Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AR51 · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| AR51 (12, 10) | EXPERIMENTAL | Participants were vaccinated with 0.5 ml of AR51 (12, 10) formulation via intramuscular injection as a primary series at 2, 3, and 4 months of age, and as a booster at 12 to 14 months of age. |
| PR51 (3, 10) | EXPERIMENTAL | Participants were vaccinated with 0.5 ml of PR51 (3, 10) formulation via intramuscular injection as a primary series at 2, 3, and 4 months of age, and as a booster at 12 to 14 months of age. |
| PR51 (6, 10) | EXPERIMENTAL | Participants were vaccinated with 0.5 ml of PR51 (6, 10) formulation via intramuscular injection as a primary series at 2, 3, and 4 months of age, and as a booster at 12 to 14 months of age. |
| PR51 (6, 15) | EXPERIMENTAL | Participants were vaccinated with 0.5 ml of PR51 (6, 15) formulation via intramuscular injection as a primary series at 2, 3, and 4 months of age, and as a booster at 12 to 14 months of age. |
| PENTACEL™ + RECOMBIVAX HB™ | ACTIVE_COMPARATOR | Participants were vaccinated with 0.5 ml each of PENTACEL™ + RECOMBIVAX HB™ via intramuscular injection as a primary series at 2, 4, and 6 months of age, and with 0.5 ml PENTACEL™ as a booster at 12 to 14 months of age. |
| Name | Type | Description |
|---|---|---|
| AR51 (12, 10) | BIOLOGICAL | vaccine formulation containing 12 mcg of PRP-T and 10 mcg of HBsAg |
| PR51 (3, 10) | BIOLOGICAL | vaccine formulation containing 3 mcg of PRP-OMPC and 10 mcg of HBsAg |
| PR51 (6, 10) | BIOLOGICAL | vaccine formulation containing 6 mcg of PRP-OMPC and 10 mcg of HBsAg |
| PR51 (6, 15) | BIOLOGICAL | vaccine formulation containing 6 mcg of PRP-OMPC and 15 mcg of HBsAg |
| PENTACEL™ | BIOLOGICAL | licensed vaccine for diphtheria, tetanus, pertussis, poliomyelitis, and invasive disease due to Haemophilus influenzae type b, administered open-label |
| RECOMBIVAX HB™ | BIOLOGICAL | licensed vaccine for hepatitis, administered open-label |
Inclusion Criteria: * Healthy infants 2 months of age who have not received prior vaccinations for Haemophilus influenzae type b (Hib), hepatitis B, Diptheria/Pertussis/Tetanus (DPT), or Polio Exclusion Criteria : * Documented HIV infection (child or mother) * Documented HBsAg-seropositivity (chi...
AR51 is an investigational monoclonal antibody being developed for the prevention of bacterial infections and virus diseases. It is currently in Phase 2 clinical development, with studies conducted in healthy infants. The drug is being evaluated for its safety and effectiveness in this population.
AR51 is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The company is conducting clinical trials to evaluate the safety and tolerability of AR51 in healthy infants.
AR51 is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. Two Phase 2 clinical trials have been completed, and the drug is being studied for its safety and effectiveness in preventing bacterial infections and virus diseases.
AR51 has been studied in two completed Phase 2 clinical trials. NCT00551629 enrolled 708 healthy infants aged 6 weeks and older to test the safety and effectiveness of the drug. NCT00551915 enrolled 756 healthy infants to study safety and tolerability at 2, 4, 6, and 12 to 14 months of age.
AR51 is a monoclonal antibody, not a vaccine. While it is being studied for the prevention of bacterial infections and virus diseases, it works differently from a vaccine. The clinical trials for AR51 are described as vaccine studies, but the drug itself is a monoclonal antibody.