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

This study has been completed.
Sponsor:
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT00192283
First received: September 12, 2005
Last updated: April 8, 2009
Last verified: April 2009
  Purpose

The purpose of this study is to determine the efficacy of the liquid formulation of CAIVT against culture confirmed influenza illness in healthy children aged at least 6 months and less than 36 months, attending day care centers in Europe. In addition, the trial provides the opportunity to investigate the effect of CAIV-T on acute otitis media, on healthcare resource utilization and economic resources.


Condition Intervention Phase
Influenza
Biological: CAIV-T
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
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 Attending Day Care Centers

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 in a study child of a cultureconfirmed influenza illness. [ Time Frame: 28 days after vaccination ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The secondary endpoint for culture-confirmed influenza illness is the first episode caused by any community-acquired antigenic subtype which occurs following receipt of the second dose of study vaccine or placebo. [ Time Frame: 28 days after vaccination ] [ Designated as safety issue: Yes ]

Enrollment: 2903
Study Start Date: September 2000
Study Completion Date: May 2002
Primary Completion Date: April 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
CAIV-T
Biological: CAIV-T
The total single-dose volume of 0.2 mL was administered intranasally with the spray applicator intended for commercial use (approximately 0.1 mL into each nostril).
Placebo Comparator: 2
Placebo
Other: Placebo
A single dose of placebo volume of 0.2 mL was administered intranasally with the spray applicator intended for commercial use (approximately 0.1 mL into each nostril).

  Eligibility

Ages Eligible for Study:   6 Months to 36 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • who are aged at least 6 months and less than 36 months of age at the time of enrollment, attending day care for at least three days a week, four hours a day;
  • 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; 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);
  • who, in the two weeks prior to entry into this study, received a dose of any influenza treatment (commercial or investigational);
  • with a documented history of hypersensitivity to egg or egg protein or any other component of the study vaccine or placebo;
  • with a clinically confirmed 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;
  • who were administered any live virus vaccine within one month prior to enrollment or expected to receive another live virus vaccine within one month of vaccination in this 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: A pregnant household member is not considered a contraindication to enrollment.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00192283

Locations
Finland
Tampere University Medical School
Tampere, Finland, 33520
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

Responsible Party: Robert Walker, M.D., MedImmune Inc.
ClinicalTrials.gov Identifier: NCT00192283     History of Changes
Other Study ID Numbers: D153 P502
Study First Received: September 12, 2005
Last Updated: April 8, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 16, 2014