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NCT00138294 · ClinicalTrials.gov registry record · Phase 4

Control of Epidemic Influenza Through a School-based Influenza Vaccination Program

A Phase 4 study, sponsored by Baylor College of Medicine.

Completed
Registry status
Phase 4
Development phase
29,255
Enrollment target

NCT00138294: Completed Phase 4 study, sponsored by Baylor College of Medicine.

NCT00138294 is a Phase 4 study that has completed, run by Baylor College of Medicine. The registered enrollment target is 29,255 participants, above the 515-participant average among 9,235 other Phase 4 trials with a reported enrollment target (5581% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00138294, a Phase 4 study, has completed, sponsored by Baylor College of Medicine.

COMPLETED
Registry status
Phase 4
Development phase
29,255 participants
Enrollment target

Study Summary

The main purpose of this study is to learn if influenza vaccines (live attenuated and inactivated influenza vaccines), when given to school-aged children 4 to 18 years of age, can stop or lessen the influenza (flu) outbreak in the community. Another purpose is to show that vaccination of these children will significantly reduce breathing problems (in the vaccinated children and unvaccinated people they come in contact with in the community) that require a visit to the doctor for treatment. Another purpose is to continue to collect safety and flu protection information on live attenuated influenza vaccine (LAIV or FluMist) given to children. The study investigators believe that vaccination of healthy school-aged children is an effective plan for preventing many people in the community from catching the flu. Children will take part in the study for 5 to 10 months.

Primary Outcome

The rate of MAARI (MAARIs/1000 persons-week) were compared between the intervention and comparison cities during the epidemic period (irrespective of the vaccination status). This data was obtained from the SWHP database.

Interventions

  • BIOLOGICAL live attenuated and inactivated influenza vaccines

Trial Details

FieldValue
Enrollment Target 29,255 participants
Start Date 1998-10
Est. Completion 2010-06
Phase Phase 4
Baylor College of Medicine

616 total trials

What the finished NCT00138294 record still lists

NCT00138294 is an interventional study that assigns participants to a tested intervention. Its 29,255 participants enrollment target places it among the larger protocols in the corpus, above the 515-participant average among 9,235 other Phase 4 trials with a reported enrollment target (5581% higher).

The record links to 0 conditions, and to 1 intervention - of which live attenuated and inactivated influenza vaccines is the first listed.

NCT00138294 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00138294 about?

NCT00138294 is a clinical study titled "Control of Epidemic Influenza Through a School-based Influenza Vaccination Program". The main purpose of this study is to learn if influenza vaccines (live attenuated and inactivated influenza vaccines), when given to school-aged children 4 to 18 years of age, can stop or lessen the influenza (flu) outbreak in the community. Another purpose is to show that vaccination of these child...

What is the current status of trial NCT00138294?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 29,255 participants. The study started on 1998-10. Estimated completion is 2010-06.

What interventions are being tested in trial NCT00138294?

The interventions under investigation include: live attenuated and inactivated influenza vaccines (BIOLOGICAL).

Who is sponsoring clinical trial NCT00138294?

This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00138294's enrollment target sits among peer trials

29,255 5th of 2000 higher than 1,996 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00138294, the US trial registry maintained by the National Library of Medicine. NCT00138294 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.