Drugs / PCV21
Trials 7
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 36 trials | ||||||
| Phase 3 | NCT07247188 | Jan 2026 → Jan 2027 expected | sickle cell disease | Sanofi | Recruiting | No outcome recorded |
| Phase 3 | NCT07348692 | Jan 2026 → Jun 2027 expected | — | Sanofi | Recruiting | No outcome recorded |
| Phase 3 | NCT06975878 | May 2025 → Aug 2027 expected | — | Sanofi | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06838000 | Feb 2025 → Dec 2026 expected | pneumococcal infection | Sanofi Pasteur, a Sanofi Company | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06824194 | Feb 2025 → Oct 2027 expected | — | Sanofi | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06736041 | Dec 2024 → May 2027 expected | — | Sanofi Pasteur, a Sanofi Company | Active not recruiting | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT07135453 | Jul 2026 → Mar 2027 expected | pneumococcal infection | University of Alabama at Birmingham | Recruiting | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 3 | NCT07284654 Comparator | Dec 2025 → Jan 2027 expected | — | Vaxcyte, Inc. | Active not recruiting | Met primary |
News releases announcing trial results or a regulatory action · 16
| Date | Issuer | Release |
|---|---|---|
| 2026-06-18 | Merck Sharp & Dohme LLC | Regulatory U.S. FDA Approves an Additional Indication for CAPVAXIVE® (Pneumococcal 21-valent Conjugate Vaccine) in Children and Adolescents Aged 2 through 17 at Increased Risk for Pneumococcal Disease merck.com ↗
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for CAPVAXIVE ® (Pneumococcal 21-valent Conjugate Vaccine) to include children and adolescents aged 2 through 17 years who have completed a primary pediatric pneumococcal vaccination series and have one or more chronic medical conditions that put them at an increased risk for pneumococcal disease. |
| 2025-10-21 | Merck Sharp & Dohme LLC | Results Systematic Review of 15 Studies Focused on Epidemiology and Antimicrobial Resistance of Pneumococcal Serotypes Covered by CAPVAXIVE® (Pneumococcal 21-valent Conjugate Vaccine) in U.S. Adults merck.com ↗
Results of this systematic literature review showed that CAPVAXIVE-unique serotypes are more prevalent in U.S. adults with PD than PCV20-unique serotypes. |
| 2025-09-11 | Merck Sharp & Dohme LLC | Results CAPVAXIVE® (Pneumococcal 21-valent Conjugate Vaccine) Demonstrates Positive Immune Responses in Children and Adolescents at Increased Risk of Pneumococcal Disease merck.com ↗ |
| 2025-03-26 | Merck Sharp & Dohme LLC | Regulatory European Commission (EC) Approves Merck’s CAPVAXIVE® (Pneumococcal 21-valent Conjugate Vaccine) for Prevention of Invasive Pneumococcal Disease and Pneumococcal Pneumonia in Adults merck.com ↗
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the European Commission (EC) has approved CAPVAXIVE ® (Pneumococcal 21-valent Conjugate Vaccine) for active immunization for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F and 35B in individuals 18 years of age and older. |
| 2025-01-31 | Merck Sharp & Dohme LLC | Regulatory Merck Receives Positive EU CHMP Opinion for CAPVAXIVE™ (Pneumococcal 21-valent Conjugate Vaccine) for Pneumococcal Vaccination in Adults merck.com ↗
We are pleased with the CHMP recommendation and look forward to the European Commission’s decision. |
| 2024-10-31 | Merck Sharp & Dohme LLC | Regulatory Merck Announces Third-Quarter 2024 Financial Results merck.com ↗
CAPVAXIVE Recommended by the CDC’s ACIP for Pneumococcal Vaccination in Adults 50 Years of Age and Older |
| 2024-10-23 | Merck Sharp & Dohme LLC | Regulatory CDC’S ACIP Recommends Merck’s CAPVAXIVE™ (Pneumococcal 21-valent Conjugate Vaccine) for Pneumococcal Vaccination in Adults 50 Years of Age and Older merck.com ↗
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the U.S. Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices (ACIP) voted to update the adult age-based pneumococcal vaccination guidelines and recommends CAPVAXIVE™ (Pneumococcal 21-valent Conjugate Vaccine) for pneumococcal vaccination in adults 50 years of age and older. |
| 2024-10-16 | Merck Sharp & Dohme LLC | Results Merck’s CAPVAXIVE™ (Pneumococcal 21-valent Conjugate Vaccine) Demonstrates Positive Immune Responses in Adults with Increased Risk for Pneumococcal Disease merck.com ↗
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced results from STRIDE-8, a Phase 3 trial evaluating CAPVAXIVE™ (Pneumococcal 21-valent Conjugate Vaccine), at IDWeek 2024 in Los Angeles, California. |
| 2024-06-27 | Merck Sharp & Dohme LLC | Regulatory CDC’S ACIP Unanimously Recommends Merck’s CAPVAXIVE™ (Pneumococcal 21-valent Conjugate Vaccine) for Pneumococcal Vaccination in Appropriate Adults merck.com ↗
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the U.S. Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices (ACIP) unanimously voted to recommend CAPVAXIVE™ (Pneumococcal 21-valent Conjugate Vaccine) as an option for adults 65 years of age and older for pneumococcal vaccination. |
| 2024-06-18 | Ligand Pharmaceuticals | Regulatory Ligand Collaborator Merck Receives FDA Approval for CAPVAXIVE™ (Pneumococcal 21-valent Conjugate Vaccine) for Adults ligand.com ↗ |
| 2024-06-17 | Merck Sharp & Dohme LLC | Regulatory U.S. FDA Approves CAPVAXIVE™ (Pneumococcal 21-valent Conjugate Vaccine) for Prevention of Invasive Pneumococcal Disease and Pneumococcal Pneumonia in Adults merck.com ↗
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has approved CAPVAXIVE™ (Pneumococcal 21-valent Conjugate Vaccine) for: |
| 2024-04-29 | Merck Sharp & Dohme LLC | Results Merck Announces Positive Data for V116, an Investigational, 21-Valent Pneumococcal Conjugate Vaccine Specifically Designed for Adults merck.com ↗
V116 elicited immune responses that were noninferior compared to PPSV23 for the 12 serotypes (or strains) common to both vaccines, as measured by serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) at Day 30. |
| 2023-11-28 | Merck Sharp & Dohme LLC | Results Merck’s V116, an Investigational, 21-valent Pneumococcal Conjugate Vaccine Specifically Designed to Protect Adults, Demonstrated Superior Immunogenicity for 10 of 11 Unique Serotypes Compared to PCV20 in Adults 50 Years of Age and Older merck.com ↗
Immune responses elicited by V116 were superior for 10 of 11 serotypes included in V116 but not in PCV20 as measured by OPA GMTs at Day 30 and the proportions of patients with a greater than or equal to four-fold increase in OPA from Day 1 to Day 30. |
| 2023-06-29 | Sanofi | Results Press Release: Vaccines R&D pipeline raises the bar in RSV, influenza, meningitis, and pneumococcal disease sanofi.com ↗
with positive safety and immunogenicity of the first PCV21 vaccine |
| 2022-06-21 | Merck Sharp & Dohme LLC | Results Merck Presents Positive Results from Phase 1/2 Study Evaluating V116, the Company’s Investigational Pneumococcal Conjugate Vaccine for Adults merck.com ↗
In both populations, V116 met the primary immunogenicity objectives and was well-tolerated with an overall safety profile generally comparable to PNEUMOVAX ® 23 (Pneumococcal Vaccine Polyvalent) across age groups. |
| 2022-04-14 | Merck Sharp & Dohme LLC | Regulatory Merck Announces U.S. FDA has Granted Breakthrough Therapy Designation for V116, the Company’s Investigational 21-Valent Pneumococcal Conjugate Vaccine, for the Prevention of Invasive Pneumococcal Disease and Pneumococcal Pneumonia in Adults merck.com ↗ |
All press releases naming this drug 17 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 9 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | PCV21 | “Will receive PCV21” NCT07135453 ↗ |
| Modality | Vaccine | “A 21-valent pneumococcal conjugate vaccine, PCV21” PMID 40833801 ↗ Jul 2025 |
| Route | Intramuscular | “Route of administration:Intramuscular” NCT06736041 ↗ |