NCT00192348

CompletedPhase 1

A Prospective, Randomized, Double-Blind, Placebo-Controlled ...

MedImmune LLC Source

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Other study identifiers

Sponsor study identifier

D153-P518

Study Type

interventional

Reported enrollment (type unavailable)

120

Locations

1 country

Sites

1

Timeline

Study Start

May 2002

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

Not reported

Date not reported

Study Completion

December 2002

Date type not reported

This date has not been verified as actual or estimated.

Brief Summary

Trial to compare the safety and tolerability of one and two doses of influenza virus vaccine.

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: December 2002
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
May 2002
Date type not reported
This date has not been verified as actual or estimated.
Study Completion
December 2002
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

Healthy

Outcome Measures

Primary Outcomes (1)

- To compare the safety and tolerability of one and two doses of influenza virus vaccine, trivalent,(CAIV-T) with placebo when administered intranasally

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 Weeks - 24 Weeks

Sexall

Healthy VolunteersYes

Age GroupsChild (0-17)

You may qualify if:

children at least 6 weeks of age and less than 24 weeks of age at the time of enrollment, of \>37 weeks gestational age and with a birth weight of \>2500 g, and in good health as determined by medical history, physical examination and clinical judgment;
whose parent/legal guardian provided written informed consent after the nature of the study was explained;

Sponsors & Collaborators

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

Study Sites (1)

University of Tampere

Tampere, 33014, Finland

Related Publications (1)

Vesikari T, Karvonen A, Smith HM, Dunning A, Razmpour A, Saville MK, Gruber WC, Forrest BD. Safety and tolerability of cold-adapted influenza vaccine, trivalent, in infants younger than 6 months of age. Pediatrics. 2008 Mar;121(3):e568-73. doi: 10.1542/peds.2007-1405. Epub 2008 Feb 25.
PMID: 18299305DERIVED

MeSH Terms

Interventions

FluMist

Study Officials

Robert Walker, MD
MedImmune LLC
STUDY DIRECTOR

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: DOUBLE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 19, 2005

Study Start

May 2002

Date type not reported

This date has not been verified as actual or estimated.

Study Completion

December 2002

Date type not reported

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who, along with their parent or legal guardian, were available for the three month duration of the trial (from enrollment to study completion);

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

You may not qualify if:

whose parents or legal guardians were 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; or cytotoxic agents;
who received any blood products, including immunoglobulin, in the period from birth through to the conclusion of the study;
had 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 vaccines or placebo;
who were administered any live virus vaccine within one month prior to enrollment; or expected to receive another live vaccine within 1 month of vaccination in the study.
for whom there was 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) two weeks prior to enrollment. The prophylactic use of influenza antivirals was not permitted;
who, at anytime prior to study enrollment, received any influenza vaccine (commercial or investigational);
with a respiratory illness with wheezing within two weeks prior to each dose of study vaccine;
who received aspirin (acetylsalicylic acid) or aspirin-containing products in the two weeks prior to enrollment or for which use was anticipated during the study;
with any medical conditions that in the opinion of the investigator might have interfered with interpretation of the study results.
Note: Pregnancy in any person who had regular contact with the subjects was 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: NCT00192348
Data provider: ClinicalTrials.gov
Source updated: 2021-09-13
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:28:26 UTC

Locations

FI(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)

Related Publications (1)

MeSH Terms

Interventions

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations