NCT00192192

CompletedPhase 3

Trial to Investigate Immune Responses Elicited by a Liquid F...

MedImmune LLC Source

MedImmune LLC

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

D153 P001

Study Type

interventional

Reported enrollment (type unavailable)

20

Locations

1 country

Sites

1

Timeline

Study Start

November 2000

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

Not reported

Date not reported

Study Completion

December 2000

Date type not reported

This date has not been verified as actual or estimated.

Brief Summary

To perform a variety of assays on blood, serum, nasal wash samples and cells obtained from healthy adult subjects for the purposes of developing assays for application in the further investigation of immune responses generated by influenza virus vaccine, trivalent, types A and B, live, cold-adapted (liquid CAIV-T; Wyeth Lederle Vaccines, Marietta, PA).

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): 20 participants
Study completion date: December 2000
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
November 2000
Date type not reported
This date has not been verified as actual or estimated.
Study Completion
December 2000
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
September 12, 2005
Actual (reported)
First Posted
September 19, 2005
Actual (reported)

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

Conditions

Influenza

Outcome Measures

Primary Outcomes (1)

Assays on blood, serum, nasal wash samples and cells obtained from healthy adult subjects

Interventions

CAIV-TBiological

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

Eligibility Criteria

Age18 Years - 64 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

who are between 18 to 64 years of age. Subject must be at least 18 years of age and no older than 64 years of age at the time informed consent is obtained;
eligible female subjects, who are of childbearing potential, who have a negative urine pregnancy test results prior to study vaccination. Females who are surgically sterile or post-menopausal do not require pregnancy testing.

Sponsors & Collaborators

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

Study Sites (1)

Stamford Hospital

Stamford, Connecticut, 06904, United States

MeSH Terms

Conditions

Influenza, Human

Interventions

FluMist

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

Robert Walker, MD
MedImmune LLC
STUDY DIRECTOR

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: DOUBLE
Purpose: PREVENTION
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 19, 2005

Study Start

November 2000

Date type not reported

This date has not been verified as actual or estimated.

Study Completion

December 2000

Date type not reported

Phase 3Completed

NCT00192426

Trial to Evaluate the Immune Response to OPV When Administered Concomitantly With CAIV-T to Healthy Children.

Phase 3Completed

NCT00192309

Phase II Study to Investigate the Kinetics of the Immune Response Generated by Influenza Virus Vaccine.

Phase 2Completed

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

NCT00240877

Study to Evaluate the Safety of a Monovalent Vaccine of a New 6:2 Reassortant in Healthy Adults (AV024)

Phase 3Completed

NCT00192413

Trial to Compare the Safety, Tolerability, and Efficacy of Influenza Virus Vaccine, (CAIV-T) With Inactivated, Influenza Vaccine, Trivalent, Types A & B, in Adults Aged 60 Years and Older Against Culture-confirmed Influenza

Phase 3Completed

NCT00192127

Study to Evaluate the Safety of a Bivalent Vaccine of New 6:2 Influenza Virus Reassortants in Healthy Adults

Phase 3Completed

who are determined by medical history, physical examination and clinical judgement to be eligible for this study. Subjects with stable pre-existing disease, defined as disease not requiring change in therapy or hospitalization within 12 weeks before receipt of study vaccination will be eligible.

who have provided written informed consent after the nature of the study has been explained;

who, will be available for two month duration of the trial (from enrollment to study completion);

who can be reached by study staff for the post-vaccination contact \[telephone, clinic or home visit\]

You may not qualify if:

who are perceived to be unavailable or difficult to contact for evaluation or study visits during the study period
with a known or suspected disease of the immune system or those receiving immunosuppressive therapy, including systemic corticosteroids; or cytotoxic agents;
who received any blood products, including immunoglobulin, in the period from six months prior to vaccination through to the conclusion of the study;
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 were administered any live virus vaccine within one month prior to enrollment;
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;
who, received a dose of influenza treatment (commercial or investigational) one month prior to enrollment. The prophylactic use of influenza antivirals is not permitted.
who receive any influenza vaccine in the 6 months prior to enrollment, or a non-study influenza vaccine since enrollment;
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: 2006-10

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: NCT00192192
Data provider: ClinicalTrials.gov
Source updated: 2021-09-13
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:35:38 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)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations