Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Menactra TM · 1 trial · 1 indication
Anti-D and anti-T antibodies cut-off values assessed include 1.0 international unit per milliliter (IU/mL)
Concentrations given as Geometric Means Concentrations (GMCs)
Titers given as Geometric Mean Titers (GMTs)
| Arm | Type | Description |
|---|---|---|
| Cervarix + Boostrix/Menactra Group | EXPERIMENTAL | Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6. |
| Cervarix + Menactra/Boostrix Group | EXPERIMENTAL | Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6. |
| Cervarix + Boostrix + Menactra Group | EXPERIMENTAL | Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6. |
| Boostrix/Cervarix Group | EXPERIMENTAL | Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7. |
| Menactra/Cervarix Group | EXPERIMENTAL | Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7. |
| Cervarix Group | EXPERIMENTAL | Subjects received Cervarix at Months 0, 1 and 6. |
| Name | Type | Description |
|---|---|---|
| Different formulations of GSK Biologicals' HPV vaccine (580299) | BIOLOGICAL | Three doses of vaccine administered intramuscularly, with the second and third dose given one month and six months after the first dose respectively |
| Menactra TM | BIOLOGICAL | One dose of vaccine administered intramuscularly |
| Boostrix TM | BIOLOGICAL | One dose of vaccine administered intramuscularly |
Inclusion Criteria: * Subjects who the investigator believes that they can, and will, comply with the requirements of the protocol should be enrolled in the study. * A female between, and including, 11 and 18 years of age at the time of the first vaccination. * Written informed consent obtained fro...
Menactra TM is a monoclonal antibody being developed for infections and papillomavirus. It is currently in Phase 3 clinical development as an investigational therapy. The drug is being studied in healthy female subjects aged 11 years and older in the United States.
Menactra TM is being developed by GSK plc, a biopharmaceutical company traded on the stock exchange under the ticker symbol GSK. The company is conducting clinical trials to evaluate the safety and immunogenicity of the drug in healthy female subjects.
Menactra TM is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 3 trial has been completed, involving 1,330 participants, to evaluate the drug's safety and immunogenicity.
Menactra TM has one completed Phase 3 clinical trial registered under NCT00369824. The trial, titled "Evaluation of Safety and Immunogenicity of Co-administering HPV Vaccine With Other Vaccines in Healthy Female Subjects," enrolled 1,330 healthy female participants aged 11 years and older in the United States.
Menactra TM is a monoclonal antibody, not a vaccine. It is being studied for its potential role in preventing infections and papillomavirus. The drug is in Phase 3 clinical development and is being evaluated for safety and immunogenicity in healthy female subjects.
Menactra TM is a monoclonal antibody, which means it is designed to target specific proteins involved in disease processes. However, the specific molecular target of Menactra TM has not been disclosed in available information. The drug is being studied for infections and papillomavirus.