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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Formulation 1 Group | Experimental | Subjects in this group will receive two doses of GSK3206641A H7N9 vaccine formulation 1 at a 21 day interval |
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| Formulation 2 Group | Experimental | Subjects in this group will receive two doses of GSK3206641A H7N9 vaccine formulation 2 at a 21 day interval |
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| Formulation 3 Group | Experimental | Subjects in this group will receive two doses of GSK3206641A H7N9 vaccine formulation 3 at a 21 day interval |
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| Formulation 4 Group | Experimental | Subjects in this group will receive two doses of GSK3206641A H7N9 vaccine formulation 4 at a 21 day interval |
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| Formulation 5 Group | Experimental | Subjects in this group will receive two doses of GSK3206640A H7N9 vaccine formulation 5 at a 21 day interval |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Investigational H7N9 vaccine GSK3206641A | Biological | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | At Day 42 |
| Occurrence of each solicited local symptom | 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 | 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 | At Day 0 visit | |
| Occurrence of clinical safety laboratory abnormalities reported for samples | At Day 7 visit | |
| Occurrence of clinical safety laboratory abnormalities reported for samples | At Day 21 visit | |
| Occurrence of clinical safety laboratory abnormalities reported for samples | At Day 28 visit | |
| Occurrence of clinical safety laboratory abnormalities reported for samples | At Day 42 visit | |
| Occurrence of unsolicited adverse events |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | At Day 42 |
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Inclusion Criteria:
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.
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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Jacksonville | Florida | 32216 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27609809 | Derived | 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. |
| Label | URL |
|---|---|
| Results for study 201072 can be found on the GSK Clinical Study Register | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 201072 | Informed Consent Form | View IPD |
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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| Placebo Group | Placebo Comparator | Subjects in this group will receive two doses of placebo at a 21 day interval |
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| Investigational H7N9 vaccine GSK3206640A | Biological | 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 |
|
| Placebo | Biological | 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 |
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| 21 days after each dose |
| Occurrence of Medically Attended Adverse Events (MAEs), potential Immune Mediated Diseases (pIMDs) and Serious Adverse Events (SAEs) | From Day 0 until the 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 | 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 | 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 | 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) | 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 | Until the Month 12 visit |
| Stockbridge |
| Georgia |
| 30281 |
| United States |
| GSK Investigational Site | Boise | Idaho | 83642 | United States |
| GSK Investigational Site | Erie | Pennsylvania | 16506 | United States |
| GSK Investigational Site | Seattle | Washington | 98105 | United States |
| GSK Investigational Site | Truro | Nova Scotia | B2N 1L2 | Canada |
| GSK Investigational Site | Woodstock | Ontario | N4S 5P5 | Canada |
| GSK Investigational Site | Sherbrooke | Quebec | J1H 2G2 | Canada |
For additional information about this study please refer to the GSK Clinical Study Register |
| 201072 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 201072 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 201072 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 201072 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 201072 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 201072 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
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