2017 A/H7N9 IIV Revaccination
Public ClinicalTrials.gov record NCT03738241. 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 to Assess the Safety, Reactogenicity and Immunogenicity of a Single Dose of 2017 A/H7N9 Inactivated Influenza Vaccine (IIV) Administered Intramuscularly With or Without AS03 Adjuvant in 2013 A/H7N9 IIV Primed or A/H7 IIV Naïve Subjects
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a Phase II clinical trial in up to 420 males and non-pregnant females, 19 to 70 years of age, inclusive, who are in good health and meet all eligibility criteria. This clinical trial is designed to assess the safety, reactogenicity and immunogenicity of one dose of a monovalent inactivated split influenza 2017 A/H7N9 virus vaccine (2017 A/H7N9 IIV), administered intramuscularly (IM) at 3.75 mcg hemagglutinin (HA) per dose, given with or without AS03 adjuvant to subjects primed with a monovalent inactivated split influenza 2013 A/H7N9 virus vaccine (2013 A/H7N9 IIV) in DMID Protocols 13-0032 and 13-0033, or to those who are A/H7 IIV-naïve. Phosphate buffered saline (PBS) diluent will be used to achieve the targeted dosage. The study will be conducted at 9 Vaccine and Treatment Evaluation Unit (VTEU) sites (including their subcontractors). Study duration is approximately 17 months with subject participation duration up to 13 months. The primary objectives are: 1) to assess the safety and reactogenicity of 2017 A/H7N9 IIV given with or without AS03 adjuvant following receipt of one dose of study vaccine; 2) to assess the serum hemagglutination inhibition (HAI) and neutralizing (Neut) antibody responses following receipt of the study vaccine.
Study identification
- NCT ID
- NCT03738241
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 304 participants
Conditions and interventions
Conditions
Interventions
- A/H7N9 Biological
- AS03 Drug
- Phosphate Buffered Saline (PBS) diluent Other
Biological · Drug · Other
Eligibility (public fields only)
- Age range
- 19 Years to 70 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
- Dec 18, 2018 (Actual)
- Primary completion
- Jun 19, 2020 (Actual)
- Completion
- Jun 19, 2020 (Actual)
- Last update posted
- Jul 30, 2021
2018 – 2020
United States locations
- U.S. sites
- 9
- U.S. states
- 8
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Emory Children's Center - Pediatric Infectious Diseases | Atlanta | Georgia | 30322-1014 | — |
| University of Iowa - Vaccine Research and Education Unit | Iowa City | Iowa | 52242-2600 | — |
| University of Maryland Baltimore - School of Medicine - Medicine | Baltimore | Maryland | 21201-1509 | — |
| Saint Louis University - Center for Vaccine Development | St Louis | Missouri | 63104-1015 | — |
| Cincinnati Children's Hospital Medical Center - Infectious Diseases | Cincinnati | Ohio | 45229-3039 | — |
| Vanderbilt University Medical Center - Infectious Diseases | Nashville | Tennessee | 37232-0011 | — |
| The University of Texas Medical Branch - Sealy Center for Vaccine Development (SCVD) | Galveston | Texas | 77555-1121 | — |
| Baylor College of Medicine - Molecular Virology and Microbiology | Houston | Texas | 77030-3411 | — |
| Kaiser Permanente Washington Health Research Institute - Vaccines and Infectious Diseases | Seattle | Washington | 98101-1466 | — |
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 NCT03738241, 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 Jul 30, 2021 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03738241 live on ClinicalTrials.gov.