CompletedPhase 1/2

A Clinical Trail Of An Adjuvanted Inactivated H7N9 Influenza Vaccine

China360 participantsStarted 2017-12-29

Plain-language summary

The aim of this study is to investigate the immunogenicity and safety of the inactivated whole-virion vaccine for teenagers and adults. The investigators will test the vaccine in participants aged 12-60 years, for a randomized, blind, placebo-controlled, age-stratified clinical study. The investigators designed three dosage groups: 7.5 μg,15 μg and 30 μg of hemagglutinin antigen. According to the age of the subjects, Each group was divided into different age subgroups. Phosphate buffer solution and Aluminum hydroxide adjuvant as placebo controls were both set up in the subgroups.Participants will receive 2 doses of vaccine at 21-day intervals.Safety up to 6 months and changes in hemagglutinin inhibition (HI) titers at 21 days after each vaccination were determined.

Who can participate

Age range

12 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: * Over the age of 12 years,healthy population * Subjects/ (and the guardian) informed consent, voluntarily participated and signed the informed consent form, with the ability to use thermometers, scales and to fill in diary cards as required * To comply with the requirements of clinical trial program, receive blood test before and after immunization and cooperate with follow-up Exclusion Criteria: * A history of influenza A (H7N9) virus infection or suspected infection Abnormal blood routine, blood biochemistry and urine routine examination indexes * Allergy to any component in the vaccine (allergy history of any previous vaccination), especially for egg allergy * History of asthma, history of thyroid resection, vascular nerve edema, diabetes mellitus, hypertension can not be controlled by medicine, liver and kidney diseases or malignant tumor history * Suffered from any serious illness, such as cancer, autoimmune disease, progressive atherosclerotic disease or complications of diabetes, chronic obstructive pulmonary disease, need oxygen therapy for acute or progressive liver or kidney disease, congestive heart-failure etc. * History of signs disease or symptoms of neurological symptoms * Suffering from severe chronic diseases (such as Down's syndrome, diabetes, sicklemia or neurological disorders, Green's Barre syndrome) * Acute attacks of various acute or chronic diseases in the past 7 days * Known or suspected of respiratory disease, acute infection …

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

Reactogenicity Events

Timeframe: Continuous observation for 30 days after two inoculations

Trial details

NCT IDNCT03369808

SponsorShanghai Institute Of Biological Products

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-08-29

View on ClinicalTrials.gov More H7N9 Influenza trials