H5N8 Mix and Match With or Without AS03 or MF59 in Healthy Adults: Immunology
Public ClinicalTrials.gov record NCT03014310. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase I Cohort-Randomized, Double-Blind, Controlled Trial in Healthy Adults to Assess the Safety, Reactogenicity, and Immunogenicity of a Monovalent Inactivated Influenza A/H5N8 Virus Vaccine Administered Intramuscularly at Different Dosages Given With or Without AS03 or MF59 Adjuvants: Assessment of Immunological Responses and Lymphocyte Interplay
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a Phase I cohort-randomized, double-blind, controlled trial designed to assess the safety, reactogenicity, and immunogenicity of a monovalent inactivated influenza A/H5N8 virus vaccine administered at different dosages (3.75 and 15 mcg of HA per dose) given with or without AS03 or MF59 adjuvants. This study will be conducted at 6 sites and enroll 150 (up to 380) males and non-pregnant females, 19 to 64 years old, inclusive who are in good health and meet all eligibility criteria. The entire study duration is approximately 24 months and each subject participation duration is approximately 13 months. The primary objectives are: 1) To assess the safety and reactogenicity of a monovalent inactivated influenza A/H5N8 virus vaccine following receipt of two doses administered intramuscularly at different dosages (3.75 and 15 mcg of HA per dose) given with or without AS03 or MF59 adjuvants approximately 21 days apart. 2) To assess the serum HAI and Neut antibody responses to a monovalent inactivated influenza A/H5N8 virus vaccine following receipt of two doses administered intramuscularly at different dosages (3.75 and 15 mcg of HA per dose) given with or without AS03 or MF59 adjuvants approximately 21 days apart.
Study identification
- NCT ID
- NCT03014310
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 388 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 19 Years to 64 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 8, 2017
- Primary completion
- Dec 18, 2018
- Completion
- Dec 18, 2018
- Last update posted
- Sep 22, 2024
2017 – 2018
United States locations
- U.S. sites
- 7
- U.S. states
- 7
- U.S. cities
- 7
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Emory University School of Medicine | Atlanta | Georgia | 30322-1014 | — |
| University of Maryland Baltimore - School of Medicine - Medicine | Baltimore | Maryland | 21201-1509 | — |
| Saint Louis University Center for Vaccine Development | St Louis | Missouri | 63104-1015 | — |
| Duke Vaccine and Trials Unit | Durham | North Carolina | 27704 | — |
| Cincinnati Children's Hospital Medical Center Vaccine Research Center | Cincinnati | Ohio | 45229-3039 | — |
| Vanderbilt University - Pediatric - Vanderbilt Vaccine Research Center | Nashville | Tennessee | 37232-2573 | — |
| The University of Texas Medical Branch - Sealy Center for Vaccine Development (SCVD) | Galveston | Texas | 77555-1121 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03014310, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 22, 2024 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03014310 live on ClinicalTrials.gov.