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COMPLETED Phase 4

A Study to Evaluate the Safety and Tolerability of Trivalent Influenza Virus Vaccine in Children Aged 5 Years to < 9 Years

NCT02212106 · View on ClinicalTrials.gov ↗

Study Summary

This is a study to assess the safety of a bioCSL split virion, inactivated Trivalent Influenza Virus vaccine containing the 2014/2015 Northern Hemisphere strains of vaccine in children aged 5 years to less than 9 years. Comparison will be made to a licensed Quadrivalent Influenza Virus vaccine that complies with the FDA recommendations for the 2014/2015 influenza season in the US.

Conditions Studied

Interventions

  • BIOLOGICAL bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)
  • BIOLOGICAL Comparator Quadrivalent Influenza Virus Vaccine

Study Locations (11)

North Carolina

  • Site 290 — Durham
  • Site 281 — Raleigh
  • Site 280 — Winston-Salem

Texas

  • Site 283 — Austin
  • Site 282 — Fort Worth
  • Site 288 — San Angelo

California

  • Site 286 — Los Angeles

Idaho

  • Site 289 — Boise

Missouri

  • Site 287 — St Louis

New York

  • Site 285 — Binghamton

South Carolina

  • Site 284 — Charleston

Trial Details

FieldValue
Enrollment Target 402 participants
Start Date 2014-09
Est. Completion 2014-12
Phase Phase 4

Sponsor

Seqirus

4 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02212106

The ClinicalTrials.gov registry entry for NCT02212106 describes a study currently listed as completed. It is categorized as Phase 4, 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 402 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Seqirus, which has 4 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, Human appearing as the primary indexed condition, and to 2 interventions — of which bioCSL Trivalent Influenza Virus Vaccine (CSL TIV) 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: NCT02212106 reports 11 study locations spanning 7 distinct geographic areas — top geographies include North Carolina, Texas, 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 NCT02212106 about?

NCT02212106 is a clinical study titled "A Study to Evaluate the Safety and Tolerability of Trivalent Influenza Virus Vaccine in Children Aged 5 Years to < 9 Years". This is a study to assess the safety of a bioCSL split virion, inactivated Trivalent Influenza Virus vaccine containing the 2014/2015 Northern Hemisphere strains of vaccine in children aged 5 years to less than 9 years. Comparison will be made to a licensed Quadrivalent Influenza Virus vaccine that ...

What is the current status of trial NCT02212106?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 402 participants. The study started on 2014-09. Estimated completion is 2014-12.

What conditions does trial NCT02212106 study?

This clinical trial studies the following conditions: Influenza, Human. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02212106?

The interventions under investigation include: bioCSL Trivalent Influenza Virus Vaccine (CSL TIV) (BIOLOGICAL), Comparator Quadrivalent Influenza Virus Vaccine (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02212106?

This trial is sponsored by Seqirus, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT02212106 being conducted?

This trial has 11 study locations across California, Idaho, Missouri, New York, North Carolina. 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