InfluenzaPhase 1NCT02177734
Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Influenza Vaccine(s) GSK3277510A and GSK3277509A in Adults 18 to 60 Years of Age
A Phase 1 study testing Investigational H7N9 vaccine GSK3277510A and Investigational H7N9 vaccine GSK3277509A in people with Influenza, run by GlaxoSmithKline.
Trial summary
The purpose of this study is to evaluate the safety and immunogenicity of different formulations of GSK Biologicals' H7N9 influenza vaccine in subjects 18 to 60 years of age. 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?
- Investigational H7N9 vaccine GSK3277510A and Investigational H7N9 vaccine GSK3277509A
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to May 2017
- 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
- Male or female adults who are 18 to 60years of age (inclusive) at the time of first study vaccination.
- Written informed consent obtained from subject.
- Subjects who the investigator believes can and will comply with the requirements of the protocol.
- Healthy subjects as established by medical history and physical examination.
- Access to a consistent means of telephone contact.
- For subjects who undergo a screening visit: Results of screening safety laboratory tests that figure in eligibility assessment must be within reference ranges before dosing.
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- Female subjects of non-childbearing potential may be enrolled in the study.
- Female subjects of childbearing potential may be enrolled in the study, if they
- have practiced adequate contraception for 30 days prior to vaccination, and
- have a negative pregnancy test on the day of vaccination, and agree to continue to practice adequate contraception until 2 months after the last dose administered.
Who cannot join
- Presence or evidence of neurological or psychiatric diagnoses which, although stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
- Presence or evidence of substance abuse.
- Diagnosed with cancer, or treatment for cancer within three years.
- Diagnosed with excessive daytime sleepiness, or narcolepsy; or history of narcolepsy in a subject's parent, sibling or child.
- Presence of a temperature ≥ 38.0ºC (≥100.4ºF), or acute symptoms greater than "mild" severity on the scheduled date of first vaccination.
- Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus (HIV) infection.
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- Receipt of systemic glucocorticoids within 30 days prior to the first dose of study vaccine/placebo, or any other cytotoxic, immunosuppressive or immune-modifying drugs within 6 months of first study vaccine/ placebo dose.
- Any significant disorder of coagulation or treatment with warfarin derivatives or heparin.
- An acute evolving neurological disorder or Guillain Barré Syndrome within 42 days of receipt of prior seasonal or pandemic influenza vaccine.
- Administration of an inactive vaccine within 14 days or of a live attenuated vaccine within 30 days before the first dose of study vaccine/placebo.
- Planned administration of any vaccine other than the study vaccine/placebo before blood sampling at the Day 42 visit.
- Previous administration of any H7 vaccine or physician-confirmed H7 disease.
- Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine/placebo, or planned use during the study period.
- Receipt of any immunoglobulins and/or any blood products within 90 days before the first dose of study vaccine/placebo, or planned administration of any of these products during the study period.
- Any known or suspected allergy to any constituent of influenza vaccines or component used in the manufacturing process of the study vaccine including a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine.
- Known pregnancy or a positive urine beta-human chorionic gonadotropin (β-hCG) test result before the first dose of study vaccine/placebo.
- Lactating or nursing women.
- Any condition which, in the opinion of the investigator, prevents the subject from participating in the study.
About this study
Official title: An Observer-blind Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Influenza Vaccine(s) GSK3277510A and GSK3277509A Administered in Adults 18 to 60 Years of Age
The purpose of this study is to evaluate the safety and immunogenicity of different formulations of GSK Biologicals' H7N9 influenza vaccine in subjects 18 to 60 years of age.
- Conditions
- Influenza
- Being tested
- Investigational H7N9 vaccine GSK3277510A, Investigational H7N9 vaccine GSK3277509A, Placebo
- Keywords
- Adjuvant, Safety, Influenza, H7N9, Immunogenicity, Adults
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational H7N9 vaccine GSK3277510ABiological
One dose of GSK3277510A H7N9 vaccine administered intramuscularly (IM) in the deltoid region of non-dominant arm at Day 0 and the second dose of GSK3277510A H7N9 vaccine administered IM in the deltoid region of dominant arm at Day 21
Investigational H7N9 vaccine GSK3277509ABiological
One dose of GSK3277509A H7N9 vaccine administered IM at the deltoid region of non-dominant arm at Day 0 and the second dose of GSK3277509A H7N9 vaccine administered IM at the deltoid region of dominant arm at Day 21
PlaceboBiological
One dose of placebo administered IM at the deltoid region of non-dominant arm at Day 0 and the second dose of placebo administered IM at the deltoid region of dominant arm at Day 21
| Study group | Role | What they receive |
|---|---|---|
| Formulation 1 Group | Experimental | Subjects in this group will receive two doses of GSK3277510A H7N9 vaccine formulation 1 at a 21 day interval Receives: Biological: Investigational H7N9 vaccine GSK3277510A |
| Formulation 2 Group | Experimental | Subjects in this group will receive two doses of GSK3277510A H7N9 vaccine formulation 2 at a 21 day interval Receives: Biological: Investigational H7N9 vaccine GSK3277510A |
| Formulation 3 Group | Experimental | Subjects in this group will receive two doses of GSK3277510A H7N9 vaccine formulation 3 at a 21 day interval Receives: Biological: Investigational H7N9 vaccine GSK3277510A |
| Formulation 4 Group | Experimental | Subjects in this group will receive two doses of GSK3277510A H7N9 vaccine formulation 4 at a 21 day interval Receives: Biological: Investigational H7N9 vaccine GSK3277510A |
| Formulation 5 Group | Experimental | Subjects in this group will receive two doses of GSK3277509A H7N9 vaccine formulation 5 at a 21 day interval Receives: Biological: Investigational H7N9 vaccine GSK3277509A |
| Placebo Group | Placebo comparator | Subjects in this group will receive two doses of placebo at a 21 day interval Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Humoral immune response in terms of vaccine-homologous hemagglutination inhibition (HI) antibody titers
Measured: At Day 42.
Occurrence of each solicited local symptom
Measured: During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccination.
Occurrence of each solicited general symptom
Measured: During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccination.
Occurrence of clinical safety laboratory abnormalities reported for samples
Measured: At the Day 0, 7, 21, 28 and 42 visits.
Occurrence of unsolicited adverse events (AEs)
Measured: 21 days after each dose.
Occurrence of Medically Attended Adverse Events (MAEs), potential Immune Mediated Diseases (pIMDs) and Serious Adverse Events (SAEs)[Active Phase]
Measured: From Day 0 until Day 42.
Secondary outcomes (7)
Evaluation of adjuvant effect as assessed by vaccine-homologous hemagglutination inhibition (HI) antibody titers
Measured: At Day 42.
Humoral immune response in terms of vaccine-homologous hemagglutination inhibition (HI) antibody titers for plain antigen vaccine group
Measured: At Day 42.
Humoral immune response in terms of vaccine-homologous (H7N9) HI antibody titers.
Measured: GMTs and Seropositivity rates at Days 0, 21, 42 and Months 6 and 12. SCR and MGI at Days 21, 42 (Placebo group only) and Months 6 and 12. SPR at Days 0, 21, 42 (Placebo group only) and Months 6 and 12.
Humoral immune response in terms of vaccine-homologous (H7N9) neutralizing (MN) antibody titres.
Measured: GMTs and Seropositivity rates at the Days 0, 21, 42 and Month 6 visits. VRR at Days 21, 42 and Month 6 visits.
Humoral immune response in terms of vaccine-homologous (H7N9) HI antibody titers by age stratum.
Measured: GMTs, Seropositivity rates and SPR at Days 0, 21, 42 and Months 6 and 12. SCR and MGI at Days 21, 42 and Months 6 and 12.
Humoral immune response in terms of vaccine homologous (H7N9) neutralizing (MN) antibody titers for each study group by age stratum (18-40 years; 41-60 years)
Measured: GMTs and Seropositivity rates at Days 0, 21, 42 and Month 6. VRR at Days 21, 42 and Month 6.
Occurrence of MAEs, pIMDs and SAEs
Measured: Until the Month 12 visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2014 (estimated)
- Study startMar 2016
- Primary completionJun 2016 (estimated)
- Study completionMay 2017 (estimated)
Why it stopped: The study was cancelled for scientifically legitimate reasons not related to safety or efficacy of the vaccine.
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 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
- NCT02177734
- Sponsor's protocol ID
- 201300
- Other IDs
- 2014-000796-27, 2014
- Status last verified
- Jun 2016
- First submitted
- 19 Jun 2014
- Last updated
- 20 Jun 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observer-blind Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Influenza Vaccine(s) GSK3277510A and GSK3277509A Administered in Adults 18 to 60 Years of Age
- ClinicalTrials.gov ID
- NCT02177734
- Acronym / sponsor ID
- 201300
- Conditions
- Influenza
- Keywords
- Adjuvant, Safety, Influenza, H7N9, Immunogenicity, Adults
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was cancelled for scientifically legitimate reasons not related to safety or efficacy of the vaccine.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Mar 2016
- Primary completion
- Jun 2016 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 30 Jun 2014 (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.
The purpose of this study is to evaluate the safety and immunogenicity of different formulations of GSK Biologicals' H7N9 influenza vaccine in subjects 18 to 60 years of age.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Formulation 1 Group | Experimental | Biological: Investigational H7N9 vaccine GSK3277510ASubjects in this group will receive two doses of GSK3277510A H7N9 vaccine formulation 1 at a 21 day interval |
| Formulation 2 Group | Experimental | Biological: Investigational H7N9 vaccine GSK3277510ASubjects in this group will receive two doses of GSK3277510A H7N9 vaccine formulation 2 at a 21 day interval |
| Formulation 3 Group | Experimental | Biological: Investigational H7N9 vaccine GSK3277510ASubjects in this group will receive two doses of GSK3277510A H7N9 vaccine formulation 3 at a 21 day interval |
| Formulation 4 Group | Experimental | Biological: Investigational H7N9 vaccine GSK3277510ASubjects in this group will receive two doses of GSK3277510A H7N9 vaccine formulation 4 at a 21 day interval |
| Formulation 5 Group | Experimental | Biological: Investigational H7N9 vaccine GSK3277509ASubjects in this group will receive two doses of GSK3277509A H7N9 vaccine formulation 5 at a 21 day interval |
| Placebo Group | Placebo comparator | Biological: PlaceboSubjects in this group will receive two doses of placebo at a 21 day interval |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Male or female adults who are 18 to 60years of age (inclusive) at the time of first study vaccination.
- Written informed consent obtained from subject.
- Subjects who the investigator believes can and will comply with the requirements of the protocol.
- Healthy subjects as established by medical history and physical examination.
- Access to a consistent means of telephone contact.
Key exclusion criteria (18 listed)
- Presence or evidence of neurological or psychiatric diagnoses which, although stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
- Presence or evidence of substance abuse.
- Diagnosed with cancer, or treatment for cancer within three years.
- Diagnosed with excessive daytime sleepiness, or narcolepsy; or history of narcolepsy in a subject's parent, sibling or child.
- Presence of a temperature ≥ 38.0ºC (≥100.4ºF), or acute symptoms greater than "mild" severity on the scheduled date of first vaccination.
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 |
|---|---|---|
| Investigational H7N9 vaccine GSK3277510AOne dose of GSK3277510A H7N9 vaccine administered intramuscularly (IM) in the deltoid region of non-dominant arm at Day 0 and the second dose of GSK3277510A H7N9 vaccine administered IM in the deltoid region of dominant arm at Day 21 | Biological | Formulation 1 Group, Formulation 2 Group, Formulation 3 Group, Formulation 4 Group |
| Investigational H7N9 vaccine GSK3277509AOne dose of GSK3277509A H7N9 vaccine administered IM at the deltoid region of non-dominant arm at Day 0 and the second dose of GSK3277509A H7N9 vaccine administered IM at the deltoid region of dominant arm at Day 21 | Biological | Formulation 5 Group |
| PlaceboOne dose of placebo administered IM at the deltoid region of non-dominant arm at Day 0 and the second dose of placebo administered IM at the deltoid region of dominant arm at Day 21 | Biological | Placebo Group |
Primary outcome
Humoral immune response in terms of vaccine-homologous hemagglutination inhibition (HI) antibody titers
Time frame: At Day 42.
Occurrence of each solicited local symptom
Time frame: During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccination.
Occurrence of each solicited general symptom
Time frame: During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccination.
Occurrence of clinical safety laboratory abnormalities reported for samples
Time frame: At the Day 0, 7, 21, 28 and 42 visits.
Occurrence of unsolicited adverse events (AEs)
Time frame: 21 days after each dose.
Occurrence of Medically Attended Adverse Events (MAEs), potential Immune Mediated Diseases (pIMDs) and Serious Adverse Events (SAEs)[Active Phase]
Time frame: From Day 0 until Day 42.
7 secondary outcomes
Evaluation of adjuvant effect as assessed by vaccine-homologous hemagglutination inhibition (HI) antibody titers
Time frame: At Day 42.
Humoral immune response in terms of vaccine-homologous hemagglutination inhibition (HI) antibody titers for plain antigen vaccine group
Time frame: At Day 42.
Humoral immune response in terms of vaccine-homologous (H7N9) HI antibody titers.
Time frame: GMTs and Seropositivity rates at Days 0, 21, 42 and Months 6 and 12. SCR and MGI at Days 21, 42 (Placebo group only) and Months 6 and 12. SPR at Days 0, 21, 42 (Placebo group only) and Months 6 and 12.
Humoral immune response in terms of vaccine-homologous (H7N9) neutralizing (MN) antibody titres.
Time frame: GMTs and Seropositivity rates at the Days 0, 21, 42 and Month 6 visits. VRR at Days 21, 42 and Month 6 visits.
Humoral immune response in terms of vaccine-homologous (H7N9) HI antibody titers by age stratum.
Time frame: GMTs, Seropositivity rates and SPR at Days 0, 21, 42 and Months 6 and 12. SCR and MGI at Days 21, 42 and Months 6 and 12.
Humoral immune response in terms of vaccine homologous (H7N9) neutralizing (MN) antibody titers for each study group by age stratum (18-40 years; 41-60 years)
Time frame: GMTs and Seropositivity rates at Days 0, 21, 42 and Month 6. VRR at Days 21, 42 and Month 6.
Occurrence of MAEs, pIMDs and SAEs
Time frame: Until the Month 12 visit.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2016.
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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
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Investigational H7N9 vaccine GSK3277510A and Investigational H7N9 vaccine GSK3277509A in people with Influenza, run by GlaxoSmithKline.
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 10 inclusion and 18 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: withdrawn, as of the sponsor's last update on 20 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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?
Humoral immune response in terms of vaccine-homologous hemagglutination inhibition (HI) antibody titers (time frame: At Day 42.). The study lists 6 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 20 Jun 2016.