Evaluating the Safety and Immunogenicity of a Live Attenuated Virus Vaccine to Prevent Influenza H3N2v Disease
NCT ID: NCT02883426
Last Updated: 2018-05-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
1 participants
INTERVENTIONAL
2016-09-30
Brief Summary
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Detailed Description
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The study will enroll participants sequentially in four groups: Group 1 will include H3N2v seronegative adults ages 18-26 years; Group 2 will include H3N2v seropositive adolescents ages 13-17 years; Group 3 will include H3N2v seronegative adolescents ages 13-17 years; and Group 4 will include children ages 6 to 12 years, who will not be screened for H3N2v serostatus.
At study entry (Day 0), participants in Group 1 will receive one dose of H3N2v LAIV. Participants in Groups 2, 3, and 4 will be randomly assigned to receive two doses of either H3N2v LAIV or placebo, receiving the first dose on Day 0 and the second dose on Day 28. On Day 84, all participants will receive one dose of H3N2v IIV (an inactivated booster vaccine).
Participants will attend several additional study visits through Day 180. These visits may include a physical examination; respiratory examination; and collection of blood, urine, or nasal fluids.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Group 1: H3N2v Seronegative Adults: H3N2v LAIV
Participants will receive one dose of H3N2v LAIV on Day 0 (study entry). They will then receive one dose of H3N2v IIV on Day 84.
H3N2v MN 2010/AA ca live attenuated influenza vaccine (LAIV)
Approximately 10\^7.0 Fluorescent Focus Units (FFU) per 0.2 mL dose; administered intranasally
H3N2v inactivated subvirion influenza vaccine
15 μg; administered intramuscularly
Group 2: H3N2v Seropositive Adolescents: H3N2v LAIV
Participants will receive two doses of H3N2v LAIV, the first dose on Day 0 (study entry) and the second dose on Day 28. They will then receive one dose of H3N2v IIV on Day 84.
H3N2v MN 2010/AA ca live attenuated influenza vaccine (LAIV)
Approximately 10\^7.0 Fluorescent Focus Units (FFU) per 0.2 mL dose; administered intranasally
H3N2v inactivated subvirion influenza vaccine
15 μg; administered intramuscularly
Group 2: H3N2v Seropositive Adolescents: Placebo
Participants will receive two doses of placebo, the first dose on Day 0 (study entry) and the second dose on Day 28. They will then receive one dose of H3N2v IIV on Day 84.
H3N2v inactivated subvirion influenza vaccine
15 μg; administered intramuscularly
Placebo
Administered by nasal spray
Group 3: H3N2v Seronegative Adolescents: H3N2v LAIV
Participants will receive two doses of H3N2v LAIV, the first dose on Day 0 (study entry) and the second dose on Day 28. They will then receive one dose of H3N2v IIV on Day 84.
H3N2v MN 2010/AA ca live attenuated influenza vaccine (LAIV)
Approximately 10\^7.0 Fluorescent Focus Units (FFU) per 0.2 mL dose; administered intranasally
H3N2v inactivated subvirion influenza vaccine
15 μg; administered intramuscularly
Group 3: H3N2v Seronegative Adolescents: Placebo
Participants will receive two doses of placebo, the first dose on Day 0 (study entry) and the second dose on Day 28. They will then receive one dose of H3N2v IIV on Day 84.
H3N2v inactivated subvirion influenza vaccine
15 μg; administered intramuscularly
Placebo
Administered by nasal spray
Group 4: Children: H3N2v LAIV
Participants will receive two doses of H3N2v LAIV, the first dose on Day 0 (study entry) and the second dose on Day 28. They will then receive one dose of H3N2v IIV on Day 84.
H3N2v MN 2010/AA ca live attenuated influenza vaccine (LAIV)
Approximately 10\^7.0 Fluorescent Focus Units (FFU) per 0.2 mL dose; administered intranasally
H3N2v inactivated subvirion influenza vaccine
15 μg; administered intramuscularly
Group 4: Children: Placebo
Participants will receive two doses of placebo, the first dose on Day 0 (study entry) and the second dose on Day 28. They will then receive one dose of H3N2v IIV on Day 84.
H3N2v inactivated subvirion influenza vaccine
15 μg; administered intramuscularly
Placebo
Administered by nasal spray
Interventions
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H3N2v MN 2010/AA ca live attenuated influenza vaccine (LAIV)
Approximately 10\^7.0 Fluorescent Focus Units (FFU) per 0.2 mL dose; administered intranasally
H3N2v inactivated subvirion influenza vaccine
15 μg; administered intramuscularly
Placebo
Administered by nasal spray
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Pregnancy as determined by a positive urine or serum human choriogonadotropin (β-HCG) test.
* Currently breast-feeding.
* Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history or physical examination.
* Behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, affects the ability of the subject to understand and cooperate with the study protocol.
* Other condition that, in the opinion of the investigator, would jeopardize the safety or rights of a subject participating in the trial or would render the subject unable to comply with the protocol.
* History of anaphylaxis.
* Allergy to oseltamivir as determined by subject report.
* Current diagnosis of asthma or reactive airway disease (within the past 2 years).
* Use of aspirin or salicylate-containing medications within 28 days prior to randomization or expected receipt through 28 days after final vaccination.
* History of Guillain-Barré Syndrome.
* Known history of HIV, hepatitis C, or active hepatitis B infection.
* Known immunodeficiency syndrome.
* Use of corticosteroids (excluding topical preparations) or immunosuppressive drugs within 30 days prior to vaccination.
* Receipt of a live vaccine within 4 weeks or a killed vaccine within 2 weeks prior to study vaccination.
* Receipt of blood or blood-derived products (including immunoglobulin) within 6 months prior to study vaccination.
* Travel to the Southern Hemisphere within 14 days prior to study vaccination.
* Travel on a cruise ship within 14 days prior to study vaccination.
* Receipt of another investigational vaccine or drug within 30 days prior to study vaccination.
* Allergy to eggs or egg products, gentamicin, or gelatin.
* Chronic use of intranasal medications.
6 Years
26 Years
ALL
Yes
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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John Treanor, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Rochester
Locations
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University of Rochester Medical Center (URMC), Vaccine Research Unit (Outpatient)
Rochester, New York, United States
Countries
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Other Identifiers
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URMC 16-001
Identifier Type: -
Identifier Source: org_study_id
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