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PR5I · 1 trial · 3 indications
The percentage of participants with an anti-HBsAg antibody titer ≥10 mill-International Units/mL (mIU/mL) was assessed. Participant serum samples were collected for analysis with an enhanced chemiluminescence assay to determine the concentration of antibodies to HBsAg.
The percentage of participants with an anti-Polyribosylribitol Phosphate (PRP) antibody titer ≥0.15 µg/mL was assessed. Participant serum samples were collected for analysis by radioimmunoassay to determine the concentration of antibodies to PRP, a Haemophilus influenzae type b (Hib) capsular polysaccharide.
| Arm | Type | Description |
|---|---|---|
| PR5I (V1); Pediacel® (V2); PR5I (V3) | EXPERIMENTAL | \[Vaccination 1\]: Single doses of PR5I (V419) + NeisVac-C® + Prevenar 13® by intramuscular (IM) injection + oral RotaTeq®, given at 2 months of age. \[Vaccination 2\]: Single doses of Pediacel® + NeisVac-C® + Prevenar 13® by IM injection + oral RotaTeq®, given at 4 months of age. \[Vaccination 3\]: Single dose of PR5I (V419) by IM injection + oral RotaTeq®, given at 6 months of age. |
| Name | Type | Description |
|---|---|---|
| PR5I | BIOLOGICAL | Hexavalent PR5I vaccine (DTaP-HB-IPV-Hib = Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed \[DTaP\], Hepatitis B \[HB; Recombinant DNA\], Inactivated Poliovirus \[IPV\], and Haemophilus influenzae type b \[Hib\] conjugate vaccine \[adsorbed\]) at 0.5 mL for IM injection (left upper thigh) at 2 and 6 months of age. |
| Pediacel® | BIOLOGICAL | Pentavalent Pediacel® vaccine (DTaP-IPV-Hib = Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed \[DTaP\], Inactivated Poliovirus \[IPV\], and Haemophilus influenzae type b \[Hib\] conjugate vaccine \[adsorbed\]) at 0.5 mL for IM injection (left upper thigh) at 4 months of age. |
| NeisVac-C® | BIOLOGICAL | Meningococcal group C (MCC) polysaccharide conjugate vaccine (adsorbed) at 0.5 mL for IM injection (right upper thigh) at 2 and 4 months of age. |
| RotaTeq® | BIOLOGICAL | Human-bovine rotavirus reassortants (live) vaccine 2 mL oral administration at 2, 4 and 6 months of age. RotaTeq® administered prior to any other vaccine administration to avoid having the infant participants spit up the RotaTeq® when crying. |
| Prevenar 13® | BIOLOGICAL | Pneumococcal polysaccharide conjugate vaccine \[PCV; 13-valent, adsorbed\]) at 0.5 mL for IM injection (right upper thigh) at 2 and 4 months of age. |
Inclusion Criteria: * Healthy infant 46 to 74 days (both inclusive) * Documented receipt of only one dose of monovalent hepatitis B vaccine within the 3 days after birth * Parent(s)/legal representative able to comply with the study procedures Exclusion Criteria: * Participation in any study with...
PR5I is an investigational monoclonal antibody being developed for the prevention of Neisseria meningitidis infection, a cause of bacterial meningitis. It is being studied in the context of infectious disease, specifically for use in infants as young as 46 days old.
PR5I is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The company is conducting clinical research on this monoclonal antibody for the prevention of Neisseria meningitidis infection.
PR5I is in Phase 3 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to evaluate its safety and efficacy for preventing Neisseria meningitidis infection.
PR5I has been studied in one Phase 3 clinical trial with the identifier NCT01839188, titled "Spanish Mixed HEXA/PENTA/HEXA Schedule (V419-010)". This completed trial enrolled 385 participants and evaluated the drug in healthy volunteers for conditions including Neisseria meningitidis and bacterial infections.
PR5I is a monoclonal antibody, which means it is designed to target specific components of the immune system to help prevent infection. In this case, it is being studied for its ability to protect against Neisseria meningitidis, the bacteria that causes meningococcal disease.