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Study to Evaluate the Safety of 3 New 6:2 Influenza Virus Reassortants in Adults

Information source: MedImmune LLC
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Influenza; Healthy

Intervention: Trivalent Influenza Vaccine (Biological); Placebo (Other)

Phase: Phase 4

Status: Completed

Sponsored by: MedImmune LLC

Official(s) and/or principal investigator(s):
Raburn Mallory, MD, Study Director, Affiliation: MedImmune LLC


This prospective annual release study is designed to evaluate the safety on new influenza virus vaccine strains to be included in FluMist Quadrivalent for the 2013-2014 influenza season.

Clinical Details

Official title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety of 3 New 6:2 Influenza Virus Reassortants in Adults

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: Percentage of Participants With Fever Greater Than or Equal to (>=) 101 Degrees Fahrenheit (F)

Secondary outcome:

Percentage of Participants With Solicited Symptoms

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) and New Onset Chronic Diseases (NOCDs)

Percentage of Participants Who Required Antipyretic and/or Analgesic Medication

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 1 dose of investigational product on Day 1. The duration of study participation for each subject is the time from study vaccination through 180 days after study vaccination.


Minimum age: 18 Years. Maximum age: 49 Years. Gender(s): Both.


Inclusion Criteria:

- Age 18 through 49 years

- Written informed consent

- Subject available by telephone

- Ability to understand and comply with the requirements of the protocol, as judged by

the Investigator Exclusion Criteria:

- Concurrent enrollment in another clinical study up to 180 days after receipt of

investigational product (Day 181)

- 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

- Any condition for which the inactivated influenza vaccine is indicated, including

chronic disorders of the pulmonary or cardiovascular systems (example [eg], asthma), chronic metabolic diseases (eg, diabetes mellitus), renal dysfunction, or hemoglobinopathies that required regular medical follow-up or hospitalization during the preceding year

- Acute febrile (greater than [>] 100. 0 degrees Fahrenheit [F] oral or equivalent)

and/or clinically significant respiratory illness (example, cough or sore throat) within 14 days prior to randomization

- Any known immunosuppressive condition or immune deficiency disease, including human

immunodeficiency virus infection, or ongoing immunosuppressive therapy

- History of Guillain-Barré syndrome

Locations and Contacts

Research Site, Miami, Florida, United States

Research Site, Stockbridge, Georgia, United States

Research Site, Portland, Oregon, United States

Additional Information

Starting date: May 2013
Last updated: November 7, 2014

Page last updated: August 20, 2015

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