Study of Quadrivalent Influenza Vaccine Among Children
Public ClinicalTrials.gov record NCT01240746. 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
Safety and Immunogenicity Among Children 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 (B1), and the investigational TIV containing the alternate B (B2) strain in children. 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 children aged 6 months to less than 9 years of age Secondary Objective: To demonstrate superiority of antibody responses to each B strain in QIV compared with antibody titers following vaccination with the TIV that does not contain the corresponding B strain, as assessed by GMT ratios and seroconversion rates. Observational Objective: To describe the safety profile of QIV among subjects 6 months to less than 9 years of age, 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
- NCT01240746
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 4,363 participants
Conditions and interventions
Conditions
Interventions
- Licensed 2010-2011 Trivalent Influenza Vaccine, No Preservative Biological
- Investigational Trivalent Influenza Vaccine with alternate B strain, No Preservative Biological
- Quadrivalent Influenza Vaccine, No Preservative Biological
Biological
Eligibility (public fields only)
- Age range
- 6 Months to 8 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
- Nov 2010 (Type not available)
- Primary completion
- Dec 2011 (Actual)
- Completion
- Feb 2012 (Actual)
- Last update posted
- Jul 14, 2015
2010 – 2012
United States locations
- U.S. sites
- 67
- U.S. states
- 26
- U.S. cities
- 58
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Dothan | Alabama | 36305 | — |
| Not listed | Chandler | Arizona | 85224 | — |
| Not listed | Chandler | Arizona | 85225 | — |
| Not listed | Mesa | Arizona | 85203 | — |
| Not listed | Mesa | Arizona | 85213 | — |
| Not listed | Scottsdale | Arizona | 85258 | — |
| Not listed | Little Rock | Arkansas | 72205 | — |
| Not listed | Los Angeles | California | 90036 | — |
| Not listed | San Diego | California | 92103 | — |
| Not listed | San Diego | California | 92108 | — |
| Not listed | Colorado Spring | Colorado | 80922 | — |
| Not listed | Denver | Colorado | 80239 | — |
| Not listed | Ridgefield | Connecticut | 06877 | — |
| Not listed | Boca Raton | Florida | 33432 | — |
| Not listed | Jacksonville | Florida | 32216 | — |
| Not listed | Melbourne | Florida | 32935 | — |
| Not listed | Miami Beach | Florida | 33141 | — |
| Not listed | Ponte Vedra | Florida | 32081 | — |
| Not listed | Sarasota | Florida | 34231 | — |
| Not listed | Sarasota | Florida | 34239 | — |
| Not listed | South Miami | Florida | 33143 | — |
| Not listed | Marietta | Georgia | 30625 | — |
| Not listed | Arkansas City | Kansas | 67005 | — |
| Not listed | Newton | Kansas | 67114 | — |
| Not listed | Overland Park | Kansas | 66202 | — |
| Not listed | Wichita | Kansas | 67205 | — |
| Not listed | Wichita | Kansas | 67207 | — |
| Not listed | Bardstown | Kentucky | 40004 | — |
| Not listed | Crestview Hills | Kentucky | 41017 | — |
| Not listed | Lexington | Kentucky | 40509 | — |
| Not listed | Metairie | Louisiana | 70006 | — |
| Not listed | Columbia | Maryland | 21045 | — |
| Not listed | Kansas City | Missouri | 64114 | — |
| Not listed | St Louis | Missouri | 63141 | — |
| Not listed | Las Vegas | Nevada | 89104 | — |
| Not listed | Binghamton | New York | 13901 | — |
| Not listed | Cary | North Carolina | 27518 | — |
| Not listed | Akron | Ohio | 44311 | — |
| Not listed | Cleveland | Ohio | 44121 | — |
| Not listed | Columbus | Ohio | 43212 | — |
| Not listed | Portland | Oregon | 97203 | — |
| Not listed | Pittsburgh | Pennsylvania | 15220 | — |
| Not listed | Pittsburgh | Pennsylvania | 15227 | — |
| Not listed | Scranton | Pennsylvania | 18510 | — |
| Not listed | Warwick | Rhode Island | 02886 | — |
| Not listed | Barnwell | South Carolina | 26812 | — |
| Not listed | Mt. Pleasant | South Carolina | 29464 | — |
| Not listed | Clarksville | Tennessee | 37043 | — |
| Not listed | Kingsport | Tennessee | 37664 | — |
| Not listed | Austin | Texas | 78705 | — |
| Not listed | Fort Worth | Texas | 76107 | — |
| Not listed | Fort Worth | Texas | 76135 | — |
| Not listed | Houston | Texas | 77074 | — |
| Not listed | Katy | Texas | 77450 | — |
| Not listed | Layton | Utah | 84041 | — |
| Not listed | Murray | Utah | 84107 | — |
| Not listed | Orem | Utah | 84057 | — |
| Not listed | Provo | Utah | 84604 | — |
| Not listed | Salt Lake City | Utah | 84109 | — |
| Not listed | Salt Lake City | Utah | 84121 | — |
| Not listed | Salt Lake City | Utah | 84124 | — |
| Not listed | South Jordan | Utah | 84095 | — |
| Not listed | West Jordan | Utah | 84088 | — |
| Not listed | Charlottesville | Virginia | 22902 | — |
| Not listed | Midlothian | Virginia | 23113 | — |
| Not listed | Williamsburg | Virginia | 23185 | — |
| 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 NCT01240746, 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 Jul 14, 2015 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01240746 live on ClinicalTrials.gov.