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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-000796-27 | EudraCT Number |
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The study was cancelled for scientifically legitimate reasons not related to safety or efficacy of the vaccine.
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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 60 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 GSK3277510A 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 GSK3277510A 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 GSK3277510A 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 GSK3277510A 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 GSK3277509A H7N9 vaccine formulation 5 at a 21 day interval |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Investigational H7N9 vaccine GSK3277510A | Biological | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Humoral immune response in terms of vaccine-homologous hemagglutination inhibition (HI) antibody titers | 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 the Day 0, 7, 21, 28 and 42 visits. | |
| Occurrence of unsolicited adverse events (AEs) | 21 days after each dose. | |
| Occurrence of Medically Attended Adverse Events (MAEs), potential Immune Mediated Diseases (pIMDs) and Serious Adverse Events (SAEs)[Active Phase] | From Day 0 until Day 42. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of adjuvant effect as assessed by vaccine-homologous hemagglutination inhibition (HI) antibody titers | At Day 42. | |
| Humoral immune response in terms of vaccine-homologous hemagglutination inhibition (HI) antibody titers for plain antigen vaccine group |
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Inclusion Criteria:
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.
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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
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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 GSK3277509A | Biological | 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 |
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| Placebo | Biological | 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 |
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| At Day 42. |
| Humoral immune response in terms of vaccine-homologous (H7N9) HI antibody titers. | 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. | 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. | 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) | 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. |
| 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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