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

This study has been completed.
Sponsor:
Information provided by:
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT00192491
First received: September 12, 2005
Last updated: February 7, 2008
Last verified: February 2008
  Purpose
  • 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.

Condition Intervention Phase
Influenza
Biological: FluMist
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 1200
Study Start Date: December 2000
Study Completion Date: December 2003
Estimated Primary Completion Date: September 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 2
FluMist
Biological: FluMist
Nasal sprayer of FluMist
Placebo Comparator: 3
Placebo
Other: Placebo
Nasal Sprayer of Placebo
Active Comparator: 1
FluMist with other solution
Biological: FluMist
Nasal Sprayer of one dosage of FluMist and other experimental

  Eligibility

Ages Eligible for Study:   12 Months to 15 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00192491

Sponsors and Collaborators
MedImmune LLC
Investigators
Study Director: Robert Walker, M.D. MedImmune LLC
  More Information

No publications provided by MedImmune LLC

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Robert Walker, M.D., MedImmune Inc.
ClinicalTrials.gov Identifier: NCT00192491     History of Changes
Other Study ID Numbers: AV018
Study First Received: September 12, 2005
Last Updated: February 7, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Chickenpox
Influenza, Human
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Orthomyxoviridae Infections
RNA Virus Infections
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 29, 2014