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COMPLETED Phase 3

Study of Quadrivalent Influenza Vaccine Among Children

NCT01240746 · View on ClinicalTrials.gov ↗

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

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

43 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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 4,363 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi Pasteur, a Sanofi Company, which has 43 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01240746 reports 20 study locations spanning 7 distinct geographic areas — top geographies include Florida, Arizona, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01240746?

This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 43 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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