Pneumococcal Disease Clinical Trial
Official title:
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
| Verified date | November 2023 |
| Source | Merck Sharp & Dohme LLC |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This is a phase 3, randomized, double-blind, active comparator-controlled study of the safety, tolerability, and immunogenicity of V116 in pneumococcal vaccine-naïve adults 50 years of age and older. The polyvalent (23-valent) pneumococcal vaccine, PPSV23, is the active comparator. In addition to studying safety/tolerability, it is hypothesized that, at 30 days postvaccination, the immunogenicity of V116 is noninferior to PPSV23 for the 12 common serotypes in V116 and PPSV23, and that V116 is superior to PPSV23 for the 9 serotypes unique to V116. It is also hypothesized that V116 is superior to PPSV23 in the percentage of participants with ≥4-fold rise from baseline in unique V116 serotypes, as measured by serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs).
| Status | Active, not recruiting |
| Enrollment | 1484 |
| Est. completion date | April 2, 2025 |
| Est. primary completion date | October 30, 2023 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 50 Years and older |
| Eligibility | 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 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 |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Fundacion Estudios Clinicos ( Site 0200) | Rosario | Santa Fe |
| Australia | Paratus Clinical Research Brisbane ( Site 1501) | Albion | Queensland |
| Australia | Paratus Clinical Research Western Sydney ( Site 1500) | Blacktown | New South Wales |
| Australia | Northern Beaches Clinical Research ( Site 1502) | Brookvale | New South Wales |
| Colombia | IPS Centro Científico Asistencial S.A.S ( Site 0407) | Barranquilla | Atlantico |
| Colombia | Fundacion Valle del Lili- CIC ( Site 0415) | Cali | Valle Del Cauca |
| Germany | Medizentrum Essen Borbeck ( Site 0902) | Essen | Nordrhein-Westfalen |
| Germany | InfektioResearch ( Site 0903) | Frankfurt am Main | Hessen |
| Germany | Universitaetsklinikum Hamburg-Eppendorf-Infektiologie ( Site 0901) | Hamburg | |
| Germany | Universitaetsklinikum Koeln ( Site 0900) | Köln | Nordrhein-Westfalen |
| Germany | klinikum rechts der isar der technischen universität münchen ( Site 0904) | München | Bayern |
| Israel | Rambam Health Care Campus ( Site 1002) | Haifa | |
| Israel | Hadassah Medical Center-Clinical Reaserch Unit ( Site 1004) | Jerusalem | |
| Israel | Meir Medical Center-Infectious unit ( Site 1003) | Kfar Saba | |
| Israel | Sheba Medical Center ( Site 1000) | Ramat Gan | |
| Israel | Clalit Health Services - Sakhnin Community Clinic-Research Unit ( Site 1001) | Sakhnin | |
| Korea, Republic of | Korea University Ansan Hospital ( Site 1801) | Ansan-si | Kyonggi-do |
| Korea, Republic of | Soon Chun Hyang University Bucheon Hospital ( Site 1812) | Bucheon | Kyonggi-do |
| Korea, Republic of | Dong-A University Hospital ( Site 1810) | Busan | Pusan-Kwangyokshi |
| Korea, Republic of | Kyungpook National University Chilgok Hospital-Division of Infectious Diseases ( Site 1804) | Deagu | Taegu-Kwangyokshi |
| Korea, Republic of | Chonnam National University Hospital-Infectious Diseases ( Site 1811) | Gwangju-si | Kwangju-Kwangyokshi |
| Korea, Republic of | Hallym University Dongtan Sacred Heart Hospital ( Site 1813) | Hwaseong-si | Kyonggi-do |
| Korea, Republic of | Chungnam national university hospital ( Site 1814) | Jung-gu | Taejon-Kwangyokshi |
| Korea, Republic of | Asan Medical Center ( Site 1809) | Seoul | |
| Korea, Republic of | Ewha Womans University Mokdong Hospital-Infectious Diseases ( Site 1805) | Seoul | |
| Korea, Republic of | Hallym University Kangnam Sacred Heart Hospital ( Site 1807) | Seoul | |
| Korea, Republic of | Korea University Guro Hospital ( Site 1800) | Seoul | |
| Korea, Republic of | The Catholic Univ. of Korea Seoul St. Mary's Hospital ( Site 1806) | Seoul | |
| Korea, Republic of | The Catholic University of Korea, Eunpyeong St. Mary's Hospital ( Site 1802) | Seoul | |
| Korea, Republic of | The Catholic University Of Korea St. Vincent's Hospital-Internal Medicine ( Site 1803) | Suwon-si | Kyonggi-do |
| Korea, Republic of | Wonju Severance Christian Hospital ( Site 1808) | Wonju | Kang-won-do |
| New Zealand | Optimal Clinical Trials ( Site 1600) | Auckland | |
| New Zealand | P3 Research - Lower Hutt ( Site 1601) | Lower Hutt | Wellington |
| New Zealand | P3 Research - Palmerston North ( Site 1602) | Palmerston North | Manawatu-Wanganui |
| Spain | Centre d'Atenció Primària Vallcarca - Sant Gervasi ( Site 1101) | Barcelona | |
| Spain | EAP Sardenya ( Site 1102) | Barcelona | |
| Spain | EBA CENTELLES ( Site 1100) | Centelles | Cataluna |
| Spain | Hospital Universitario Getafe ( Site 1111) | Getafe | Madrid, Comunidad De |
| Spain | Hospital La Princesa-Clinical Pharmacology ( Site 1115) | Madrid | |
| Spain | Fundación Oftalmologica del Mediterraneo-Vaccine Research ( Site 1118) | València | Valenciana, Comunitat |
| Taiwan | Kaohsiung Medical University Chung-Ho Memorial Hospital-Infectious diseases Division, Department of | Kaohsiung | |
| Taiwan | National Cheng Kung University Hospital ( Site 1901) | Tainan | |
| Taiwan | National Taiwan University Hospital ( Site 1900) | Taipei | |
| Taiwan | Chang Gung Medical Foundation-Linkou Branch ( Site 1902) | Taoyuan | |
| Turkey | ANKARA UNIVERSITY IBNI SINA HOSPITAL ( Site 1304) | Ankara | |
| Turkey | Gazi University Health Research and Application Center Gazi Hospital-Enfeksiyon Hastaliklari ( Site | Ankara | |
| Turkey | Hacettepe Universite Hastaneleri-Infection ( Site 1300) | Ankara | |
| Turkey | Acibadem Universitesi Atakent Hastanesi-Infectious Disease ( Site 1301) | Istanbul | |
| Turkey | Sancaktepe Sehit Prof.Dr. Ilhan Varank Egitim ve Arastirma Hastanesi ( Site 1305) | Sancaktepe | Istanbul |
| United Kingdom | Layton Medical Centre ( Site 1400) | Blackpool | Lancashire |
| United Kingdom | Accellacare - Northamptonshire ( Site 1403) | Corby | Northamptonshire |
| United Kingdom | Accellacare - Warwickshire ( Site 1404) | Coventry | Warwickshire |
| United Kingdom | Barts Health NHS Trust-William Harvey Clinical Research Centre ( Site 1407) | London | England |
| United Kingdom | Royal Free Hospital-Ian Charleson Day Centre RESEARCH ( Site 1402) | London | England |
| United Kingdom | Accellacare - Yorkshire-MeDiNova Yorkshire ( Site 1405) | Shipley | Bradford |
| Lead Sponsor | Collaborator |
|---|---|
| Merck Sharp & Dohme LLC |
Argentina, Australia, Colombia, Germany, Israel, Korea, Republic of, New Zealand, Spain, Taiwan, Turkey, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of participants with solicited injection-site AEs | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs consisted of pain/tenderness, redness/erythema, and swelling. | Up to 5 days postvaccination | |
| Primary | Percentage of participants with solicited systemic AEs | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited systemic AEs consist of muscle aches all over body/myalgia, headache, and tiredness/fatigue. | Up to 5 days postvaccination | |
| Primary | Percentage of participants with vaccine-related serious AE (SAE) | An SAE is any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an other important medical event. SAEs that were reported to be at least possibly related by the investigator to study vaccination will be summarized. | Up to 6 months postvaccination | |
| Primary | Serotype-specific opsonophagocytic (OPA) geometric mean titers (GMTs) | The serotype-specific OPA GMTs for the 21 serotypes contained in V116 will be determined using the multiplex opsonophagocytic assay (MOPA). | Day 30 postvaccination | |
| Primary | Percentage of participants with =4-fold rise from baseline in serotype-specific OPAs (unique to V116) | The percentage of participants with =4-fold rise from baseline in serotype-specific OPAs for the unique serotypes contained in V116 will be determined. | Baseline (Day 1) and Day 30 postvaccination | |
| Secondary | Percentage of participants with =4-fold rise from baseline in serotype-specific cross-reactive OPAs | The percentage of participants with =4-fold rise from baseline in serotype-specific cross-reactive OPAs will be determined. | Baseline (Day 1) and Day 30 postvaccination | |
| Secondary | Serotype-specific Immunoglobulin G (IgG) geometric mean concentrations (GMCs) | The GMCs for serotype-specific IgG antibodies will be determined using pneumococcal electrochemiluminescence (PnECL). | Day 30 postvaccination | |
| Secondary | Serotype-specific geometric mean fold rise (GMFR) in OPA GMTs | The GMFR from baseline in serotype-specific OPA GMTs will be determined using MOPA. | Baseline (Day 1) and Day 30 postvaccination | |
| Secondary | Serotype-specific GMFR in IgG GMCs | The GMFR from baseline in GMCs for serotype-specific IgG antibodies will be determined using PnECL. | Baseline (Day 1) and Day 30 postvaccination | |
| Secondary | Percentage of participants with =4-fold rise from baseline in serotype-specific OPA GMTs (all serotypes) | The percentage of participants with =4-fold rise from baseline in serotype-specific OPA GMTs will be determined with MOPA. | Baseline (Day 1) and Day 30 postvaccination | |
| Secondary | Percentage of participants with =4-fold rise from baseline in serotype-specific IgG GMCs | The percentage of participants with =4-fold rise from baseline in serotype-specific IgG GMCs will be determined using PnECL. | Baseline (Day 1) and Day 30 postvaccination |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04546425 -
20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 3-Dose Series in Healthy Infants
|
Phase 3 | |
| Recruiting |
NCT06044077 -
A Clinical Trial to Evaluate the Immunogenicity and Safety of the 23-valent Pneumococcal Polysaccharide Vaccine in Healthy People
|
Phase 3 | |
| Completed |
NCT02146365 -
Nasopharyngeal Carriage Study in Healthy Kenyan Toddlers
|
||
| Completed |
NCT04525599 -
A Study to Assess the Safety, Tolerability and Immunogenicity of ASP3772, a Pneumococcal Vaccine, in Toddlers 12 to 15 Months of Age in Comparison to an Active Comparator
|
Phase 1 | |
| Active, not recruiting |
NCT05512819 -
A Study to Describe the Safety and Immunogenicity of 20vPnC in Infants in India and Taiwan
|
Phase 3 | |
| Completed |
NCT04530838 -
20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study in Healthy Japanese Infants
|
Phase 3 | |
| Active, not recruiting |
NCT06026748 -
A Phase I Study of XJ103 in Chinese Healthy Subjects
|
Phase 1 | |
| Completed |
NCT04526574 -
Safety and Immunogenicity of 20vPnC Coadministered With SIIV in Adults ≥65 Years of Age
|
Phase 3 | |
| Completed |
NCT05329259 -
A Study to Describe the Safety of a Vaccine (Called 13vPnC) in Healthy People 18 to 49 Years of Age in India
|
Phase 4 | |
| Completed |
NCT00234338 -
Study Evaluating Prevenar in High-Risk Children
|
N/A | |
| Completed |
NCT01767402 -
Study to Evaluate Safety, Reactogenicity and Immunogenicity of the Pneumococcal Protein PhtD Vaccine in Healthy Adults
|
Phase 1 | |
| Completed |
NCT01111214 -
Child Pneumococcal Serotype Epidemiology In Greece
|
N/A | |
| Completed |
NCT01298544 -
A Study to Assess the Antibody Response of Healthy Chinese Children Who Have Been Vaccinated Previously With 4-doses of Prevenar (a Pneumococcal Vaccine) as Babies and Toddlers
|
Phase 4 | |
| Completed |
NCT04830358 -
Safety and Immunogenicity of the 'EuPCV15' in Healthy Korean Adults
|
Phase 1 | |
| Completed |
NCT04379713 -
20-valent Pneumococcal Conjugate Vaccine Safety Study in Healthy Infants
|
Phase 3 | |
| Completed |
NCT04887948 -
Safety and Immunogenicity Study of 20vPnC When Coadministered With a Booster Dose of BNT162b2
|
Phase 3 | |
| Completed |
NCT04382326 -
20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 4-Dose Series in Healthy Infants
|
Phase 3 | |
| Not yet recruiting |
NCT00843895 -
Multicenter Prospective Evaluation of the Incidence and Serotyes of Invasive Pneumoccocal Disease (IPD) Among Children Below 5 Years
|
N/A | |
| Completed |
NCT01734239 -
A Phase III Clinical Trial to Study the Safety and Immunogenicity of Pneumovax™ 23 (V110) in Participants From the Russian Population (V110-018)
|
Phase 3 | |
| Completed |
NCT05408429 -
Safety and Immunogenicity of 20vPnC in Toddlers With 2 Prior Doses of Prevenar 13
|
Phase 3 |