Clinical trial NCT00481065: Immunogenicity, Safety and Tolerability of Prepandemic Influenza and Seasonal Influenza Vaccine in Adult Subjects
Official title: A Phase II, Randomized, Controlled, Open Label, Single-Center Study to Evaluate the Immunogenicity, Safety and Tolerability of an H5N1-vaccine and a Seasonal Influenza Vaccine in Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pandemic
Avian Influenza
Keywords: Bird flu
influenza vaccine
Seasonal influenza vaccine
Prepandemic vaccine
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Novartis Vaccines
First posted: 2007-06-01
Enrollment: 405
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study evaluates the immunogenicity, safety and tolerability of an H5N1 vaccine with a seasonal trivalent influenza vaccine, containing the strains recommended by WHO for the 2007 influenza season in the Southern Hemisphere.


Eligibility criteria: Inclusion Criteria:

* Healthy subjects

Primary outcomes:
measure: Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine
timeFrame: 21 days after second and third vaccinations (day 43 and day 403)
measure: Geometric Mean Ratio After Two or Three Vaccinations of the MF59-eH5N1 Influenza Vaccine
timeFrame: 21 days after second and third vaccinations (day 22 and day 43)
measure: Number of Subjects Who Responded to Two Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H1N1)
timeFrame: 21 days after second vaccination (day 43)
measure: Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H3N2)
timeFrame: 21 days after second and third vaccinations (day 43 and day 403)
measure: Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain B)
timeFrame: 21 days after second and third vaccinations (day 43 and day 403)
measure: Geometric Mean Ratio After Two Doses of the Seasonal eTIV_a Influenza Vaccine (Strain H1N1)
timeFrame: 21 days after second vaccination (day 43)
measure: Geometric Mean Ratio After Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccine (Strain H3N1)
timeFrame: 21 days after second and third vaccinations (day 43 and day 403)
measure: Geometric Mean Ratio After Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccine (Strain B)
timeFrame: 21 days after second and third vaccinations (day 43 and day 403)
Secondary outcomes:
measure: Number of Subjects Reporting Local and Systemic Reactions by Vaccination
timeFrame: 21 days after second and third vaccinations (day 43 and day 403)
measure: Number of Subjects With Immunogenicity Results After the Booster Vaccination Against the MF59-eH5N1 Influenza Vaccine Mixed Extemporaneously With the Seasonal eTIV_a Influenza Vaccine
timeFrame: 21 days after booster vaccination (day 403)
measure: Geometric Mean Ratio After the Booster Vaccination Against the MF59-eH5N1 Influenza Vaccine Mixed Extemporaneously With the Seasonal eTIV_a Influenza Vaccine
timeFrame: 21 days after booster vaccination (day 403)
Other outcomes:
Locations:
city: Bogotà
country: Colombia
Study officials:
affiliation: Novartis
name: Novartis Drug Information Services +1 800 244 7668
role: STUDY_CHAIR
References:
citation: Lopez P, Caicedo Y, Sierra A, Tilman S, Banzhoff A, Clemens R. Combined, concurrent, and sequential administration of seasonal influenza and MF59-adjuvanted A/H5N1 vaccines: a phase II randomized, controlled trial of immunogenicity and safety in healthy adults. J Infect Dis. 2011 Jun 15;203(12):1719-28. doi: 10.1093/infdis/jir191.
citation: Lopez P, Caicedo Y, Sierra A, Tilman S, Clemens R, Banzhoff A. Combined administration of MF59-adjuvanted A/H5N1 prepandemic and seasonal influenza vaccines: long-term antibody persistence and robust booster responses 1 year after a one-dose priming schedule. Clin Vaccine Immunol. 2013 May;20(5):753-8. doi: 10.1128/CVI.00626-12. Epub 2013 Mar 27.