Pandemic Influenza DiseasePhase 2NCT00992212
Immunogenicity, Tolerability and Safety of One or Two Doses of an Adjuvanted Swine-origin A H1N1 Influenza Vaccine in Healthy Subjects 18 or More Years of Age Both Vaccinated and Not Yet Vaccinated Against Seasonal Influenza 2009/10
A Phase 2 study testing Monovalent A/H1N1 influenza vaccine in people with Pandemic Influenza Disease, run by Novartis Vaccines at 5 sites in Italy.
Trial summary
This present study, a phase II, open label study will evaluate the immunogenicity, tolerability and safety of an adjuvanted, inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in healthy subjects aged 18 years and above. Read more about this study
- Who is it for?
- Ages 18 months and olderHealthy volunteers can take part
- Conditions the study is for
- Pandemic Influenza Disease
- What is being tested?
- Monovalent A/H1N1 influenza vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 418 participants
- Where
- 5 sitesItaly
- Study dates
- Aug 2009to Nov 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- For study Groups A and B : subjects aged 18 years and above on the day of enrollment, who took part to the seasonal trials for the 2009/10 vaccine registration; For study Groups C to E: subjects aged 18 years and above on the day of enrollment, not yet exposed to the current seasonal formulation (2009/10 for NH) of the influenza vaccines;
- Individuals in good health as determined by medical history, physical examination and clinical judgment of the investigator;
- Documented consent obtained after the nature of the study has been explained according to local regulatory requirements;
- Individuals are able to comply with all study procedures and are available for all clinic visits scheduled in the study.
- Willingness to allow for serum samples to be stored beyond the study period, for potential additional future testing to better characterize immune response.
Who cannot join
- Individuals who are not able to comprehend and to follow all required study procedures; individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the subject's ability to participate in the study;
- Individuals with history or any illness that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study;
- Individuals who have had received an influenza vaccine for the 2009/10 NH influenza season (for subjects to be included in Groups C to E only) prior to Visit 1;
- Individuals who have had documented confirmed or suspected influenza disease within 6 months prior to Day 1.
- Receipt of another investigational agent within 4 weeks prior to enrollment, or before completion of the safety follow-up period in this or in another study;
- Individuals who received any other vaccines within 4 weeks prior to enrollment in this study and individuals who have ever received blood, blood products and/or plasma derivatives in the past 12 weeks;
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- Individuals with axillary temperature ≥ 38.0°C within 3 days of study vaccination;
- Known or suspected impairment/alteration of immune function, for example resulting from:
- receipt of immunosuppressive therapy,
- cancer chemotherapy,
- receipt of immunostimulants within 60 days prior to Visit 1,
- receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within 3 months prior to Visit 1 or planned during the full length of the study,
- known HIV infection or HIV-related disease.
- Surgery planned during the study period;
- If female, of childbearing potential, and has not used any of the "acceptable contraceptive methods" for at least 2 months prior to study entry;
- Females who are pregnant or nursing (breastfeeding) mothers, or females of childbearing potential who are sexually active and have not used or do not plan to use acceptable birth control measures during the first 3 weeks after vaccination.
- Members of the research staff or their relatives (research staff are individuals with direct or indirect contact with trial subjects, or study site personnel who have access to any study documents containing subject information, including: e.g. receptionists, persons scheduling appointments or making screening calls, regulatory specialists, laboratory technicians); hospital personnel and health care providers not involved in the study can be enrolled.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
About this study
Official title: A Phase II, Open Label Study to Evaluate the Immunogenicity, Tolerability and Safety of an Adjuvanted, Inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in Healthy Subjects Aged 18 Years and Above
This present study, a phase II, open label study will evaluate the immunogenicity, tolerability and safety of an adjuvanted, inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in healthy subjects aged 18 years and above. This study will explore the effect of the previous and concomitant exposure to a seasonal influenza vaccination to the immunogenicity and safety profile of two different doses of an adjuvanted H1N1sw vaccine.
Read the detailed description
At enrolment, subjects were stratified into two age strata (18 to 60 years, over 60 years). Total duration of the study is eight weeks, which include two weeks for enrolment and 6 weeks for study participation. Vaccinations were to be administered on day 1 and day 22. Blood samples were collected at day 1 (baseline, before the first vaccination), at day 22 (before the second vaccination), at day 29 (one week after the second vaccination) and at day 43 (three weeks after the second vaccination). Sera were tested by Hemagglutination Inhibition (HI) and Microneutralization (MN) assays. Safety was assessed until 3 weeks after the first and second vaccination.
- Conditions
- Pandemic Influenza Disease
- Being tested
- Monovalent A/H1N1 influenza vaccine
- Keywords
- Pandemic influenza, vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monovalent A/H1N1 influenza vaccineBiological
This trial will be performed at multiple sites; appr. 160 subjects exposed to the annual vaccine registration will be invited to take part into this study. In addition, a total of 224 healthy subjects not yet exposed to the seasonal influenza vaccines will be enrolled.
| Study group | Role | What they receive |
|---|---|---|
| Group A (Seasonal TIV + 7.5mcg HA+ full dose MF59) | Experimental | Not described Receives: Biological: Monovalent A/H1N1 influenza vaccine |
| Group B (Ajuvanted Seasonal TIV + 7.5mcg HA+ full dose MF59) | Experimental | Not described Receives: Biological: Monovalent A/H1N1 influenza vaccine |
| Group C (7.5mcg HA+ full dose MF59) | Experimental | Not described Receives: Biological: Monovalent A/H1N1 influenza vaccine |
| Group D (7.5mcg HA+ full dose MF59 + Seasonal TIV) | Experimental | Not described Receives: Biological: Monovalent A/H1N1 influenza vaccine |
| Group E (3.75mcg HA+ ½ dose MF59+ Seasonal TIV) | Experimental | Not described Receives: Biological: Monovalent A/H1N1 influenza vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the immunogenicity, safety and tolerability of 1 and 2 IM doses of MF59-H1N1sw flu vaccine in adult-elderly subjects previously exposed to 09/10 NH TIV and in those not yet vaccinated against flu season 09/10.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2009 (estimated)
- Study startAug 2009
- Primary completionOct 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pandemic Influenza DiseaseStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 418 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Vaccines
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Vaccines, Study chair, Novartis Vaccines
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00992212
- Sponsor's protocol ID
- V111_04
- Status last verified
- Jan 2012
- First submitted
- 8 Oct 2009
- Last updated
- 1 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Gasparini R, Schioppa F, Lattanzi M, Barone M, Casula D, Pellegrini M, Veitch K, Gaitatzis N. Impact of prior or concomitant seasonal influenza vaccination on MF59-adjuvanted H1N1v vaccine (Focetria) in adult and elderly subjects. Int J Clin Pract. 2010 Mar;64(4):432-8. doi: 10.1111/j.1742-1241.2009.02309.x. Epub 2009 Dec 17.
PubMed 20039974
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open Label Study to Evaluate the Immunogenicity, Tolerability and Safety of an Adjuvanted, Inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in Healthy Subjects Aged 18 Years and Above
- ClinicalTrials.gov ID
- NCT00992212
- Acronym / sponsor ID
- V111_04
- Conditions
- Pandemic Influenza Disease
- Keywords
- Pandemic influenza, vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 418 participants (actual)
- Lead sponsor
- Novartis VaccinesIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 9 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This present study, a phase II, open label study will evaluate the immunogenicity, tolerability and safety of an adjuvanted, inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in healthy subjects aged 18 years and above. This study will explore the effect of the previous and concomitant exposure to a seasonal influenza vaccination to the immunogenicity and safety profile of two different doses of an adjuvanted H1N1sw vaccine.
Detailed description
At enrolment, subjects were stratified into two age strata (18 to 60 years, over 60 years). Total duration of the study is eight weeks, which include two weeks for enrolment and 6 weeks for study participation. Vaccinations were to be administered on day 1 and day 22. Blood samples were collected at day 1 (baseline, before the first vaccination), at day 22 (before the second vaccination), at day 29 (one week after the second vaccination) and at day 43 (three weeks after the second vaccination). Sera were tested by Hemagglutination Inhibition (HI) and Microneutralization (MN) assays. Safety was assessed until 3 weeks after the first and second vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group A (Seasonal TIV + 7.5mcg HA+ full dose MF59) | Experimental | Biological: Monovalent A/H1N1 influenza vaccine |
| Group B (Ajuvanted Seasonal TIV + 7.5mcg HA+ full dose MF59) | Experimental | Biological: Monovalent A/H1N1 influenza vaccine |
| Group C (7.5mcg HA+ full dose MF59) | Experimental | Biological: Monovalent A/H1N1 influenza vaccine |
| Group D (7.5mcg HA+ full dose MF59 + Seasonal TIV) | Experimental | Biological: Monovalent A/H1N1 influenza vaccine |
| Group E (3.75mcg HA+ ½ dose MF59+ Seasonal TIV) | Experimental | Biological: Monovalent A/H1N1 influenza vaccine |
Who may qualify
- Ages
- 18 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- For study Groups A and B : subjects aged 18 years and above on the day of enrollment, who took part to the seasonal trials for the 2009/10 vaccine registration; For study Groups C to E: subjects aged 18 years and above on the day of enrollment, not yet exposed to the current seasonal formulation (2009/10 for NH) of the influenza vaccines;
- Individuals in good health as determined by medical history, physical examination and clinical judgment of the investigator;
- Documented consent obtained after the nature of the study has been explained according to local regulatory requirements;
- Individuals are able to comply with all study procedures and are available for all clinic visits scheduled in the study.
- Willingness to allow for serum samples to be stored beyond the study period, for potential additional future testing to better characterize immune response.
Key exclusion criteria (17 listed)
- Individuals who are not able to comprehend and to follow all required study procedures; individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the subject's ability to participate in the study;
- Individuals with history or any illness that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study;
- Individuals who have had received an influenza vaccine for the 2009/10 NH influenza season (for subjects to be included in Groups C to E only) prior to Visit 1;
- Individuals who have had documented confirmed or suspected influenza disease within 6 months prior to Day 1.
- Receipt of another investigational agent within 4 weeks prior to enrollment, or before completion of the safety follow-up period in this or in another study;
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 |
|---|---|---|
| Monovalent A/H1N1 influenza vaccineThis trial will be performed at multiple sites; appr. 160 subjects exposed to the annual vaccine registration will be invited to take part into this study. In addition, a total of 224 healthy subjects not yet exposed to the seasonal influenza vaccines will be enrolled. | Biological | Group A (Seasonal TIV + 7.5mcg HA+ full dose MF59), Group B (Ajuvanted Seasonal TIV + 7.5mcg HA+ full dose MF59), Group C (7.5mcg HA+ full dose MF59), Group D (7.5mcg HA+ full dose MF59 + Seasonal TIV), Group E (3.75mcg HA+ ½ dose MF59+ Seasonal TIV) |
Primary outcome
To evaluate the immunogenicity, safety and tolerability of 1 and 2 IM doses of MF59-H1N1sw flu vaccine in adult-elderly subjects previously exposed to 09/10 NH TIV and in those not yet vaccinated against flu season 09/10.
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2016.
- Results publication: PubMed 20039974Gasparini R, Schioppa F, Lattanzi M, Barone M, Casula D, Pellegrini M, Veitch K, Gaitatzis N. Impact of prior or concomitant seasonal influenza vaccination on MF59-adjuvanted H1N1v vaccine (Focetria) in adult and elderly subjects. Int J Clin Pract. 2010 Mar;64(4):432-8. doi: 10.1111/j.1742-1241.2009.02309.x. Epub 2009 Dec 17.
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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 study chair
Novartis Vaccines
5 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 Monovalent A/H1N1 influenza vaccine in people with Pandemic Influenza Disease, run by Novartis Vaccines at 5 sites in Italy.
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 5 inclusion and 17 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 1 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 evaluate the immunogenicity, safety and tolerability of 1 and 2 IM doses of MF59-H1N1sw flu vaccine in adult-elderly subjects previously exposed to 09/10 NH TIV and in those not yet vaccinated against flu season 09/10. (time frame: 3 months). 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 NCT00992212, 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 1 Dec 2016.