Clinical trial NCT01766921: Safety and Immunogenicity of Two Doses of H5N1 Influenza Vaccine in Elderly Subjects
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 Elderly Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pandemic H5N1 Influenza
Keywords: Influenza, Pandemic, H5N1, Elderly adults
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Department of Health and Human Services
First posted: 2013-01-11
Enrollment: 1393
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_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 elderly subjects


Eligibility criteria: Inclusion Criteria:

1. Healthy elderly subjects ≥65 years,
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 serious 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. Body mass index (BMI) ≥ 35 kg/m2,
15. History of drug or alcohol abuse,
16. Any planned surgery during study period,
17. Individuals conducting the study and their immediate family members,
18. Individuals with behavioral or cognitive impairment or psychiatric diseases.

Primary outcomes:
measure: The Percentages Of Subjects Achieving Hemagglutination Inhibition (HI) Titers ≥40 Against A/H5N1 Strain.
timeFrame: Baseline (day 1) and Three weeks after 2nd vaccination (day 43)
measure: The 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, After Any Vaccination.
timeFrame: From day 1 through day 7 after any vaccination.
measure: Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination.
timeFrame: Day 1 through day 387 after any vaccination
Secondary outcomes:
measure: Geometric Mean Ratios (GMR) 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: The Percentages Of Subjects Achieving Seroconversion Against A/H5N1 Strain
timeFrame: Day 22, day 43 and day 387
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: 1 Tatum Highlands Med Ass PLLC
state: Arizona
city: Hollywood
country: United States
facility: 5 Broward Research Group Pembroke Pines
state: Florida
city: Wichita
country: United States
facility: 7 Heartland Rsrch Ass LLC
state: Kansas
city: Wichita
country: United States
facility: 9 Heartland Research Associates
state: Kansas
city: Saint Louis
country: United States
facility: 2 Mercy Health Research
state: Missouri
city: Saint Louis
country: United States
facility: 3 Saint Louis University
state: Missouri
city: Endwell
country: United States
facility: 6 Regional Clinical Research Endwell,
state: New York
city: Austin
country: United States
facility: 4 Benchmark Medical Research
state: Texas
city: Georgetown
country: United States
facility: 12 Tekton Research
state: Texas
city: Salt Lake City
country: United States
facility: 8 J. Lewis Research Inc.
state: Utah
city: South Cottonwood Heights
country: United States
facility: 10 Foothill Family Clinic
state: Utah
city: South Jordan
country: United States
facility: 11 Jordan River Family Medicine
state: Utah
city: Newcastle
country: Australia
facility: 42 Hunter Clinical Research
state: New South Wales
city: Auchenflower
country: Australia
facility: 44 Wesley Research Institute Clinical Trials Center
state: Queensland
city: Adelaide
country: Australia
facility: 40 CMAX
state: South Australia
city: Nedlands
country: Australia
facility: 41 Linear Clinical Research
state: Western Australia
city: Perth
country: Australia
facility: 45 Childrens Clin Rsrch Facility
state: Western Australia
city: Beckenham
country: New Zealand
facility: 50 Southern Clinical Trials
state: Christchurch
city: Riccarton
country: New Zealand
facility: 51 Riccarton Clinic
state: Christchurch
city: Bangkok
country: Thailand
facility: 72 Faculty of Medicine, Chulalongkorn University - Queen Saovabha Memorial Institute
city: Bangkok
country: Thailand
facility: 71 Phramongkutklao Hospital
city: Bangkok
country: Thailand
facility: 73 Siriraj Clinical Research Ctr
city: Bangkok
country: Thailand
facility: 74 Chiang Mai Uni Hospital Clinical Trial Center
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.