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

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Immunogenicity outcomes were assessed in serum samples by hemagglutination inhibition (HAI) assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as \<10.

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
Sanofi Pasteur, a Sanofi Company

153 total trials

What the finished NCT01240746 record still lists

NCT01240746 is an interventional study that assigns participants to a tested intervention. Its 4,363 participants enrollment target places it among the larger protocols in the corpus, below the 36,776-participant average among 156 other Influenza trials with a reported enrollment target (88% lower).

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 names 20 study sites across 7 states, led by 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.

Learn More About Clinical Trials

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.

Where NCT01240746's enrollment target sits among peer trials

4,363 20th of 156 higher than 137 of 156 other Influenza trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Influenza 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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Related registry views

Source: ClinicalTrials.gov NCT01240746, the US trial registry maintained by the National Library of Medicine. NCT01240746 (large enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.