Safety and Immunogenicity of Fluzone® Quadrivalent Vaccine Administered to Healthy Children
Public ClinicalTrials.gov record NCT02915302. 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 of Fluzone® Quadrivalent Vaccine Administered to Healthy Children 6 to < 36 Months of Age
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The aim of the study was to describe the safety and immunogenicity of a 0.5-mL dose (15 μg hemagglutinin \[HA\] per strain) of Fluzone Quadrivalent vaccine in children 6 to \<36 months of age. Primary objective: * To compare the rate of any fever (temperature ≥100.4 degrees Fahrenheit \[38.0 degrees Celsius) following a 0.5-mL dose of Fluzone Quadrivalent vaccine to that following a 0.25-mL dose of Fluzone Quadrivalent vaccine during the 7 days after either vaccination (Dose 1 and Dose 2 combined) in participants 6 to \< 36 months of age. Secondary objective: * To compare antibody responses induced by a 0.5-mL dose of Fluzone Quadrivalent vaccine to those induced by a 0.25-mL dose of Fluzone Quadrivalent vaccine as assessed by geometric mean titer (GMT) ratios and seroconversion rate differences after the final vaccination in participants 6 to \< 36 months of age. Other objectives: * To describe the safety of 2 different dose levels of the 2016-2017 formulation of Fluzone Quadrivalent vaccine in participants 6 to \< 36 months of age. * To describe the immunogenicity of 2 different dose levels of the 2016-2017 formulation of Fluzone Quadrivalent vaccine in participants 6 months to \< 36 months of age. * To submit available sera from approximately 30 participants to the Center for Biologics Evaluation and Research for further analysis by the World Health Organization, the Centers for Disease Control and Prevention, and the FDA to support formulation recommendations for subsequent influenza vaccines.
Study identification
- NCT ID
- NCT02915302
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 1,950 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 6 Months to 35 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
- Sep 23, 2016 (Type not available)
- Primary completion
- Mar 6, 2017 (Actual)
- Completion
- Mar 6, 2017 (Actual)
- Last update posted
- Mar 29, 2022
2016 – 2017
United States locations
- U.S. sites
- 35
- U.S. states
- 18
- U.S. cities
- 31
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Birmingham | Alabama | 35205 | — |
| Not listed | Harrisburg | Arkansas | 72432 | — |
| Not listed | Downey | California | 90241 | — |
| Not listed | Paramount | California | 90723 | — |
| Not listed | Sacramento | California | 95815 | — |
| Not listed | San Diego | California | 92111 | — |
| Not listed | Thornton | Colorado | 80233 | — |
| Not listed | Miami | Florida | 33142 | — |
| Not listed | Miami Beach | Florida | 33140 | — |
| Not listed | Meridian | Idaho | 83642 | — |
| Not listed | Bardstown | Kentucky | 40004 | — |
| Not listed | Metairie | Louisiana | 70006 | — |
| Not listed | Lincoln | Nebraska | 68504 | — |
| Not listed | Lincoln | Nebraska | 68505 | — |
| Not listed | Lincoln | Nebraska | 68516 | — |
| Not listed | Norfolk | Nebraska | 68701 | — |
| Not listed | Omaha | Nebraska | 68131 | — |
| Not listed | Omaha | Nebraska | 68134 | — |
| Not listed | Syracuse | New York | 13057 | — |
| Not listed | Dayton | Ohio | 45414 | — |
| Not listed | Grove City | Ohio | 43123 | — |
| Not listed | Gresham | Oregon | 97030 | — |
| Not listed | Erie | Pennsylvania | 16505 | — |
| Not listed | Charleston | South Carolina | 29407 | — |
| Not listed | Charleston | South Carolina | 29414 | — |
| Not listed | Tullahoma | Tennessee | 37388 | — |
| Not listed | Fort Worth | Texas | 76107 | — |
| Not listed | Houston | Texas | 77055 | — |
| Not listed | Layton | Utah | 84041 | — |
| Not listed | Orem | Utah | 84057 | — |
| Not listed | Provo | Utah | 84604 | — |
| Not listed | Roy | Utah | 84067 | — |
| Not listed | South Jordan | Utah | 84095 | — |
| Not listed | West Jordan | Utah | 84088 | — |
| Not listed | Burke | Virginia | 22015 | — |
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 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02915302, 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 29, 2022 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02915302 live on ClinicalTrials.gov.