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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03738241
The ClinicalTrials.gov registry entry for NCT03738241 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 304 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 3 interventions - of which AS03 is the first listed.
NCT03738241 reports 0 study locations.
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.
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