The study evaluates the safety, immunogenicity, and efficacy of the GSK S. aureus candidate vaccine (GSK3878858A) when administered to two groups: healthy adults (dose-escalation phase) and adults aged 18 to 64 years with a recent S. aureus skin and soft tissue infection (SSTI). In the dose-escalation safety lead-in phase, the safety and immunogenicity of four different vaccine compositions are assessed in healthy adults. Once safety has been established in this phase, the second phase, known as the proof of principle (PoP) phase, will assess the safety, immunogenicity, and efficacy of the final vaccine composition in adults with a recent SSTI.
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Dose-escalation Safety lead-in: Number of Participants With Any and Grade 3 Solicited Administration Site Adverse Events (AEs) After Each Vaccination
Timeframe: Within 7 days post vaccination (day of administration and 6 subsequent days post-each vaccination; Vaccination 1 on Day 1 and Vaccination 2 on Day 61)
PoP: Number of Participants With Any and Grade 3 Solicited Administration Site AEs After Each Vaccination
Timeframe: Within 7 days post vaccination (day of administration and 6 subsequent days post-each vaccination; Vaccination 1 on Day 1 and Vaccination 2 on Day 61)
Dose-escalation Safety lead-in: Number of Participants With Any and Grade 3 Solicited Systemic AEs After Each Vaccination
Timeframe: Within 7 days post vaccination (day of administration and 6 subsequent days post-each vaccination; Vaccination 1 on Day 1 and Vaccination 2 on Day 61)
PoP: Number of Participants With Any and Grade 3 Solicited Systemic AEs After Each Vaccination
Timeframe: Within 7 days post vaccination (day of administration and 6 subsequent days post-each vaccination; Vaccination 1 on Day 1 and Vaccination 2 on Day 61)
Dose-escalation Safety lead-in: Number of Participants With Unsolicited AEs (Any, Grade 3, Related, Related Grade 3) After Each Vaccination
Timeframe: During 30 days after each vaccination (day of administration and 29 subsequent days post-each vaccination; Vaccination 1 on Day 1 and Vaccination 2 on Day 61)
PoP: Number of Participants With Unsolicited AEs (Any, Grade 3, Related, Related Grade 3) After Each Vaccination
Timeframe: During 30 days after each vaccination (day of administration and 29 subsequent days post-each vaccination; Vaccination 1 on Day 1 and Vaccination 2 on Day 61)
Dose-escalation Safety lead-in: Number of Participants With Serious AEs (SAEs) up to 1 Year Post First Vaccination
Timeframe: From Day 1 to Day 366
Dose-escalation Safety lead-in: Number of Participants With SAEs up to 1 Year Post Second Vaccination
Timeframe: From Day 61 to Day 426 (post vaccination at Day 61)
PoP: Number of Participants With SAEs
Timeframe: From Day 1 to Day 426
Dose-escalation Safety lead-in: Number of Participants With Potential Immune-mediated Diseases (pIMDs) up to 1 Year Post First Vaccination
Timeframe: From Day 1 to Day 366
Dose-escalation Safety lead-in: Number of Participants With pIMDs up to 1 Year Post Second Vaccination
Timeframe: From Day 61 to Day 426 (post vaccination at Day 61)
PoP: Number of Participants With Potential Immune-mediated Diseases (pIMDs)
Timeframe: From Day 1 to Day 426
Number of Participants With Maximum Toxicity Grade Increase From Baseline for Haematological and Biochemical Laboratory Parameters
Timeframe: On Day 8 compared to Baseline (Day 1)
Number of Participants With Maximum Toxicity Grade Increase From Baseline for Haematological and Biochemical Laboratory Parameters
Timeframe: On Day 68 compared to Baseline (Day 61)
Number of Participants With Haematological and Biochemical Laboratory Change From Baseline Values
Timeframe: On Day 8
Number of Participants With Haematological and Biochemical Laboratory Change From Baseline Values
Timeframe: On Day 68