Pneumococcal Disease Clinical Trial
Official title:
A Phase 3 Randomized, Double-blind, Active Comparator-controlled, Lot-to-Lot Consistency Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Adults 18 to 49 Years of Age
| Verified date | February 2024 |
| Source | Merck Sharp & Dohme LLC |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This study will evaluate the safety, tolerability, and immunogenicity of a pneumococcal 21-valent conjugate vaccine (V116) in pneumococcal vaccine-naïve adults 18 to 49 years of age. The primary study hypothesis is that all 3 lots of V116 are equivalent as assessed by the serotype-specific opsonophagocytic activity (OPA) Geometric Mean Titers (GMTs) at 30 days postvaccination for all serotypes included in V116.
| Status | Completed |
| Enrollment | 2162 |
| Est. completion date | May 25, 2023 |
| Est. primary completion date | May 25, 2023 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 49 Years |
| Eligibility | The key inclusion and exclusion criteria include but are not limited to the following: Inclusion Criteria: - Has underlying chronic conditions but assessed to be stable as per investigator - Has ability to complete electronic Vaccine Report Card (eVRC) data collection without assistance as per investigator Exclusion Criteria: - Has a history of invasive pneumococcal disease (IPD) or other culture-positive pneumococcal disease =3 years before Visit 1 (Day 1) - Has a known or suspected congenital immunodeficiency, functional or anatomic asplenia, or history of autoimmune disease - Has a coagulation disorder contraindicating intramuscular vaccination - Has a recent illness with fever - Has a known malignancy that is progressing or has required active treatment <3 years before enrollment - Is expected to receive any pneumococcal vaccine during the study outside of the protocol - Has received systemic corticosteroids for =14 consecutive days and has not completed treatment =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 - Has received any non-live vaccine =14 days before receipt of study vaccine or is scheduled to receive any non-live vaccine =30 days after receipt of study vaccine - Has received any live vaccine =30 days before receipt of study vaccine or is scheduled to receive any live vaccine =30 days after receipt of study vaccine - Has received a blood transfusion or blood products, including immunoglobulins =6 months before receipt of study vaccine or is scheduled to receive a blood transfusion or blood product =30 days after receipt of study vaccine |
| Country | Name | City | State |
|---|---|---|---|
| Austria | Medizinische Universität Graz-Klinische Abteilung für Pulmonologie ( Site 0304) | Graz | Steiermark |
| Austria | Medizinische Universitaet Innsbruck ( Site 0301) | Innsbruck | Tirol |
| Austria | Tropeninstitut Wien 1060 ( Site 0300) | Vienna | Wien |
| Austria | Medizinische Universität Wien ( Site 0302) | Wien | |
| Canada | Hamilton Medical Research Group ( Site 0208) | Hamilton | Ontario |
| Canada | Milestone Research Inc. ( Site 0201) | London | Ontario |
| Canada | Manna Research Mirabel ( Site 0207) | Mirabel | Quebec |
| Canada | Manna Research Montreal ( Site 0203) | Pointe-Claire | Quebec |
| Canada | Q&T Research Sherbrooke Inc. ( Site 0204) | Sherbrooke | Quebec |
| Canada | Manna Research Toronto ( Site 0209) | Toronto | Ontario |
| Canada | Diex Recherche Trois-Rivieres ( Site 0206) | Trois-Rivieres | Quebec |
| Canada | Colchester Research Group ( Site 0202) | Truro | Nova Scotia |
| Denmark | Sanos Clinic - Nordjylland ( Site 0401) | Aalborg | Nordjylland |
| Denmark | Danske Lægers Vaccinations Service - Århus ( Site 0403) | Aarhus | Midtjylland |
| Denmark | Sanos Clinic-Sanos Clinic ( Site 0402) | Herlev | Hovedstaden |
| Denmark | Danske Lægers Vaccinations Service - Søborg ( Site 0404) | Soborg | Hovedstaden |
| Denmark | Sanos Clinic - Syddanmark ( Site 0400) | Vejle | Syddanmark |
| Finland | FVR, Espoon rokotetutkimusklinikka ( Site 0509) | Espoo | Uusimaa |
| Finland | FVR, Etelä-Helsingin rokotetutkimusklinikka ( Site 0503) | Helsinki | Uusimaa |
| Finland | Helsinki East Vaccine Research Clinic ( Site 0502) | Helsinki | Uusimaa |
| Finland | FVR, Oulun rokotetutkimusklinikka ( Site 0501) | Oulu | Pohjois-Pohjanmaa |
| Finland | FVR, Porin rokotetutkimusklinikka ( Site 0508) | Pori | Satakunta |
| Finland | FVR, Seinäjoen rokotetutkimusklinikka ( Site 0504) | Seinajoki | Sodra Osterbotten |
| Finland | FVR, Turun rokotetutkimusklinikka ( Site 0500) | Turku | Varsinais-Suomi |
| Israel | Rambam Health Care Campus ( Site 0603) | Haifa | |
| Israel | Hadassah Medical Center ( Site 0600) | Jerusalem | |
| Israel | Maccabi Healthcare Services ( Site 0606) | Jerusalem | |
| Israel | Meir Medical Center ( Site 0601) | Kfar Saba | |
| Israel | Sheba Medical Center-Early Phase Clinical Trials Unit ( Site 0604) | Ramat Gan | |
| Israel | Clalit Health Services - Sakhnin Community Clinic-Research Unit ( Site 0602) | Sakhnin | |
| Poland | Centrum Medyczne Pratia Bydgoszcz-Centrum Medyczne Pratia Bydgoszcz ( Site 0709) | Bydgoszcz | Kujawsko-pomorskie |
| Poland | IN VIVO ( Site 0711) | Bydgoszcz | Kujawsko-pomorskie |
| Poland | Alergotest s.c Specjalistyczne Centrum Medyczne ( Site 0703) | Lublin | Lubelskie |
| Poland | Centrum Medyczne Medyk ( Site 0704) | Rzeszow | Podkarpackie |
| Poland | Clinmedica OMC ( Site 0701) | Skierniewice | Lodzkie |
| Poland | MICS Centrum Medyczne Torun ( Site 0706) | Torun | Kujawsko-pomorskie |
| Spain | Centre d'Atenció Primària Vallcarca - Sant Gervasi ( Site 0801) | Barcelona | |
| Spain | EAP Sardenya ( Site 0802) | Barcelona | |
| Spain | EBA CENTELLES ( Site 0800) | Centelles | Cataluna |
| Spain | Hospital La Princesa-Clinical Pharmacology ( Site 0815) | Madrid | |
| Spain | HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-Respiratory ( Site 0808) | Pozuelo de Alarcon | Madrid |
| Spain | Fundación Oftalmologica del Mediterraneo-Vaccine Research ( Site 0818) | València | Valenciana, Comunitat |
| United States | Lynn Institute of Denver ( Site 0003) | Aurora | Colorado |
| United States | Kentucky Pediatric/ Adult Research ( Site 0036) | Bardstown | Kentucky |
| United States | Charlottesville Medical Research ( Site 0013) | Charlottesville | Virginia |
| United States | Velocity Clinical Research, Providence ( Site 0018) | East Greenwich | Rhode Island |
| United States | Healthcare Research Network - Chicago ( Site 0006) | Flossmoor | Illinois |
| United States | Methodist Physicians Clinic/CCT Research ( Site 0029) | Fremont | Nebraska |
| United States | Velocity Clinical Research, Greenville ( Site 0021) | Greenville | South Carolina |
| United States | Indago Research & Health Center, Inc ( Site 0011) | Hialeah | Florida |
| United States | Alliance for Multispecialty Research, LLC ( Site 0031) | Kansas City | Missouri |
| United States | Healor Primary Care / CCT Research ( Site 0028) | Las Vegas | Nevada |
| United States | Baptist Health Center For Clinical Research ( Site 0015) | Little Rock | Arkansas |
| United States | DCOL Center for Clinical Research ( Site 0025) | Longview | Texas |
| United States | Desert Clinical Research/ CCT Research ( Site 0019) | Mesa | Arizona |
| United States | L&C Professional Medical Research Institute ( Site 0012) | Miami | Florida |
| United States | Clinical Research Associates Inc ( Site 0039) | Nashville | Tennessee |
| United States | Health Research of Hampton Roads, Inc. ( Site 0002) | Newport News | Virginia |
| United States | Valley Clinical Trials, Inc. ( Site 0023) | Northridge | California |
| United States | Lynn Health Science Institute ( Site 0014) | Oklahoma City | Oklahoma |
| United States | Headlands Research Orlando ( Site 0017) | Orlando | Florida |
| United States | M3 Wake Research Associates ( Site 0035) | Raleigh | North Carolina |
| United States | Clinical Research Prime Rexburg ( Site 0040) | Rexburg | Idaho |
| United States | Rochester Clinical Research, Inc. ( Site 0033) | Rochester | New York |
| United States | IMA Clinical Research San Antonio ( Site 0020) | San Antonio | Texas |
| United States | Artemis Institute for Clinical Research ( Site 0027) | San Diego | California |
| United States | Axces Research ( Site 0034) | Santa Fe | New Mexico |
| United States | Millennium Clinical Trials ( Site 0004) | Simi Valley | California |
| United States | Clinical Research Trials of Florida ( Site 0001) | Tampa | Florida |
| United States | Fiel Family and Sports Medicine, PC/CCT Research ( Site 0008) | Tempe | Arizona |
| United States | Dynamed Clinical Research, LP d/b/a DM Clinical Research ( Site 0016) | Tomball | Texas |
| United States | Diablo Clinical Research, Inc. ( Site 0022) | Walnut Creek | California |
| Lead Sponsor | Collaborator |
|---|---|
| Merck Sharp & Dohme LLC |
United States, Austria, Canada, Denmark, Finland, Israel, Poland, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of participants with solicited injection-site adverse events (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 include pain/tenderness, redness/erythema, and swelling. | Up to ~5 days | |
| 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 include headache, muscle aches/myalgia, and tiredness/fatigue. | Up to ~5 days | |
| Primary | Percentage of participants with vaccine-related serious adverse events (SAEs) | An SAE is any untoward medical occurrence that, at any dose, 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 another 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 | |
| Primary | Geometric mean titers (GMTs) of serotype-specific opsonophagocytic activity (OPA) for all serotypes in V116 following vaccination with 1 of 3 different lots of V116 | Serotype-specific OPA GMT for all serotypes in V116 following vaccination will be determined using multiplex opsonophagocytic assay (MOPA). | Day 30 | |
| Secondary | GMTs of serotype-specific OPA for all serotypes in V116 following vaccination: combined lots of V116 or PNEUMOVAX™ | Serotype-specific OPA GMT for all serotypes in V116 following vaccination will be determined using MOPA. | Day 30 | |
| Secondary | Geometric mean concentrations (GMCs) of serotype-specific Immunoglobulin G (IgG) for all serotypes in V116 following vaccination with separate V116 lots | Serotype-specific IgG GMC for all serotypes in V116 following vaccination will be determined using pneumococcal electrochemiluminescence (PnECL). | Day 30 | |
| Secondary | GMCs of serotype-specific IgG for all serotypes in V116 following vaccination: combined lots of V116 or PNEUMOVAX™ | Serotype-specific IgG GMC for all serotypes in V116 following vaccination will be determined using PnECL. | Day 30 | |
| Secondary | Geometric mean fold rise (GMFR) in serotype-specific OPA for all serotypes in V116 following vaccination with separate V116 Lots | Serotype-specific OPA GMFR for all serotypes in V116 following vaccination will be determined using MOPA. | Baseline (Day 1) and Day 30 | |
| Secondary | Percentage of participants with =4-fold rise in serotype-specific OPA for all serotypes in V116 following vaccination with separate V116 Lots | Percentage of participants with a =4-fold rise in serotype-specific OPA for all serotypes in V116 following vaccination will be reported. | Baseline (Day 1) and Day 30 | |
| Secondary | GMFR in serotype-specific IgG for all serotypes in V116 following vaccination with separate V116 Lots | Serotype-specific IgG GMFR for all serotypes in V116 following vaccination will be determined using PnECL. | Baseline (Day 1) and Day 30 | |
| Secondary | Percentage of participants with =4-fold rise in serotype-specific IgG for all serotypes in V116 following vaccination with separate V116 Lots | Percentage of participants with a =4-fold rise in serotype-specific IgG for all serotypes in V116 following vaccination will be reported. | Baseline (Day 1) and Day 30 | |
| Secondary | GMTs of serotype-specific OPA for cross-reactive serotypes following vaccination with separate V116 Lots | Serotype-specific OPA GMTs for cross-reactive serotypes following vaccination will be determined using MOPA. | Day 30 |
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