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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 is a Phase 2 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 665 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03698279
The ClinicalTrials.gov registry entry for NCT03698279 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 665 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi Pasteur, a Sanofi Company, which has 153 total studies on file at ClinicalTrials.gov.
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 reports 0 study locations.
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.
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