Status:
COMPLETED
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
Lead Sponsor:
MedImmune LLC
Conditions:
Influenza
Eligibility:
All Genders
12-15 years
Phase:
PHASE3
Brief Summary
* 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2003
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT00192491
Start Date
December 1 2000
End Date
December 1 2003
Last Update
February 8 2008
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