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NCT01218646 · ClinicalTrials.gov registry record · Phase 3
Study of Quadrivalent Influenza Vaccine Among Adults
A Phase 3 study, sponsored by Sanofi Pasteur, a Sanofi Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 739
- Enrollment target
NCT01218646 is a Phase 3 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 739 participants.
The verdict
NCT01218646, a Phase 3 study, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 739 participants
- Enrollment target
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, and the investigational TIV containing the alternate B strain in adult subjects. 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 subjects 65 years of age and older Observational Objective: * To describe the safety profiles of TIV among subjects 18 years of age and older and QIV in subjects 65 years and older, 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.
Interventions
- BIOLOGICAL Investigational Quadrivalent Inactivated Influenza Vaccine, No Preservative
- BIOLOGICAL Investigational Trivalent Inactivated Influenza Vaccine, No Preservative
- BIOLOGICAL Fluzone®: 2010-2011 Trivalent Inactivated Influenza Vaccine, No Preservative
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 739 participants |
| Start Date | 2010-10 |
| Est. Completion | 2011-04 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01218646
The ClinicalTrials.gov registry entry for NCT01218646 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 739 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 153 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Investigational Quadrivalent Inactivated Influenza Vaccine, No Preservative is the first listed.
NCT01218646 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01218646 about?
NCT01218646 is a clinical study titled "Study of Quadrivalent Influenza Vaccine Among Adults". 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, and the investigational TIV containing the alternate B strain in adult subjects. Primary Objective: * To demonstrate non-i...
What is the current status of trial NCT01218646?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 739 participants. The study started on 2010-10. Estimated completion is 2011-04.
What interventions are being tested in trial NCT01218646?
The interventions under investigation include: Investigational Quadrivalent Inactivated Influenza Vaccine, No Preservative (BIOLOGICAL), Investigational Trivalent Inactivated Influenza Vaccine, No Preservative (BIOLOGICAL), Fluzone®: 2010-2011 Trivalent Inactivated Influenza Vaccine, No Preservative (BIOLOGICAL).
Who is sponsoring clinical trial NCT01218646?
This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 153 total clinical trials registered on ClinicalTrials.gov.
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