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...
The Chlamydia mRNA Vaccine is an investigational vaccine developed by Sanofi for immunization against Chlamydia trachomatis. It uses mRNA technology to stimulate an immune response against the bacterium that causes chlamydia. The vaccine is currently in Phase 1 clinical development and has not been approved for use.
The Chlamydia mRNA Vaccine is being developed for immunization against Chlamydia trachomatis, the bacterium that causes chlamydia infection. It is intended to prevent chlamydia, which is a common sexually transmitted infection. The vaccine is investigational and its safety and efficacy have not been established.
The Chlamydia mRNA Vaccine is being developed by Sanofi, a global pharmaceutical company. Sanofi trades on the New York Stock Exchange under the ticker symbol SNY. The company is responsible for the research and clinical development of this vaccine candidate.
The Chlamydia mRNA Vaccine is in Phase 1 clinical development. A Phase 1/2 trial is currently recruiting participants. The vaccine is investigational and has not received regulatory approval for any indication.
The Chlamydia mRNA Vaccine is being evaluated in a Phase 1/2 clinical trial, NCT06891417, titled 'Phase 1/2 Study of Chlamydia Trachomatis mRNA Vaccine in Adults Aged 18 to 29 Years.' The trial is recruiting 1,560 participants in Australia. It is randomized, double-blind, and placebo-controlled, enrolling healthy volunteers aged 18 to 29.