Completed
MI-MA182A Prospective, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety of a Trivalent Vaccine of New 6:2 Influenza Virus Reassortants in Healthy Adults
What is being tested
Trivalent influenza virus vaccine
+ Placebo
Biological
Who is being recruted
Infections+4
+ Influenza, Human
+ Orthomyxoviridae Infections
From 18 to 49 Years
+21 Eligibility Criteria
How is the trial designed
Prevention Study
Placebo-ControlledPhase 4
Interventional
Study Start: June 2008
Summary
Principal SponsorMedImmune LLC
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: June 1, 2008
Actual date on which the first participant was enrolled.This was a prospective, randomized, double-blind, placebo-controlled release study. Eligible subjects were randomly assigned in a 4:1 fashion to receive a single dose of trivalent vaccine or placebo by intranasal spray. Randomization was stratified by site. Each subject received 1 dose of study vaccine on Study Day 0. The duration of study participation for each subject was the time from study vaccination through 180 days after study vaccination.
Official TitleA Prospective, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety of a Trivalent Vaccine of New 6:2 Influenza Virus Reassortants in Healthy Adults
Principal SponsorMedImmune LLC
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
300 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 18 to 49 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
InfectionsInfluenza, HumanOrthomyxoviridae InfectionsRespiratory Tract DiseasesRespiratory Tract InfectionsRNA Virus InfectionsVirus Diseases
Criteria
8 inclusion criteria required to participate
Male or female, 18 to 49 years of age (not yet reached their 50th birthday) at the time of study vaccination
Healthy by medical history and health assessment
Sexually active females, unless surgically sterile or at least 1 year post-menopausal, must have used an effective method of avoiding pregnancy (including oral, implanted, injectable, or transdermal contraceptives, IUD, female condom, diaphragm with spermicide, cervical cap, abstinence, use of a condom by the sexual partner or sterile sexual partner) for at least 30 days prior to study vaccination, and must agree to continue using such precautions for at least 90 days after study vaccination; the subject must also have a negative serum or urine pregnancy test within 14 days prior to study vaccination (if screening and study vaccination do not occur on the same day) and on the day of study vaccination prior to randomization
Sexually active males, unless surgically sterile, must use an effective method of birth control (condom or abstinence) and must agree to continue using such precautions for at least 30 days after study vaccination
Show More Criteria
13 exclusion criteria prevent from participating
History of hypersensitivity to any component of the vaccine, including egg or egg protein
History of hypersensitivity to gentamicin
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
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
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalFrozen trivalent vaccine containing new strains
Group II
Placebotreatment with placebo
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 3 locations
Suspended
Suspended
Covance, Portland
Portland, United StatesSuspended
Covance, Austin
Austin, United StatesCompleted3 Study Centers