Study of Quadrivalent Influenza Vaccine Among Adults
Public ClinicalTrials.gov record NCT01218646. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
All trial information on this site comes from the official ClinicalTrials.gov public API (clinicaltrials.gov/api/v2), run by the U.S. National Library of Medicine. We only display that public information; we do not add opinions, endorsements, or any other intent. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Safety and Immunogenicity Trial Among Adults Administered Quadrivalent Influenza Vaccine
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01218646
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 739 participants
Conditions and interventions
Conditions
Interventions
- 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
Biological
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 2010 (Type not available)
- Primary completion
- Mar 2011 (Actual)
- Completion
- Apr 2011 (Actual)
- Last update posted
- Oct 23, 2013
2010 – 2011
United States locations
- U.S. sites
- 12
- U.S. states
- 10
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Hoover | Alabama | 35216 | — |
| Not listed | South Miami | Florida | 33143 | — |
| Not listed | Springfield | Missouri | 65802 | — |
| Not listed | New York | New York | 10004 | — |
| Not listed | Rochester | New York | 14609 | — |
| Not listed | Cincinnati | Ohio | 45249 | — |
| Not listed | Allentown | Pennsylvania | 18102 | — |
| Not listed | Bensalem | Pennsylvania | 19020 | — |
| Not listed | Warwick | Rhode Island | 02866 | — |
| Not listed | Mt. Pleasant | South Carolina | 29464 | — |
| Not listed | Nashville | Tennessee | 37212 | — |
| Not listed | San Antonio | Texas | 78229 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01218646, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 23, 2013 · Synced Nov 10, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01218646 live on ClinicalTrials.gov.