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NCT03698279 · ClinicalTrials.gov registry record · Phase 2
Safety and Immunogenicity of Different Dosages of High-Dose Quadrivalent Influenza Vaccine in Children 6 Months to 17 Years of Age
A Phase 2 study, sponsored by Sanofi Pasteur, a Sanofi Company.
- Completed
- Registry status
- Phase 2
- Development phase
- 665
- Enrollment target
NCT03698279: Completed Phase 2 study, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT03698279 is a Phase 2 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 665 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (400% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03698279, a Phase 2 study, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 665 participants
- Enrollment target
Study Summary
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.
Primary Outcome
An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination. Unsolicited AEs includes both serious (SAEs) and non-serious unsolicited AEs. An SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a c
Interventions
- BIOLOGICAL 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)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 665 participants |
| Start Date | 2018-10-09 |
| Est. Completion | 2019-10-16 |
| Phase | Phase 2 |
What the finished NCT03698279 record still lists
NCT03698279 is an interventional study that assigns participants to a tested intervention. The registered 665 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (400% higher).
The record links to 0 conditions, and to 5 interventions - of which High-Dose Quadrivalent Influenza Vaccine (QIV-HD) 30 μg (split-virion, inactivated) is the first listed.
NCT03698279 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03698279 about?
NCT03698279 is a clinical study titled "Safety and Immunogenicity of Different Dosages of High-Dose Quadrivalent Influenza Vaccine in Children 6 Months to 17 Years of Age". 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 descr...
What is the current status of trial NCT03698279?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 665 participants. The study started on 2018-10-09. Estimated completion is 2019-10-16.
What interventions are being tested in trial NCT03698279?
The interventions under investigation include: 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).
Who is sponsoring clinical trial NCT03698279?
This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 153 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03698279's enrollment target sits among peer trials
665 49th of 2000 higher than 1,952 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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