NCT00192231

CompletedPhase 3

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

MedImmune LLC Source

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

D153 P510

Study Type

interventional

Reported enrollment (type unavailable)

120

Locations

1 country

Sites

1

Timeline

Study Start

April 2001

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

Not reported

Date not reported

Study Completion

June 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 perform a variety of immunological assays on blood, serum, nasal wash samples, and cells obtained from healthy adult subjects for the purpose 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).

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): 120 participants
Study completion date: June 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
April 2001
Date type not reported
This date has not been verified as actual or estimated.
Study Completion
June 2001
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)

The safety objective was to assess the safety and tolerability of CAIV-T vaccine.

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+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Healthy adults aged 18 to 59 years or \> 60 years.
Female subjects of childbearing potential who had a negative urine pregnancy test result prior to study vaccination. Females who were surgically sterilized or post-menopausal did not require pregnancy testing.

Sponsors & Collaborators

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

Study Sites (1)

Austin & Repatriation Medical Centre

Heidelburg, Victoria, 3084, Australia

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

April 2001

Date type not reported

This date has not been verified as actual or estimated.

Study Completion

June 2001

Date type not reported

Phase 3Completed

NCT00192361

Trial of the Safety, Transmissibility, and Phenotypic and Genotypic Stability of Influenza Virus Vaccine,(CAIV-T), in Children Who Attend Day Care. (Final Report Version 2.0)

Phase 3Completed

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

NCT00192309

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

Phase 2Completed

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

NCT00128167

Trivalent, Live, Cold Adapted Influenza Vaccine (CAIV-T) Against Inactivated Influenza Vaccine (TIV) in Children 6-59 Months of Age

Phase 3Completed

NCT00192400

Trial to Assess the Safety and Tolerability of the Liquid Formulation of CAIV-T in Healthy Children.

Phase 3Completed

Adults who were determined by medical history, physical examination and clinical judgment 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, were eligible.

Subjects who provided written informed consent after the nature of the study was explained.

Subjects who were available for the duration of the study (from enrollment to study completion).

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

You may not qualify if:

Subjects who resided in a nursing home or long-term care facility or other institution receiving skilled or semi-skilled nursing care. An ambulatory subject who resided in a retirement home or village was eligible for participation.
Subjects with evidence of dementia or other severe cognitive impairment based on Mini Mental State Examination (MMSE) score of 22 or greater. Note: Administration of MMSE was performed only if clinically indicated.
For all study subjects:
Subjects who were perceived to be unavailable or difficult to contact for evaluation of study visits during the study period.
Subjects with a known or suspected disease of the immune system or those receiving immunosuppressive therapy, including systemic corticosteroids; or cytotoxic agents.
Subjects who received any blood products, including immunoglobulin, in the period from six months prior to vaccination through to the conclusion of the study.
Subjects who resided in the same household as an immunosuppressed or immunocompromised individual.
Subjects with a documented history of hypersensitivity to egg or egg protein or any other component of the study vaccine or placebo.
Subjects who were administered any live virus vaccine within one month prior to enrollment.
Subjects for whom there was intent to administer any other investigational vaccine or agent from one month prior to enrollment through the conclusion of the study.
Subjects who received a dose of influenza treatment (commercial or investigational) one month prior to enrollment. Prophylactic use of influenza antivirals was not permitted.
Subjects who received any influenza vaccine in the six months prior to enrollment, or nonstudy influenza vaccine since enrollment.
Subjects with any medical conditions that in the opinion of the investigator might interfere with the interpretation of the study results.

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: NCT00192231
Data provider: ClinicalTrials.gov
Source updated: 2021-09-13
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:18:51 UTC

Locations

AU(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