Safety and Immunogenicity of Two Doses of H5N1 Influenza Vaccine in Elderly Subjects

Phase 2

Completed

Conditions: Pandemic H5N1 Influenza

Interventions: Biological: Adjuvanted H5N1 pandemic influenza vaccine

Registration Number: NCT01766921

Lead Sponsor: Novartis Vaccines

Brief Summary: Evaluate Safety, Tolerability and Immune response of adjuvanted H5N1 cell culture derived influenza vaccine in elderly subjects

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1393

Inclusion Criteria

Healthy elderly subjects ≥65 years,
Individuals willing to provide written informed consent,
Individuals in good health,
Individuals willing to allow for their serum samples to be stored beyond the study period.

Exclusion Criteria

Individuals not able to understand and follow study procedures,
History of any significant illness,
History of any serious chronic medical condition or progressive disease,
Presence of medically significant cancer,
Known or suspected impairment/alteration of immune function,
Presence of any progressive or severe neurologic disorder,
Presence of any bleeding disorders or conditions that prolongs bleeding time,
History of allergy to vaccine components,
Receipt of any other investigational product within 30 days prior to entry into the study,
History of previous H5N1 vaccination,
Receipt of any other type of seasonal vaccination within 2 months prior to entry into the study,
Receipt of any other vaccine within 2 weeks prior to entry into the study
Body temperature ≥38°C.0 (≥100.4° F) and/or acute illness within 3 days of intended study vaccination,
Body mass index (BMI) ≥ 35 kg/m2,
History of drug or alcohol abuse,
Any planned surgery during study period,
Individuals conducting the study and their immediate family members,
Individuals with behavioral or cognitive impairment or psychiatric diseases.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
aH5N1c - Low dose	Adjuvanted H5N1 pandemic influenza vaccine	-
aH5N1c - High dose	Adjuvanted H5N1 pandemic influenza vaccine	-

Primary Outcome Measures

Name	Time	Method
The Percentages Of Subjects Achieving Hemagglutination Inhibition (HI) Titers ≥40 Against A/H5N1 Strain.	Baseline (day 1) and Three weeks after 2nd vaccination (day 43)	The optimal aH5N1c vaccine formulation was evaluated in terms of percentages of subjects achieving HI titers ≥40 against homologous A/H5N1 strain, three weeks after second vaccination with either low dose or high dose of aH5N1c vaccine, according to the Center for Biologics Evaluation and Research (CBER) criterion. The CBER criterion for the elderly population is met if the lower limit of the two-sided 95% confidence interval (CI) for the percentages of subjects achieving HI titer ≥40 meets or exceeds 60%.
The Percentages Of Subjects Achieving Seroconversion Against A/H5N1 Strain.	Three weeks after 2nd vaccination (day 43)	Immunogenicity was measured in terms of the percentages of subjects achieving seroconversion or significant increase in HI titer against the vaccine strain, three weeks after receiving two injections of low dose or high dose of aH5N1c vaccine according to the CBER criterion. Seroconversion is defined as, a postvaccination titer ≥40 in subjects with a prevaccination HI titer \<10; or in subjects with prevaccination HI titer ≥10, a minimum four-fold rise in postvaccination HI antibody titer. The CBER criterion for the elderly population is met if the lower limit of the two-sided 95% CI for the percentages of subjects achieving seroconversion for HI antibody titer meets or exceeds 30%.
Number of Subjects Reporting Solicited Local and Systemic Adverse Events, After Any Vaccination.	From day 1 through day 7 after any vaccination.	Safety was assessed as the number of subjects who reported solicited local and systemic adverse events following vaccination with either low or high dose of aH5N1c vaccine.
Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination.	Day 1 through day 387 after any vaccination	Safety was assessed using the number of subjects who reported any unsolicited adverse events, adverse events possibly or probably related to study vaccine, serious adverse events (SAEs), new onset of chronic diseases (NOCDs), medically attended AEs, AEs of special interest (AESIs), AEs leading to withdrawal from study following vaccination with aH5N1c vaccine

Secondary Outcome Measures

Name	Time	Method
Percentages Of Subjects With HI Titers ≥40 Against A/H5N1 Strain	Day 1, day 22, day 43 and day 387.	Immunogenicity was assessed in terms of percentage of subjects achieving HI titers \>40, three weeks after second vaccination with aH5N1c according to the CHMP criterion. The European Licensure (CHMP) criterion is met if the percentage of subjects achieving HI titers ≥40 is \>60%.
The Percentages Of Subjects Achieving Seroconversion Against A/H5N1 Strain	Day 22, day 43 and day 387	Immunogenicity was assessed in terms of percentages of subjects achieving seroconversion in HI titers, three weeks after receiving two injections of either low dose or high dose aH5N1c vaccine according to the CHMP criterion. Seroconversion is defined as a postvaccination titer ≥40 in subjects with a prevaccination HI titer \<10; or in subjects with prevaccination HI titer ≥10, a minimum four-fold rise in postvaccination HI antibody titer. The criterion is met according to the European (CHMP) guideline if the percentage of subjects achieving seroconversion is \>30%.
Geometric Mean Ratios (GMR) Against A/H5N1 Strain Following 2-dose Vaccination Schedule of Either Low Dose or High Dose aH5N1c Vaccine.	Day 1; day 22; day 43 and day 387	Immunogenicity was measured as the GMR. The ratio of postvaccination to prevaccination HI geometric mean titers (GMTs) is reported. The criterion is met according to the European Committee for Medicinal Products for Human Use (CHMP) criterion if the geometric mean increase GMR (day 43/day 1) in HI antibody titer is \>2.0 for subjects \>60 years of age.

Trial Locations

Locations (23): 7 Heartland Rsrch Ass LLC
🇺🇸
Wichita, Kansas, United States
71 Phramongkutklao Hospital
🇹🇭
Bangkok, Thailand
4 Benchmark Medical Research
🇺🇸
Austin, Texas, United States
51 Riccarton Clinic
🇳🇿
Riccarton, Christchurch, New Zealand
73 Siriraj Clinical Research Ctr
🇹🇭
Bangkok, Thailand
9 Heartland Research Associates
🇺🇸
Wichita, Kansas, United States
2 Mercy Health Research
🇺🇸
Saint Louis, Missouri, United States
5 Broward Research Group Pembroke Pines
🇺🇸
Hollywood, Florida, United States
8 J. Lewis Research Inc.
🇺🇸
Salt Lake City, Utah, United States
40 CMAX
🇦🇺
Adelaide, South Australia, Australia
12 Tekton Research
🇺🇸
Georgetown, Texas, United States
45 Childrens Clin Rsrch Facility
🇦🇺
Perth, Western Australia, Australia
3 Saint Louis University
🇺🇸
Saint Louis, Missouri, United States
74 Chiang Mai Uni Hospital Clinical Trial Center
🇹🇭
Bangkok, Thailand
42 Hunter Clinical Research
🇦🇺
Newcastle, New South Wales, Australia
44 Wesley Research Institute Clinical Trials Center
🇦🇺
Auchenflower, Queensland, Australia
72 Faculty of Medicine, Chulalongkorn University - Queen Saovabha Memorial Institute
🇹🇭
Bangkok, Thailand
50 Southern Clinical Trials
🇳🇿
Beckenham, Christchurch, New Zealand
1 Tatum Highlands Med Ass PLLC
🇺🇸
Phoenix, Arizona, United States
41 Linear Clinical Research
🇦🇺
Nedlands, Western Australia, Australia
11 Jordan River Family Medicine
🇺🇸
South Jordan, Utah, United States
6 Regional Clinical Research Endwell,
🇺🇸
Endwell, New York, United States
10 Foothill Family Clinic
🇺🇸
South Cottonwood Heights, Utah, United States