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NCT00972816 · ClinicalTrials.gov registry record · Phase 2

Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Children (3 to < 9 Years)

A Phase 2 study of Influenza, sponsored by Novartis Vaccines.

Completed
Registry status
Phase 2
Development phase
1,357
Enrollment target
20
Study locations

NCT00972816 is a Phase 2 study of Influenza that has completed, run by Novartis Vaccines. The registered enrollment target is 1,357 participants, below the 36,795-participant average among 156 other Influenza trials with a reported enrollment target (96% lower). The trial reports 20 study locations across 13 states.

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The verdict

NCT00972816, a Phase 2 study of Influenza, has completed, sponsored by Novartis Vaccines.

COMPLETED
Registry status
Phase 2
Development phase
1,357 participants
Enrollment target
20
Study locations

Study Summary

This study will evaluate the safety and immunogenicity of different combinations of A/H1N1 S-OIV (swine flu) vaccine in healthy young children.

Conditions Studied

Interventions

  • BIOLOGICAL MF59-eH1N1

Study Locations (20)

California

  • Premier Health Research Center, LLC - Downey
  • Madera Family Medical Group - Madera
  • Center for Clincal Trials, LLC - Paramount
  • Center for Clinical Trials, LLC - Paramount
  • Center for Clinical Trials of San Gabriel - West Covina

Georgia

  • Pediatrics and Adolescent Medicine - Marietta
  • Pediatrics and Adolescent Medicine - Woodstock

Kansas

  • Heartland Research Associates LLC - Arkansas City
  • Heartland Research Associates LLC - Newton

Ohio

  • Dr. Senders and Associates, Pediatrics - Cleveland
  • Prestige Clinical Research - Franklin

Colorado

  • 1st International Research Centers - Thornton

Illinois

  • Northern Illinois Research Associates - DeKalb

Indiana

  • Bluegrass Clinical Research, Inc. - New Albany

Kentucky

  • Bluegrass Clinical Research, Inc (Brownsboro for drug shipment) - Louisville

Trial Details

FieldValue
Enrollment Target 1,357 participants
Start Date 2009-09
Est. Completion 2010-10
Phase Phase 2

Sponsor

Novartis Vaccines

32 total trials

What the Registry Record Tells You About NCT00972816

The ClinicalTrials.gov registry entry for NCT00972816 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 1,357 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 36,795-participant average among 156 other Influenza trials with a reported enrollment target (96% lower). The listed sponsor is Novartis Vaccines, which has 32 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Influenza appearing as the primary indexed condition, and to 1 intervention - of which MF59-eH1N1 is the first listed.

NCT00972816 reports 20 study locations spanning 13 distinct geographic areas - top geographies include California, Georgia, Kansas.

Frequently Asked Questions

What is clinical trial NCT00972816 about?

NCT00972816 is a clinical study titled "Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Children (3 to < 9 Years)". This study will evaluate the safety and immunogenicity of different combinations of A/H1N1 S-OIV (swine flu) vaccine in healthy young children.

What is the current status of trial NCT00972816?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 1,357 participants. The study started on 2009-09. Estimated completion is 2010-10.

What conditions does trial NCT00972816 study?

This clinical trial studies the following conditions: Influenza.

What interventions are being tested in trial NCT00972816?

The interventions under investigation include: MF59-eH1N1 (BIOLOGICAL).

Who is sponsoring clinical trial NCT00972816?

This trial is sponsored by Novartis Vaccines, which has 32 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00972816 being conducted?

This trial has 20 study locations across California, Colorado, Georgia, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Influenza

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.