Safety and Immunogenicity of Different Dosages of High-Dose Quadrivalent Influenza Vaccine in Children 6 Months to 17 Years of Age
Public ClinicalTrials.gov record NCT03698279. 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.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The objectives of this study were: * To describe the safety of each dosage of high-dose quadrivalent influenza vaccine (QIV-HD) used in the study during the 28 days following each vaccination, and serious adverse events (including adverse events of special interest throughout the study). * To describe the antibody response induced by each dosage of QIV-HD used in the study compared with unadjuvanted standard-dose quadrivalent influenza vaccine (QIV-SD) by hemagglutination inhibition (HAI) measurement method. * To describe the antibody response induced by each dosage of QIV-HD used in the study compared with unadjuvanted QIV-SD by virus seroneutralization (SN) measurement method. * To describe the antibody response induced by the highest acceptable dosage of QIV-HD compared with adjuvanted trivalent influenza vaccine (TIV) by HAI and virus SN measurement methods.
Study identification
- NCT ID
- NCT03698279
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 665 participants
Conditions and interventions
Conditions
Interventions
- High-Dose Quadrivalent Influenza Vaccine (QIV-HD) 30 μg (split-virion, inactivated) Biological
- High-Dose Quadrivalent Influenza Vaccine (QIV-HD) 45 μg, (split-virion, inactivated) Biological
- High-Dose Quadrivalent Influenza Vaccine (QIV-HD) 60 µg (split-virion, inactivated) Biological
- Fluarix Quadrivalent Influenza vaccine (Unadjuvanted QIV-SD) (Inactivated) Biological
- FLUAD Pediatric (adjuvanted TIV) (Surface Antigen, Inactivated) Biological
Biological
Eligibility (public fields only)
- Age range
- 6 Months to 17 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 8, 2018
- Primary completion
- Oct 15, 2019
- Completion
- Oct 15, 2019
- Last update posted
- Apr 3, 2022
2018 – 2019
United States locations
- U.S. sites
- 13
- U.S. states
- 8
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Investigational Site Number 8400004 | San Diego | California | 92123-1881 | — |
| Investigational Site Number 8400001 | Miami | Florida | 33186 | — |
| Investigational Site Number 8400002 | Atlanta | Georgia | 30322 | — |
| Investigational Site Number 8400013 | El Dorado | Kansas | 67042 | — |
| Investigational Site Number 8400015 | Newton | Kansas | 67114 | — |
| Investigational Site Number 8400009 | Wichita | Kansas | 67207 | — |
| Investigational Site Number 8400007 | Metairie | Louisiana | 70006 | — |
| Investigational Site Number 8400010 | Las Vegas | Nevada | 89104 | — |
| Investigational Site Number 8400011 | Warwick | Rhode Island | 02886 | — |
| Investigational Site Number 8400003 | Salt Lake City | Utah | 84107 | — |
| Investigational Site Number 8400012 | Salt Lake City | Utah | 84109 | — |
| Investigational Site Number 8400005 | Salt Lake City | Utah | 84121 | — |
| Investigational Site Number 8400014 | West Jordan | Utah | 84088-8865 | — |
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 3 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03698279, 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 Apr 3, 2022 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03698279 live on ClinicalTrials.gov.