NCT00481065|CompletedPhase 2Results

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

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

Novartis ClinicalTrials.gov

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1 other identifier

V87P5

Study Type

interventional

Target

405

Locations

1 country

Sites

Timeline

RegisteredJun 2007

StartedApr 2007

CompletionDec 2008

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

405

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Apr 2007

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.7 years study duration

Study Start

First participant enrolled

April 1, 2007

Completed

2 months until next milestone

First Submitted

Initial submission to the registry

May 31, 2007

Completed

1 day until next milestone

First Posted

Study publicly available on registry

June 1, 2007

Completed

1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed

4.2 years until next milestone

Results Posted

Study results publicly available

February 28, 2013

Completed

Last Updated

February 3, 2014

Status Verified

December 1, 2013

Enrollment Period

1.7 years

First QC Date

May 31, 2007

Results QC Date

August 26, 2011

Last Update Submit

December 31, 2013

Conditions

Pandemic Avian Influenza

Keywords

Bird fluinfluenza vaccineSeasonal influenza vaccinePrepandemic vaccine

Outcome Measures

Primary Outcomes (8)

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)
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)
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)
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)
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)
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)
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)
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)

Secondary Outcomes (3)

Number of Subjects Reporting Local and Systemic Reactions by Vaccination
21 days after second and third vaccinations (day 43 and day 403)
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
21 days after booster vaccination (day 403)
Geometric Mean Ratio After the Booster Vaccination Against the MF59-eH5N1 Influenza Vaccine Mixed Extemporaneously With the Seasonal eTIV_a Influenza Vaccine
21 days after booster vaccination (day 403)

Study Arms (8)

Concomitant alone

EXPERIMENTAL

1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV\_a into the other arm on day 1 then 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382.