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NCT03318315 · ClinicalTrials.gov registry record · Phase 2
Co-Administration of AS03 Adjuvanted A/H7N9 IIV With IIV4
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 149
- Enrollment target
NCT03318315 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 149 participants.
The verdict
NCT03318315, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 149 participants
- Enrollment target
Study Summary
This is a randomized, un-blinded, Phase II study in males and non-pregnant females, who are in good health, 19 to 64 years of age. This study is designed to assess the safety, reactogenicity, and immunogenicity of a pre-pandemic AS03 (GSK) adjuvanted 2017 monovalent inactivated influenza A/H7N9 vaccine, when two doses are administered 21 days apart either sequentially or simultaneously (within 15 minutes) with licensed seasonal influenza vaccine. Subjects will be randomized into one of three treatment groups. The study will enroll approximately 150 individuals who have no history of influenza A/H7N9 infection or prior receipt of an influenza virus H7 subtype vaccine. Study duration is approximately 16 months with subject participation duration of approximately 13 months. The primary objectives of this study are: 1) to assess the safety and reactogenicity following sequential or simultaneous IM administration of 2 doses of AS03-adjuvanted 2017 H7N9 IIV and one dose of seasonal influenza vaccine (IIV4); 2) to assess the serum HAI and Neut antibody responses against A/H7N9 at approximately 21 days following receipt of two doses of AS03-adjuvanted 2017 H7N9 IIV administered IM approximately 21 days apart; 3) to assess the serum HAI and Neut antibody responses against the seasonal influenza strains at approximately 21 days following receipt of IIV4.
Interventions
- DRUG AS03
- OTHER Phosphate Buffered Saline (PBS) diluent
- BIOLOGICAL Influenza Virus Quadrivalent Inactivated Vaccine
- BIOLOGICAL Inactivated influenza H7N9 vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 149 participants |
| Start Date | 2018-02-20 |
| Est. Completion | 2019-07-25 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03318315
The ClinicalTrials.gov registry entry for NCT03318315 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 149 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 4 interventions - of which AS03 is the first listed.
NCT03318315 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03318315 about?
NCT03318315 is a clinical study titled "Co-Administration of AS03 Adjuvanted A/H7N9 IIV With IIV4". This is a randomized, un-blinded, Phase II study in males and non-pregnant females, who are in good health, 19 to 64 years of age. This study is designed to assess the safety, reactogenicity, and immunogenicity of a pre-pandemic AS03 (GSK) adjuvanted 2017 monovalent inactivated influenza A/H7N9 vacc...
What is the current status of trial NCT03318315?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 149 participants. The study started on 2018-02-20. Estimated completion is 2019-07-25.
What interventions are being tested in trial NCT03318315?
The interventions under investigation include: AS03 (DRUG), Phosphate Buffered Saline (PBS) diluent (OTHER), Influenza Virus Quadrivalent Inactivated Vaccine (BIOLOGICAL), Inactivated influenza H7N9 vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT03318315?
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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