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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 by Merck & Company, Inc. (MRK) for bacterial infections and virus diseases. It is in Phase 2 clinical development and has been studied in two completed trials enrolling a total of 1,464 participants. AR51 is not approved and remains an investigational product.
AR51 is being studied for bacterial infections and virus diseases. Both completed Phase 2 trials enrolled healthy infants from 6 weeks of age, evaluating AR51 in a pediatric preventive setting. The trials were randomized, double-blind, and controlled, with 1,464 participants enrolled across the two studies.
AR51 is developed by Merck & Company, Inc., which trades under the ticker MRK. Merck sponsored both Phase 2 trials of AR51 in healthy infants, one enrolling 756 participants and the other 708 participants, for a combined total of 1,464 participants.
AR51 is in Phase 2 clinical development. Two Phase 2 trials have been completed, and no trials are currently active. AR51 is an investigational monoclonal antibody and is not an approved product. Both completed studies were randomized, double-blind, and controlled.
AR51 has been evaluated in two completed Phase 2 trials. NCT00551915 studied safety and tolerability in healthy infants at 2, 4, 6, and 12 to 14 months of age, enrolling 756 participants. NCT00551629 tested safety and effectiveness in infants, enrolling 708 participants. Both trials enrolled participants from 6 weeks of age.
Yes, AR51 (12, 10) is another name used for AR51, the investigational monoclonal antibody developed by Merck & Company, Inc. (MRK). Searches for either name refer to the same Phase 2 asset being studied for bacterial infections and virus diseases in healthy infants.