Immunogenicity, Safety and Tolerability of Prepandemic Influenza and Seasonal Influenza Vaccine in Adult Subjects
This study has been completed.
Sponsor:
Novartis
Collaborator:
Novartis Vaccines
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00481065
First received: May 31, 2007
Last updated: January 23, 2013
Last verified: January 2013
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pandemic Avian Influenza |
Biological: MF59-eH5N1 Biological: eTIV_a Biological: MF59-eH5N1 + eTIV_a |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| 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 |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine [ Time Frame: 21 days after second and third vaccinations (day 43 and day 403) ] [ Designated as safety issue: No ]
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.
- Geometric Mean Ratio After Two or Three Vaccinations of the MF59-eH5N1 Influenza Vaccine [ Time Frame: 21 days after second and third vaccinations (day 22 and day 43) ] [ Designated as safety issue: No ]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.
- Number of Subjects Who Responded to Two Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H1N1) [ Time Frame: 21 days after second vaccination (day 43) ] [ Designated as safety issue: No ]
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.
- Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H3N2) [ Time Frame: 21 days after second and third vaccinations (day 43 and day 403) ] [ Designated as safety issue: No ]
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.
- Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain B) [ Time Frame: 21 days after second and third vaccinations (day 43 and day 403) ] [ Designated as safety issue: No ]
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.
- Geometric Mean Ratio After Two Doses of the Seasonal eTIV_a Influenza Vaccine (Strain H1N1) [ Time Frame: 21 days after second vaccination (day 43) ] [ Designated as safety issue: No ]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.
- Geometric Mean Ratio After Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccine (Strain H3N1) [ Time Frame: 21 days after second and third vaccinations (day 43 and day 403) ] [ Designated as safety issue: No ]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.
- Geometric Mean Ratio After Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccine (Strain B) [ Time Frame: 21 days after second and third vaccinations (day 43 and day 403) ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- Number of Subjects Reporting Local and Systemic Reactions by Vaccination [ Time Frame: 21 days after second and third vaccinations (day 43 and day 403) ] [ Designated as safety issue: Yes ]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.
- 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 [ Time Frame: 21 days after booster vaccination (day 403) ] [ Designated as safety issue: No ]
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.
- Geometric Mean Ratio After the Booster Vaccination Against the MF59-eH5N1 Influenza Vaccine Mixed Extemporaneously With the Seasonal eTIV_a Influenza Vaccine [ Time Frame: 21 days after booster vaccination (day 403) ] [ Designated as safety issue: No ]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.
| Enrollment: | 405 |
| Study Start Date: | April 2007 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Concomitant alone
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.
|
Biological: MF59-eH5N1 Biological: eTIV_a Biological: MF59-eH5N1 + eTIV_a |
|
Experimental: Concomitant +Mixed
1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
|
Biological: MF59-eH5N1 Biological: eTIV_a Biological: MF59-eH5N1 + eTIV_a |
|
Experimental: Concomitant +MF59-eH5N1
1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
|
Biological: MF59-eH5N1 Biological: eTIV_a Biological: MF59-eH5N1 + eTIV_a |
|
Experimental: Mixed
1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
|
Biological: MF59-eH5N1 Biological: eTIV_a Biological: MF59-eH5N1 + eTIV_a |
|
Experimental: Mixed and mixed
1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382
|
Biological: MF59-eH5N1 Biological: eTIV_a Biological: MF59-eH5N1 + eTIV_a |
|
Experimental: Mixed+MF59-eH5N1
1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
|
Biological: MF59-eH5N1 Biological: eTIV_a Biological: MF59-eH5N1 + eTIV_a |
|
Experimental: MF59-eH5N1+eTIV_a
1 dose of MF59-eH5N1 on day 1, 1 dose of eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
|
Biological: MF59-eH5N1 Biological: eTIV_a Biological: MF59-eH5N1 + eTIV_a |
|
Experimental: eTIV_a+MF59-eH5N1
1 dose of eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
|
Biological: MF59-eH5N1 Biological: eTIV_a Biological: MF59-eH5N1 + eTIV_a |
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Healthy subjects
Contacts and Locations More Information
Publications:
| Responsible Party: | Novartis |
| ClinicalTrials.gov Identifier: | NCT00481065 History of Changes |
| Other Study ID Numbers: | V87P5 |
| Study First Received: | May 31, 2007 |
| Results First Received: | August 26, 2011 |
| Last Updated: | January 23, 2013 |
| Health Authority: | Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos |
Keywords provided by Novartis:
|
Bird flu influenza vaccine Seasonal influenza vaccine Prepandemic vaccine |
Additional relevant MeSH terms:
|
Influenza in Birds Influenza, Human Orthomyxoviridae Infections RNA Virus Infections |
Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 16, 2013