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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: Completed Phase 3 study, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT01218646 is a Phase 3 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 739 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
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.
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.
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 |
What the finished NCT01218646 record still lists
NCT01218646 is an interventional study that assigns participants to a tested intervention. The registered 739 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Investigational Quadrivalent Inactivated Influenza Vaccine, No Preservative is the first listed.
NCT01218646 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01218646's enrollment target sits among peer trials
739 478th of 2000 higher than 1,522 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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