InfluenzaPhase 1NCT01659086
Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Influenza Vaccines GSK2654911A and GSK2654909A Administered to Adults 18 to 64 Years of Age
A Phase 1 study testing Investigational H9N2 vaccine GSK2654911A and Investigational H9N2 vaccine GSK2654909A in people with Influenza, run by GlaxoSmithKline at 4 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the safety, reactogenicity, and immunogenicity of different formulations of a two-dose primary series and booster vaccination of monovalent Influenza H9N2 vaccine manufactured in Quebec, Canada with and without adjuvant, in adults 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 H9N2 vaccine GSK2654911A and Investigational H9N2 vaccine GSK2654909A
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 422 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 22 Aug 2012to 19 Mar 2014
- 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 from 18 to 64 years of age (inclusive) at time of first study vaccination.
- Written informed consent obtained from the 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.
- Body weight of at least 110 lbs (49.9 kg).
- Access to a consistent means of telephone contact, which may be either in the home or at the workplace, land line or mobile, but NOT a pay phone or other multiple-user device (i.e., a common-use phone serving multiple rooms or apartments).
- 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 booster dose administration.
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.
- Persons with a history of cancer who are disease-free without treatment for three years or more are eligible.
- Persons with a history of histologically-confirmed basal cell carcinoma of the skin successfully treated with local excision only are excepted and may enroll, but other histologic types of skin cancer are exclusionary.
- Women who are disease-free three years or more after treatment for breast cancer and receiving long-term prophylaxis may enroll.
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- 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 (no laboratory testing required).
- Receipt of systemic glucocorticoids (e.g., prednisone ≥ 10 mg/day for more than 14 consecutive days) within 30 days prior to the first dose of study vaccine, or any other cytotoxic, immunosuppressive or immune-modifying drugs within 365 days of study enrollment. Topical, intra-articularly injected, or inhaled glucocorticoids, topical calcineurin inhibitors or imiquimod are allowed.
- Any significant disorder of coagulation or treatment with warfarin derivatives or heparin. Persons receiving individual doses of low molecular weight heparin outside of 24 hours prior to vaccination are eligible. Persons receiving prophylactic antiplatelet medications, e.g., low-dose aspirin, and without a clinically-apparent bleeding tendency, are eligible.
- 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/product.
- Planned administration of any vaccine other than the study vaccine/product before blood sampling at the Day 42 visit.
- Previous administration of any H9 vaccine or physician-confirmed H9 disease.
- Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Receipt of any immunoglobulins and/or any blood products within 90 days before study enrolment 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 vaccination.
- 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
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
GSK Investigational Site
Austin, Texas, 78705
GSK Investigational Site
Edison, New Jersey, 08817
GSK Investigational Site
Miami, Florida, 33143
About this study
Official title: An Observer-blind Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Influenza Vaccines GSK2654911A and GSK2654909A Administered to Adults 18 to 64 Years of Age
The purpose of this study is to evaluate the safety, reactogenicity, and immunogenicity of different formulations of a two-dose primary series and booster vaccination of monovalent Influenza H9N2 vaccine manufactured in Quebec, Canada with and without adjuvant, in adults 18 to 64 years of age.
- Conditions
- Influenza
- Being tested
- Investigational H9N2 vaccine GSK2654911A, Investigational H9N2 vaccine GSK2654909A, Placebo
- Keywords
- Influenza, Immunogenicity, H9N2, Safety
- 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 H9N2 vaccine GSK2654911ABiological
2 or 3 doses of GSK2654911A (different formulations) followed by 1 or 0 dose of saline placebo respectively, depending in the treatment group. All doses to be administered intramuscularly (IM) in deltoid region of arm.
Investigational H9N2 vaccine GSK2654909ABiological
2 or 3 doses of GSK2654909A followed by 1 or 0 dose of saline placebo, respectively (treatment 5). All doses to be administered IM in deltoid region of arm.
PlaceboBiological
1 dose of saline placebo administered intramuscularly (IM) in deltoid region of arm.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Subjects will receive the investigational vaccine GSK2654911A formulation 1 and placebo Receives: Biological: Investigational H9N2 vaccine GSK2654911A; Biological: Placebo |
| Group B | Experimental | Subjects will receive the investigational vaccine GSK2654911A formulation 2 and placebo Receives: Biological: Investigational H9N2 vaccine GSK2654911A; Biological: Placebo |
| Group C | Experimental | Subjects will receive the investigational vaccine GSK2654911A formulation 3 and placebo Receives: Biological: Investigational H9N2 vaccine GSK2654911A; Biological: Placebo |
| Group D | Experimental | Subjects will receive the investigational vaccine GSK2654911A formulation 4 and placebo Receives: Biological: Investigational H9N2 vaccine GSK2654911A; Biological: Placebo |
| Group E | Experimental | Subjects will receive the investigational vaccine GSK2654909A and placebo Receives: Biological: Investigational H9N2 vaccine GSK2654909A; Biological: Placebo |
| Group F | Experimental | Subjects will receive the investigational vaccine GSK2654911A formulation 5 Receives: Biological: Investigational H9N2 vaccine GSK2654911A |
| Group G | Experimental | Subjects will receive the investigational vaccine GSK2654911A formulation 6 Receives: Biological: Investigational H9N2 vaccine GSK2654911A |
| Group H | Experimental | Subjects will receive the investigational vaccine GSK2654911A formulation 7 Receives: Biological: Investigational H9N2 vaccine GSK2654911A |
| Group I | Experimental | Subjects will receive the investigational vaccine GSK2654911A formulation 8 Receives: Biological: Investigational H9N2 vaccine GSK2654911A |
| Group J | Experimental | Subjects will receive the investigational vaccine GSK2654909A Receives: Biological: Investigational H9N2 vaccine GSK2654909A |
| Placebo Group | Placebo comparator | Subjects will receive Placebo 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 HI antibodies against H9N2 v-like antigen
Measured: Day 21
Humoral immune response in terms of HI antibodies against H9N2 v-like antigen
Measured: Day 42
Secondary outcomes (9)
Humoral immune response in terms of HI antibodies against H9N2 antigen
Measured: GMTs and seropositivity rates, SPR on Days 0, 7, 21, 28, 42, 182, 191, 385 and 546. SCR and MGI on Days 7, 21, 28, 42, 182, 191, 385 and 546. B-SCR and BF on Days 191, 385 and 546.
Humoral immune response in terms of HI antibodies against H9N2 antigen for each vaccine group and for age strata (18-40 years; 41-64 years)
Measured: GMTs and seropositivity rates, SPR on Days 0, 7, 21, 28, 42, 182, 191, 385 and 546. SCR and MGI on Days 7, 21, 28, 42, 182, 191, 385 and 546. B-SCR and BF on Days 191, 385 and 546.
Humoral immune response in terms of HI antibodies against any drift strain from H9N2 antigen or against any other H9 subtype antigen
Measured: GMTs and seropositivity rates on Days 0, 7, 21, 28, 42, 182 , 191, 385 and 546. SCR and MGI on Days 21, 42, 182, 191, 385, 546. SPR on Days 0, 21, 42, 182, 191, 385 and 546. B-SCR and BF on Days 191, 385 and 546.
Humoral immune response in terms of neutralizing (MN) antibodies against H9N2 and against any drift strain (or other H9 subtype)
Measured: GMTs and seropositivity rate on Days 0, 21, 42, 182, 191, 385 and 546. VRR on Days 21, 42, 182, 191, 385, 546. Booster-VRR on Day 191, 385 and 546.
Occurrence of local and general symptoms
Measured: During the 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after any vaccination
Occurrence and relationship to vaccination of unsolicited adverse events
Measured: Within 21 days (Day 0 to Day 20, 21 to 41, 182 to 202) after any vaccination
Occurrence and relationship to vaccination of adverse events with medically attended visits
Measured: During the entire study period (Day 0 - Day 546)
Occurrence and relationship to vaccination of Adverse events of special interest (AESIs), potential Immune-Mediated Diseases (pIMDs), Serious Adverse Events (SAEs) and adverse pregnancy outcome
Measured: During the entire study period (Day 0 - Day 546)
Number of subjects with clinical safety laboratory abnormalities
Measured: Days 0, 7, 21, 28, 42, 182, 191, and 385.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2012 (estimated)
- Study start22 Aug 2012
- Primary completion26 Oct 2012
- Study completion19 Mar 2014
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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 422 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
- NCT01659086
- Sponsor's protocol ID
- 116358
- Status last verified
- Jun 2018
- First submitted
- 3 Aug 2012
- Last updated
- 18 Jun 2018
- Results posted
- No
- Individual data sharing
- Yes: IPD for this study will be made available via the Clinical Study Data Request site.
Publications
Madan A, Collins H, Sheldon E, Frenette L, Chu L, Friel D, Drame M, Vaughn DW, Innis BL, Schuind A. Evaluation of a primary course of H9N2 vaccine with or without AS03 adjuvant in adults: A phase I/II randomized trial. Vaccine. 2017 Aug 16;35(35 Pt B):4621-4628. doi: 10.1016/j.vaccine.2017.07.013. Epub 2017 Jul 15.
PubMed 28720281
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2018. 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 Vaccines GSK2654911A and GSK2654909A Administered to Adults 18 to 64 Years of Age
- ClinicalTrials.gov ID
- NCT01659086
- Acronym / sponsor ID
- 116358
- Conditions
- Influenza
- Keywords
- Influenza, Immunogenicity, H9N2, Safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 422 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 22 Aug 2012 (actual)
- Primary completion
- 26 Oct 2012 (actual)
- Study completion
- 19 Mar 2014 (actual)
- First posted
- 7 Aug 2012 (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, reactogenicity, and immunogenicity of different formulations of a two-dose primary series and booster vaccination of monovalent Influenza H9N2 vaccine manufactured in Quebec, Canada with and without adjuvant, in adults 18 to 64 years of age.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Biological: Investigational H9N2 vaccine GSK2654911A, Biological: PlaceboSubjects will receive the investigational vaccine GSK2654911A formulation 1 and placebo |
| Group B | Experimental | Biological: Investigational H9N2 vaccine GSK2654911A, Biological: PlaceboSubjects will receive the investigational vaccine GSK2654911A formulation 2 and placebo |
| Group C | Experimental | Biological: Investigational H9N2 vaccine GSK2654911A, Biological: PlaceboSubjects will receive the investigational vaccine GSK2654911A formulation 3 and placebo |
| Group D | Experimental | Biological: Investigational H9N2 vaccine GSK2654911A, Biological: PlaceboSubjects will receive the investigational vaccine GSK2654911A formulation 4 and placebo |
| Group E | Experimental | Biological: Investigational H9N2 vaccine GSK2654909A, Biological: PlaceboSubjects will receive the investigational vaccine GSK2654909A and placebo |
| Group F | Experimental | Biological: Investigational H9N2 vaccine GSK2654911ASubjects will receive the investigational vaccine GSK2654911A formulation 5 |
| Group G | Experimental | Biological: Investigational H9N2 vaccine GSK2654911ASubjects will receive the investigational vaccine GSK2654911A formulation 6 |
| Group H | Experimental | Biological: Investigational H9N2 vaccine GSK2654911ASubjects will receive the investigational vaccine GSK2654911A formulation 7 |
| Group I | Experimental | Biological: Investigational H9N2 vaccine GSK2654911ASubjects will receive the investigational vaccine GSK2654911A formulation 8 |
| Group J | Experimental | Biological: Investigational H9N2 vaccine GSK2654909ASubjects will receive the investigational vaccine GSK2654909A |
| Placebo Group | Placebo comparator | Biological: PlaceboSubjects will receive Placebo |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Male or female adults from 18 to 64 years of age (inclusive) at time of first study vaccination.
- Written informed consent obtained from the 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.
- Body weight of at least 110 lbs (49.9 kg).
Key exclusion criteria (20 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.
- 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 (no laboratory testing required).
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 H9N2 vaccine GSK2654911A2 or 3 doses of GSK2654911A (different formulations) followed by 1 or 0 dose of saline placebo respectively, depending in the treatment group. All doses to be administered intramuscularly (IM) in deltoid region of arm. | Biological | Group A, Group B, Group C, Group D, Group F, Group G, Group H, Group I |
| Investigational H9N2 vaccine GSK2654909A2 or 3 doses of GSK2654909A followed by 1 or 0 dose of saline placebo, respectively (treatment 5). All doses to be administered IM in deltoid region of arm. | Biological | Group E, Group J |
| Placebo1 dose of saline placebo administered intramuscularly (IM) in deltoid region of arm. | Biological | Group A, Group B, Group C, Group D, Group E, Placebo Group |
Primary outcome
Humoral immune response in terms of HI antibodies against H9N2 v-like antigen
Time frame: Day 21
Humoral immune response in terms of HI antibodies against H9N2 v-like antigen
Time frame: Day 42
9 secondary outcomes
Humoral immune response in terms of HI antibodies against H9N2 antigen
Time frame: GMTs and seropositivity rates, SPR on Days 0, 7, 21, 28, 42, 182, 191, 385 and 546. SCR and MGI on Days 7, 21, 28, 42, 182, 191, 385 and 546. B-SCR and BF on Days 191, 385 and 546.
Humoral immune response in terms of HI antibodies against H9N2 antigen for each vaccine group and for age strata (18-40 years; 41-64 years)
Time frame: GMTs and seropositivity rates, SPR on Days 0, 7, 21, 28, 42, 182, 191, 385 and 546. SCR and MGI on Days 7, 21, 28, 42, 182, 191, 385 and 546. B-SCR and BF on Days 191, 385 and 546.
Humoral immune response in terms of HI antibodies against any drift strain from H9N2 antigen or against any other H9 subtype antigen
Time frame: GMTs and seropositivity rates on Days 0, 7, 21, 28, 42, 182 , 191, 385 and 546. SCR and MGI on Days 21, 42, 182, 191, 385, 546. SPR on Days 0, 21, 42, 182, 191, 385 and 546. B-SCR and BF on Days 191, 385 and 546.
Humoral immune response in terms of neutralizing (MN) antibodies against H9N2 and against any drift strain (or other H9 subtype)
Time frame: GMTs and seropositivity rate on Days 0, 21, 42, 182, 191, 385 and 546. VRR on Days 21, 42, 182, 191, 385, 546. Booster-VRR on Day 191, 385 and 546.
Occurrence of local and general symptoms
Time frame: During the 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after any vaccination
Occurrence and relationship to vaccination of unsolicited adverse events
Time frame: Within 21 days (Day 0 to Day 20, 21 to 41, 182 to 202) after any vaccination
Occurrence and relationship to vaccination of adverse events with medically attended visits
Time frame: During the entire study period (Day 0 - Day 546)
Occurrence and relationship to vaccination of Adverse events of special interest (AESIs), potential Immune-Mediated Diseases (pIMDs), Serious Adverse Events (SAEs) and adverse pregnancy outcome
Time frame: During the entire study period (Day 0 - Day 546)
Number of subjects with clinical safety laboratory abnormalities
Time frame: Days 0, 7, 21, 28, 42, 182, 191, and 385.
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 18 Jun 2018.
- Derived from this study: PubMed 28720281Madan A, Collins H, Sheldon E, Frenette L, Chu L, Friel D, Drame M, Vaughn DW, Innis BL, Schuind A. Evaluation of a primary course of H9N2 vaccine with or without AS03 adjuvant in adults: A phase I/II randomized trial. Vaccine. 2017 Aug 16;35(35 Pt B):4621-4628. doi: 10.1016/j.vaccine.2017.07.013. Epub 2017 Jul 15.
- Results for study 116358 can be found on the GSK Clinical Study RegisterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request 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
4 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 H9N2 vaccine GSK2654911A and Investigational H9N2 vaccine GSK2654909A in people with Influenza, run by GlaxoSmithKline at 4 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 8 inclusion and 20 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 18 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 HI antibodies against H9N2 v-like antigen (time frame: Day 21). The study lists 2 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 NCT01659086, 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 18 Jun 2018.