NCT00192153

CompletedPhase 2

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 P003

Study Type

interventional

Reported enrollment (type unavailable)

240

Locations

1 country

Sites

2

Timeline

Study Start

July 2001

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

Not reported

Date not reported

Study Completion

October 2001

Date type not reported

This date has not been verified as actual or estimated.

Brief Summary

The purpose of this clinical study was to evaluate immune responses measuring antibodies in serum and secretions and cellular immune responses generated by CAIV-T vaccine in healthy adults aged 18 years and older as a means to develop assays for application in investigating potential immunological correlates of protection and/or establishing assays to measure vaccine take.

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): 240 participants
Study completion date: October 2001
Date type not reported
This date has not been verified as actual or estimated.
Listed locations: 1 countries · 2 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
July 2001
Date type not reported
This date has not been verified as actual or estimated.
Study Completion
October 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)

To perform a variety of immunological assays using blood, serum, nasal washed an cells for application in the further investigation of immune responses generated by influenza virus vaccine, trivalent, types A and B, live, cold-adapted.

Interventions

CAIV-T or TIVBiological

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

Eligibility Criteria

Age18 Years - 60 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

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 sterile 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 (2)

West Coast Medical Associates

New Port Richey, Florida, 34652, United States

University of VA Health Sciences Center

Charlottesville, Virginia, 22908, United States

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

Robert Walker, MD
MedImmune LLC
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: phase 2
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

July 2001

Date type not reported

This date has not been verified as actual or estimated.

Study Completion

October 2001

Date type not reported

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

NCT00170443

Trivalent rHA Dose Escalation Study in Elderly Subjects

Phase 2Completed

NCT00307177

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

Phase 2Completed

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, will be 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:

For subjects \> 60 years of age only:
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) scores. Note: Prior to study vaccination, all subjects \>60 years of age must have completed a MMSE.
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 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, placebo or TIV.
Subjects who had a current wheezing episode that was considered a change from the subject's usual clinical state.

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: NCT00192153
Data provider: ClinicalTrials.gov
Source updated: 2021-09-13
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:26:22 UTC

Locations

US(2)

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 (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations