Completed

A Prospective, Double-Blind, Randomized Trial to Demonstrate Equivalent Immunogenicity of CAIV-T and FLUMIST in Healthy Participants Ages 5 Through 49 Years

What is being tested

CAIV-T

+ CAIVT

+ FluMist

Biological

Who is being recruted

From 5 to 49 Years

+23 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 3

Interventional

Study Start: July 2004

See protocol details

Summary

Principal SponsorMedImmune LLC

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2004

Actual date on which the first participant was enrolled.

* Primary objective is to demonstrate equivalent immunogeniticity of CAIV-T and FluMist * Secondary objective of this study is to assess the safety and tolerability of CAIV-T compared to FluMist

Official TitleA Prospective, Double-Blind, Randomized Trial to Demonstrate Equivalent Immunogenicity of CAIV-T and FLUMIST in Healthy Participants Ages 5 Through 49 Years

NCT00192335

Principal SponsorMedImmune LLC

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

890 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 5 to 49 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

5 inclusion criteria required to participate

Age 5 through 49 years (not yet reached their 50th birthday);

In general good health;

Individual or parent/guardian available by telephone;

Ability of the participant or parent/guardian to understand and comply with the requirements of the protocol; and

Show More Criteria

18 exclusion criteria prevent from participating

History of hypersensitivity to any component of FluMist or CAIV-T, including egg or egg products;

History of hypersensitivity to gentamicin;

Any known immunosuppressive condition or immune deficiency disease (including HIV infection), or ongoing receipt of any immunosuppressive therapy;

Household contact who is immunocompromised (participants should also avoid close contact with other immunocompromised individuals for at least 21 days);

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Active Comparator

CAIVT-The total volume of 0.2 mL will be administered intranasally with a spray applicator (approximately 0.1 mL into each nostril).

Group II

Active Comparator

FluMist- The total volume of 0.5 mL will be administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

Suspended

Heart of America Research Institute

Shawnee Mission, United StatesOpen Heart of America Research Institute in Google Maps

Suspended

Kentucky Pediatric/Adult Research, Inc.

Bardstown, United States

Suspended

R/D Clinical Research, Inc.

Lake Jackson, United States

Completed3 Study Centers