Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Chlamydia mRNA Vaccine · 1 trial · 1 indication
Number of participants with immediate unsolicited systemic adverse events (AEs) reported in the 30 minutes after each vaccine injection.
Number of participants with solicited injection site and systemic reactions occurring up to 7 days after each vaccine injection.
Participants with unsolicited AEs reported up to 28 days after each vaccine injection.
Number of participants with MAAEs reported after each vaccine injection and up to 6 months after last vaccine injection.
Number of participants with SAEs and all AESIs reported after each vaccine injection and up to 12 months after last vaccine injection
Number of participants with related SAEs, and fatal SAEs throughout the study
Number of participants with out-of-range biological test results up to 7 days after each vaccine injection
| Arm | Type | Description |
|---|---|---|
| Sentinel Cohort A Group 1: Chlamydia trachomatis Seronegative | EXPERIMENTAL | Participants will receive three low dose injections of Chlamydia mRNA Vaccine |
| Sentinel Cohort B Group 2: Chlamydia trachomatis Seronegative | EXPERIMENTAL | Participants will receive three medium dose injections of Chlamydia mRNA Vaccine |
| Sentinel Cohort C Group 3: Chlamydia trachomatis Seronegative | EXPERIMENTAL | Participants will receive three high dose injections of Chlamydia mRNA Vaccine |
| Sentinel Cohort A, B and C Group 4: Chlamydia trachomatis Seronegative | PLACEBO_COMPARATOR | Participants will receive three injections of Placebo |
| Sentinel Cohort A Group 5: Chlamydia trachomatis Seropositive | EXPERIMENTAL | Participants will receive three low dose injections of Chlamydia mRNA Vaccine |
| Sentinel Cohort B Group 6: Chlamydia trachomatis Seropositive | EXPERIMENTAL | Participants will receive three medium dose injections of Chlamydia mRNA Vaccine |
| Sentinel Cohort C Group 7: Chlamydia trachomatis Seropositive | EXPERIMENTAL | Participants will receive three medium dose injections of Chlamydia mRNA Vaccine |
| Sentinel Cohort A, B and C Group 8: Chlamydia trachomatis Seropositive | PLACEBO_COMPARATOR | Participants will receive three injections of Placebo |
| Main Cohort Group 9: Chlamydia trachomatis Seronegative | EXPERIMENTAL | Participants will receive three low dose injections of Chlamydia mRNA Vaccine |
| Main Cohort Group 10: Chlamydia trachomatis Seronegative | EXPERIMENTAL | Participants will receive three medium dose injections of Chlamydia mRNA Vaccine |
| Main Cohort Group 11: Chlamydia trachomatis Seronegative | EXPERIMENTAL | Participants will receive three high dose injections of Chlamydia mRNA Vaccine |
| Main Cohort Group 12: Chlamydia trachomatis Seronegative | PLACEBO_COMPARATOR | Participants will receive three injections of Placebo |
| Main Cohort Group 13: Chlamydia trachomatis Seropositive | EXPERIMENTAL | Participants will receive three low dose injections of Chlamydia mRNA Vaccine |
| Main Cohort Group 14: Chlamydia trachomatis Seropositive | EXPERIMENTAL | Participants will receive three medium dose injections of Chlamydia mRNA Vaccine |
| Main Cohort Group 15: Chlamydia trachomatis Seropositive | EXPERIMENTAL | Participants will receive three high dose injections of Chlamydia mRNA Vaccine |
| Main Cohort Group 16: Chlamydia trachomatis Seropositive | PLACEBO_COMPARATOR | Participants will receive three injections of Placebo |
| Name | Type | Description |
|---|---|---|
| Chlamydia mRNA Vaccine | BIOLOGICAL | Pharmaceutical Form: Suspension for injection Route of Administration: Intramuscular injection |
| Placebo | OTHER | Pharmaceutical Form: Solution for injection Route of Administration: Intramuscular injection |
Inclusion Criteria: * Aged 18 to 29 years on the day of inclusion * New sex partner within the past 6 months, or more than one current sex partner, or partner with known previous or coexisting sexually transmitted infection (STI), or inconsistent condom use * A female participant is eligible to par...
Chlamydia mRNA Vaccine is an investigational vaccine being developed for immunization against Chlamydia trachomatis infection. It is currently in Phase 1 clinical development, studied in healthy adults aged 18 to 29 years. The vaccine is designed to prevent chlamydia, a common sexually transmitted infection.
Chlamydia mRNA Vaccine is being developed by Sanofi, a global biopharmaceutical company listed on the stock exchange under the ticker SNY. Sanofi is conducting clinical trials to evaluate the safety and immunogenicity of this investigational vaccine for Chlamydia trachomatis immunization.
Chlamydia mRNA Vaccine is currently in Phase 1 clinical development. It is an investigational vaccine, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials. The ongoing Phase 1/2 study is recruiting participants to evaluate the vaccine's safety and immune response.
Chlamydia mRNA Vaccine is being evaluated in a Phase 1/2 clinical trial with the identifier NCT06891417. This randomized, double-blind, placebo-controlled study is recruiting 1,560 healthy adults aged 18 to 29 years in Australia. The trial is currently active and recruiting participants.
No, Chlamydia mRNA Vaccine is not a monoclonal antibody. Despite its modality being listed as such in some databases, the drug name indicates it is an mRNA-based vaccine. It is designed to elicit an immune response against Chlamydia trachomatis, rather than acting as a therapeutic antibody.