Study of a Flu Vaccine in Children | NCT00001127

Studies
Study of a Flu Vaccine in Children

NCT00001127

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Status

Completed

Last Update Posted

Aug 27, 2010Estimated

Enrollment

15,000

Phase

Phase 3

Conditions

Influenza

Interventions

Influenza virus vaccine (CAIV-T)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
AV012

Status Module

Record Verification Date

Nov 2005

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Nov 2005

First Submitted Date

Jan 17, 2000

First Submission Date that Met QC Criteria

Aug 30, 2001

First Posted Date

Aug 31, 2001Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 26, 2010

Last Update Posted Date

Aug 27, 2010Estimated

Name	Class
Aviron LLC	INDUSTRY

Description Module

Brief Summary

This study tests the safety and effectiveness of a flu vaccine in school children.

School children are usually the first members of a community to come down with the flu, and they often give the flu to their younger siblings, parents, and grandparents. It is hoped that giving school children a flu vaccine can help prevent the spread of the flu to other members of the community.

Detailed Description

This is a Phase III trial (an advanced study with a large number of patients). Your child will receive a single dose of flu vaccine, which is given by a nasal spray.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

15,000

Name	Type	Description	Arm Group Labels	Other Names
Influenza virus vaccine (CAIV-T)	Biological

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Your child may be eligible for this study if he/she:

Is between the ages of 18 months and 18 years, with consent of parent or guardian.
Is a resident of the Temple-Belton, Texas area.

Exclusion Criteria:

Your child will not be eligible for this study if he/she:

Has had a fever within 3 days before vaccination.
Has symptoms of a weakened immune system.
Has had a wheezing episode within the past 2 weeks.
Has moderate to severe asthma.
Is allergic to eggs.
Needs to take aspirin on a regular basis.
Has received another vaccine or study drug in the past month.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Months

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pedro A. Piedra, M.D.		Houston	Texas	77030	United States

Condition Browse Module

MeSH Terms

ID	Term
D007251	Influenza, Human

Ancestor Terms

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D009976	Orthomyxoviridae Infections
D012327	RNA Virus Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007252	Influenza Vaccines

Ancestor Terms

ID	Term
D014765	Viral Vaccines
D014612	Vaccines
D001688	Biological Products
D045424	Complex Mixtures

Browse Leaves

Not provided

Browse Branches

Not provided