Study of Intradermal Quadrivalent Influenza Vaccine in Adults Aged 18 Through 64 Years
Public ClinicalTrials.gov record NCT01712984. 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.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Immunogenicity and Safety Trial of Quadrivalent Influenza Vaccine Administered by Intradermal Route in Adult Subjects Aged 18 Through 64 Years
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The aim of the study is to demonstrate safety and immunogenicity of the quadrivalent influenza intradermal (QIV-ID) vaccine compared to the trivalent influenza vaccine (TIV) containing the B strain from the primary (Yamagata) lineage (TIV-ID1) and the trivalent influenza vaccine containing B strain from the alternate (Victoria) lineage (TIV-ID2) vaccines in producing protection against four strains of influenza virus. Primary Objective: * To demonstrate that QIV-ID induces an immune response (as assessed by hemagglutination inhibition (HAI) geometric mean titers (GMTs) and seroconversion rates) that is non-inferior to responses induced by TIV-ID1 and TIV-ID2 for the 4 virus strains at 28 days post-vaccination. Secondary Objectives: * To demonstrate that each B strain in QIV-ID induces an immune response (as assessed by HAI GMTs and seroconversion rates) that is superior to the response induced by the TIV-ID that does not contain the corresponding B strain. * To describe the rate of post-vaccination seroprotection induced by QIV-ID and TIV-ID. * To describe post-vaccination immunogenicity stratified by age (18-49 years and 50-64 years), race, ethnicity, gender, previous vaccination status, and baseline seropositivity status. * To describe the safety profile for subjects who receive QIV-ID and TIV-ID. Observational Objectives: * To demonstrate non-inferiority of QIV-ID compared to TIV-ID in terms of all Grade 2 or Grade 3 solicited systemic reactions combined * To demonstrate non-inferiority of QIV-ID compared to TIV-ID in terms of all Grade 3 solicited injection site reactions combined.
Study identification
- NCT ID
- NCT01712984
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 3,360 participants
Conditions and interventions
Conditions
Interventions
- Influenza Virus Vaccine USP Quadrivalent, (Zonal Purified Subvirion) 2012 2013 Formulation Biological
- Influenza Virus Vaccine USP Trivalent Types A and B (Zonal Purified Subvirion) Fluzone Intradermal Biological
Biological
Eligibility (public fields only)
- Age range
- 18 Years to 64 Years
- 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 2012 (Type not available)
- Primary completion
- Jun 2013 (Actual)
- Completion
- Oct 2013 (Actual)
- Last update posted
- May 7, 2015
2012 – 2013
United States locations
- U.S. sites
- 38
- U.S. states
- 18
- U.S. cities
- 35
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Hoover | Alabama | 35216 | — |
| Not listed | Huntsville | Alabama | 35802 | — |
| Not listed | Chandler | Arizona | 85224 | — |
| Not listed | Mesa | Arizona | 85213 | — |
| Not listed | Phoenix | Arizona | 85020 | — |
| Not listed | Tucson | Arizona | 85704 | — |
| Not listed | Chula Vista | California | 91911 | — |
| Not listed | Sacramento | California | 95816 | — |
| Not listed | San Diego | California | 92103 | — |
| Not listed | Milford | Connecticut | 06460 | — |
| Not listed | Coral Gables | Florida | 33134 | — |
| Not listed | Melbourne | Florida | 32935 | — |
| Not listed | Pinellas Park | Florida | 33781 | — |
| Not listed | South Miami | Florida | 33143 | — |
| Not listed | Boise | Idaho | 83642 | — |
| Not listed | Iowa City | Iowa | 52242 | — |
| Not listed | Overland Park | Kansas | 66212 | — |
| Not listed | Wichita | Kansas | 67207 | — |
| Not listed | Kansas City | Missouri | 64114 | — |
| Not listed | Springfield | Missouri | 65802 | — |
| Not listed | St Louis | Missouri | 63104 | — |
| Not listed | Omaha | Nebraska | 68134 | — |
| Not listed | Binghamton | New York | 13901 | — |
| Not listed | Rochester | New York | 14609 | — |
| Not listed | Rochester | New York | 14621 | — |
| Not listed | Allentown | Pennsylvania | 18102 | — |
| Not listed | Bensalem | Pennsylvania | 19020 | — |
| Not listed | Warwick | Rhode Island | 02886 | — |
| Not listed | Mt. Pleasant | South Carolina | 29464 | — |
| Not listed | Dakota Dunes | South Dakota | 57049 | — |
| Not listed | Austin | Texas | 78745 | — |
| Not listed | Fort Worth | Texas | 76107 | — |
| Not listed | Fort Worth | Texas | 76135 | — |
| Not listed | San Angelo | Texas | 76904 | — |
| Not listed | Salt Lake City | Utah | 84109 | — |
| Not listed | Salt Lake City | Utah | 84121 | — |
| Not listed | West Jordan | Utah | 84088 | — |
| Not listed | Marshfield | Wisconsin | 54449 | — |
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 NCT01712984, 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 May 7, 2015 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01712984 live on ClinicalTrials.gov.