Immunogenicity and Safety Study of Inactivated Subunit H5N1 Influenza Vaccine in Prior Recipients… (NCT03816878) | Clinical Trial Compass
CompletedPhase 1
Immunogenicity and Safety Study of Inactivated Subunit H5N1 Influenza Vaccine in Prior Recipients of Live Attenuated H2N2, H6N1 and H9N2 Influenza Vaccines and in H5N1 and Live Attenuated Vaccine NaĂŻve Individuals
United States32 participantsStarted 2019-01-08
Plain-language summary
The purpose of this study is to evaluate the immunogenicity and safety of inactivated subunit H5N1 influenza vaccine in individuals who have previously received live attenuated H2N2, H6N1, or H9N2 influenza vaccine, as well as in individuals who have never previously received H5N1 or other pandemic live attenuated influenza vaccines.
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion Criteria:
* Adult males and non-pregnant females between 18 years and 60 years of age inclusive.
* General good health, without significant medical illness, physical examination findings, or significant laboratory abnormalities as determined by the investigator.
* Available for the duration of the trial.
* Able to demonstrate understanding of key study concepts, study rationale, and study participation requirements by scoring greater than or equal to 70% on a written comprehension assessment in 3 or fewer attempts.
* Willingness to participate in the study as evidenced by signing the informed consent document.
* Willingness to allow storage and testing of laboratory samples for future research.
* Received 2 doses of live attenuated H2N2, H6N1, or H9N2 vaccine in a prior trial (Cohort 1) or H2N2, H6N1 and H9N2 naĂŻve (Cohort 2)
* Willingness to forego seasonal influenza virus vaccination from 1 month before vaccination until 3 months after vaccination.
* Female subjects of childbearing potential must agree to have used effective birth control methods beginning at least one month prior to vaccination, and continuing with 'per label/fully effective use' for the chosen method for duration of the study, from amongst these:
* pharmacologic/hormonal contraceptives, including oral, parenteral, subcutaneous, and transcutaneous delivery;
* condoms with spermicide;
* diaphragm with spermicide;
* intrauterine device;
* absolute abstinence from heterosexual intercours…
What they're measuring
1
Fold Rise in Titer of Anti-group 1 Stalk-antibodies in Recipients of the Pandemic Live Attenuated Influenza Vaccines (pLAIVs) (H2N2, H6N1 and H9N2) Compared to the Control pLAIV-naĂŻve Cohort
Timeframe: Measured through Day 28
Trial details
NCT IDNCT03816878
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)