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

Condition(s) targeted: Influenza

Intervention: FluMist (Biological); FluMist (Biological); Placebo (Other)

Phase: Phase 3

Status: Completed

Sponsored by: MedImmune LLC

Official(s) and/or principal investigator(s):
Robert Walker, M.D., Study Director, Affiliation: MedImmune LLC

- 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 MMRIIÃ’ and VARIVAXÃ’ 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

MMRIIÃ’ and VARIVAXÃ’.

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)

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Primary outcome: compare immune responses to measles, mumps, rubella, and varicella antigens following vaccination in children who receive FluMist concurrently with MMRIIÃ’ and VARIVAXÃ’ and in children

Secondary outcome: 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

Minimum age: 12 Months. Maximum age: 15 Months. Gender(s): Both.

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.

Starting date: December 2000
Last updated: February 7, 2008