Loading clinical trials...

A Phase 2 Study to Evaluate Immune Responses of FluMist® | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A Phase 2 Study to Evaluate Immune Responses of FluMist®

A Phase 2, Prospective, Randomized, Open-Label Study to Evaluate the Immune Responses of FluMist® Compared With Trivalent Inactivated Vaccine (TIV) in Children 12 to <36 Months of Age

NCT00461981•MedImmune LLC

View on ClinicalTrials.gov

Summary

The primary objective of this study is to describe the level of serum antibody and cellular immune responses conferred by FluMist and TIV against influenza virus strains.

Detailed Description

The primary objective of this study is to describe the level of serum antibody and cellular immune responses conferred by FluMist and TIV against antigenically matched and antigenically mismatched influenza virus strains. The secondary objective of this study is to describe the safety of FluMist and TIV in subjects 12 to \<36 months of age.

Eligibility

Age

1 - 2 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Male or female aged 12 to \<36 months (reached their 1st year but not yet reached their 3rd year birthday) at the time of randomization
•Written informed consent and HIPAA authorization obtained from the subject's legal representative
•Ability of the subject's legal representative to understand and comply with the requirements of the study
•Subject's legal representative available by telephone
•Ability to complete follow-up period of 180 days after final study vaccination as required by the protocol

Exclusion Criteria

•History of hypersensitivity to any component of FluMist or TIV, including egg or egg products
•History of hypersensitivity to gentamicin
•Any known immunosuppressive condition or immune deficiency disease (including HIV infection), or ongoing receipt of any immunosuppressive therapy
•Household contact who is immunocompromised (participants should also avoid close contact with immunocompromised individuals for at least 21 days after each study vaccination)
•History of Guillain-Barré syndrome
•Any prior history of wheezing or asthma
•Acute febrile (≥100.0°F oral or equivalent) and/or clinically significant respiratory illness (e.g., cough or sore throat) within 72 hours prior to either study vaccination
•Use of aspirin or aspirin-containing products within the 30 days prior to randomization, or expected receipt through 180 days after final study vaccination
•Receipt of any prior influenza vaccine
•Use of anti-influenza medications (including amantadine, rimantadine, oseltamivir, and zanamivir) within 14 days prior to randomization, or expected receipt through 35 days after final study vaccination
+6 more criteria

Locations (19)

Harvey Pediatrics

Jonesboro, Arkansas, United States

Arkansas Pediatric Clinic

Little Rock, Arkansas, United States

NuLife Clinical Research

Anaheim, California, United States

Palm Beach Research Center

West Palm Beach, Florida, United States

Central Kentucky Research Associates

Lexington, Kentucky, United States

Peak Medical Research, LLC

Owensboro, Kentucky, United States

Benchmark Research

Metairie, Louisiana, United States

Meridian Clinical Research, LLC

Omaha, Nebraska, United States

Henderson Pediatrics

Henderson, Nevada, United States

Regional Clinical Research, Inc.

Endwell, New York, United States

Key Dates

Start Date

May 1, 2007

Primary Completion Date

December 1, 2007

Completion Date

February 1, 2008

Last Updated

October 6, 2021

Enrollment

101

ACTUAL participants

Conditions

Influenza Vaccine

Interventions

TIV, Trivalent Inactivated Influenza Virus Vaccine

BIOLOGICAL

FluMist, Influenza Virus Vaccine Live

BIOLOGICAL

Clinical Trial of Quadrivalent Subunit Influenza Vaccine (Adjuvant) in Chinese Population Aged 65 Years and Older

NCT07421037

InfluenzaInfluenza Vaccine

View study

COMPLETEDNA

Evaluation of a Multilevel Intervention on Adult COVID-19 and Influenza Vaccination Rate

NCT06646406

COVID-19 ImmunisationInfluenza Vaccine

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 6, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Phase 2 Study to Evaluate Immune Responses of FluMist®

Inclusion Criteria

Exclusion Criteria

Clinical Trial of Quadrivalent Subunit Influenza Vaccine (Adjuvant) in Chinese Population Aged 65 Years and Older

Evaluation of a Multilevel Intervention on Adult COVID-19 and Influenza Vaccination Rate

Cost-effectiveness of the Influenza Vaccination

Safety and Immunogenicity of the Sing2016 M2SR H3N2 Monovalent Influenza Vaccine in Adults Ages 50 to 85 Years Old

Placebo Controlled Study to Generate Data Characterising Clinical Events, Physiological Responses and Immune Responses

Financing Strategies of Influenza Vaccination in China