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PENTACEL™
Pentacel™, marketed by Merck Sharp & Dohme LLC, is a combination vaccine with an unknown mechanism of action, currently holding a position in the vaccine market. The key composition patent for Pentacel™ is set to expire in 2028, which may provide a period of market exclusivity and revenue protection. However, the primary risk lies in the lack of a clear mechanism of action, which could limit further development and differentiation from competitors.
At a glance
| Generic name | PENTACEL™ |
|---|---|
| Also known as | Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced. |
| Sponsor | Merck Sharp & Dohme LLC |
| Modality | Biologic |
| Therapeutic area | Other |
| Phase | FDA-approved |
Approved indications
Common side effects
- Fussiness/irritability
- Inconsolable crying
- Tenderness at injection site
- Increased circumference of injected arm
Serious adverse events
- Hypotonic hyporesponsive episodes (HHE)
- Hypotonia not fulfilling HHE criteria
- Seizures
Key clinical trials
- Safety, Tolerability, and Immunogenicity of V114 in Healthy Infants (V114-029) (PHASE3)
- A Study to Evaluate the Interchangeability of V114 and Prevnar 13™ in Healthy Infants (V114-027/PNEU-DIRECTION) (PHASE3)
- Surveillance Program to Determine Product Specific Rates of Invasive Hib Disease
- Safety, Tolerability, and Immunogenicity of V419 Given Concomitantly With Prevnar 13™ and RotaTeq™ (V419-005) (PHASE3)
- A Study of V419 Given Concomitantly With Prevnar 13™ and RotaTeq™ (V419-006) (PHASE3)
- Consistency & Immunogenicity Study of 3 Lots of GSK's Hib Conjugate Vaccine Versus ActHIB & Pentacel in Healthy Infants (PHASE3)
- Safety and Immunogenicity of DAPTACEL® as 5th Dose in Children 4 to 6 Years Old After 4 Doses of Pentacel™ or DAPTACEL® (PHASE3)
- Study of DAPTACEL® Administered as a 5th Dose in 4 to 6-Year-Old Children Previously Immunized With PENTACEL™ (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- PENTACEL™ CI brief — competitive landscape report
- PENTACEL™ updates RSS · CI watch RSS
- Merck Sharp & Dohme LLC portfolio CI