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NCT01240746 · ClinicalTrials.gov registry record · Phase 3

Study of Quadrivalent Influenza Vaccine Among Children

A Phase 3 study of Influenza, sponsored by Sanofi Pasteur, a Sanofi Company.

Completed
Registry status
Phase 3
Development phase
4,363
Enrollment target
20
Study locations

NCT01240746 is a Phase 3 study of Influenza that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 4,363 participants, below the 36,776-participant average among 156 other Influenza trials with a reported enrollment target (88% lower). The trial reports 20 study locations across 7 states.

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The verdict

NCT01240746, a Phase 3 study of Influenza, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.

COMPLETED
Registry status
Phase 3
Development phase
4,363 participants
Enrollment target
20
Study locations

Study Summary

The aim of the study is to evaluate a prototype quadrivalent influenza vaccine (QIV), the licensed 2010-2011 trivalent influenza vaccine (TIV) containing the primary B strain (B1), and the investigational TIV containing the alternate B (B2) strain in children. Primary Objective: To demonstrate non-inferiority of antibody responses to QIV compared with licensed 2010-2011 TIV (containing the primary B strain) and investigational TIV (containing the alternate B strain) as assessed by geometric mean titer (GMT) ratios for each of the four virus strains separately among children aged 6 months to less than 9 years of age Secondary Objective: To demonstrate superiority of antibody responses to each B strain in QIV compared with antibody titers following vaccination with the TIV that does not contain the corresponding B strain, as assessed by GMT ratios and seroconversion rates. Observational Objective: To describe the safety profile of QIV among subjects 6 months to less than 9 years of age, as assessed by solicited injection site and systemic adverse events (AEs) collected for 7 days post-vaccination, unsolicited adverse events collected from 21 days post-vaccination, and adverse events of special interest and serious adverse events (SAEs) collected from Visit 1 to Visit 2.

Conditions Studied

Influenza

Interventions

  • BIOLOGICAL Licensed 2010-2011 Trivalent Influenza Vaccine, No Preservative
  • BIOLOGICAL Investigational Trivalent Influenza Vaccine with alternate B strain, No Preservative
  • BIOLOGICAL Quadrivalent Influenza Vaccine, No Preservative

Study Locations (20)

Florida

  • - Boca Raton
  • - Jacksonville
  • - Melbourne
  • - Miami Beach
  • - Ponte Vedra
  • - Sarasota
  • - Sarasota

Arizona

  • - Chandler
  • - Chandler
  • - Mesa
  • - Mesa
  • - Scottsdale

California

  • - Los Angeles
  • - San Diego
  • - San Diego

Colorado

  • - Colorado Spring
  • - Denver

Alabama

  • - Dothan

Arkansas

  • - Little Rock

Connecticut

  • - Ridgefield

Trial Details

FieldValue
Enrollment Target 4,363 participants
Start Date 2010-11
Est. Completion 2012-02
Phase Phase 3

Sponsor

Sanofi Pasteur, a Sanofi Company

153 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01240746

The ClinicalTrials.gov registry entry for NCT01240746 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 4,363 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 36,776-participant average among 156 other Influenza trials with a reported enrollment target (88% lower). The listed sponsor is Sanofi Pasteur, a Sanofi Company, which has 153 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Influenza appearing as the primary indexed condition, and to 3 interventions - of which Licensed 2010-2011 Trivalent Influenza Vaccine, No Preservative is the first listed.

NCT01240746 reports 20 study locations spanning 7 distinct geographic areas - top geographies include Florida, Arizona, California.

Frequently Asked Questions

What is clinical trial NCT01240746 about?

NCT01240746 is a clinical study titled "Study of Quadrivalent Influenza Vaccine Among Children". The aim of the study is to evaluate a prototype quadrivalent influenza vaccine (QIV), the licensed 2010-2011 trivalent influenza vaccine (TIV) containing the primary B strain (B1), and the investigational TIV containing the alternate B (B2) strain in children. Primary Objective: To demonstrate non...

What is the current status of trial NCT01240746?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 4,363 participants. The study started on 2010-11. Estimated completion is 2012-02.

What conditions does trial NCT01240746 study?

This clinical trial studies the following conditions: Influenza.

What interventions are being tested in trial NCT01240746?

The interventions under investigation include: Licensed 2010-2011 Trivalent Influenza Vaccine, No Preservative (BIOLOGICAL), Investigational Trivalent Influenza Vaccine with alternate B strain, No Preservative (BIOLOGICAL), Quadrivalent Influenza Vaccine, No Preservative (BIOLOGICAL).

Who is sponsoring clinical trial NCT01240746?

This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 153 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01240746 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.