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NCT01938742 · ClinicalTrials.gov registry record · Phase 2
H7N9 Mix and Match With MF59 in Healthy Adults
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 700
- Enrollment target
NCT01938742 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 700 participants.
The verdict
NCT01938742, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 700 participants
- Enrollment target
Study Summary
This is a Phase II randomized, double-blinded, controlled study in up to 700 males and non-pregnant females, 19 to 64 years old, inclusive, designed to assess the safety, reactogenicity, and immunogenicity of a monovalent influenza A/H7N9 virus vaccine administered at different dosages (3.75, 7.5, or 15 mcg of HA/0.5 mL dose) given with and without MF59 adjuvant and without adjuvant (15 mcg of HA/0.5 mL dose and 45 mcg of HA/0.75 mL dose). Subjects will receive two doses via intramuscular injection, approximately 21 days apart. Safety, reactogenicity, and immunogenicity data will be collected at standard time points with safety follow-up to continue through one year post dose 2. The duration of the study for each subject will be approximately 13 months.
Interventions
- DRUG MF59
- BIOLOGICAL Influenza Virus Vaccine, Monovalent A/H7N9 A/Shanghai/2/2013
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 700 participants |
| Start Date | 2013-09 |
| Est. Completion | 2014-11 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01938742
The ClinicalTrials.gov registry entry for NCT01938742 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 700 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 2 interventions - of which MF59 is the first listed.
NCT01938742 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01938742 about?
NCT01938742 is a clinical study titled "H7N9 Mix and Match With MF59 in Healthy Adults". This is a Phase II randomized, double-blinded, controlled study in up to 700 males and non-pregnant females, 19 to 64 years old, inclusive, designed to assess the safety, reactogenicity, and immunogenicity of a monovalent influenza A/H7N9 virus vaccine administered at different dosages (3.75, 7.5, o...
What is the current status of trial NCT01938742?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 700 participants. The study started on 2013-09. Estimated completion is 2014-11.
What interventions are being tested in trial NCT01938742?
The interventions under investigation include: MF59 (DRUG), Influenza Virus Vaccine, Monovalent A/H7N9 A/Shanghai/2/2013 (BIOLOGICAL).
Who is sponsoring clinical trial NCT01938742?
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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