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NCT02251288 · ClinicalTrials.gov registry record · Phase 1
A Phase I Study Priming With an Inactivated A/H7N9 Influenza Virus Vaccine With or Without MF59 Adjuvant Followed by Live Attenuated A/H7N9 Influenza Virus Vaccine
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 62
- Enrollment target
NCT02251288 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 62 participants.
The verdict
NCT02251288, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 62 participants
- Enrollment target
Study Summary
A phase I prospective, randomized study in healthy adult subjects at a single center. Adult subjects age 18 to 47 years and meeting all enrollment criteria will choose to participate as subjects who receive inactivated vaccine followed by a live vaccine boost at 4 weeks (Group 1), 12 weeks (Group 2), or 24 weeks (Group 3), or to be in an observational group (Group 4) which will not be scheduled for a booster dose but may serve as a roll-over group for subjects who withdraw prior to the second vaccination but agree to remain in follow-up. A fifth group will receive two intramuscular doses of adjuvanted H7N9 pIIV separated by four weeks. The primary objectives of this study are to (1) assess the safety of H7N9 pLAIV administered to individuals who have previously received MF59-adjuvanted or unadjuvanted H7N9 pIIV, (2) evaluate the ability of a single dose of unadjuvanted H7N9 pIIV to prime for enhanced immunogenicity (booster response) to subsequent administration of antigenically-matched H7N9 pLAIV vaccine, and to (3) evaluate the ability of a single dose of MF59-adjuvanted H7N9 pIIV to prime for enhanced immunogenicity (booster response) to subsequent administration of antigenically-matched H7N9 pLAIV vaccine.
Interventions
- DRUG MF59 adjuvant
- BIOLOGICAL Influenza Virus Vaccine, Monovalent A/H7N9 A/Shanghai/2/2013
- BIOLOGICAL Influenza Virus Vaccine, Live Attenuated H7N9 Anhui 2013/AA ca
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2015-05-18 |
| Est. Completion | 2018-08-17 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02251288
The ClinicalTrials.gov registry entry for NCT02251288 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 62 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 MF59 adjuvant is the first listed.
NCT02251288 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02251288 about?
NCT02251288 is a clinical study titled "A Phase I Study Priming With an Inactivated A/H7N9 Influenza Virus Vaccine With or Without MF59 Adjuvant Followed by Live Attenuated A/H7N9 Influenza Virus Vaccine". A phase I prospective, randomized study in healthy adult subjects at a single center. Adult subjects age 18 to 47 years and meeting all enrollment criteria will choose to participate as subjects who receive inactivated vaccine followed by a live vaccine boost at 4 weeks (Group 1), 12 weeks (Group 2)...
What is the current status of trial NCT02251288?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 62 participants. The study started on 2015-05-18. Estimated completion is 2018-08-17.
What interventions are being tested in trial NCT02251288?
The interventions under investigation include: MF59 adjuvant (DRUG), Influenza Virus Vaccine, Monovalent A/H7N9 A/Shanghai/2/2013 (BIOLOGICAL), Influenza Virus Vaccine, Live Attenuated H7N9 Anhui 2013/AA ca (BIOLOGICAL).
Who is sponsoring clinical trial NCT02251288?
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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