Clinical trial NCT00620815: Safety and Immunogenicity of Two Doses of a Tetravalent Influenza Vaccine in Adults Aged 18 Years and Above
Official title: A Phase II, Randomized, Placebo-controlled, Observer-blind, Multi Center Study on the Safety and Immunogenicity of Novartis Tetravalent Influenza Vaccine (Containing Both Interpandemic Strains and H5N1) in Adults Aged 18 Years and Above
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza
Keywords: avian flu
seasonal influenza vaccine
influenza vaccine
prepandemic vaccine
virus strain with the potential to cause pandemic
tetravalent vaccine
Prophylaxis of influenza
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-02-22
Enrollment: 601
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Evaluate the immune response and reactogenicity of H5N1 vaccination in adults aged 18 years and above (as part of a tetravalent vaccine)


Eligibility criteria: Inclusion Criteria:

* Healthy subjects (aged 18 years and above) who have signed an informed consent form

Exclusion Criteria:

* Any acute or chronic illness
* Receipt of seasonal influenza vaccine for the current season 2007/2008
* Known or suspected impairment/alteration of immune function
* Receipt of another vaccine within 3 weeks prior to Visit 1 or planned vaccination within 3 weeks following the last study vaccination
* Any serious disease
* Hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein,neomycin or kanamycin or any other component of the study vaccine
* Receipt of blood, blood products or immunoglobulins 3 months prior to vaccination

Primary outcomes:
measure: To Demonstrate the Equivalence of Antibody Response Against A/H5N1 Strain Elicited by the Three Different Immunization Schedules on Day 43.
timeFrame: up to day 43
Secondary outcomes:
measure: Number of Subjects (Subjects ≤ 60 Years) With Reported Local Reactions After First Vaccination
timeFrame: Up to 7 days after 1st vaccination
measure: Number of Subjects (Subjects ≤60 Years) With Reported Local Reactions After Second Vaccination
timeFrame: Up to 7 days after 2nd vaccination
measure: Number of Subjects (Subjects ≤ 60 Years) With Reported Systemic Reactions After 1st and 2nd Vaccinations.
timeFrame: 7 days after 1st and 2nd vaccinations each
measure: Percentages of Subjects Achieving Seroconversion/Significant Increase in Antibody Titre/ Area as Measured by SRH and (HI) and at Least 4 Fold Rise in Titres by Micro-neutralization (MN) Assay-H5N1 Strain
timeFrame: up to day 43
measure: Percentages of Subjects Achieving HI/MN ≥ 1:40 and SRH Area ≥ 25^mm2
timeFrame: Up to 43 days
measure: Antibody Response Determined by HI and MN Assay.
timeFrame: Up to 43 days
measure: Percentages of B-cell Antibodies Against H5N1 and H1N1 After Each Vaccination.
timeFrame: Three weeks after first vaccination (day 22) and three weeks after second vaccination (day 43)
measure: Mean T-Cells Per Million Total Cells (95% CI) in Response to H5 Peptides and H5N1 Subunit
timeFrame: Three weeks after 1st vaccination (day 22) and three weeks after 2nd vaccination (day 43)
Other outcomes:
Locations:
city: Holzkirchen
country: Germany
facility: ATRIUM Gesundheitszentrum;
city: Munich
country: Germany
facility: International Medicine & Public Health Dept. of Infect. Diseases
Study officials:
affiliation: Novartis
name: Novartis Vaccines and Diagnostics
role: STUDY_CHAIR
References:
citation: Herbinger KH, von Sonnenburg F, Nothdurft HD, Perona P, Borkowski A, Fragapane E, Nicolay U, Clemens R. A phase II study of an investigational tetravalent influenza vaccine formulation combining MF59(R): adjuvanted, pre-pandemic, A/H5N1 vaccine and trivalent seasonal influenza vaccine in healthy adults. Hum Vaccin Immunother. 2014;10(1):92-9. doi: 10.4161/hv.26495. Epub 2013 Sep 20.