Immunogenicity, Safety and Tolerability of Prepandemic Influenza and Seasonal Influenza Vaccine in Adult Subjects

Avian Influenza Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00481065
• Other study ID #: V87P5
• Status: Completed
• Phase: Phase 2
• First received: May 31, 2007
• Last updated: December 31, 2013
• Start date: April 2007
• Est. completion date: December 2008

Study information

• Verified date: December 2013
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 405
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Healthy subjects

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Avian Influenza
• Influenza, Human
• Pandemic

Intervention

Biological:
• MF59-eH5N1

• eTIV_a

• MF59-eH5N1 + eTIV_a

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Novartis	Novartis Vaccines

Country where clinical trial is conducted

Colombia, 

References & Publications (1)

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 a — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	Seroconversion (serocon.) is defined as negative pre-vaccination serum (titer <10 for HI [Haemagglutination Inhibition], area =4 mm^2 for SRH [Single Radial Haemolysis]) / positive post-vaccination titer (titer = 40 for HI, area = 25 mm^2 for SRH).; Significant increase in antibody titer is defined as at least a fourfold increase from non-negative pre-vaccination serum (HI = 10) or at least 50% increase in the SRH area.; Seroprotection is defined as a HI titer =40 and a SRH area =25 mm^2.	21 days after second and third vaccinations (day 43 and day 403)	No
Primary	Geometric Mean Ratio After Two or Three Vaccinations of the MF59-eH5N1 Influenza Vaccine	Geometric mean Ratio (GMR) was calculated for the haemagglutination inhibition (HI), microneutralization (MN) and single-radial haemolysis (SRH) result as well as the associated 95% confidence intervals. GMR was calculated as 21 days after second and third vaccinations over day 1.	21 days after second and third vaccinations (day 22 and day 43)	No
Primary	Number of Subjects Who Responded to Two Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H1N1)	seroconversion: negative pre-vaccination serum (HI titer <10, SRH area =<4 mm^2)/positive post-vaccination titer (HI titer =>10) or at least 50% increase in the SRH area.; Seroprotection is defined as a HI titer =40 and a SRH area =25 mm^2.	21 days after second vaccination (day 43)	No
Primary	Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H3N2)	seroconversion (serocon.): negative pre-vaccination serum (HI titer <10, SRH area =<4 mm^2)/positive post-vaccination titer (HI titer =>10) or at least 50% increase in the SRH area.; Seroprotection is defined as a HI titer =40 and a SRH area =25 mm^2.	21 days after second and third vaccinations (day 43 and day 403)	No
Primary	Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain B)	seroconversion (serocon.): negative pre-vaccination serum (HI titer <10, SRH area =<4 mm^2)/positive post-vaccination titer (HI titer =>10) or at least 50% increase in the SRH area.; Seroprotection is defined as a HI titer =40 and a SRH area =25 mm^2.	21 days after second and third vaccinations (day 43 and day 403)	No
Primary	Geometric Mean Ratio After Two Doses of the Seasonal eTIV_a Influenza Vaccine (Strain H1N1)	For each vaccine group, the least squares GMRs were calculated for the haemagglutination inhibition (HI) results as well as the associated 95% confidence intervals. GMR was calculated over day 1.	21 days after second vaccination (day 43)	No
Primary	Geometric Mean Ratio After Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccine (Strain H3N1)	For each vaccine group, the least squares GMRs were calculated for the haemagglutination inhibition (HI) results for each time point of the study, as well as the associated 95% confidence intervals. GMR was calculated over day 1.	21 days after second and third vaccinations (day 43 and day 403)	No
Primary	Geometric Mean Ratio After Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccine (Strain B)	For each vaccine group, the least squares GMRs were calculated for the haemagglutination inhibition (HI) results for each time point of the study, as well as the associated 95% confidence intervals. GMR was calculated over day 1.	21 days after second and third vaccinations (day 43 and day 403)	No
Secondary	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	The evaluate the safety of the administration of two or three vaccinations of MF59-eH5N1 influenza vaccine, either given sequentially, concomitantly or mixed extemporaneously with seasonal eTIV_a influenza vaccine.	21 days after second and third vaccinations (day 43 and day 403)	Yes
Secondary	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	Booster was given on day 382; seroconversion: negative pre-vaccination serum (HI titer <10, SRH area = 4 mm^2)/positive post-vaccination titer (HI titer =10) or at least 50% increase in SRH area; Seroprotection is defined as a HI titer =40 and a SRH area =25 mm^2.; The number of subjects achieving seroconversion or significant increase and seroprotection were calculated at day 382.	21 days after booster vaccination (day 403)	No
Secondary	Geometric Mean Ratio After the Booster Vaccination Against the MF59-eH5N1 Influenza Vaccine Mixed Extemporaneously With the Seasonal eTIV_a Influenza Vaccine	For each vaccine group, the least squares GMRs were calculated for the HI and SRH results for each time point of the study, as well as the associated 95% confidence intervals. GMR was calculated over day 382 for all time points for the booster dose.	21 days after booster vaccination (day 403)	No