Clinical trial NCT01776541: Safety and Immunogenicity of Two Doses of H5N1 Influenza Vaccine in Healthy Adults
Official title: A Phase II, Randomized, Observer-Blind,Multi-Center, Study to Evaluate Safety, Tolerability and Immunogenicity of an Adjuvanted Cell Culture-Derived H5N1 Subunit Influenza Virus Vaccine at Two Different Formulations in Healthy Adult Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pandemic H5N1 Influenza
Keywords: Influenza, Pandemic, H5N1, Adults
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Department of Health and Human Services
First posted: 2013-01-28
Enrollment: 979
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 Safety, Tolerability and Immune Response of Adjuvanted H5N1 Cell Culture Derived Influenza Vaccine in Adult Subjects.


Eligibility criteria: Inclusion Criteria:

1. Healthy adult subjects 18 to 64 years of age,
2. Individuals willing to provide written informed consent,
3. Individuals in good health,
4. Individuals willing to allow for their serum samples to be stored beyond the study period.

Exclusion Criteria:

1. Individuals not able to understand and follow study procedures,
2. History of any significant illness,
3. History of any chronic medical condition or progressive disease,
4. Presence of medically significant cancer,
5. Known or suspected impairment/alteration of immune function,
6. Presence of any progressive or severe neurologic disorder,
7. Presence of any bleeding disorders or conditions that prolongs bleeding time,
8. History of allergy to vaccine components,
9. Receipt of any other investigational product within 30 days prior to entry into the study,
10. History of previous H5N1 vaccination,
11. Receipt of any other type of seasonal vaccination within 2 months prior to entry into the study,
12. Receipt of any other vaccine within 2 weeks prior to entry into the study
13. Body temperature ≥38°C.0 (≥100.4° F) and/or acute illness within 3 days of intended study vaccination,
14. Pregnant or breast feeding,
15. Females of childbearing potential refusing to use acceptable method of birth control,
16. Body mass index (BMI) ≥ 35 kg/m2,
17. History of drug or alcohol abuse,
18. Any planned surgery during study period,
19. Individuals conducting the study and their immediate family members,
20. Individuals with behavioral or cognitive impairment or psychiatric diseases.

Primary outcomes:
measure: Percentages Of Subjects Achieving Hemagglutinin Inhibition (HI) Titers ≥40 Against A/H5N1 Strain.
timeFrame: Three weeks after 2nd vaccination (day 43)
measure: Percentages Of Subjects Achieving Seroconversion Against A/H5N1 Strain.
timeFrame: Three weeks after 2nd vaccination (day 43)
measure: Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AE), After Any Vaccination.
timeFrame: From day 1 through day 7 after any vaccination.
measure: Number of Subjects Reporting Unsolicited AEs After Any Vaccination.
timeFrame: Any unsolicited AEs - day 1 through day 22 after any vaccination. SAEs, NOCDs. medically attended AEs, AESIs, AEs leading to study withdrawal- day 1 to day 387
Secondary outcomes:
measure: Geometric Mean Ratios Against A/H5N1 Strain Following 2-dose Vaccination Schedule of Either Low Dose or High Dose aH5N1c Vaccine.
timeFrame: Day 1; day 22; day 43 and day 387
measure: Percentages Of Subjects With HI Titers ≥40 Against A/H5N1 Strain.
timeFrame: Day 1, day 22, day 43 and day 387
measure: Percentages Of Subjects Achieving Seroconversion Against A/H5N1 Strain.
timeFrame: Day 22, day 43 and day 387
Other outcomes:
Locations:
city: Miami
country: United States
facility: 1 Miami Research Associates
state: Florida
city: St. Louis
country: United States
facility: 2 Mercy Health Research
state: Missouri
city: St. Louis
country: United States
facility: 3 Saint Louis University
state: Missouri
city: Austin
country: United States
facility: 4 Benchmark Medical Research
state: Texas
city: Newcastle
country: Australia
facility: 48 Hunter Clinical Research
state: New South Wales
city: Adelaide
country: Australia
facility: 46 CMAX
state: South Australia
city: Nedlands
country: Australia
facility: 47 Linear Clinical Research
state: Western Australia
city: Bangkok
country: Thailand
facility: 80 Faculty of Tropical Medicine
Study officials:
affiliation: Novartis Vaccines
name: Novartis Vaccines and Diagnostics
role: STUDY_CHAIR
References:
citation: Frey SE, Shakib S, Chanthavanich P, Richmond P, Smith T, Tantawichien T, Kittel C, Jaehnig P, Mojares Z, Verma B, Kanesa-Thasan N, Hohenboken M. Safety and Immunogenicity of MF59-Adjuvanted Cell Culture-Derived A/H5N1 Subunit Influenza Virus Vaccine: Dose-Finding Clinical Trials in Adults and the Elderly. Open Forum Infect Dis. 2019 Mar 1;6(4):ofz107. doi: 10.1093/ofid/ofz107. eCollection 2019 Apr.