Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Low dose Strep A Alum · 1 trial · 1 indication
Solicited administration-site events include pain, redness, and swelling at the administration site.
Solicited systemic events include fever, headache, myalgia (muscle pain), arthralgia (joint pain), and fatigue (tiredness). Fever is defined as body temperature equal to or above 38.0°C. The preferred location for measuring temperature is the axilla.
An unsolicited AE is an AE that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events. Unsolicited AEs include both serious and nonserious AEs.
AESIs include potential immune-mediated disorders (pIMDs) and rheumatic carditis.
An SAE is defined as any untoward medical occurrence that results in death, is life threatening, requires hospitalization or prolongs existing hospitalization, results in disability/incapacity, abnormal pregnancy outcomes, or other medically significant events.
| Arm | Type | Description |
|---|---|---|
| Low dose Strep A Alum Group | EXPERIMENTAL | Participants randomized to receive 3 doses of Low dose Strep A Alum vaccine on Day 1, Day 31, and Day 121. |
| Medium dose Strep A Alum Group | EXPERIMENTAL | Participants randomized to receive 3 doses of Medium dose Strep A Alum vaccine on Day 1, Day 31, and Day 121. |
| High dose Strep A Alum Group | EXPERIMENTAL | Participants randomized to receive 3 doses of High dose Strep A Alum vaccine on Day 1, Day 31, and Day 121. |
| Low dose Strep A AS37 Group | EXPERIMENTAL | Participants randomized to receive 3 doses of Low dose Strep A AS37 vaccine on Day 1, Day 31, and Day 121. |
| Medium dose Strep A AS37 Group | EXPERIMENTAL | Participants randomized to receive 3 doses of Medium dose Strep A AS37 vaccine on Day 1, Day 31, and Day 121. |
| High dose Strep A AS37 Group | EXPERIMENTAL | Participants randomized to receive 3 doses of High dose Strep A AS37 vaccine on Day 1, Day 31, and Day 121. |
| Strep A Alum Placebo Group | PLACEBO_COMPARATOR | Participants randomized to receive 3 doses of Strep A Alum Placebo on Day 1, Day 31, and Day 121. |
| Name | Type | Description |
|---|---|---|
| Low dose Strep A Alum | BIOLOGICAL | Low dose Strep A Alum vaccine will be administered intramuscularly (IM) |
| Medium dose Strep A Alum | BIOLOGICAL | Medium dose Strep A Alum vaccine will be administered IM |
| High dose Strep A Alum | BIOLOGICAL | High dose Strep A Alum vaccine will be administered IM |
| Low dose Strep A AS37 | BIOLOGICAL | Low dose Strep A AS37 vaccine will be administered IM |
| Medium dose Strep A AS37 | BIOLOGICAL | Medium dose Strep A AS37 vaccine will be administered IM |
| High dose Strep A AS37 | BIOLOGICAL | High dose Strep A AS37 vaccine will be administered IM |
| Strep A Alum Placebo | DRUG | Strep A Alum Placebo will be administered IM |
Inclusion Criteria: * 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 particip...
Low dose Strep A Alum is an investigational vaccine being developed for the prevention of Streptococcal Infections. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities. The vaccine is being studied in healthy young adults to evaluate its safety, reactogenicity, and immunogenicity.
Low dose Strep A Alum is being developed by GSK plc, a biopharmaceutical company listed on the stock exchange under the ticker symbol GSK. The company is conducting a Phase 1 clinical trial to evaluate the vaccine's safety and immune response in healthy adults.
Low dose Strep A Alum is currently in Phase 1 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. The ongoing Phase 1 trial is recruiting participants to assess the vaccine's safety, reactogenicity, and immunogenicity in healthy young adults.
Low dose Strep A Alum is being evaluated in a Phase 1 clinical trial with the identifier NCT07085702. This study is titled 'A Study to Evaluate Safety, Reactogenicity, and Immunogenicity of the GSK 4-component Strep A Vaccine With Aluminum Hydroxide (Alum) or AS37 in Healthy Young Adults' and is currently recruiting participants in Australia.
Low dose Strep A Alum is a formulation of the GSK 4-component Strep A vaccine that uses aluminum hydroxide as an adjuvant. The Phase 1 clinical trial NCT07085702 is evaluating this vaccine with either aluminum hydroxide (Alum) or the AS37 adjuvant system in healthy young adults.