Trial to Compare the Safety, Tolerability, Immunogenicity and Efficacy of Three Dose Levels of a Liquid Formulation of Influenza Virus Vaccine, (CAIV-T) in Healthy Children

A Prospective, Randomized, Double-Blind, Placebo-Controlled, Phase III, Multicenter Trial to Compare the Safety, Tolerability, Immunogenicity and Efficacy of Three Dose Levels of a Liquid Formulation of Influenza Virus Vaccine, Trivalent, Types A & B,Live, Cold-Adapted (CAIV-T) in Healthy Children

- Trial to Compare the Safety, Tolerability, Immunogenicity and Efficacy of Three Dose Levels of a Liquid Formulation of(CAIV-T) in Healthy Children.

Study Overview

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

Detailed Description

- A Prospective, Randomized, Double-Blind, Placebo-Controlled, Phase III, Multicenter Trial to Compare the Safety, Tolerability, Immunogenicity and Efficacy of Three Dose Levels of a Liquid Formulation of Influenza Virus Vaccine, Trivalent, Types A & B, Live Cold-Adapted (CAIV-T) in Healthy Children

• Study Type: Interventional
• Enrollment: 1920
• Phase: Phase 3

Contacts and Locations

Study Locations

• Philippines
  • Muntinlupa City, Philippines
    • Department of Microbiology, Research Institute for Tropical Medicine
• Thailand
  • Bangkok, Thailand, 10400
    • Queen Sirikit National Institute of Child Health (Children's 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 aged at least 6 months and less than 36 months of age at the time of first vaccination

  • who are in good health as determined by medical history, physical examination and clinical judgement
  • whose parent(s)/legal guardian(s) have provided written informed consent after the nature of the study has been explained
  • who, along with their parent(s)/legal guardian(s), will be available for duration of the trial (8 months ±1 month)
  • whose parent(s)/legal guardian(s), can be reached by study staff for the post-vaccination contacts [telephone, clinic or home visit].

Exclusion Criteria:

• whose parent(s)/legal guardian(s) are perceived to be unavailable 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 (see Section 4.2.1)
  • 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
  • have an immunosuppressed or an immunocompromised 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)
  • with a documented history of hypersensitivity to egg or egg protein or any other component of the assigned study vaccine
  • who received aspirin (acetylsalicylic acid) or aspirin-containing products in the two weeks prior to vaccination 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. If any of these criteria are met following enrolment, the subject will be excluded from subsequent vaccine dosing.

Note: Pregnancy in a household member or any person who has regular contact with the subject is not a contraindication to the enrollment or ongoing participation of the subject in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The primary efficacy endpoint was the first episode in a study child of a culture-confirmed influenza illness, caused by community-acquired subtypes antigenically similar to those contained in the vaccine.

Secondary Outcome Measures

Outcome Measure
A secondary efficacy endpoint was the first episode of culture-confirmed influenza illness caused by any community-acquired antigenic subtype.

Collaborators and Investigators

• Sponsor: MedImmune LLC
• Collaborators: Wyeth is now a wholly owned subsidiary of Pfizer
• Investigators: Principal Investigator: Tawee Chotpitayasunondh, Dr., Queen Sirikit National Institute of Child Health (Children's Hospital); Principal Investigator: Rosario Z. Capeding, Dr., Department of Microbiology, Research Institute for Tropical Medicine

Study record dates

Study Major Dates

• Study Start: February 1, 2002
• Study Completion: November 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-P513