NCT00192491

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)

Completed Phase 3 Last updated 7 February 2008

What this trial tests

Phase 3 trial testing FluMist in Influenza in 1,200 participants. Completed in 1 December 2003.

Timeline

1 December 2000

Primary endpoint
1 September 2003

1 December 2003

Quick facts

Lead sponsor	MedImmune LLC
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	prevention
Enrollment	1,200
Start date	1 December 2000
Primary completion	1 September 2003
Estimated completion	1 December 2003

Drugs / interventions tested

• FluMist
• FluMist
• Placebo

Conditions studied

• Influenza — all drugs for Influenza →

Sponsor

MedImmune LLC — full company profile →

Who can join

Adults 12 Months to 15 Months, any sex, with Influenza. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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

Sponsor's own description

* 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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Statement on Seasonal Influenza Vaccine for 2012-2013: Appendix I: New Evidence Review for Children 24 to 59 Months of Age: An Advisory Committee Statement (ACS) National Advisory Committee on Immunization (NACI).
   · 2012 · cited 4× · PMID 31702744 · DOI 10.14745/ccdr.v38i00a02a