Co-Administration of AS03 Adjuvanted A/H7N9 IIV With IIV4
Public ClinicalTrials.gov record NCT03318315. 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 II Study in Healthy Adults (19-64 Years of Age) to Assess the Safety, Reactogenicity and Immunogenicity of Sequential or Simultaneous Intramuscular Administration of an AS03-adjuvanted A/H7N9 Inactivated Influenza Vaccine With Seasonal Influenza Vaccine
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03318315
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 149 participants
Conditions and interventions
Conditions
Interventions
- AS03 Drug
- Inactivated influenza H7N9 vaccine Biological
- Influenza Virus Quadrivalent Inactivated Vaccine Biological
- Phosphate Buffered Saline (PBS) diluent Other
Drug · Biological · Other
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
- Feb 19, 2018
- Primary completion
- Jul 24, 2019
- Completion
- Jul 24, 2019
- Last update posted
- Aug 5, 2020
2018 – 2019
United States locations
- U.S. sites
- 4
- U.S. states
- 4
- U.S. cities
- 4
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham School of Medicine - Alabama Vaccine Research Clinic | Birmingham | Alabama | 35294-2050 | — |
| University of Maryland School of Medicine - Center for Vaccine Development - Baltimore | Baltimore | Maryland | 21201-1509 | — |
| Cincinnati Children's Hospital Medical Center - Infectious Diseases | Cincinnati | Ohio | 45229-3039 | — |
| Vanderbilt University Medical Center - Infectious Diseases | Nashville | Tennessee | 37232-0011 | — |
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 NCT03318315, 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 Aug 5, 2020 · Synced Sep 19, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03318315 live on ClinicalTrials.gov.