Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03945825 · ClinicalTrials.gov registry record · Phase 1
Flublok or Fluzone With Advax-CpG55.2 or AF03
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 241
- Enrollment target
NCT03945825 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 241 participants.
The verdict
NCT03945825, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 241 participants
- Enrollment target
Study Summary
This is a Phase I, randomized, double blinded, clinical trial in up to 240 males and non-pregnant females, 18-45 years of age, inclusive, who are in good health and meet all eligibility criteria. This clinical trial is designed to assess the safety, reactogenicity and immunogenicity of either the 2018/2019 seasonal Fluzone or Flublok Quadrivalent Influenza Vaccine (QIV) manufactured by Sanofi Pasteur (SP) given without adjuvant or with one of two adjuvant formulations, AF03 or Advax-CpG55.2. Eight Vaccine and Treatment Evaluation Unit (VTEU) sites will be included in the study. Study duration is approximately 18 months, and subject participation duration is 12 months. The primary objectives of this study are: 1) to assess the safety and reactogenicity of 2018/2019 Fluzone and Flublok with and without AF03 or Advax-CpG55.2 adjuvant; 2) to assess the serum hemagglutination inhibition (HAI) antibody responses against 2018/2019 QIV strains from baseline (Day 1) to approximately Day 29 after receipt of 2018/2019 Fluzone and Flublok with and without AF03 or Advax-CpG55.2 adjuvant; 3) to assess the serum neuraminidase inhibition antibody (NAI) responses by enzyme-linked lectin assay (ELLA) against NA antigens in the 2018/2019 QIV from baseline (Day 1) to approximately Day 29 after receipt of 2018/2019 Fluzone and Flublok with and without AF03 or Advax-CpG55.2 adjuvant; 4) to assess the influenza neutralizing (Neut) antibody titer responses against 2018/2019 QIV strains from baseline (Day 1) to approximately Day 29 after receipt of 2018/2019 Fluzone and Flublok with and without AF03 or Advax- CpG55.2 adjuvant.
Interventions
- BIOLOGICAL Quadrivalent Recombinant Seasonal Influenza Vaccine
- BIOLOGICAL Influenza Virus Quadrivalent Inactivated Vaccine
- DRUG AF03
- BIOLOGICAL Delta Inulin-CpG55.2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 241 participants |
| Start Date | 2019-06-10 |
| Est. Completion | 2020-09-18 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03945825
The ClinicalTrials.gov registry entry for NCT03945825 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 241 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Quadrivalent Recombinant Seasonal Influenza Vaccine is the first listed.
NCT03945825 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03945825 about?
NCT03945825 is a clinical study titled "Flublok or Fluzone With Advax-CpG55.2 or AF03". This is a Phase I, randomized, double blinded, clinical trial in up to 240 males and non-pregnant females, 18-45 years of age, inclusive, who are in good health and meet all eligibility criteria. This clinical trial is designed to assess the safety, reactogenicity and immunogenicity of either the 20...
What is the current status of trial NCT03945825?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 241 participants. The study started on 2019-06-10. Estimated completion is 2020-09-18.
What interventions are being tested in trial NCT03945825?
The interventions under investigation include: Quadrivalent Recombinant Seasonal Influenza Vaccine (BIOLOGICAL), Influenza Virus Quadrivalent Inactivated Vaccine (BIOLOGICAL), AF03 (DRUG), Delta Inulin-CpG55.2 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03945825?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.