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

Pandemic H5N1 Influenza Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01766921
• Other study ID #: V89_13
• Status: Completed
• Phase: Phase 2
• Start date: January 2013
• Est. completion date: July 2014

Study information

• Verified date: January 2019
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1393
• Est. completion date: July 2014
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Influenza, Human
• Pandemic H5N1 Influenza

Intervention

Biological:
• Adjuvanted H5N1 pandemic influenza vaccine
Comparison of two doses of aH5N1c vaccine

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Novartis Vaccines	Department of Health and Human Services

Countries where clinical trial is conducted

United States,  Australia,  New Zealand,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Percentages Of Subjects Achieving Hemagglutination Inhibition (HI) Titers =40 Against A/H5N1 Strain.	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%.	Baseline (day 1) and Three weeks after 2nd vaccination (day 43)
Primary	The Percentages Of Subjects Achieving Seroconversion Against A/H5N1 Strain.	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%.	Three weeks after 2nd vaccination (day 43)
Primary	Number of Subjects Reporting Solicited Local and Systemic Adverse Events, 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.	From day 1 through day 7 after any vaccination.
Primary	Number of Subjects Reporting Unsolicited Adverse Events 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	Day 1 through day 387 after any vaccination
Secondary	Geometric Mean Ratios (GMR) Against A/H5N1 Strain Following 2-dose Vaccination Schedule of Either Low Dose or High Dose aH5N1c Vaccine.	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.	Day 1; day 22; day 43 and day 387
Secondary	Percentages Of Subjects With HI Titers =40 Against A/H5N1 Strain	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%.	Day 1, day 22, day 43 and day 387.
Secondary	The Percentages Of Subjects Achieving Seroconversion Against A/H5N1 Strain	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%.	Day 22, day 43 and day 387