InfluenzaPhase 1NCT00309647
Study to Evaluate the Safety and Immunogenicity of Pandemic Monovalent (H5N1) Influenza Vaccines (Whole Virus Formulation) in Adults 18 and 60 Years of Age
A Phase 1 study testing Influenza Monovalent Whole virus (H5N1) adjuvanted vaccine and Influenza Monovalent Whole virus (H5N1) in people with Influenza, run by GlaxoSmithKline at 9 sites in Germany.
Trial summary
Today, the leading contender for the next pandemic of influenza is H5N1, a strain of avian virus. Prevention and control of a pandemic will depend on the rapid production and worldwide distribution of specific pandemic vaccines. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Influenza Monovalent Whole virus (H5N1) adjuvanted vaccine and Influenza Monovalent Whole virus (H5N1)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 9 sitesGermany
- Study dates
- 29 Mar 2006to 16 Nov 2006
- Phase
- Phase 1
- 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
- A male or female between, and including, 18 and 60 years of age at the time of the first vaccination.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- If the subject is female, she must be of non-childbearing potential.
Who cannot join
- Administration of any vaccine during the period starting 15 days before the first administration of the study vaccine and ending 21 after the second one.
- Administration of an influenza vaccine other than the study vaccines during the entire study period.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first administration of the study vaccine.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
- History of hypersensitivity to vaccines.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
Show all 11Show fewer
- Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- Acute disease at the time of enrolment.
- Administration of immunoglobulins and/or any blood products within the three months preceding the first administration of the study vaccine or during the study.
- lactating women
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days prior to the first vaccination, or planned use during the study period.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Germany9 sites
GSK Investigational Site
Bad Segeberg, Schleswig-Holstein, 23795
GSK Investigational Site
Dresden, Saxony, 01129
GSK Investigational Site
Dresden, Saxony, 01307
GSK Investigational Site
Elmshorn, Schleswig-Holstein, 25335
GSK Investigational Site
Finsterwalde, Brandenburg, 03238
GSK Investigational Site
Freiberg, Saxony, 09599
GSK Investigational Site
Geringswalde, Saxony, 09326
GSK Investigational Site
Schmiedeberg, Saxony, 01762
GSK Investigational Site
Tostedt, Lower Saxony, 21255
About this study
Official title: A Partially-blind Multi-centric Study in Adults Aged Between 18-60 Years Designed to Evaluate the Reactogenicity and Immunogenicity of 1 and 2 Doses of Pandemic Monovalent (H5N1) Influenza Vaccines (Whole Virus Formulation) Administered at Different Doses and Adjuvanted or Not
Today, the leading contender for the next pandemic of influenza is H5N1, a strain of avian virus. Prevention and control of a pandemic will depend on the rapid production and worldwide distribution of specific pandemic vaccines. Candidate 'pandemic-like' vaccines must be developed and tested in clinical trials to determine the most optimal formulation and the best vaccination schedule.This study is designed to test in healthy adults aged between 18-60 years the reactogenicity and immunogenicity of one and two administrations of a candidate pandemic H5N1 vaccine formulated from Whole Virus. The vaccines contain different antigen doses. For each dose, adjuvanted vaccine will be compared to the plain vaccine in order to detect the optimal formulation for immunization against the H5N1 influenza strain.
- Conditions
- Influenza
- Being tested
- Influenza Monovalent Whole virus (H5N1) adjuvanted vaccine, Influenza Monovalent Whole virus (H5N1)
- Keywords
- prophylaxis of pandemic influenza
- 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 Monovalent Whole virus (H5N1) adjuvanted vaccineBiological
2 doses administered intramuscularly at the deltoid region of the non-dominant arm at Days 0 and 21
Influenza Monovalent Whole virus (H5N1)Biological
2 doses administered intramuscularly at the deltoid region of the non-dominant arm at Days 0 and 21
| Study group | Role | What they receive |
|---|---|---|
| H5N1 Formulation 1 Group | Experimental | Subjects in this group received 2 doses of H5N1 adjuvanted formulation 1 vaccine at a 21-day interval Receives: Biological: Influenza Monovalent Whole virus (H5N1) adjuvanted vaccine |
| H5N1 Formulation 2 Group | Experimental | Subjects in this group received 2 doses of H5N1 adjuvanted formulation 2 vaccine at a 21-day interval Receives: Biological: Influenza Monovalent Whole virus (H5N1) adjuvanted vaccine |
| H5N1 Formulation 3 Group | Experimental | Subjects in this group received 2 doses of H5N1 adjuvanted formulation 3 vaccine at a 21-day interval Receives: Biological: Influenza Monovalent Whole virus (H5N1) adjuvanted vaccine |
| H5N1 Formulation 4 Group | Experimental | Subjects in this group received 2 doses of H5N1 adjuvanted formulation 4 vaccine at a 21-day interval Receives: Biological: Influenza Monovalent Whole virus (H5N1) adjuvanted vaccine |
| H5N1 Formulation 5 Group | Active comparator | Subjects in this group received 2 doses of H5N1 formulation 5 vaccine at a 21-day interval Receives: Biological: Influenza Monovalent Whole virus (H5N1) |
| H5N1 Formulation 6 Group | Active comparator | Subjects in this group received 2 doses of H5N1 formulation 6 vaccine at a 21-day interval Receives: Biological: Influenza Monovalent Whole virus (H5N1) |
| H5N1 Formulation 7 Group | Active comparator | Subjects in this group received 2 doses of H5N1 formulation 7 vaccine at a 21-day interval Receives: Biological: Influenza Monovalent Whole virus (H5N1) |
| H5N1 Formulation 8 Group | Active comparator | Subjects in this group received 2 doses of H5N1 formulation 8 vaccine at a 21-day interval Receives: Biological: Influenza Monovalent Whole virus (H5N1) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the humoral immune response induced by the study vaccines in term of anti-haemagglutinin antibody titers
Geometric mean titers (GMTs) of serum antibodies
Measured: At Days 0, 21, 42 and 180
To evaluate the humoral immune response induced by the study vaccines in terms of seroconversion rates (SCRs), Conversion factors and protection rates to H5N1 virus
Measured: At days 21, 42 and 180
Occurrence of solicited local and general adverse events
Measured: During a 7 day follow-up period (i.e. day of vaccination and 6 subsequent days) after each dose of vaccine and overall
Occurrence of unsolicited adverse events
Measured: During a 21 day follow-up period after the first vaccination and 30 day follow-up period after the second vaccination
Occurrence of serious adverse events
Measured: During the entire study (Days 0 to 180)
Secondary outcomes (3)
To evaluate the humoral immune response induced by the study vaccines in term of serum neutralizing antibody titers
Geometric mean titers (GMTs) of serum antibodies
Measured: At Days 0, 21, 42 and 180
To evaluate the cell-mediated immune response induced by the study vaccines in term of frequency of influenza-specific CD4/CD8 T lymphocytes
Measured: At days 0, 21, 42 and 180
To evaluate the humoral immune response induced by the study vaccines in terms of SCR for serum neutralizing antibody titers
Measured: At Days 21, 42 and 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2006 (estimated)
- Study start29 Mar 2006
- Primary completion1 Nov 2006
- Study completion16 Nov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00309647
- Sponsor's protocol ID
- 106378
- Status last verified
- May 2017
- First submitted
- 31 Mar 2006
- Last updated
- 8 May 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Partially-blind Multi-centric Study in Adults Aged Between 18-60 Years Designed to Evaluate the Reactogenicity and Immunogenicity of 1 and 2 Doses of Pandemic Monovalent (H5N1) Influenza Vaccines (Whole Virus Formulation) Administered at Different Doses and Adjuvanted or Not
- ClinicalTrials.gov ID
- NCT00309647
- Acronym / sponsor ID
- 106378
- Conditions
- Influenza
- Keywords
- prophylaxis of pandemic influenza
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 29 Mar 2006 (actual)
- Primary completion
- 1 Nov 2006 (actual)
- Study completion
- 16 Nov 2006 (actual)
- First posted
- 3 Apr 2006 (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.
Today, the leading contender for the next pandemic of influenza is H5N1, a strain of avian virus. Prevention and control of a pandemic will depend on the rapid production and worldwide distribution of specific pandemic vaccines. Candidate 'pandemic-like' vaccines must be developed and tested in clinical trials to determine the most optimal formulation and the best vaccination schedule.This study is designed to test in healthy adults aged between 18-60 years the reactogenicity and immunogenicity of one and two administrations of a candidate pandemic H5N1 vaccine formulated from Whole Virus. The vaccines contain different antigen doses. For each dose, adjuvanted vaccine will be compared to the plain vaccine in order to detect the optimal formulation for immunization against the H5N1 influenza strain.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| H5N1 Formulation 1 Group | Experimental | Biological: Influenza Monovalent Whole virus (H5N1) adjuvanted vaccineSubjects in this group received 2 doses of H5N1 adjuvanted formulation 1 vaccine at a 21-day interval |
| H5N1 Formulation 2 Group | Experimental | Biological: Influenza Monovalent Whole virus (H5N1) adjuvanted vaccineSubjects in this group received 2 doses of H5N1 adjuvanted formulation 2 vaccine at a 21-day interval |
| H5N1 Formulation 3 Group | Experimental | Biological: Influenza Monovalent Whole virus (H5N1) adjuvanted vaccineSubjects in this group received 2 doses of H5N1 adjuvanted formulation 3 vaccine at a 21-day interval |
| H5N1 Formulation 4 Group | Experimental | Biological: Influenza Monovalent Whole virus (H5N1) adjuvanted vaccineSubjects in this group received 2 doses of H5N1 adjuvanted formulation 4 vaccine at a 21-day interval |
| H5N1 Formulation 5 Group | Active comparator | Biological: Influenza Monovalent Whole virus (H5N1)Subjects in this group received 2 doses of H5N1 formulation 5 vaccine at a 21-day interval |
| H5N1 Formulation 6 Group | Active comparator | Biological: Influenza Monovalent Whole virus (H5N1)Subjects in this group received 2 doses of H5N1 formulation 6 vaccine at a 21-day interval |
| H5N1 Formulation 7 Group | Active comparator | Biological: Influenza Monovalent Whole virus (H5N1)Subjects in this group received 2 doses of H5N1 formulation 7 vaccine at a 21-day interval |
| H5N1 Formulation 8 Group | Active comparator | Biological: Influenza Monovalent Whole virus (H5N1)Subjects in this group received 2 doses of H5N1 formulation 8 vaccine at a 21-day interval |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- A male or female between, and including, 18 and 60 years of age at the time of the first vaccination.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- If the subject is female, she must be of non-childbearing potential.
Key exclusion criteria (11 listed)
- Administration of any vaccine during the period starting 15 days before the first administration of the study vaccine and ending 21 after the second one.
- Administration of an influenza vaccine other than the study vaccines during the entire study period.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first administration of the study vaccine.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
- History of hypersensitivity to vaccines.
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 Monovalent Whole virus (H5N1) adjuvanted vaccine2 doses administered intramuscularly at the deltoid region of the non-dominant arm at Days 0 and 21 | Biological | H5N1 Formulation 1 Group, H5N1 Formulation 2 Group, H5N1 Formulation 3 Group, H5N1 Formulation 4 Group |
| Influenza Monovalent Whole virus (H5N1)2 doses administered intramuscularly at the deltoid region of the non-dominant arm at Days 0 and 21 | Biological | H5N1 Formulation 5 Group, H5N1 Formulation 6 Group, H5N1 Formulation 7 Group, H5N1 Formulation 8 Group |
Primary outcome
To evaluate the humoral immune response induced by the study vaccines in term of anti-haemagglutinin antibody titers
Time frame: At Days 0, 21, 42 and 180
Geometric mean titers (GMTs) of serum antibodies
To evaluate the humoral immune response induced by the study vaccines in terms of seroconversion rates (SCRs), Conversion factors and protection rates to H5N1 virus
Time frame: At days 21, 42 and 180
Occurrence of solicited local and general adverse events
Time frame: During a 7 day follow-up period (i.e. day of vaccination and 6 subsequent days) after each dose of vaccine and overall
Occurrence of unsolicited adverse events
Time frame: During a 21 day follow-up period after the first vaccination and 30 day follow-up period after the second vaccination
Occurrence of serious adverse events
Time frame: During the entire study (Days 0 to 180)
3 secondary outcomes
To evaluate the humoral immune response induced by the study vaccines in term of serum neutralizing antibody titers
Time frame: At Days 0, 21, 42 and 180
To evaluate the cell-mediated immune response induced by the study vaccines in term of frequency of influenza-specific CD4/CD8 T lymphocytes
Time frame: At days 0, 21, 42 and 180
To evaluate the humoral immune response induced by the study vaccines in terms of SCR for serum neutralizing antibody titers
Time frame: At Days 21, 42 and 180
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 8 May 2017.
- Results for study 106378 can be found on the GSK Clinical Study RegisterLink provided by the sponsor.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Influenza Monovalent Whole virus (H5N1) adjuvanted vaccine and Influenza Monovalent Whole virus (H5N1) in people with Influenza, run by GlaxoSmithKline at 9 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 3 inclusion and 11 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 8 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 humoral immune response induced by the study vaccines in term of anti-haemagglutinin antibody titers (time frame: At Days 0, 21, 42 and 180). The study lists 5 primary outcomes in all. 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 8 May 2017.