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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: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
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, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (302% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Local adverse events (AEs) solicited on a memory aid provided to participants included Pain, Tenderness, Itching/Pruritus, Ecchymosis/Bruising (functional grade based on interference with daily activities), Ecchymosis/Bruising (any measured value \>0mm), Erythema/Redness (functional grade), Erythema/ Redness (any measured value \>0mm), Induration/Swelling (functional grade), and Induration/Swelling (any measured value \>0mm). Systemic AEs solicited on a memory aid provided to participants inclu
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 |
What the finished NCT03945825 record still lists
NCT03945825 is an interventional study that assigns participants to a tested intervention. The registered 241 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (302% higher).
The record links to 0 conditions, and to 4 interventions - of which Quadrivalent Recombinant Seasonal Influenza Vaccine is the first listed.
NCT03945825 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT03945825's enrollment target sits among peer trials
241 196th of 2000 higher than 1,804 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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