Clinical trial NCT01579916: A Study to Evaluate the Safety of 3 New 6:2 Influenza Virus Reassortants in Adults
Official title: A Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Safety of 3 New 6:2 Influenza Virus Reassortants in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Influenza
Keywords: Trivalent, Influenza, FluMist, Vaccine, Prevention
Lead sponsor: MedImmune LLC
Sponsor class: INDUSTRY
Collaborators: name: AstraZeneca
First posted: 2012-04-18
Enrollment: 303
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This prospective annual release study was designed to assess the safety of a trivalent influenza virus vaccine using two new strains recommended for the 2012-2013 influenza season not previously contained in the trivalent intranasal FluMist vaccine.

Three hundred healthy adults will receive a single dose of vaccine or placebo and will be followed for 180 days after study vaccination.

Detailed description: This prospective, randomized, double-blind, placebo-controlled release study will enroll approximately 300 healthy adults 18 to 49 years of age. Eligible subjects will be randomly assigned in a 4:1 fashion to receive a single dose of trivalent vaccine or placebo by intranasal spray. Randomization will be stratified by site.

This study will be conducted at 3 sites in the United States of America. Each subject will receive one dose of investigational product on Study Day 1. The duration of study participation for each subject is the time from study vaccination through 180 days after study vaccination.

Eligibility criteria: Inclusion Criteria:

1. Age 18 through 49 years at the time of investigational product administration
2. Written informed consent and any locally required authorization (ie, HIPAA in the USA) obtained from the subject/legal representative prior to performing any protocol-related procedures, including screening evaluations
3. Females of childbearing potential who are sexually active with a nonsterilized male partner must use effective contraception for 30 days prior to study vaccination, and must agree to continue using such precautions for 60 days after study vaccination
4. Nonsterilized males who are sexually active with a female partner of child-bearing potential must use an effective method of contraception from prior to study vaccination amd must agree to continue using such precautions for at least 30 days after receipt study vaccination
5. Healthy by medical history and physical examination
6. Female subjects of child-bearing potential must also have a negative urine or blood pregnancy test at screening and, if screening and Day 1 do not occur on the same day, on the day of vaccination prior to randomization.
7. Subject available by telephone
8. Ability to understand and comply with the requirements of the protocol, as judged by the investigator
9. Ability to complete follow-up period of 180 days after dosing as required by the protocol

Exclusion Criteria:

1. Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results
2. Concurrent enrollment in another clinical study up to 180 days after receipt of investigational product (Day 181)
3. Employees of the clinical study site or any other individuals involved with the conduct of the study, or immediate family members of such individuals
4. History of hypersensitivity to any component of the vaccine, including egg or egg protein or serious, life threatening, or severe reactions to previous influenza vaccinations
5. History of hypersensitivity to gentamicin
6. Any condition for which the inactivated influenza vaccine is indicated, including chronic disorders of the pulmonary or cardiovascular systems (eg, asthma), chronic metabolic diseases (eg, diabetes mellitus), renal dysfunction, or hemoglobinopathies that required regular medical follow-up or hospitalization during the preceding year
7. Acute febrile (\> 100.0°F oral or equivalent) and/or clinically significant respiratory illness (eg, cough or sore throat) within 14 days prior to randomization
8. Any known immunosuppressive condition or immune deficiency disease, including human immunodeficiency virus infection, or ongoing immunosuppressive therapy
9. History of Guillain-Barré syndrome
10. A household contact who is severely immunocompromised (eg, hematopoietic stem cell transplant recipient, during those periods in which the immunocompromised individual requires care in a protective environment); additionally, subject should avoid close contact with severely immunocompromised individuals for at least 21 days after study vaccination
11. Receipt of any investigational agent within 30 days prior to randomization, or expected receipt through 30 days after study vaccination (use of licensed agents for indications not listed in the package insert is permitted)
12. Receipt of any non-study vaccine within 30 days prior to randomization, or expected receipt through 30 days after study vaccination
13. Expected receipt of antipyretic or analgesic medication on a daily or every other day basis from randomization through 14 days after study vaccination
14. Administration of intranasal medications within 14 days prior to randomization, or expected receipt through 14 days after study vaccination
15. Receipt of influenza antiviral therapy or antiviral agents within 48 hours prior to study vaccination or expected receipt of influenza antiviral therapy or antiviral agents through 14 days after study vaccination
16. Known or suspected mitochondrial encephalomyopathy
17. Nursing mother

Primary outcomes:
measure: Percentage of Participants Reporting Fever Within 7 Days Post Vaccination
timeFrame: Study Days 1 - 8
Secondary outcomes:
measure: Percentage of Participants Reporting Other Solicited Symptoms Within 7 Days Post Vaccination
timeFrame: Study Days 1- 8
measure: Percentage of Participants Reporting Any Adverse Event (AE) Within 7 Days Post Vaccination
timeFrame: Study Days 1 - 8
measure: Percentage of Participants Reporting Other Solicited Symptoms Within 14 Days Post Vaccination
timeFrame: Study Days 1 - 15
measure: Percentage of Participants Reporting Any Adverse Event (AE) Within 14 Days Post Vaccination
timeFrame: Study Days 1 - 15
measure: Percentage of Participants Reporting Any Serious Adverse Event (SAE) Within 28 Days Post Vaccination
timeFrame: Study Days 1 - 29
measure: Percentage of Participants Reporting Any Serious Adverse Event (SAE) Within 180 Days Post Vaccination
timeFrame: Study Days 1 - 181
measure: Percentage of Participants Reporting Any New Onset Chronic Diseases (NOCDs) Within 28 Days Post Vaccination
timeFrame: Study Days 1 - 29
measure: Percentage of Participants Reporting Any New Onset Chronic Diseases (NOCDs) Within 180 Days Post Vaccination
timeFrame: Study Days 1 - 181
measure: Percentage of Participants Who Used Antipyretic or Analgesic Agents Within 7 Days Post Vaccination
timeFrame: Study Days 1 - 8
measure: Percentage of Participants Who Used Antipyretic or Analgesic Agents Within 14 Days Post Vaccination
timeFrame: Study Days 1 - 15
Other outcomes:
Locations:
city: Miami
country: United States
facility: Research Site
state: Florida
city: Stockbridge
country: United States
facility: Research Site
state: Georgia
city: Portland
country: United States
facility: Research Site
state: Oregon
Study officials:
affiliation: MedImmune LLC
name: Raburn Mallory, MD
role: STUDY_DIRECTOR
References: