Phase 1
Completed N=402
Dose-finding Study of Four Dosage Levels of an H7N9 Influenza Vaccine in Adults Between Ages of 18 Years and 65 Years
H7N9 Influenza
Source: ClinicalTrials.gov NCT01928472 ↗
Enrolled (actual)
402
Serious AEs
2.0%
Results posted
May 2015
Primary outcomePrimary: Geometric Mean Titers Of Subjects After Each Vaccination Of a Cell-Culture Derived H7N9c Monovalent Vaccine, Hemagglutination Inhibition Assay (Day 43) — 5; 5; 5; 5.05 Titers
Summary
Evaluate the safety and immunogenicity of four different doses of H7N9 vaccination in adults between the ages of 18 years and 65 years.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Geometric Mean Titers Of Subjects After Each Vaccination Of a Cell-Culture Derived H7N9c Monovalent Vaccine, Hemagglutination Inhibition Assay (Day 43) |
5; 5; 5; 5.05; 12; 19 | — |
| PRIMARY Geometric Mean Ratios In Subjects After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Day 43) |
2.42; 3.7; 5.2; 1.14 | — |
| PRIMARY Percentages Of Subjects Achieving Seroconversion After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 43) |
26; 44; 52; 3 | — |
| PRIMARY Percentages Of Subjects With an HI Titers ≥1:40 After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 43) |
0; 0; 0; 0; 26; 44 | — |
| PRIMARY Number of Subjects Reporting Unsolicited Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine |
29; 31; 24; 24; 6; 11 | — |
| PRIMARY Number of Subjects Reporting Unsolicited Serious Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine |
2; 2; 3; 1; 0; 0 | — |
| PRIMARY Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine |
47; 77; 60; 30; 42; 74 | — |
| SECONDARY Geometric Mean Titers Of Subjects After Each Vaccination Of A Cell-Culture Derived H7N9c Monovalent Vaccine, HI Assay (Day 22) |
5; 5; 5; 5.05; 5.07; 5 | — |
| SECONDARY Geometric Mean Ratios In Subjects After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Day 22) |
1.01; 1; 1; 1.01 | — |
| SECONDARY Percentages Of Subjects Achieving Seroconversion After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 22) |
0; 0; 0; 0 | — |
| SECONDARY Percentages Of Subjects With an HI Titers≥1:40 After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 22) |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Geometric Mean Titers at Six Months and One Year After Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Persistence) |
5.17; 5.43; 5.99; 5.16; 5; 5.14 | — |
| SECONDARY Geometric Mean Ratios at Six Months and One Year After the First Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Persistence) |
1.03; 1.09; 1.2; 1.02; 1; 1.03 | — |
| SECONDARY Percentages Of Subjects Achieving Seroconversion at Six Months and One Year After Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Persistence) |
0; 1; 1; 1; 0; 1 | — |
| SECONDARY Percentages Of Subjects With an HI Titers ≥1:40 at Six Months and at One Year After the First Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Persistence) |
0; 1; 1; 1; 0; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy adult subject ages 18-64 years.
- Individuals willing to provide written informed consent
- Individuals in good health.
- Individuals who can comply with study procedures and follow-up.
Exclusion Criteria
- Individuals with history of cognitive or behavioral impairment or psychiatric disease,
- Individuals unable to understand and follow study procedures,
- History of significant illness,
- History of chronic medical condition or progressive disease,
- Allergy to any vaccine component or adverse event related to a vaccine component,
- Impairment/alteration of the immune system,
- Presence of progressive or severe neurological disorder,
- Pregnant or breast-feeding,
- Female of Child-bearing potential unwilling to use acceptable method of birth control,
- Presence of medically significant cancer,
- Receipt of investigational product within 30 day prior to entry into the study,
- History of previous or suspected illness from avian flu caused by H7N9 virus,
- History of H7 vaccination,
- Body temperature of greater than or equal to 38.0°C (100.4◦F) and/or acute illness within 3 days of intended study vaccination,
- Receipt of any flu vaccination 2 weeks before study entry or 4 weeks after study vaccination,
- Receipt of any vaccination 2 weeks before study entry or 4 weeks after study vaccination,
- History of drug or alcohol abuse within the past 2 years,
- Body Mass Index (BMI) greater than or equal to 35kg/m2,
- Individuals conducting the study or their immediate family members.
Data sourced from ClinicalTrials.gov (NCT01928472). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.