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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00192387
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : December 28, 2006
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
MedImmune LLC

Brief Summary:
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 or disease Intervention/treatment Phase
Influenza Biological: CAIV-T, Liquid Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
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)
Study Start Date : September 2001
Study Completion Date : December 2001

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   6 Months to 18 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00192387

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United States, Wisconsin
Monroe Clinic
Monroe, Wisconsin, United States, 53566
Sponsors and Collaborators
MedImmune LLC
Wyeth is now a wholly owned subsidiary of Pfizer
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Study Director: Robert Walker, MD MedImmune LLC
Layout table for additonal information Identifier: NCT00192387    
Other Study ID Numbers: D153-P005
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: December 28, 2006
Last Verified: December 2006
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases