Clinical trial NCT01928472: Dose-finding Study of Four Dosage Levels of an H7N9 Influenza Vaccine in Adults Between Ages of 18 Years and 65 Years
Official title: Phase I Multi-center, Observer-Blind, Randomized Dose-Ranging Study of Adjuvanted and Non-Adjuvanted Cell Culture-Derived, Inactivated A/H7N9 Monovalent Subunit Influenza Virus Vaccine (H7N9c) in Adults 18 to <65 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: H7N9 Influenza
Keywords: Influenza, H7N9, Vaccine
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2013-08-26
Enrollment: 402
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Evaluate the safety and immunogenicity of four different doses of H7N9 vaccination in adults between the ages of 18 years and 65 years.


Eligibility criteria: Inclusion Criteria:

1. Healthy adult subject ages 18-64 years.
2. Individuals willing to provide written informed consent
3. Individuals in good health.
4. Individuals who can comply with study procedures and follow-up.

Exclusion Criteria:

1. Individuals with history of cognitive or behavioral impairment or psychiatric disease,
2. Individuals unable to understand and follow study procedures,
3. History of significant illness,
4. History of chronic medical condition or progressive disease,
5. Allergy to any vaccine component or adverse event related to a vaccine component,
6. Impairment/alteration of the immune system,
7. Presence of progressive or severe neurological disorder,
8. Pregnant or breast-feeding,
9. Female of Child-bearing potential unwilling to use acceptable method of birth control,
10. Presence of medically significant cancer,
11. Receipt of investigational product within 30 day prior to entry into the study,
12. History of previous or suspected illness from avian flu caused by H7N9 virus,
13. History of H7 vaccination,
14. 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,
15. Receipt of any flu vaccination 2 weeks before study entry or 4 weeks after study vaccination,
16. Receipt of any vaccination 2 weeks before study entry or 4 weeks after study vaccination,
17. History of drug or alcohol abuse within the past 2 years,
18. Body Mass Index (BMI) greater than or equal to 35kg/m2,
19. Individuals conducting the study or their immediate family members.

Primary outcomes:
measure: Geometric Mean Titers Of Subjects After Each Vaccination Of a Cell-Culture Derived H7N9c Monovalent Vaccine, Hemagglutination Inhibition Assay (Day 43)
timeFrame: Day 1 and 43
measure: Geometric Mean Ratios In Subjects After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Day 43)
timeFrame: Day 43
measure: Percentages Of Subjects Achieving Seroconversion After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 43)
timeFrame: Day 43
measure: Percentages Of Subjects With an HI Titers ≥1:40 After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 43)
timeFrame: Day 1 and 43
measure: Number of Subjects Reporting Unsolicited Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine
timeFrame: Day 1 to Day 43
measure: Number of Subjects Reporting Unsolicited Serious Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine
timeFrame: Day 1 to Day 366.
measure: Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine
timeFrame: Day 1 through Day 7 after each vaccination.
Secondary outcomes:
measure: Geometric Mean Titers Of Subjects After Each Vaccination Of A Cell-Culture Derived H7N9c Monovalent Vaccine, HI Assay (Day 22)
timeFrame: Day 1 and 22
measure: Geometric Mean Ratios In Subjects After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Day 22)
timeFrame: Day 22
measure: Percentages Of Subjects Achieving Seroconversion After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 22)
timeFrame: Day 22
measure: Percentages Of Subjects With an HI Titers≥1:40 After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 22)
timeFrame: Day 1 and 22.
measure: Geometric Mean Titers at Six Months and One Year After Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Persistence)
timeFrame: Day 183 and 366.
measure: Geometric Mean Ratios at Six Months and One Year After the First Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Persistence)
timeFrame: Day 183 and 366
measure: Percentages Of Subjects Achieving Seroconversion at Six Months and One Year After Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Persistence)
timeFrame: Day 183 and 366
measure: 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)
timeFrame: Day 183 and 366
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Site 04: Accelovance
state: California
city: Melbourne
country: United States
facility: Site 01: Accelovance
state: Florida
city: Peoria
country: United States
facility: Site 02: Accelovance
state: Illinois
city: Rockville
country: United States
facility: Site 03: Accelovance
state: Maryland
city: Salt Lake City
country: United States
facility: Site 05: Janet Lewis
state: Utah
city: Salt Lake City
country: United States
facility: Site 06: Janet Lewis
state: Utah
Study officials:
affiliation: Novartis Vaccines
name: Novartis Vaccines and Diagnostics
role: STUDY_CHAIR
References: