← Back to Search

Virus Vaccine

Arm 1 for Avian Flu

Phase 2
Waitlist Available
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 pre-vaccination 1; days 2, 4, 8, and 29 post-vaccination 1 (day 2, 4, 8, and 29, respectively); days 2, 4, and 8 post-vaccination 2 (day 30, 32, and 36, respectively)
Awards & highlights

Summary

This is a single center, randomized, partially-blinded, Phase II, small, targeted, prospective study in approximately 30 healthy male and non-pregnant female subjects aged 18 to 49 years old, inclusive, designed to evaluate and compare the immunogenicity between an intramuscular monovalent inactivated influenza A/H7N9 virus vaccine given with and without AS03 adjuvant, and an intramuscular unadjuvanted monovalent inactivated influenza A/H3N2v virus vaccine. The primary objectives are (1) assessing the serum anti-HA hemagglutination-inhibition (HAI) response to influenza A/H7N9 antigen (with and without adjuvant) at Day 57 (approximately one month after the second study vaccination with A/H7N9 vaccine with or without AS03) and influenza A/H3N2v antigen at Day 29 (approximately one month after the study vaccination with A/H3N2v), and (2) identifying differentially expressed genes in human immune cells on Days 2, 4, and 29 (following the first study vaccination with A/H7N9 vaccine with or without AS03) and on Days 30, 32, and 36 (following the second study vaccination with A/H7N9 vaccine with or without AS03), compared to baseline assessments performed prior to each study vaccination (Days -7, 1, and 29).

Eligible Conditions
  • Avian Flu
  • Flu
  • Influenza

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 pre-vaccination 1; days 2, 4, 8, and 29 post-vaccination 1 (day 2, 4, 8, and 29, respectively); days 2, 4, and 8 post-vaccination 2 (day 30, 32, and 36, respectively)
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 pre-vaccination 1; days 2, 4, 8, and 29 post-vaccination 1 (day 2, 4, 8, and 29, respectively); days 2, 4, and 8 post-vaccination 2 (day 30, 32, and 36, respectively) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Differentially Expressed Genes Based on RNA Expression in Human Immune Cells (A/H7N9 Vaccine, With and Without Adjuvant)
Percentage of Participants Achieving Seroconversion Based on HAI Titer (A/H3N2v Vaccine)
Percentage of Participants Achieving Seroconversion Based on HAI Titer (A/H7N9 Vaccine, With and Without Adjuvant)
Secondary outcome measures
Chemokine CXCL10
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 2
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 3
+9 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Arm 3Experimental Treatment1 Intervention
10 Subjects: two doses of 3.75 µg of A/H7N9, at Day 1 and Day 29
Group II: Arm 2Experimental Treatment2 Interventions
10 Subjects: two doses of 3.75 µg of AH7N9 AS03,at Day 1 and at Day 29
Group III: Arm 1Experimental Treatment1 Intervention
10 Subjects: one dose of 15 µg of A/H3N2v, at Day 1
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AS03
2017
Completed Phase 2
~5460
Influenza Virus Vaccine, Monovalent A/H3N2v A/Minnesota/11/2010 NYMC X-203
2016
Completed Phase 2
~300
Monovalent influenza A/H7N9 virus vaccine
2016
Completed Phase 2
~60

Find a Location

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,283 Previous Clinical Trials
5,498,902 Total Patients Enrolled
~3 spots leftby Jul 2025