Trials Sponsors Conditions Drugs Pricing

Conditions

Influenza

Outcome Measures

Primary Outcomes (3)

The primary efficacy endpoint of this study is the relative efficacy of CAIV-T
compared to TIV against the incidence of culture-confirmed symptomatic influenza infection caused by community-acquired wild-type strains antigenically similar to those contained in the vaccine, occurring during the
influenza surveillance period and at least 14 days after the last required vaccination

Secondary Outcomes (5)

Culture-confirmed symptomatic influenza infection regardless of antigenic match
Febrile acute otitis media (AOM) with antibiotic use associated with culture-confirmed influenza infection antigenically similar to vaccine strains
Febrile acute otitis media (AOM) with antibiotic use associated with culture-confirmed influenza infection regardless of antigenic match
Lower respiratory illness (LRI) with culture-confirmed influenza infection antigenically similar to vaccine strains and
Lower respiratory illness (LRI) with culture-confirmed influenza infection regardless of antigenic match

Interventions

Liquid CAIV-TDrug

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age6 Months - 59 Months

Sexall

Healthy VolunteersYes

Age GroupsChild (0-17)

You may qualify if:

Age 6-59 months of age (not yet reached their 5th birthday)
Parent or guardian available by telephone

Sponsors & Collaborators

MedImmune LLC
Industrylead

Study Sites (161)

Clinical Research Consultants, Inc

Hoover, Alabama, 35216, United States

University of Alabama

Tuscaloosa, Alabama, 35401, United States

Little Rock Allergy and Asthma Clinical

Little Rock, Arkansas, 72205, United States

Friendly Care Medical Group

Anaheim, California, 92805, United States

Impact Clinical Trials

Beverly Hills, California, 90211, United States

Family Medical Center

Foothill Ranch, California, 92610, United States

Edinger Mecial Group

Fountain Valley, California, 92708-7504, United States

Related Publications (1)

Belshe RB, Edwards KM, Vesikari T, Black SV, Walker RE, Hultquist M, Kemble G, Connor EM; CAIV-T Comparative Efficacy Study Group. Live attenuated versus inactivated influenza vaccine in infants and young children. N Engl J Med. 2007 Feb 15;356(7):685-96. doi: 10.1056/NEJMoa065368.
PMID: 17301299DERIVED

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

Robert Walker, M.D.
MedImmune LLC
STUDY DIRECTOR

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: DOUBLE
Purpose: PREVENTION
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

August 5, 2005

First Posted

August 9, 2005

Study Start

October 2004

Date type not reported

This date has not been verified as actual or estimated.

Study Completion

December 2005

Date type not reported

You may not qualify if:

History of hypersensitivity to any component of CAIV-T or inactivated influenza vaccine, including egg or egg protein
History of hypersensitivity to gentamicin
Any known immunosuppressive condition or immune deficiency disease (including HIV infection), or ongoing receipt of any immunosuppressive therapy
History of Guillain-Barre syndrome
Medically-diagnosed wheezing, bronchodilator use, or steroid use (systemic or inhaled) within the previous 42 days by parent report or chart review (e.g., children with recent persistent asthma are excluded), or history of severe asthma
Acute febrile (\>100.0 degrees F or \>37.8 degrees C oral or equivalent) illness or acute respiratory illness, including sore throat, within three days prior to enrollment
Receipt of an investigational product within 30 days prior to enrollment or expected receipt during this study
Use of aspirin or salicylate-containing products 30 days prior to enrollment or expected receipt during this study
Use of anti-influenza medications (including amantadine, rimantadine, oseltamivir, and zanamivir) within 14 days prior to enrollment or expected receipt during this study
Receipt of any blood product within 90 days prior to vaccination or expected receipt during this study
Administration of any live virus vaccine within 30 days prior to enrollment, or if receipt of another live virus vaccine is expected within 30 days of any study vaccination
Administration of any inactivated vaccine within 14 days prior to enrollment or if receipt of another inactivated vaccine is expected within 14 days prior to enrollment or if receipt of another inactivated vaccine is expected within 14 days of any study vaccination
Close contact who is severely immunocompromised (e.g., transplant recipient)
Family member or household contact who is an employee of the research center or otherwise involved with the conduct of the study and
Any condition that, in the opinion of the investigator, might interfere with the interpretation or evaluation of the vaccines.

Trivalent, Live, Cold Adapted Influenza Vaccine (CAIV-T) Against Inactivated Influenza Vaccine (TIV) in Children 6-59 Months of Age

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Study Completion

Conditions

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (5)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (161)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Study Completion

Conditions

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (5)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (161)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations