NCT00192387

CompletedPhase 2

Trial to Investigate Viral Shedding in Healthy Children Vacc...

MedImmune LLC Source

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

D153-P005

Study Type

interventional

Reported enrollment (type unavailable)

60

Locations

1 country

Sites

1

Timeline

Study Start

September 2001

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

Not reported

Date not reported

Study Completion

December 2001

Date type not reported

This date has not been verified as actual or estimated.

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Reported enrollment (type unavailable): 60 participants
Study completion date: December 2001
Date type not reported
This date has not been verified as actual or estimated.
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
September 2001
Date type not reported
This date has not been verified as actual or estimated.
Study Completion
December 2001
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
September 13, 2005
Actual (reported)
First Posted
September 19, 2005
Actual (reported)

Last Updated: September 13, 2021
Status Verified: December 2006
Last Update Submitted: September 10, 2021

Conditions

Influenza

Outcome Measures

Primary Outcomes (1)

Measurement of influenza-specific immune response following receipt of CAIV-T.

Interventions

CAIV-T, LiquidBiological

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age6 Months - 18 Months

Sexall

Healthy VolunteersYes

Age GroupsChild (0-17)

You may qualify if:

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;

Sponsors & Collaborators

Wyeth is now a wholly owned subsidiary of Pfizer
Industrycollaborator
MedImmune LLC
Industrylead

Study Sites (1)

Monroe Clinic

Monroe, Wisconsin, 53566, United States

MeSH Terms

Conditions

Influenza, Human

Interventions

Fluid Therapy

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeutics

Study Officials

Robert Walker, MD
MedImmune LLC
STUDY DIRECTOR

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: DOUBLE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 19, 2005

Study Start

September 2001

Date type not reported

This date has not been verified as actual or estimated.

Study Completion

December 2001

Date type not reported

Phase 2

Completed

NCT00192166

Trial to Assess Safety, Efficacy, Tolerability and Immunogenicity of Influenza Virus Vaccine, Liquid Formulation (CAIV-T), Administered Concomitantly With a Combination Live, Attenuated, Mumps, Measles, and Rubella Vaccine in Healthy Children Aged 11 - 24 Months

Phase 2Completed

NCT00192179

A Phase II, Trial to Assess the Safety and Tolerability of Influenza Virus Vaccine, CAIV-T in Healthy Children and Adolescents Ages 6 to Less Than 18 Years.

Phase 2Completed

NCT00006146

Half-Dose Flu Vaccine Study in Healthy Adults

Phase 2Completed

NCT00766285

High Dose Influenza in Immunosuppressed Subjects

Phase 2Withdrawn

NCT00307177

Trivalent Baculovirus-expressed Influenza HA Vaccine in Adults With Non-Hodgkin's B-cell Lymphoma

Phase 2Completed

NCT00170443

Trivalent rHA Dose Escalation Study in Elderly Subjects

Phase 2Completed

who, along with their parent or legal guardian, will be available for the two month duration of the trial (from enrollment to study completion).

You may not qualify if:

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.

Contact the study team to confirm eligibility.

This date has not been verified as actual or estimated.

Last Updated

September 13, 2021

Record last verified: 2006-12

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00192387
Data provider: ClinicalTrials.gov
Source updated: 2021-09-13
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:30:27 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations