InfluenzaPhase 1NCT01999842
Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Influenza Vaccine(s) GSK3206641A and GSK3206640A Administered in Adults 18 to 64 Years of Age
A Phase 1 study testing Investigational H7N9 vaccine GSK3206641A and Investigational H7N9 vaccine GSK3206640A in people with Influenza, run by GlaxoSmithKline at 8 sites in 2 countries.
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 64 years of age. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Investigational H7N9 vaccine GSK3206641A and Investigational H7N9 vaccine GSK3206640A
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 424 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 25 Nov 2013to 19 Jan 2015
- 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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female adults who are 18 to 64 years 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 all safety laboratory tests obtained at the screening visit must be within reference ranges. Results of any repeat testing cannot be used to qualify a subject for enrolment.
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- Female subjects of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as current tubal ligation, hysterectomy, ovariectomy or post-menopause.
- 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.
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
United States5 sites
GSK Investigational Site
Boise, Idaho, 83642
GSK Investigational Site
Erie, Pennsylvania, 16506
GSK Investigational Site
Jacksonville, Florida, 32216
GSK Investigational Site
Seattle, Washington, 98105
GSK Investigational Site
Stockbridge, Georgia, 30281
Canada3 sites
GSK Investigational Site
Sherbrooke, Quebec, J1H 2G2
GSK Investigational Site
Truro, Nova Scotia, B2N 1L2
GSK Investigational Site
Woodstock, Ontario, N4S 5P5
About this study
Official title: An Observer-blind Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Influenza Vaccine(s) GSK3206641A and GSK3206640A Administered in Adults 18 to 64 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 64 years of age.
- Conditions
- Influenza
- Being tested
- Investigational H7N9 vaccine GSK3206641A, Investigational H7N9 vaccine GSK3206640A, Placebo
- Keywords
- H7N9, Influenza, Safety, Adults, Adjuvant, Immunogenicity
- 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 GSK3206641ABiological
One dose of GSK3206641A H7N9 vaccine administered intramuscularly (IM) in the deltoid region of arm at Day 0 and the second dose of GSK3206641A H7N9 vaccine administered IM in the deltoid region of arm at Day 21
Investigational H7N9 vaccine GSK3206640ABiological
One dose of GSK3206640A H7N9 vaccine administered IM at the deltoid region of arm at Day 0 and the second dose of GSK3206640A H7N9 vaccine administered IM at the deltoid region of arm at Day 21
PlaceboBiological
One dose of placebo administered IM at the deltoid region of arm at Day 0 and the second dose of placebo administered IM at the deltoid region of arm at Day 21
| Study group | Role | What they receive |
|---|---|---|
| Formulation 1 Group | Experimental | Subjects in this group will receive two doses of GSK3206641A H7N9 vaccine formulation 1 at a 21 day interval Receives: Biological: Investigational H7N9 vaccine GSK3206641A |
| Formulation 2 Group | Experimental | Subjects in this group will receive two doses of GSK3206641A H7N9 vaccine formulation 2 at a 21 day interval Receives: Biological: Investigational H7N9 vaccine GSK3206641A |
| Formulation 3 Group | Experimental | Subjects in this group will receive two doses of GSK3206641A H7N9 vaccine formulation 3 at a 21 day interval Receives: Biological: Investigational H7N9 vaccine GSK3206641A |
| Formulation 4 Group | Experimental | Subjects in this group will receive two doses of GSK3206641A H7N9 vaccine formulation 4 at a 21 day interval Receives: Biological: Investigational H7N9 vaccine GSK3206641A |
| Formulation 5 Group | Experimental | Subjects in this group will receive two doses of GSK3206640A H7N9 vaccine formulation 5 at a 21 day interval Receives: Biological: Investigational H7N9 vaccine GSK3206640A |
| 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
The following aggregate variables will be calculated for each adjuvanted H7N9 vaccine group: • Seroconversion rates (SCR); • Seroprotection rates (SPR); • Mean Geometric Increase (MGI)
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 Day 0 visit
Occurrence of clinical safety laboratory abnormalities reported for samples
Measured: At Day 7 visit
Occurrence of clinical safety laboratory abnormalities reported for samples
Measured: At Day 21 visit
Occurrence of clinical safety laboratory abnormalities reported for samples
Measured: At Day 28 visit
Occurrence of clinical safety laboratory abnormalities reported for samples
Measured: At Day 42 visit
Occurrence of unsolicited adverse events
Measured: 21 days after each dose
Occurrence of Medically Attended Adverse Events (MAEs), potential Immune Mediated Diseases (pIMDs) and Serious Adverse Events (SAEs)
Measured: From Day 0 until the Day 42
Secondary outcomes (6)
Humoral immune response in terms of vaccine-homologous hemagglutination inhibition (HI) antibody titers
The following aggregate variables will be calculated for each adjuvanted (GSK3206641A) vaccine group which successfully meets CBER and CHMP criteria, and for the unadjuvanted (GSK3206640A) plain antigen vaccine group: • Geometric mean reciprocal serum HI antibody titers (GMTs); • SCR
Measured: At Day 42
Humoral immune response in terms of vaccine-homologous hemagglutination inhibition (HI) antibody titers
The following aggregate variables will be calculated for the unadjuvanted plain antigen vaccine group: • SCR; • SPR; • MGI
Measured: At Day 42
Humoral immune response in terms of vaccine-homologous (H7N9) HI antibody titers
The following aggregate variables will be calculated for each study group: • GMTs; • Seropositivity rates; • SCR; • SPR; • MGI
Measured: GMTs and Seropositivity rates at Days 0, 21, 42 and Months 6 and 12; SCR and MGI at Day 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) HI antibody titers by age stratum
The following aggregate variables will be calculated for each study group by age stratum (18-40 years; 41-64 years): • GMTs; • Seropositivity rates; • SCR; • SPR; • MGI
Measured: GMTs, Seropositivity rates and SPR at Days 0, 21, 42 and Months 6 and 12; SCR and MGI at Day 21, 42 and Months 6 and 12
Humoral immune response in terms of vaccine homologous (H7N9) neutralizing (MN) antibody titers
The following parameters will be calculated for a subset of subjects in each study group: • GMTs; • Seropositivity rates; • Vaccine response rate (VRR)
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 posted3 Dec 2013 (estimated)
- Study start25 Nov 2013
- Primary completion1 Feb 2014
- Study completion19 Jan 2015
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 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
- 424 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
- NCT01999842
- Sponsor's protocol ID
- 201072
- Status last verified
- May 2017
- First submitted
- 21 Nov 2013
- Last updated
- 30 May 2017
- Results posted
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Publications
Madan A, Segall N, Ferguson M, Frenette L, Kroll R, Friel D, Soni J, Li P, Innis BL, Schuind A. Immunogenicity and Safety of an AS03-Adjuvanted H7N9 Pandemic Influenza Vaccine in a Randomized Trial in Healthy Adults. J Infect Dis. 2016 Dec 1;214(11):1717-1727. doi: 10.1093/infdis/jiw414. Epub 2016 Sep 7.
PubMed 27609809
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. 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) GSK3206641A and GSK3206640A Administered in Adults 18 to 64 Years of Age
- ClinicalTrials.gov ID
- NCT01999842
- Acronym / sponsor ID
- 201072
- Conditions
- Influenza
- Keywords
- H7N9, Influenza, Safety, Adults, Adjuvant, Immunogenicity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 424 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 25 Nov 2013 (actual)
- Primary completion
- 1 Feb 2014 (actual)
- Study completion
- 19 Jan 2015 (actual)
- First posted
- 3 Dec 2013 (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 64 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 GSK3206641ASubjects in this group will receive two doses of GSK3206641A H7N9 vaccine formulation 1 at a 21 day interval |
| Formulation 2 Group | Experimental | Biological: Investigational H7N9 vaccine GSK3206641ASubjects in this group will receive two doses of GSK3206641A H7N9 vaccine formulation 2 at a 21 day interval |
| Formulation 3 Group | Experimental | Biological: Investigational H7N9 vaccine GSK3206641ASubjects in this group will receive two doses of GSK3206641A H7N9 vaccine formulation 3 at a 21 day interval |
| Formulation 4 Group | Experimental | Biological: Investigational H7N9 vaccine GSK3206641ASubjects in this group will receive two doses of GSK3206641A H7N9 vaccine formulation 4 at a 21 day interval |
| Formulation 5 Group | Experimental | Biological: Investigational H7N9 vaccine GSK3206640ASubjects in this group will receive two doses of GSK3206640A 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 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Male or female adults who are 18 to 64 years 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 GSK3206641AOne dose of GSK3206641A H7N9 vaccine administered intramuscularly (IM) in the deltoid region of arm at Day 0 and the second dose of GSK3206641A H7N9 vaccine administered IM in the deltoid region of arm at Day 21 | Biological | Formulation 1 Group, Formulation 2 Group, Formulation 3 Group, Formulation 4 Group |
| Investigational H7N9 vaccine GSK3206640AOne dose of GSK3206640A H7N9 vaccine administered IM at the deltoid region of arm at Day 0 and the second dose of GSK3206640A H7N9 vaccine administered IM at the deltoid region of arm at Day 21 | Biological | Formulation 5 Group |
| PlaceboOne dose of placebo administered IM at the deltoid region of arm at Day 0 and the second dose of placebo administered IM at the deltoid region of 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
The following aggregate variables will be calculated for each adjuvanted H7N9 vaccine group: • Seroconversion rates (SCR); • Seroprotection rates (SPR); • Mean Geometric Increase (MGI)
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 Day 0 visit
Occurrence of clinical safety laboratory abnormalities reported for samples
Time frame: At Day 7 visit
Occurrence of clinical safety laboratory abnormalities reported for samples
Time frame: At Day 21 visit
Occurrence of clinical safety laboratory abnormalities reported for samples
Time frame: At Day 28 visit
Occurrence of clinical safety laboratory abnormalities reported for samples
Time frame: At Day 42 visit
Occurrence of unsolicited adverse events
Time frame: 21 days after each dose
Occurrence of Medically Attended Adverse Events (MAEs), potential Immune Mediated Diseases (pIMDs) and Serious Adverse Events (SAEs)
Time frame: From Day 0 until the Day 42
6 secondary outcomes
Humoral immune response in terms of 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
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 Day 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) 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 Day 21, 42 and Months 6 and 12
Humoral immune response in terms of vaccine homologous (H7N9) neutralizing (MN) antibody titers
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 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 30 May 2017.
- Derived from this study: PubMed 27609809Madan A, Segall N, Ferguson M, Frenette L, Kroll R, Friel D, Soni J, Li P, Innis BL, Schuind A. Immunogenicity and Safety of an AS03-Adjuvanted H7N9 Pandemic Influenza Vaccine in a Randomized Trial in Healthy Adults. J Infect Dis. 2016 Dec 1;214(11):1717-1727. doi: 10.1093/infdis/jiw414. Epub 2016 Sep 7.
- Results for study 201072 can be found on the GSK Clinical Study RegisterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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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
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Investigational H7N9 vaccine GSK3206641A and Investigational H7N9 vaccine GSK3206640A in people with Influenza, run by GlaxoSmithKline at 8 sites in 2 countries.
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 11 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: finished, as of the sponsor's last update on 30 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 8 sites in United States, Canada. 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. 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 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?
Humoral immune response in terms of vaccine-homologous hemagglutination inhibition (HI) antibody titers (time frame: At Day 42). The study lists 10 primary outcomes in all. 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 NCT01999842, 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 30 May 2017.