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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01776541




Registration number
NCT01776541
Ethics application status
Date submitted
20/01/2013
Date registered
28/01/2013
Date last updated
3/02/2015

Titles & IDs
Public title
Safety and Immunogenicity of Two Doses of H5N1 Influenza Vaccine in Healthy Adults
Scientific 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.
Secondary ID [1] 0 0
V89_04
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pandemic H5N1 Influenza 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Adjuvanted H5N1 pandemic influenza vaccine

Experimental: aH5N1c-High Dose - Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.

Experimental: aH5N1c-Low dose - Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.


Treatment: Other: Adjuvanted H5N1 pandemic influenza vaccine
Comparison of two doses of aH5N1c vaccine
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentages Of Subjects Achieving Hemagglutinin Inhibition (HI) Titers =40 Against A/H5N1 Strain.
Timepoint [1] 0 0
Three weeks after 2nd vaccination (day 43)
Primary outcome [2] 0 0
Percentages Of Subjects Achieving Seroconversion Against A/H5N1 Strain.
Timepoint [2] 0 0
Three weeks after 2nd vaccination (day 43)
Primary outcome [3] 0 0
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AE), After Any Vaccination.
Timepoint [3] 0 0
From day 1 through day 7 after any vaccination.
Primary outcome [4] 0 0
Number of Subjects Reporting Unsolicited AEs After Any Vaccination.
Timepoint [4] 0 0
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 outcome [1] 0 0
Geometric Mean Ratios Against A/H5N1 Strain Following 2-dose Vaccination Schedule of Either Low Dose or High Dose aH5N1c Vaccine.
Timepoint [1] 0 0
Day 1; day 22; day 43 and day 387
Secondary outcome [2] 0 0
Percentages Of Subjects With HI Titers =40 Against A/H5N1 Strain.
Timepoint [2] 0 0
Day 1, day 22, day 43 and day 387
Secondary outcome [3] 0 0
Percentages Of Subjects Achieving Seroconversion Against A/H5N1 Strain.
Timepoint [3] 0 0
Day 22, day 43 and day 387

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
64 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2014
Sample size
Target
Accrual to date
Final
979
Recruitment in Australia
Recruitment state(s)
NSW,SA,WA
Recruitment hospital [1] 0 0
48 Hunter Clinical Research - Newcastle
Recruitment hospital [2] 0 0
46 CMAX - Adelaide
Recruitment hospital [3] 0 0
47 Linear Clinical Research - Nedlands
Recruitment postcode(s) [1] 0 0
2292 - Newcastle
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Missouri
Country [3] 0 0
United States of America
State/province [3] 0 0
Texas
Country [4] 0 0
Thailand
State/province [4] 0 0
Bangkok

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Vaccines
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
Department of Health and Human Services
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Vaccines and Diagnostics
Address 0 0
Novartis Vaccines
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01776541