D2560C00015 FluMist Annual Safety Study 2018

MedImmune

Status and phase: Completed; Phase 4

Conditions: Healthy; Influenza

Treatments: Biological: Bivalent influenza vaccine; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03564444

D2560C00015

Details and patient eligibility

About

This prospective annual release study is designed to evaluate the safety of 2 new influenza virus vaccine strains to be included in FluMist Quadrivalent for the 2018-2019 influenza season.

Full description

This prospective. randomized, double-blind. placebo-controlled release study will enroll approximately 300 healthy adults 18 to 49 years of age (not yet reached their 50th birthday). Eligible subjects will be randomly assigned in a 4:1 fashion to receive a single dose of bivalent vaccine or placebo by intranasal spray. Randomization will be stratified by site. This study will be conducted at 2 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.

Enrollment: 300 patients

Sex: All

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

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), renaldysfunction, 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 to randomization
• Any known immunosuppressive condition or immune deficiency diseases, including human immunodeficiency virus infection, or ongoing immunosuppressive therapy
• History of Guillain-Barre syndrome.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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300 participants in 2 patient groups, including a placebo group

Bivalent influenza vaccine

Experimental group

Description:

A single dose of bivalent vaccine (10\^7±5 fluorescent focus unit of 2 cold-adapted, attenuated, temperature-sensitive, 6:2 reassortant influenza strain) will be administered as intranasal spray on Day 1

Treatment:

Biological: Bivalent influenza vaccine

Placebo

Placebo Comparator group

Description:

A single dose of placebo matched to bivalent influenza vaccine will be administered as intranasal spray on Day 1.

Treatment:

Other: Placebo