NCT00192426

CompletedPhase 3

Trial to Evaluate the Immune Response to OPV When Administer...

MedImmune LLC Source

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Other study identifiers

Sponsor study identifier

D153-P511

Study Type

interventional

Reported enrollment (type unavailable)

2,400

Locations

0 countries

Sites

N/A

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

Phase III trial to evaluate the immune response to oral poliovirus vaccine (OPV) when administered concomitantly with CAIV-T to healthy children.

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): 2,400 participants
Study completion date: December 2001
Date type not reported
This date has not been verified as actual or estimated.
Listed locations: 0 countries · 0 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: October 3, 2006
Status Verified: October 2006
Last Update Submitted: October 2, 2006

Conditions

Influenza

Outcome Measures

Primary Outcomes (1)

The primary immunogenicity endpoint is the proportion of subjects achieving a post-vaccination serum antibody response for each antigen component of OPV and CAIV-T.

Secondary Outcomes (1)

The secondary endpoint for immunogenicity is the geometric mean titer (GMT) of serum antibody for each antigen component of OPV or the geometric mean ratio relative to the baseline titer of CAIV-T serum antibody components.

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

Age6 Months - 36 Months

Sexall

Healthy VolunteersYes

Age GroupsChild (0-17)

You may qualify if:

who are aged at least 6 months and less than 36 months of age at the time of first vaccination
who have received a full primary vaccination schedule consisting of three doses of OPV in the first year of life

Sponsors & Collaborators

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

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: CROSSOVER
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 3Completed

NCT00192192

Trial to Investigate Immune Responses Elicited by a Liquid Formulation of Influenza Virus Vaccine, Trivalent, Types A & B, Live Cold Adapted (CAIV-T) in Healthy Adults

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

NCT00192400

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

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

NCT00192491

Trial to Assess Safety, Tolerability, and Immunogenicity of Influenza Virus Vaccine, Trivalent, Types A & B, Live Cold-Adapted (FluMist) and Measles, Mumps, Rubella, and Varicella Vaccines Administered Concurrently to Healthy Children

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

who are in good health as determined by medical history, physical examination and clinical judgement

whose parent(s)/legal guardian(s) have provided written informed consent after the nature of the study has been explained

who, along with their parent(s)/legal guardian(s), will be available for duration of the trial (3 months)

whose parent(s)/legal guardian(s), can be reached by study staff for the post-vaccination contacts \[telephone, clinic or home visit\].

You may not qualify if:

whose parent(s)/legal guardian(s) 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 (see Section 4.2.1)
who received any blood products, including immunoglobulin, in the period from six months prior to vaccination through to the conclusion of the study
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
have an immunosuppressed or an immunocompromised individual living in the same household
who, at any time prior to entry into this study, received a dose of any influenza vaccine (commercial or investigational)
with a documented history of hypersensitivity to egg or egg protein or any other component of the assigned study vaccine
who received aspirin (acetylsalicylic acid) or aspirin-containing products in the two weeks prior to vaccination or for which use is anticipated during the study
with any medical conditions that in the opinion of the Investigator might interfere with interpretation of the study results.
If any of these criteria are met following enrollment, the subject will be excluded from subsequent vaccine dosing.
Note: Pregnancy in a household member or any person who has regular contact with the subject is not a contraindication to the enrollment or ongoing participation of the subject in the study.

Contact the study team to confirm eligibility.

This date has not been verified as actual or estimated.

Last Updated

October 3, 2006

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: NCT00192426
Data provider: ClinicalTrials.gov
Source updated: 2006-10-03
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:27:21 UTC

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)

Secondary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record