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NCT03738241 · ClinicalTrials.gov registry record · Phase 2
2017 A/H7N9 IIV Revaccination
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 304
- Enrollment target
NCT03738241: Completed Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT03738241 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 304 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (129% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03738241, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 304 participants
- Enrollment target
Study Summary
This is a Phase II clinical trial in up to 420 males and non-pregnant females, 19 to 70 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 one dose of a monovalent inactivated split influenza 2017 A/H7N9 virus vaccine (2017 A/H7N9 IIV), administered intramuscularly (IM) at 3.75 mcg hemagglutinin (HA) per dose, given with or without AS03 adjuvant to subjects primed with a monovalent inactivated split influenza 2013 A/H7N9 virus vaccine (2013 A/H7N9 IIV) in DMID Protocols 13-0032 and 13-0033, or to those who are A/H7 IIV-naïve. Phosphate buffered saline (PBS) diluent will be used to achieve the targeted dosage. The study will be conducted at 9 Vaccine and Treatment Evaluation Unit (VTEU) sites (including their subcontractors). Study duration is approximately 17 months with subject participation duration up to 13 months. The primary objectives are: 1) to assess the safety and reactogenicity of 2017 A/H7N9 IIV given with or without AS03 adjuvant following receipt of one dose of study vaccine; 2) to assess the serum hemagglutination inhibition (HAI) and neutralizing (Neut) antibody responses following receipt of the study vaccine.
Primary Outcome
Blood was collected for HAI assay which was conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The geometric mean titer was calculated for each study arm and stratum from the available results at 21 days post study vaccination (Day 22).
Interventions
- DRUG AS03
- OTHER Phosphate Buffered Saline (PBS) diluent
- BIOLOGICAL A/H7N9
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 304 participants |
| Start Date | 2018-12-18 |
| Est. Completion | 2020-06-19 |
| Phase | Phase 2 |
What the finished NCT03738241 record still lists
NCT03738241 is an interventional study that assigns participants to a tested intervention. The registered 304 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 (129% higher).
The record links to 0 conditions, and to 3 interventions - of which AS03 is the first listed.
NCT03738241 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03738241 about?
NCT03738241 is a clinical study titled "2017 A/H7N9 IIV Revaccination". This is a Phase II clinical trial in up to 420 males and non-pregnant females, 19 to 70 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 one dose of a monovalent inactivated s...
What is the current status of trial NCT03738241?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 304 participants. The study started on 2018-12-18. Estimated completion is 2020-06-19.
What interventions are being tested in trial NCT03738241?
The interventions under investigation include: AS03 (DRUG), Phosphate Buffered Saline (PBS) diluent (OTHER), A/H7N9 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03738241?
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 NCT03738241's enrollment target sits among peer trials
304 166th of 2000 higher than 1,834 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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