Trial to Assess Safety, Tolerability, and Immunogenicity of Influenza Virus Vaccine, Trivalent, Types A & B, Live Cold-Adapted (FluMist) and Measles, Mumps, Rubella, and Varicella Vaccines Administered Concurrently to Healthy Children

February 7, 2008 updated by: MedImmune LLC

A Randomized, Placebo-Controlled, Trial to Assess Safety, Tolerability, and Immunogenicity of Influenza Virus Vaccine, Trivalent, Types A & B, Live Cold-Adapted (FluMist) and Measles, Mumps, Rubella, (MMRIIÒ) and Varicella (VARIVAXÒ) Vaccines Administered Concurrently to Healthy Children (AV018)

  • To compare immune responses to measles, mumps, rubella, and varicella antigens following vaccination in children who receive FluMist concurrently with MMRIIÒ and VARIVAXÒ and in children who receive an intranasal placebo mist concurrently with MMRIIÒ and VARIVAXÒ (Group 2 vs. Group 1).
  • To compare immune responses to the three strains of influenza (H1N1, H3N2, and B) following a two dose regimen of FluMist in children who receive the initial FluMist dose concurrently with MMRIIÒ and VARIVAXÒ and in children who receive two doses of FluMist alone (Group 2 vs. Group 3).Secondary:
  • To assess the safety and tolerability of concurrent administration of FluMist with MMRIIÒ and VARIVAXÒ.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

1200

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 12 to 15 months of age (not reached their 16th month birthday);
  • In good health;
  • Parent/guardian available by telephone or for home visits;
  • Ability of the parent/guardian to understand and comply with the requirements of the protocol;
  • Signed informed consent by parent/guardian; and
  • Up to date with the primary series of recommended vaccines per standard clinic practice and local vaccine availability.

Exclusion Criteria:

  • Previous known measles, mumps, rubella or varicella disease;
  • Previous vaccination against measles, mumps, rubella or varicella disease;
  • Hypersensitivity to egg or egg protein;
  • Signs or symptoms of any immunosuppressive or immune deficiency disease or ongoing immunosuppressive therapy; or an immunosuppressed individual living in the same household;
  • Acute febrile (>100.0oF [37.8°C] oral) illness or clinically significant upper respiratory illness within the 72 hours prior to enrollment;
  • Use of aspirin (acetylsalicylic acid) or aspirin-containing products in the month prior to enrollment, or expected use of aspirin while enrolled in this study;
  • Administration of any intranasal medication within two weeks prior to enrollment or expected receipt during this study;
  • Administration of any live virus vaccine within one month prior to enrollment through 30 days after Visit 3;
  • Administration of any inactivated vaccine within two weeks prior to enrollment through 30 days after Visit 3;
  • Participation in another investigational trial within one month prior to enrollment or expected enrollment in another investigational trial during this study;
  • Receipt of any blood product within three months prior to vaccination or expected receipt within the study duration; and
  • Any condition which, in the opinion of the investigator, would interfere with the interpretation or evaluation of the vaccines.
  • History of two or more episodes of medically attended wheezing illness by parent/guardian report.
  • History of medically attended wheezing illness or bronchodilator medication use within four weeks of enrollment by parent/guardian report.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 3
Placebo
Other: Placebo
Nasal Sprayer of Placebo
Active Comparator: 2
FluMist
Biological: FluMist
Nasal Sprayer of one dosage of FluMist and other experimental
Biological: FluMist
Nasal sprayer of FluMist
Active Comparator: 1
FluMist with other solution
Biological: FluMist
Nasal Sprayer of one dosage of FluMist and other experimental
Biological: FluMist
Nasal sprayer of FluMist

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
compare immune responses to measles, mumps, rubella, and varicella antigens following vaccination in children who receive FluMist concurrently with MMRIIÒ and VARIVAXÒ and in children
Time Frame: Day 42
Day 42

Secondary Outcome Measures

Outcome Measure
Time Frame
Compare immune responses to the three strains of influenza (H1N1, H3N2, and B) following a two dose regimen of FluMist in children who receive the initial FluMist
Time Frame: Day 42
Day 42

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MedImmune LLC

Investigators

  • Study Director: Robert Walker, M.D., MedImmune LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2000

Primary Completion (Anticipated)

September 1, 2003

Study Completion (Actual)

December 1, 2003

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 14, 2005

First Posted (Estimate)

September 19, 2005

Study Record Updates

Last Update Posted (Estimate)

February 8, 2008

Last Update Submitted That Met QC Criteria

February 7, 2008

Last Verified

February 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AV018

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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