Evaluating the Safety and Immunogenicity of a Live Attenuated Virus Vaccine to Prevent Influenza … (NCT02883426) | Clinical Trial Compass
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 range6 Years – 26 Years
SexALL
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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…
What they're measuring
1
Frequency of vaccine-related reactogenicity events (REs) that occur during the acute monitoring phase of the study
Timeframe: Measured through Day 180
2
Area under the curve of nasal virus shedding after each dose of vaccine
Timeframe: Measured through Day 180
3
Development of serum antibody
Timeframe: Measured through Day 180
Trial details
NCT IDNCT02883426
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)