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

This study has been completed.
Sponsor:
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT00192244
First received: September 12, 2005
Last updated: October 2, 2006
Last verified: October 2006
  Purpose

- 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.


Condition Intervention Phase
Healthy
Biological: CAIV-T, Liquid
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by MedImmune LLC:

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

Estimated Enrollment: 3000
Study Start Date: September 2000
Estimated Study Completion Date: October 2002
  Eligibility

Ages Eligible for Study:   6 Months to 35 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00192244

Locations
China
The Prince of Wales Hospital
Hong Kong, China
Sponsors and Collaborators
MedImmune LLC
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Robert Walker, MD MedImmune LLC
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00192244     History of Changes
Other Study ID Numbers: D153-P501
Study First Received: September 12, 2005
Last Updated: October 2, 2006
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on October 21, 2014