Trial to Determine the Safety and Efficacy of Influenza Virus Vaccine, Trivalent, Types A & B, Live, Cold-Adapted (CAIV-T) in Healthy Children

A Prospective, Randomized, Double-Blind, Placebo-Controlled, Trial to Determine the Safety and Efficacy of Influenza Virus Vaccine, Trivalent, Types A & B, Live Cold-Adapted (CAIV-T) in Healthy Children

- The purpose of this study is to determine the efficacy of CAIV-T in a diverse Asian population aged from 6 months to less than 36 months, in tropical and temperate climates, against culture-confirmed influenza illness. In addition, the trial provides the opportunity to investigate the efficacy of CAIV-T over multiple influenza seasons, and to investigate the effect of CAIV-T on acute otitis media.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Biological: CAIV-T, Liquid

• Study Type: Interventional
• Enrollment: 3000
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Hong Kong, China
    • The Prince of Wales Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 2 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• who are greater than or equal to 6 months and less than 36 months of age at the time of enrollment, and in good health as determined by medical history, physical examination, and clinical judgment;
• whose parent or legal guardian has provided written informed consent after the nature of the study has been explained;
• who, along with their parent or legal guardian, will be available for the duration of the study (24 months);
• whose parent/legal guardian can be reached by study staff for the post-immunization contacts [via telephone, clinic or home visits].

Exclusion Criteria:

• whose parents or caregiver are perceived to be unreliable or difficult to contact for evaluation or study visits during the study period;
• with any serious chronic disease (e.g., with signs of cardiac or renal failure or severe malnutrition), including progressive neurological disease;
• with Down's syndrome or other known cytogenetic disorders;
• with a known or suspected disease of the immune system or those receiving immunosuppressive therapy, including systemic corticosteroids;
• who received any blood products, including immunoglobulin, in the period from six months prior to vaccination through to the conclusion of the study;
• for whom there is intent to administer any other investigational vaccine or agent from one month prior to enrollment through to the conclusion of the study;
• with an immunosuppressed or compromised individual living in the same household;
• who, at any time prior to entry into this study, received a dose of any influenza vaccine (commercial or investigational);
• who were administered any live virus vaccine within one month prior to study vaccination or expected receipt of another live virus within one month of vaccination in this study;
• with a documented history of hypersensitivity to egg or egg protein, or any other component of the study vaccines or placebo;
• with a respiratory illness with wheezing within two weeks prior to enrollment;
• who received aspirin (acetylsalicylic acid) or aspirin-containing products in the two weeks prior to enrollment or for which use is anticipated during the study;
• with any medical conditions that in the opinion of the Investigator might interfere with interpretation of the study results; Note: A pregnant household member or day care provider is not considered a contraindication to enrollment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The primary endpoint for efficacy is the first episode during the first year in a study child of a culture-confirmed influenza-illness, caused by community-acquired subtypes.

Secondary Outcome Measures

Outcome Measure
The secondary endpoint for efficacy is the first episode during the second year in a study child of a culture-confirmed influenza-illness.

Collaborators and Investigators

• Sponsor: MedImmune LLC
• Collaborators: Wyeth is now a wholly owned subsidiary of Pfizer

Study record dates

Study Major Dates

• Study Start: September 1, 2000
• Study Completion: October 1, 2002

Study Registration Dates

• First Submitted: September 12, 2005
• First Submitted That Met QC Criteria: September 12, 2005
• First Posted (ESTIMATE): September 19, 2005

Study Record Updates

• Last Update Posted (ESTIMATE): October 3, 2006
• Last Update Submitted That Met QC Criteria: October 2, 2006
• Last Verified: October 1, 2006

More Information

Terms related to this study

• Other Study ID Numbers: D153-P501