Expired Study
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Monroe, Wisconsin 53566


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.


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.


Study is Available At:


Original ID:

D153-P005


NCT ID:

NCT00192387


Secondary ID:


Study Acronym:


Brief Title:

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


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


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

6 Months


Maximum Age:

18 Months


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

MedImmune LLC


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Intervention Model: Sing


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

60


Enrollment Type:


Overall Contact Information

Official Name:Robert Walker, MD
Study Director
MedImmune LLC

Study Dates

Start Date:September 2001
Completion Date:December 2001
Verification Date:December 2006
Last Changed Date:December 27, 2006
First Received Date:September 13, 2005

Study Outcomes

Outcome Type:Primary Outcome
Measure:Measurement of influenza-specific immune response following receipt of CAIV-T.
Safety Issues:False

Study Interventions

Intervention Type:Biological
Name:CAIV-T, Liquid

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:MedImmune LLC
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Wyeth

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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