A Phase 1 Randomized, Placebo-controlled, Observer-blind Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of the GSK 4-component Vaccine Against Group A Streptococcus Pyogenes (Strep A) With Alum or AS37 in Healthy Adults 18 to 25 Years of Age in Australia
The purpose of this study is to assess the safety of 3 doses of 2 new Strep A vaccine formulations, one with an Alum adjuvant, and the other with AS37 adjuvant. The Strep A vaccine will be tested for the first time in humans, in healthy young adults 18 to 25 years of age. The study will also assess if the vaccines have any immediate reactions and if they induce an immune response. A low, medium, and high dose of each formulation of the vaccine will be assessed in sequence.
• Participants, who, in the opinion of the Investigator, can and will comply with the requirements of the protocol (e.g., completion of electronic diaries \[eDiaries\], return for follow-up visits).
• Written or witnessed/thumb-printed informed consent obtained from the participant prior to performance of any study-specific procedure.
• Healthy participants as established by medical history, clinical examination, and laboratory assessments.
• Satisfies all screening requirements.
• Male and female participants between and including 18 and 25 years of age at the time of informed consent.
• Female participants of nonchildbearing potential may be enrolled in the study. Nonchildbearing potential is defined as premenarche, postmenopause, or had current bilateral tubal ligation or occlusion, hysterectomy, or bilateral ovariectomy.
• Female participants who are of childbearing potential may be enrolled in the study if the participant:
‣ has practiced adequate contraception for 1 month prior to study intervention administration, and
⁃ has a negative pregnancy test on the day of study intervention administration, and
⁃ has agreed to continue adequate contraception during the entire study intervention administration period and for 1 month after completion of the study intervention administration series.
• Male participants who are sexually active with a female partner of childbearing potential are eligible to participate if they agree to have their partner use a highly effective method of contraception for 1 month prior to the first study intervention administration until 1 month after completion of the study intervention administration series.
• Male participants must refrain from donating sperm for 1 month prior to the first study intervention administration until 1 month after completion of the study intervention administration series.
• Participants seronegative for human immunodeficiency virus (HIV), hepatitis B, and hepatitis C at Screening.