Healthy VolunteersPhase 4FLUSECUOEKH1NCT01119157
Comparison of the Cellular and the Humoral Immunogenicity, Safety of Different Trivalent Influenza Vaccines
A Phase 4 study testing influenza vaccine in people with Healthy Volunteers, run by National Centre for Epidemiology, Hungary at 1 site in Hungary.
Trial summary
This is a randomized, single-blinded, Phase IV, monocentric study in healthy adults aged > 18 and < 60 years to evaluate the cellular and humoral immunogenicity as well as the reactogenicity of intramuscular, inactivated, trivalent influenza vaccines, including aluminium adjuvanted whole virus vaccine, split vaccine… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- influenza vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteHungary
- Study dates
- Nov 2008to Aug 2010
- Phase
- Phase 4
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult volunteers > 18 and < 60 years of age, both sexes;
- Full contractual capacity of the participants
- Are in good health (as determined by vital signs and medical history);
- Negative urine or serum pregnancy test for females of childbearing potential.
- If the subject is female and of childbearing potential, she must use an acceptable contraception method and not become pregnant for the duration of the study. (Acceptable contraception includes implants, injectables, combined oral contraceptives, effective intrauterine devices (IUDs), sexual abstinence, or a vasectomized partner);
- Are able to understand and comply with planned study procedures;
- Signed informed consent prior to initiation of study procedures;
- Absence of existence of any exclusion criteria
Who cannot join
- Known allergy to eggs OR other components of any of the vaccines (in particular mercury);
- History of Guillain-Barré syndrome;
- Pregnancy OR breast feeding OR positive pregnancy test prior to vaccination;
- Immunosuppressive therapy in the preceding 36 months;
- Active neoplasm (i.e. requiring any form of anti-neoplastic therapy);
- Concomitant corticosteroid therapy, including inhaled corticosteroids. Local corticosteroid or corticosteroid nasal spray are permitted.
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- Psychiatric illness and/or concomitant psychiatric drug therapy that may have effect on full contractual capacity of the participant;
- Immunoglobulin (or similar blood product) therapy within 3 months prior to vaccination;
- Vaccine therapy within 4 weeks prior to the study;
- Influenza vaccination within 2 years prior to the study;
- Chronic illness that, in the opinion of the investigator, may interfere with the evaluation of the immune response;
- Documented HIV, HBV or HCV infection;
- Acute febrile respiratory illness within one week prior to vaccination;
- Experimental drug therapy within 1 month prior to vaccination;
- Alcohol or drug abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Cellular and the Humoral Immunogenicity as Well as the Safety of Different Trivalent Influenza Vaccines in Healthy Adults Between 18 and 60 Years of Age
This is a randomized, single-blinded, Phase IV, monocentric study in healthy adults aged > 18 and < 60 years to evaluate the cellular and humoral immunogenicity as well as the reactogenicity of intramuscular, inactivated, trivalent influenza vaccines, including aluminium adjuvanted whole virus vaccine, split vaccine and subunit vaccine.
Read the detailed description
This is a randomized, single-blinded study on vaccines for prevention of influenza.
Three study visits will be scheduled for each study subject, at Day 0, Day 9-11 and Day 30-35. Prior to the performance of any protocol procedures, the investigator is will obtain an informed consent from each participant.
At the first study visit (Day 0), demographic data, medical history, pre-existing conditions and concomitant medication will be recorded. Physical examination with recording of vital signs will be performed and in case of females of childbearing age, a pregnancy test will be performed. After the subject has qualified eligible, before vaccination, 60 ml venous blood will be taken for base-line immunity tests. Each subject will be randomly allocated to receive one of the three study vaccines, administered as a deep intramuscular (i.m.) injection into the deltoid muscle. The subjects will be blinded for the vaccine regimen. The principal investigator will administer the vaccines filled in ampoule or packed in pre-filled ready-to-use syringes and can thus not be blinded, but the staff and sub-investigators responsible for the routine follow-up and assessments and laboratory personnel will be blinded. A diary card will be given to each subject for recording pre-defined solicited adverse events for the vaccination day and 6 subsequent days and all other adverse events and concomitant medications.
At the second study visit (Day 9-11) the diary card will be collected. All adverse events and concomitant medication will be assessed and recorded. A physical examination will be performed and 60 ml venous blood shall be taken for immunity tests. A new diary card will be given to each subject for recording adverse events and concomitant medications.
At the third study visit (Day 30-35), the diary card will be collected. All adverse events and concomitant medication will be assessed and recorded. A physical examination will be performed and 60 ml venous blood shall be taken for immunity tests.
- Conditions
- Healthy Volunteers
- Being tested
- influenza vaccine
- Keywords
- influenza vaccine, cellular immune response, humoral immune response
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
influenza vaccineBiological
Also called FluvalAB adjuvanted trivalent seasonal influenza vaccine, Vaxigrip, Influvac
whole virus influenza vaccine adjuvanted with aluminium phosphate, 3 x 15 μg HA / 0.5 ml, for i.m. administration subunit influenza vaccine 3 x 15 μg HA / 0.5 ml, for i.m. administration split influenza vaccine 3 x 15 μg HA / 0.5 ml, for i.m. administration
| Study group | Role | What they receive |
|---|---|---|
| humoral and cellular immune response | Experimental | Not described Receives: Biological: influenza vaccine |
| reactogenicity | Experimental | Not described Receives: Biological: influenza vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of seroconversions, > 4-fold increase in Haemagglutination inhibition (HI), mean geometric increase and antibody titre the proportion of subjects achieving an HI titre > 40, virus neutralization assay, Granzyme B, INF-gamma, IL-10, side effects.
There remains substantial uncertainty about the clinical effectiveness of influenza vaccines based on current health care literature. The standard methodology to determine vaccine efficacy is based on hemagglutinin inhibition assay. Assays based on the immune response against the N antigen and based on the cellular immune response are now being designed and validated in the EU-funded Flusecure project. Importantly, recent EMEA regulations for registration of vaccines against avian influenza require an assessment of the cellular and the N-specific immune responses (EMEA/CHMP/VWP/263499/2006).
Measured: Day 35
Secondary outcomes (1)
Side effects
In the course of tolerability assessment the frequency, mean time of appearance, duration and severity of the AEs (local and general) will be assessed according to CPMP/BWP/214/968: "Note for Guidance on Harmonization of Requirements for Influenza Vaccines", 12 March 1997, Para. 2.4., 2.6., and 3.2.
Measured: 65 days after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2010 (estimated)
- Study startNov 2008
- Primary completionMar 2009
- Study completionAug 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Centre for Epidemiology, Hungary
- Sponsor type
- Other government
- Collaborators
- Netherlands Vaccine Institute, National Public Health Institute, Finland
- Investigators
- Ildikó Visontai, MD, Study director, National Centre for Epidemiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01119157
- Sponsor's protocol ID
- FLUSECURE-OEK-H01
- Other IDs
- 2008-002307-22, 2008
- Acronym
- FLUSECUOEKH1
- Status last verified
- May 2010
- First submitted
- 4 May 2010
- Last updated
- 7 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Cellular and the Humoral Immunogenicity as Well as the Safety of Different Trivalent Influenza Vaccines in Healthy Adults Between 18 and 60 Years of Age
- ClinicalTrials.gov ID
- NCT01119157
- Acronym / sponsor ID
- FLUSECUOEKH1 / FLUSECURE-OEK-H01
- Conditions
- Healthy Volunteers
- Keywords
- influenza vaccine, cellular immune response, humoral immune response
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 85 participants (actual)
- Lead sponsor
- National Centre for Epidemiology, HungaryOther government
- Collaborators
- Netherlands Vaccine Institute, National Public Health Institute, Finland
- Study start
- Nov 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Aug 2010 (estimated)
- First posted
- 7 May 2010 (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 is a randomized, single-blinded, Phase IV, monocentric study in healthy adults aged > 18 and < 60 years to evaluate the cellular and humoral immunogenicity as well as the reactogenicity of intramuscular, inactivated, trivalent influenza vaccines, including aluminium adjuvanted whole virus vaccine, split vaccine and subunit vaccine.
Detailed description
This is a randomized, single-blinded study on vaccines for prevention of influenza.
Three study visits will be scheduled for each study subject, at Day 0, Day 9-11 and Day 30-35. Prior to the performance of any protocol procedures, the investigator is will obtain an informed consent from each participant.
At the first study visit (Day 0), demographic data, medical history, pre-existing conditions and concomitant medication will be recorded. Physical examination with recording of vital signs will be performed and in case of females of childbearing age, a pregnancy test will be performed. After the subject has qualified eligible, before vaccination, 60 ml venous blood will be taken for base-line immunity tests. Each subject will be randomly allocated to receive one of the three study vaccines, administered as a deep intramuscular (i.m.) injection into the deltoid muscle. The subjects will be blinded for the vaccine regimen. The principal investigator will administer the vaccines filled in ampoule or packed in pre-filled ready-to-use syringes and can thus not be blinded, but the staff and sub-investigators responsible for the routine follow-up and assessments and laboratory personnel will be blinded. A diary card will be given to each subject for recording pre-defined solicited adverse events for the vaccination day and 6 subsequent days and all other adverse events and concomitant medications.
At the second study visit (Day 9-11) the diary card will be collected. All adverse events and concomitant medication will be assessed and recorded. A physical examination will be performed and 60 ml venous blood shall be taken for immunity tests. A new diary card will be given to each subject for recording adverse events and concomitant medications.
At the third study visit (Day 30-35), the diary card will be collected. All adverse events and concomitant medication will be assessed and recorded. A physical examination will be performed and 60 ml venous blood shall be taken for immunity tests.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| humoral and cellular immune response | Experimental | Biological: influenza vaccine |
| reactogenicity | Experimental | Biological: influenza vaccine |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy adult volunteers > 18 and < 60 years of age, both sexes;
- Full contractual capacity of the participants
- Are in good health (as determined by vital signs and medical history);
- Negative urine or serum pregnancy test for females of childbearing potential.
- If the subject is female and of childbearing potential, she must use an acceptable contraception method and not become pregnant for the duration of the study. (Acceptable contraception includes implants, injectables, combined oral contraceptives, effective intrauterine devices (IUDs), sexual abstinence, or a vasectomized partner);
Key exclusion criteria (15 listed)
- Known allergy to eggs OR other components of any of the vaccines (in particular mercury);
- History of Guillain-Barré syndrome;
- Pregnancy OR breast feeding OR positive pregnancy test prior to vaccination;
- Immunosuppressive therapy in the preceding 36 months;
- Active neoplasm (i.e. requiring any form of anti-neoplastic therapy);
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 |
|---|---|---|
| influenza vaccineAlso: FluvalAB adjuvanted trivalent seasonal influenza vaccine, Vaxigrip, Influvacwhole virus influenza vaccine adjuvanted with aluminium phosphate, 3 x 15 μg HA / 0.5 ml, for i.m. administration subunit influenza vaccine 3 x 15 μg HA / 0.5 ml, for i.m. administration split influenza vaccine 3 x 15 μg HA / 0.5 ml, for i.m. administration | Biological | humoral and cellular immune response, reactogenicity |
Primary outcome
Number of seroconversions, > 4-fold increase in Haemagglutination inhibition (HI), mean geometric increase and antibody titre the proportion of subjects achieving an HI titre > 40, virus neutralization assay, Granzyme B, INF-gamma, IL-10, side effects.
Time frame: Day 35
There remains substantial uncertainty about the clinical effectiveness of influenza vaccines based on current health care literature. The standard methodology to determine vaccine efficacy is based on hemagglutinin inhibition assay. Assays based on the immune response against the N antigen and based on the cellular immune response are now being designed and validated in the EU-funded Flusecure project. Importantly, recent EMEA regulations for registration of vaccines against avian influenza require an assessment of the cellular and the N-specific immune responses (EMEA/CHMP/VWP/263499/2006).
1 secondary outcome
Side effects
Time frame: 65 days after vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2010.
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Screening Protocol
Pain
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.
Ildikó Visontai, MD study director
National Centre for Epidemiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing influenza vaccine in people with Healthy Volunteers, run by National Centre for Epidemiology, Hungary at 1 site in Hungary.
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 8 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 7 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Number of seroconversions, > 4-fold increase in Haemagglutination inhibition (HI), mean geometric increase and antibody titre the proportion of subjects achieving an HI titre > 40, virus neutralization assay, Granzyme B, INF-gamma, IL-10, side effects. (time frame: Day 35). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 May 2010.