CClinicalTrials.gg
CompletedNCT00192491Updated Feb 8, 2008

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

A Phase 3 interventional study of FluMist and FluMist in Influenza, sponsored by MedImmune LLC. Completed. Open to participants aged 12 Months to 15 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-02-08.

Sponsored by MedImmune LLC · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
1,200
Allocation
Randomized
Ages
12 Months to 15 Months
Sex
All
01

Study 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 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.
02

Conditions studied

  • Influenza
03

In context

Influenza, Human

2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.

This study's planned enrollment of 1,200 is above the median of 238 across 1,853 interventional studies indexed under Influenza, Human.

Browse Influenza, Human studies →

Lead sponsor

MedImmune LLC is the lead sponsor of 265 studies on the registry; none are open to participants now.

Of its 50 completed or terminated interventional studies of FDA-regulated products, 28 (56%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Months to 15 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
1,200 participants (estimated)

Study arms

  • Active comparator
    2

    FluMist

    Biological: FluMist

  • Placebo comparator
    3

    Placebo

    Other: Placebo

  • Active comparator
    1

    FluMist with other solution

    Biological: FluMist

Interventions

  • BiologicalFluMist

    Nasal Sprayer of one dosage of FluMist and other experimental

  • BiologicalFluMist

    Nasal sprayer of FluMist

  • OtherPlacebo

    Nasal Sprayer of Placebo

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Nolan T, Bernstein DI, Block SL, Hilty M, Keyserling HL, Marchant C, Marshall H, Richmond P, Yogev R, Cordova J, Cho I, Mendelman PM; LAIV Study Group. Safety and immunogenicity of concurrent administration of live attenuated influenza vaccine with measles-mumps-rubella and varicella vaccines to infants 12 to 15 months of age. Pediatrics. 2008 Mar;121(3):508-16. doi: 10.1542/peds.2007-1064. PubMed 18310199 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 8, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00192491
Lead sponsor
MedImmune LLC
First posted
Sep 19, 2005
Start date
Dec 2000
Primary completion
Sep 2003 (estimated)
Completion
Dec 2003
Last update
Feb 8, 2008

Study contacts

Robert Walker, M.D.
study director · MedImmune LLC

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2008. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion