TerminatedPhase 1

Evaluating the Safety and Immunogenicity of a Live Attenuated Virus Vaccine to Prevent Influenza H3N2v Disease

United States1 participantsStarted 2016-09

Plain-language summary

This study will evaluate the safety and immunogenicity of the H3N2v MN 2010/AA ca live attenuated influenza vaccine (H3N2v LAIV) in healthy children and adults, 6 to 26 years old.

Who can participate

Age range

6 Years – 26 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: * Males and non-pregnant females between 6 and 26 years of age inclusive. * For children, presence of an adult caregiver who is in good health and able to understand and carry out the requirements * General good health, without significant medical illness, physical examination findings, or significant laboratory abnormalities as determined by the investigator. * Agree to storage of blood specimens for future research. * Available for the duration of the trial. * Willingness to participate in the study as evidenced by signing the informed consent document. Verbal assent will be obtained from minors 6 to 12 years of age and signed assent will be obtained from minors 13 and older. * Female subjects of childbearing potential must agree to use effective birth control methods for the duration of the study (e.g., pharmacologic contraceptives including oral, parenteral, and transcutaneous delivery; condoms with spermicide; diaphragm with spermicide; intrauterine device; abstinence from heterosexual intercourse, surgical sterilization). Exclusion Criteria: * Anticipated direct routine \[e.g. weekly or more frequent\] contact with individuals younger than the designated age groups being studied as a result of household contact, occupation, or participation in day care with such individuals. * Pregnancy as determined by a positive urine or serum human choriogonadotropin (β-HCG) test. * Currently breast-feeding. * Evidence of clinically significant neurologic, card…

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

Frequency of vaccine-related reactogenicity events (REs) that occur during the acute monitoring phase of the study

Timeframe: Measured through Day 180

Area under the curve of nasal virus shedding after each dose of vaccine

Timeframe: Measured through Day 180

Development of serum antibody

Timeframe: Measured through Day 180

Trial details

NCT IDNCT02883426

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2017-01-05

View on ClinicalTrials.gov More Influenza trials

Who can participate

Age range

6 Years – 26 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.

What they're measuring

Frequency of vaccine-related reactogenicity events (REs) that occur during the acute monitoring phase of the study

Timeframe: Measured through Day 180

Area under the curve of nasal virus shedding after each dose of vaccine

Timeframe: Measured through Day 180

Development of serum antibody

Timeframe: Measured through Day 180