Clinical Trials List
Protocol NumberV116-010
NCT Number(ClinicalTrials.gov Identfier)NCT05569954
Completed
2022-11-01 - 2026-05-31
Phase III
Recruiting4
A Phase 3, Randomized, Double-blind, Active Comparator-controlled Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults 50 Years of Age or Older
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Trial Applicant
Merck Sharp & Dohme (I.A.) LLC
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- 鄭鈞文 Division of Infectious Disease
- 黃集仁 Division of Emergency Medicine
- Po-Yan Huang Division of Infectious Disease
- 謝顯森 Division of Infectious Disease
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Shang-Yi Lin Division of Infectious Disease
- 蔡毓德 Division of Infectious Disease
- Chun-Yuan Lee Division of Infectious Disease
- Chung-Hao Huang Division of Infectious Disease
- 張雅婷 Division of Infectious Disease
- 邱昱堯 Division of Infectious Disease
- Po-Liang Lu Division of Infectious Disease
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Pneumococcal Disease
Objectives
Main Purpose
- Evaluate the safety and tolerability of V116 based on the proportion of subjects experiencing adverse events (AEs)
- Comparison of serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) of V116 versus PPSV23 at 30 days post-vaccination
- Compare the proportion of participants with a ≥4-fold increase in serotype-specific OPA responses from baseline 30 days after vaccination with V116 versus PPSV23 for unique serotypes in V116
Test Drug
Pneumococcal 21-Valent Conjugate Vaccine (V116)Pneumovax 23
Active Ingredient
21 PnPs of serotypes (3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20, 22F, 23A, 23B, 24F, 31, 33F, 35B)
CAPSULAR POLYSACCHARIDE PURIFIED
CAPSULAR POLYSACCHARIDE PURIFIED
Dosage Form
Injection
Injection
Injection
Dosage
0.5 mL/ syringe (含4 µg of each PnPs antigen, 84µg)
0.5 mL/ syringe
0.5 mL/ syringe
Endpoints
‧ Recorded injection site AEs occurring between day 1 and day 5 after vaccination
‧ Systemic AEs recorded between day 1 and day 5 after vaccination
‧ Vaccine-related serious adverse events (SAEs) occurring from day 1 to 6 months after vaccination
‧ Serotype-specific OPA reactions
‧ Systemic AEs recorded between day 1 and day 5 after vaccination
‧ Vaccine-related serious adverse events (SAEs) occurring from day 1 to 6 months after vaccination
‧ Serotype-specific OPA reactions
Inclution Criteria
Inclusion Criteria:
For females, is not pregnant or breastfeeding and is either not a woman of childbearing potential (WOCBP) or is a WOCBP and uses acceptable contraception/abstinence; and has medical, menstrual, and recent sexual activity history reviewed by the investigator to decrease the chance of inclusion of an early undetected pregnancy
For females, is not pregnant or breastfeeding and is either not a woman of childbearing potential (WOCBP) or is a WOCBP and uses acceptable contraception/abstinence; and has medical, menstrual, and recent sexual activity history reviewed by the investigator to decrease the chance of inclusion of an early undetected pregnancy
Exclusion Criteria
Exclusion Criteria:
Has a history of invasive pneumococcal disease (IPD) [positive blood culture, positive cerebrospinal fluid culture, or positive culture at another sterile site] or known history of other culture-positive pneumococcal disease within 3 years of Visit 1 (Day 1)
Has a known hypersensitivity to any component of V116 or PPSV23, including diphtheria toxoid
Has a known or suspected impairment of immunological function including, but not limited to, a history of congenital or acquired immunodeficiency, documented human immunodeficiency virus (HIV) infection, functional or anatomic asplenia, or history of autoimmune disease
Has a coagulation disorder contraindicating IM vaccination
Had a recent febrile illness (defined as oral or tympanic temperature ≥100.4°F [≥38.0°C] or axillary or temporal temperature ≥99.4°F [≥37.4°C]) or received antibiotic therapy for any acute illness occurring <72 hours before receipt of study vaccine
Has a known malignancy that is progressing or has required active treatment <3 years before enrollment
Received prior pneumococcal vaccine or is expected to receive any pneumococcal vaccine during the study outside the protocol
Received systemic corticosteroids (prednisone equivalent of ≥20 mg/day) for ≥14 consecutive days and has not completed intervention ≥14 days before receipt of study vaccine
Is currently receiving immunosuppressive therapy, including chemotherapeutic agents or other immunotherapies/immunomodulators used to treat cancer or other conditions, and interventions associated with organ or bone marrow transplantation, or autoimmune disease
Received any nonlive vaccine ≤14 days before receipt of study vaccine or is scheduled to receive any nonlive vaccine ≤30 days after receipt of study vaccine (inactivated influenza and SARS-CoV2 vaccines may be acceptable)
Received any live virus vaccine ≤30 days before receipt of study vaccine or is scheduled to receive any live virus vaccine ≤30 days after receipt of study vaccine
Received a blood transfusion or blood products, including immunoglobulin ≤6 months before receipt of study vaccine or is scheduled to receive a blood transfusion or blood product until the Day 30 postvaccination blood draw is complete
Has a history of invasive pneumococcal disease (IPD) [positive blood culture, positive cerebrospinal fluid culture, or positive culture at another sterile site] or known history of other culture-positive pneumococcal disease within 3 years of Visit 1 (Day 1)
Has a known hypersensitivity to any component of V116 or PPSV23, including diphtheria toxoid
Has a known or suspected impairment of immunological function including, but not limited to, a history of congenital or acquired immunodeficiency, documented human immunodeficiency virus (HIV) infection, functional or anatomic asplenia, or history of autoimmune disease
Has a coagulation disorder contraindicating IM vaccination
Had a recent febrile illness (defined as oral or tympanic temperature ≥100.4°F [≥38.0°C] or axillary or temporal temperature ≥99.4°F [≥37.4°C]) or received antibiotic therapy for any acute illness occurring <72 hours before receipt of study vaccine
Has a known malignancy that is progressing or has required active treatment <3 years before enrollment
Received prior pneumococcal vaccine or is expected to receive any pneumococcal vaccine during the study outside the protocol
Received systemic corticosteroids (prednisone equivalent of ≥20 mg/day) for ≥14 consecutive days and has not completed intervention ≥14 days before receipt of study vaccine
Is currently receiving immunosuppressive therapy, including chemotherapeutic agents or other immunotherapies/immunomodulators used to treat cancer or other conditions, and interventions associated with organ or bone marrow transplantation, or autoimmune disease
Received any nonlive vaccine ≤14 days before receipt of study vaccine or is scheduled to receive any nonlive vaccine ≤30 days after receipt of study vaccine (inactivated influenza and SARS-CoV2 vaccines may be acceptable)
Received any live virus vaccine ≤30 days before receipt of study vaccine or is scheduled to receive any live virus vaccine ≤30 days after receipt of study vaccine
Received a blood transfusion or blood products, including immunoglobulin ≤6 months before receipt of study vaccine or is scheduled to receive a blood transfusion or blood product until the Day 30 postvaccination blood draw is complete
The Estimated Number of Participants
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Taiwan
120 participants
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Global
1400 participants
