasonal TIV administered approximately 13 months after the first vaccination in the subset of participants who received two injections.
* To describe the safety profile of each vaccine in all participants.
Who can participate
Age range
3 Years – 17 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 :
All subjects:
* Provision of Informed Consent Form signed by the subject's parent(s)/legal representative (and by an independent witness if required by local regulations). In addition, provision of Assent Form signed by subjects aged 8 to 12 years, and of Informed Consent Form signed by subjects \>12 years.
* Subject and parent/guardian are able to attend all scheduled visits and to comply with all trial procedures
Subjects aged 12 to 17 years:
* Aged 12 to 17 years on the day of inclusion
* For a female of childbearing potential, 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.
Subjects aged 3 to 11 years:
* Aged 3 to 11 years on the day of inclusion
At Visit 05 (Month 8), for antibody persistence assessment:
* Having received two injections of the 15 µg HA vaccine (Group 1) or of the 3.8 µg HA + AF03 vaccine (Group 2)
* Addendum 1 to Informed Consent Form has been signed by the subject's parent(s)/guardian(s) (and by an independent witness if required by local regulations). In addition, provision of addendum 1 to Assent Form signed by subjects aged 6 to 11 years, and of addendum 1 to Informed Consent Form signed by subjects ≥ 12 years.
At Visit 06, for participants eligible for the Antibody persistence evaluation who will receive the 2010-2011 Northern Hemisphere (NH) seasonal Trivalent Influenza Vaccine:
* Addendum 2 to Informed Co…
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
1
Immunogenicity: To provide information concerning the immunogenicity of Swine A/H1N1 influenza vaccines
Timeframe: 21 days post vaccination
2
Safety: To provide information concerning the safety (in terms of solicited injection site and systemic reactions and unsolicited adverse events) of Swine A/H1N1 influenza vaccines.
Timeframe: 0-7 days post-vaccination and entire study duration