ClinicalTrials.gov record
Clinical Study to Evaluate the Safety, Immunogenicity and Efficacy of Investigational Flu Vaccine Compared to Approved Flu Vaccine in Children.
ClinicalTrials.gov ID: NCT01964989
Public ClinicalTrials.gov record NCT01964989. 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
A Phase III, Stratified, Randomized, Observer Blind, Controlled, Multicenter Clinical Study to Evaluate the Safety, Immunogenicity and Efficacy of an Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine Compared to Non-Adjuvanted Comparator Influenza Vaccine in Children ≥6 to < 72 Months of Age.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Safety, Immunogenicity and Efficacy of an Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine Compared to Non-Adjuvanted Comparator Influenza Vaccine in Children ≥6 to \<72 Months of Age. The study was conducted during the 2013/2014 and 2014/2015 northern hemisphere influenza season.
Study identification
- NCT ID
- NCT01964989
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 10,644 participants
Conditions and interventions
Conditions
Interventions
- Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV) Biological
- Non-adjuvanted Trivalent Influenza Vaccine (TIV) / Quadrivalent Influenza Vaccine (QIV) Biological
Biological
Eligibility (public fields only)
- Age range
- 6 Months to 71 Months
- 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 31, 2013
- Primary completion
- Sep 30, 2015
- Completion
- Jul 31, 2016
- Last update posted
- Mar 26, 2023
2013 – 2016
United States locations
- U.S. sites
- 91
- U.S. states
- 24
- U.S. cities
- 73
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| 222, Novartis Investigational Site | Chandler | Arizona | 85224 | — |
| 267, Novartis Investigational Site | Harrisburg | Arkansas | 72432 | — |
| 259, Novartis Investigational Site | Anaheim | California | 92801 | — |
| 280, Novartis Investigational Site | Anaheim | California | 92804 | — |
| 213, Novartis Investigational Site | Baldwin Park | California | 91706 | — |
| 407, Novartis Investigational Site | Downey | California | 90241 | — |
| 238, Novartis Investigational Site | La Puente | California | 91774 | — |
| 411, Novartis Investigational Site | Ontario | California | 91762 | — |
| 202, Novartis Investigational Site | Paramount | California | 90723 | — |
| 250, Novartis Investigational Site | San Diego | California | 92103 | — |
| 293, Novartis Investigational Site | San Francisco | California | 94102 | — |
| 243, Novartis Investigational Site | Colorado Springs | Colorado | 80902 | — |
| 249, Novartis Investigational Site | Denver | Colorado | 80902 | — |
| 229, Novartis Investigational Site | Boca Raton | Florida | 33432 | — |
| 416, Novartis Investigational Site | Hialeah | Florida | 33013 | — |
| 287, Novartis Investigational Site | Hialeah | Florida | 33106 | — |
| 412, Novartis Investigational Site | Homestead | Florida | 34239 | — |
| 224, Novartis Investigational Site | Melbourne | Florida | 32935 | — |
| 417, Novartis Investigational Site | Miami | Florida | 33015 | — |
| 404, Novartis Investigational Site | Miami | Florida | 33144 | — |
| 285, Novartis Investigational Site | Miami | Florida | 33172 | — |
| 277,Novartis Investigational Site | Miami | Florida | 33412 | — |
| 234, Novartis Investigational Site | Opa-locka | Florida | 33054 | — |
| 297, Novartis Investigational Site | Orlando | Florida | 32801 | — |
| 297, Novartis Investigational vaccine | Orlando | Florida | 32806 | — |
| 410, Novartis Investigational Site | Sarasota | Florida | 34239 | — |
| 401, Novartis iNvestiagtional Site | Atlanta | Georgia | 30322 | — |
| 299, Novartis Investigational Site | DeKalb | Illinois | 60115 | — |
| 268, Novartis Investigational Site | Peoria | Illinois | 61602 | — |
| 209, Novartis Investigational Site | Augusta | Kansas | 67010 | — |
| 210, Novartis Investigational Site | Newton | Kansas | 67114 | — |
| 274 Novartis Investigational Site | Park City | Kansas | 67219 | — |
| 211, Novartis Investigational Site | Wichita | Kansas | 67205 | — |
| 269, Novartis Investigational Site | Bardstown | Kentucky | 40004 | — |
| 226, Novartis Investigational Site | Louisville | Kentucky | 40202 | — |
| 248, Novartis Investigational Site | Louisville | Kentucky | 40217 | — |
| 207, Novartis Investigational Site | Louisville | Kentucky | 40291 | — |
| 290, Novartis Investigational Site | Louisville | Kentucky | 40291 | — |
| 265, Novartis Investigational Site | Haughton | Louisiana | 71037 | — |
| 408, Novartis Investigational Site | Mangham | Louisiana | 71259 | — |
| 225, Novartis Investigational Site | Metairie | Louisiana | 70006 | — |
| 233, Novartis Investigational Site | Metairie | Louisiana | 70006 | — |
| 418, Novartis Investigational SIte | Monroe | Louisiana | 71201 | — |
| 262, Novartis Investigational site | Annapolis | Maryland | 21401 | — |
| 263, Novartis Investigational Site | Frederick | Maryland | 21702 | — |
| 405, Novartis Investigational Site | Silver Spring | Maryland | 20910 | — |
| 278, Novartis Investigational Site | Saint Paul | Minnesota | 55108 | — |
| 221, Novartis Investigational Site | Bellevue | Nebraska | 68005 | — |
| 219, Novartis Investigational Site | Fremont | Nebraska | 68025 | — |
| 402, Novartis Investigational Site | Omaha | Nebraska | 68114 | — |
| 288, Novartis Investigational Site | Omaha | Nebraska | 68131 | — |
| 228, Novartis Investigational Site | Omaha | Nebraska | 68134 | — |
| 244, Novartis Investigational Site | Henderson | Nevada | 89014 | — |
| 286, Novartis Investigational site | Las Vegas | Nevada | 89106 | — |
| 255, Novartis Investigational Site | Binghamton | New York | 13901 | — |
| 414, Novartis Investigational Site | Brooklyn | New York | 11201 | — |
| 264, Novartis Investigational Site | Syracuse | New York | 13057 | — |
| 409, Novartis Investigational Site | Boone | North Carolina | 28607 | — |
| 266, Novartis Investigational Site | Cary | North Carolina | 27518 | — |
| 403, Novartis Investigational Site | Clyde | North Carolina | 28721 | — |
| 240, Novartis Investigational Site | Akron | Ohio | 44311 | — |
| 254, Novartis Investigational Site | Cleveland | Ohio | 44122 | — |
| 245, Novartis Investigational Site | Dayton | Ohio | 45406 | — |
| 281, Novartis Investigational Site | Dayton | Ohio | 45409 | — |
| 281, Novartis Investigational vaccines | Dayton | Ohio | 45409 | — |
| 256, Novartis Investigational Site | Tulsa | Oklahoma | 74127 | — |
| 292, Novartis Investigational Site | Erie | Pennsylvania | 16505 | — |
| 270, Novartis Investigational Site | Scottdale | Pennsylvania | 15683 | — |
| 220, Novartis Investigational Site | Anderson | South Carolina | 29621 | — |
| 406, novartis Investigational Site | Barnwell | South Carolina | 29812 | — |
| 272, Novartis Investigational Site | Charleston | South Carolina | 29407 | — |
| 232, Novartis Investigational Site | Moncks Corner | South Carolina | 29461 | — |
| 291, Novartis Investigational vaccine | Spartanburg | South Carolina | 27262 | — |
| 283, Novartis Investigational Site | Nashville | Tennessee | 37203 | — |
| 208, Novartis Investigational Site | Austin | Texas | 78705 | — |
| 247, Novartis Investigational Site | Fort Worth | Texas | 76107 | — |
| 217, Novartis Investigational Site | Fort Worth | Texas | 76135 | — |
| 214, Novartis Investigational Site | San Angelo | Texas | 76904 | — |
| 400, Novartis investigational Site | San Antonio | Texas | 78229 | — |
| 260, Novartis Investigational Site | Tomball | Texas | 77375 | — |
| 295, Novartis Investigational Site | Layton | Utah | 84041 | — |
| 236, Novartis Investigational Site | Salt Lake City | Utah | 84109 | — |
| 212, Novartis Investigational Site | Salt Lake City | Utah | 84121 | — |
| 246, Novartis Investigational Site | Salt Lake City | Utah | 84124 | — |
| 279, Novartis Investigational Site | Spanish Fork | Utah | 84660 | — |
| 282, Novartis Investigational Site | Syracuse | Utah | 84075 | — |
| 294, Novartis Investigational Site | West Haven | Utah | 84401 | — |
| 201, Novartis Investigational Site | West Jordan | Utah | 84088 | — |
| 271, Novartis Investigational Site | West Jordan | Utah | 84088 | — |
| 251, Novartis Investigational Site | Burke | Virginia | 22015 | — |
| 296, Novartis Investigational Site | Vienna | Virginia | 22180 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 76 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01964989, 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 Mar 26, 2023 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01964989 live on ClinicalTrials.gov.