Trial to Investigate Viral Shedding in Healthy Children Vaccinated With Vaccine Virus Liquid (CAIV-T)

This study has been completed.
Sponsor:
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT00192387
First received: September 13, 2005
Last updated: December 27, 2006
Last verified: December 2006
  Purpose

The primary objective of this study was to determine the proportion of subjects, seronegative to all three strains of influenza, as defined by a serum hemagglutination inhibition antibodies (HAI) antibody titer of <1:10, who shed each vaccine virus strain following a single dose of CAIV-T.


Condition Intervention Phase
Influenza
Biological: CAIV-T, Liquid
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blinded, Placebo-Controlled Trial to Investigate Viral Shedding in Healthy Children (6 Mos and Less Than or Equal to 18 Months of Age) Vaccinated With Two Doses of Liquid Formulation of Influenza Virus Vaccine, Live Cold Adapted (CAIV-T)

Resource links provided by NLM:


Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • Measurement of influenza-specific immune response following receipt of CAIV-T.

Estimated Enrollment: 60
Study Start Date: September 2001
Estimated Study Completion Date: December 2001
  Eligibility

Ages Eligible for Study:   6 Months to 18 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • children at least 6 months of age and less than or equal to 18 months of age at the time of enrollment, and in good health as determined by medical history, physical examination, and clinical judgment;
  • whose parent/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 two month duration of the trial (from enrollment to study completion).

Exclusion Criteria:

  • whose parents or legal guardians 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; intranasal steroids or cytotoxic agents;
  • have an immunosuppressed or an immunocompromised individual living in the same household;
  • with a documented history of hypersensitivity to egg or egg protein or any other component of the study vaccine or placebo;
  • who, at anytime prior to study enrollment, receives any influenza vaccine (commercial or investigational);
  • with any medical conditions that in the opinion of the investigator might interfere with interpretation of the study results.

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: NCT00192387

Locations
United States, Wisconsin
Monroe Clinic
Monroe, Wisconsin, United States, 53566
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: NCT00192387     History of Changes
Other Study ID Numbers: D153-P005
Study First Received: September 13, 2005
Last Updated: December 27, 2006
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 17, 2014