InfluenzaPhase 2NCT00620815
Safety and Immunogenicity of Two Doses of a Tetravalent Influenza Vaccine in Adults Aged 18 Years and Above
A Phase 2 study testing Pandemic influenza vaccine + seasonal influenza vaccine /pandemic influenza vaccine and Pandemic influenza vaccine + seasonal influenza vaccine / pandemic influenza vaccine in people with Influenza, run by Novartis Vaccines at 2 sites in Germany.
Trial summary
Evaluate the immune response and reactogenicity of H5N1 vaccination in adults aged 18 years and above (as part of a tetravalent vaccine) Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Pandemic influenza vaccine + seasonal influenza vaccine /pandemic influenza vaccine and Pandemic influenza vaccine + seasonal influenza vaccine / pandemic influenza vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 601 participants
- Where
- 2 sitesGermany
- Study dates
- Nov 2007to Dec 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy subjects (aged 18 years and above) who have signed an informed consent form
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
ATRIUM Gesundheitszentrum;
Holzkirchen, 83607
International Medicine & Public Health Dept. of Infect. Diseases
Munich, 80799
About this study
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
Evaluate the immune response and reactogenicity of H5N1 vaccination in adults aged 18 years and above (as part of a tetravalent vaccine)
- Conditions
- Influenza
- Being tested
- MF59-eTIV-H5N1+ placebo /pandemic influenza vaccine, Pandemic influenza vaccine + placebo /MF59-eTIV-H5N1, Pandemic influenza vaccine + seasonal influenza vaccine /pandemic influenza vaccine, Pandemic influenza vaccine + placebo / MF59-eTIV-H5N1, Pandemic influenza vaccine + seasonal influenza vaccine / pandemic influenza vaccine
- Keywords
- avian flu, seasonal influenza vaccine, influenza vaccine, prepandemic vaccine, virus strain with the potential to cause pandemic, tetravalent vaccine, Prophylaxis of influenza
- Medical subject headings
- Influenza, Human, Influenza in Birds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MF59-eTIV-H5N1+ placebo /pandemic influenza vaccineBiological
Tetravalent influenza vaccine (MF59-eTIV-H5N1)and placebo on day 1 followed 3-5 weeks later by pandemic influenza vaccine, including serology blood draw at V1+V3.
Pandemic influenza vaccine + placebo /MF59-eTIV-H5N1Biological
Pandemic influenza vaccine plus placebo on day 1 followed 3-5 weeks later by tetravalent influenza vaccine (MF59-eTIV-H5N1), including serology blood draw at V1+V3.
Pandemic influenza vaccine + seasonal influenza vaccine /pandemic influenza vaccineBiological
Pandemic influenza vaccine plus seasonal influenza vaccine, 3-5 weeks later pandemic influenza vaccine , including serology blood draw at V1+V3.
Pandemic influenza vaccine + placebo / MF59-eTIV-H5N1Biological
Pandemic influenza vaccine plus placebo followed 3-5 weeks later by tetravalent influenza vaccine (MF59-eTIV-H5N1), including serology blood draw at V1, V2 and V3.
Pandemic influenza vaccine + seasonal influenza vaccine / pandemic influenza vaccineBiological
Pandemic influenza vaccine plus seasonal influenza vaccine followed 3-5 weeks later by pandemic influenza vaccine, including serology blood draw at V1, V2 and V3.
MF59-eTIV-H5N1 + Placebo/pandemic influenza vaccineBiological
Tetravalent influenza vaccine (MF59-eTIV-H5N1)plus placebo followed 3-5 weeks later by pandemic influenza vaccine, including serology blood draw at V1, V2 and V3.
| Study group | Role | What they receive |
|---|---|---|
| T/P-A | Experimental | One dose of the tetravalent influenza vaccine (T) and concomitantly, but in a different arm, one dose of placebo (P) on day 1, followed by Aflunov (A) on day 22 Receives: Biological: MF59-eTIV-H5N1+ placebo /pandemic influenza vaccine |
| A/P-T | Experimental | One dose of the Aflunov (A) and concomitantly, but in a different arm, one dose of placebo (P) on day 1, followed by Tetravalent influenza vaccine (T) on day 22. Receives: Biological: Pandemic influenza vaccine + placebo /MF59-eTIV-H5N1 |
| A/S-A | Active comparator | One dose of Aflunov (A) and concomitantly, but in a different arm, one dose of licensed seasonal vaccine (S) on day 1, followed Aflunov (A) on day 22. Receives: Biological: Pandemic influenza vaccine + seasonal influenza vaccine /pandemic influenza vaccine |
| T/P-A (V2 blood draw) | Experimental | One dose of the tetravalent influenza vaccine (T) and concomitantly, but in a different arm, one dose of placebo (P) on day 1, followed by a blood draw at visit 2 (V2) prior to Aflunov (A) vaccination on day 22. Receives: Biological: MF59-eTIV-H5N1 + Placebo/pandemic influenza vaccine |
| A/P-T (V2 blood draw) | Experimental | One dose of the Aflunov(A) and concomitantly, but in a different arm, one dose of placebo (P) on day 1, followed by additional blood draw at visit 2 (V2) prior to the Tetravalent influenza vaccination (T) on day 22. Receives: Biological: Pandemic influenza vaccine + placebo / MF59-eTIV-H5N1 |
| A/S-A (V2 blood draw) | Active comparator | One dose of Aflunov (A)and concomitantly, but in a different arm, one dose of licensed seasonal vaccine (S) on day 1, followed by an additional blood draw at visit 2 (V2) prior to Aflunov (A) vaccination on day 22. Receives: Biological: Pandemic influenza vaccine + seasonal influenza vaccine / pandemic influenza vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Demonstrate the Equivalence of Antibody Response Against A/H5N1 Strain Elicited by the Three Different Immunization Schedules on Day 43.
The antibody response was determined by SRH assay. Geometric mean areas (GMAs) and geometric mean ratios (GMRs) in the SRH assay were used to demonstrate the equivalence.
The statistical analysis was done based on the GMRs.
Measured: up to day 43
Secondary outcomes (8)
Number of Subjects (Subjects ≤ 60 Years) With Reported Local Reactions After First Vaccination
Local reactions were collected up to 7 days after 1st vaccinations. All subjects were instructed to complete a diary card to record local reactions starting on the day of vaccination (after 6 hours) and for each of the 6 days following each immunization. The table represents local reactions after first vaccination in each arm differently.
Measured: Up to 7 days after 1st vaccination
Number of Subjects (Subjects ≤60 Years) With Reported Local Reactions After Second Vaccination
Local reactions were collected up to 7 days after 1st vaccinations. All subjects were instructed to complete a diary card to record local reactions starting on the day of vaccination (after 6 hours) and for each of the 6 days following each immunization.
Measured: Up to 7 days after 2nd vaccination
Number of Subjects (Subjects ≤ 60 Years) With Reported Systemic Reactions After 1st and 2nd Vaccinations.
Systemic reactions were collected upto 7 days after 1st and 2nd vaccinations. All subjects were instructed to complete a diary card to record systemic reactions starting on the day of vaccination (after 6 hours) and for each of the 6 days following each immunization.
Measured: 7 days after 1st and 2nd vaccinations each
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
Measurement of immunogenicity in terms of significant increase in antibody titer and Seroconversion.
Significant increase in antibody titer is defined as at least a four-fold increase from non-negative pre-vaccination serum (≥ 10) for HI or a 50% increase in area for SRH.
Seroconversion is defined as negative pre-vaccination serum / post-vaccination titer ≥40 for HI (area ≥25 mm2 for SRH)
Measured: up to day 43
Percentages of Subjects Achieving HI/MN ≥ 1:40 and SRH Area ≥ 25^mm2
Measurement of immunogenicity in terms of percentage of subjects achieving a titre ≥ 40/area ≥ 25mm^2 after immunization as determined by HI (Haemagglutination Inhibition), MN(Microneutralization) and SRH assay.
Measured: Up to 43 days
Antibody Response Determined by HI and MN Assay.
Measurement of immunogenicity in terms of Geometric mean titers (GMTs) as determined by HI and MN assay.
Measured: Up to 43 days
Percentages of B-cell Antibodies Against H5N1 and H1N1 After Each Vaccination.
The Cell Mediated Immunity (CMI) response was evaluated in a randomly selected subgroup of approximately 92 subjects from all the vaccine groups out of a total of 601 enrolled subjects.
Frequency of circulating memory B cells (MBC), capable of differentiating in vitro into cell secreting IgG (Immunoglobulin G) antibodies specific for H5N1 (the subunit from A/Vietnam/1194/2004) or for H1N1 (the subunit from A/Solomon Island/3/2006) were determined by an ELISA-coupled limiting dilution assay.The frequency of H5N1-IgG MBC and H1N1-IgG MBC was expressed as percentages (%) of total IgG producing MBC.
Measured: Three weeks after first vaccination (day 22) and three weeks after second vaccination (day 43)
Mean T-Cells Per Million Total Cells (95% CI) in Response to H5 Peptides and H5N1 Subunit
Frequency and functionality of vaccine antigen-specific CD4+ (cluster of differentiation 4) T cells was assessed in peripheral blood (PBMC) taken at days 1, 22 and 43 after in vitro stimulation with:
Library of 70 peptides spanning the whole H5 A/Vietnam/1194/2004 protein (H5 pool of 70 Vietnam) H5N1 subunit from A/Vietnam/1194/2004 (H5N1 Vietnam) H3N2 subunit from A/ Wisconsin/67/2005 (H3N2 Wisconsin) H1N1 subunit from A/Solomon Islands/3/2006 (H1N1 Solomon Islands) Polyclonal stimulus agonistic aCD3 mAb [monoclonal antibody (aCD3)].
The change in frequency of T-cells was measured.
Measured: Three weeks after 1st vaccination (day 22) and three weeks after 2nd vaccination (day 43)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2008 (estimated)
- Study startNov 2007
- Primary completionJan 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 601 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Vaccines
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Vaccines and Diagnostics, Study chair, Novartis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00620815
- Sponsor's protocol ID
- V101P1
- Other IDs
- 2007-002712-25
- Status last verified
- Mar 2016
- First submitted
- 12 Feb 2008
- Last updated
- 28 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 24047817
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00620815
- Acronym / sponsor ID
- V101P1
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 601 participants (actual)
- Lead sponsor
- Novartis VaccinesIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 22 Feb 2008 (estimated)
- Results
- Posted 19 Sep 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the immune response and reactogenicity of H5N1 vaccination in adults aged 18 years and above (as part of a tetravalent vaccine)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| T/P-A | Experimental | Biological: MF59-eTIV-H5N1+ placebo /pandemic influenza vaccineOne dose of the tetravalent influenza vaccine (T) and concomitantly, but in a different arm, one dose of placebo (P) on day 1, followed by Aflunov (A) on day 22 |
| A/P-T | Experimental | Biological: Pandemic influenza vaccine + placebo /MF59-eTIV-H5N1One dose of the Aflunov (A) and concomitantly, but in a different arm, one dose of placebo (P) on day 1, followed by Tetravalent influenza vaccine (T) on day 22. |
| A/S-A | Active comparator | Biological: Pandemic influenza vaccine + seasonal influenza vaccine /pandemic influenza vaccineOne dose of Aflunov (A) and concomitantly, but in a different arm, one dose of licensed seasonal vaccine (S) on day 1, followed Aflunov (A) on day 22. |
| T/P-A (V2 blood draw) | Experimental | Biological: MF59-eTIV-H5N1 + Placebo/pandemic influenza vaccineOne dose of the tetravalent influenza vaccine (T) and concomitantly, but in a different arm, one dose of placebo (P) on day 1, followed by a blood draw at visit 2 (V2) prior to Aflunov (A) vaccination on day 22. |
| A/P-T (V2 blood draw) | Experimental | Biological: Pandemic influenza vaccine + placebo / MF59-eTIV-H5N1One dose of the Aflunov(A) and concomitantly, but in a different arm, one dose of placebo (P) on day 1, followed by additional blood draw at visit 2 (V2) prior to the Tetravalent influenza vaccination (T) on day 22. |
| A/S-A (V2 blood draw) | Active comparator | Biological: Pandemic influenza vaccine + seasonal influenza vaccine / pandemic influenza vaccineOne dose of Aflunov (A)and concomitantly, but in a different arm, one dose of licensed seasonal vaccine (S) on day 1, followed by an additional blood draw at visit 2 (V2) prior to Aflunov (A) vaccination on day 22. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy subjects (aged 18 years and above) who have signed an informed consent form
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MF59-eTIV-H5N1+ placebo /pandemic influenza vaccineTetravalent influenza vaccine (MF59-eTIV-H5N1)and placebo on day 1 followed 3-5 weeks later by pandemic influenza vaccine, including serology blood draw at V1+V3. | Biological | T/P-A |
| Pandemic influenza vaccine + placebo /MF59-eTIV-H5N1Pandemic influenza vaccine plus placebo on day 1 followed 3-5 weeks later by tetravalent influenza vaccine (MF59-eTIV-H5N1), including serology blood draw at V1+V3. | Biological | A/P-T |
| Pandemic influenza vaccine + seasonal influenza vaccine /pandemic influenza vaccinePandemic influenza vaccine plus seasonal influenza vaccine, 3-5 weeks later pandemic influenza vaccine , including serology blood draw at V1+V3. | Biological | A/S-A |
| Pandemic influenza vaccine + placebo / MF59-eTIV-H5N1Pandemic influenza vaccine plus placebo followed 3-5 weeks later by tetravalent influenza vaccine (MF59-eTIV-H5N1), including serology blood draw at V1, V2 and V3. | Biological | A/P-T (V2 blood draw) |
| Pandemic influenza vaccine + seasonal influenza vaccine / pandemic influenza vaccinePandemic influenza vaccine plus seasonal influenza vaccine followed 3-5 weeks later by pandemic influenza vaccine, including serology blood draw at V1, V2 and V3. | Biological | A/S-A (V2 blood draw) |
| MF59-eTIV-H5N1 + Placebo/pandemic influenza vaccineTetravalent influenza vaccine (MF59-eTIV-H5N1)plus placebo followed 3-5 weeks later by pandemic influenza vaccine, including serology blood draw at V1, V2 and V3. | Biological | T/P-A (V2 blood draw) |
Primary outcome
To Demonstrate the Equivalence of Antibody Response Against A/H5N1 Strain Elicited by the Three Different Immunization Schedules on Day 43.
Time frame: up to day 43
The antibody response was determined by SRH assay. Geometric mean areas (GMAs) and geometric mean ratios (GMRs) in the SRH assay were used to demonstrate the equivalence. The statistical analysis was done based on the GMRs.
8 secondary outcomes
Number of Subjects (Subjects ≤ 60 Years) With Reported Local Reactions After First Vaccination
Time frame: Up to 7 days after 1st vaccination
Number of Subjects (Subjects ≤60 Years) With Reported Local Reactions After Second Vaccination
Time frame: Up to 7 days after 2nd vaccination
Number of Subjects (Subjects ≤ 60 Years) With Reported Systemic Reactions After 1st and 2nd Vaccinations.
Time frame: 7 days after 1st and 2nd vaccinations each
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
Time frame: up to day 43
Percentages of Subjects Achieving HI/MN ≥ 1:40 and SRH Area ≥ 25^mm2
Time frame: Up to 43 days
Antibody Response Determined by HI and MN Assay.
Time frame: Up to 43 days
Percentages of B-cell Antibodies Against H5N1 and H1N1 After Each Vaccination.
Time frame: Three weeks after first vaccination (day 22) and three weeks after second vaccination (day 43)
Mean T-Cells Per Million Total Cells (95% CI) in Response to H5 Peptides and H5N1 Subunit
Time frame: Three weeks after 1st vaccination (day 22) and three weeks after 2nd vaccination (day 43)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24047817Herbinger 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Vaccines and Diagnostics study chair
Novartis
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pandemic influenza vaccine + seasonal influenza vaccine /pandemic influenza vaccine and Pandemic influenza vaccine + seasonal influenza vaccine / pandemic influenza vaccine in people with Influenza, run by Novartis Vaccines at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Sep 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To Demonstrate the Equivalence of Antibody Response Against A/H5N1 Strain Elicited by the Three Different Immunization Schedules on Day 43. (time frame: up to day 43). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00620815, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2016.