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 | May 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) Following Vaccination With Separate V116 Lots | An AE was 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 included pain/tenderness, redness/erythema, and swelling. Per protocol, the PPSV23 treatment group was not included as it was not analyzed with the individual lots of V116. | Up to 5 days | |
| Primary | Percentage of Participants With Solicited Injection-site AEs Following Vaccination: Combined Lots of V116 or PPSV23 | An AE was 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 included pain/tenderness, redness/erythema, and swelling. Per the statistical analysis plan, within group method of dispersion (MOD) were planned or calculated. | Up to 5 days | |
| Primary | Percentage of Participants With Solicited Systemic AEs Following Vaccination With Separate V116 Lots | An AE was 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 included headache, muscle aches/myalgia, tiredness/fatigue, and pyrexia. Per protocol, the PPSV23 treatment group was not included as it was not analyzed with the individual lots of V116. | Up to 5 days | |
| Primary | Percentage of Participants With Solicited Systemic AEs Following Vaccination: Combined Lots of V116 or PPSV23 | An AE was 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 included headache, muscle aches/myalgia, tiredness/fatigue, and pyrexia. Per the statistical analysis plan, within group method of dispersion (MOD) were planned or calculated. | Up to 5 days | |
| Primary | Percentage of Participants With Vaccine-related Serious Adverse Events (SAEs) Following Vaccination With Separate V116 Lots | An SAE was any untoward medical occurrence that, at any dose, resulted in death, was life threatening, required inpatient hospitalization or prolonged existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was another important medical event. SAEs that were reported to be at least possibly related by the investigator to study vaccination were reported. Per protocol, the PPSV23 treatment group was not included as it was not analyzed with the individual lots of V116. | Up to 194 days | |
| Primary | Percentage of Participants With Vaccine-related SAEs Following Vaccination: Combined Lots of V116 or PPSV23 | An SAE was any untoward medical occurrence that, at any dose, resulted in death, was life threatening, required inpatient hospitalization or prolonged existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was another important medical event. SAEs that were reported to be at least possibly related by the investigator to study vaccination were reported. Per the statistical analysis plan, within group MOD were planned or calculated. | Up to 194 days | |
| Primary | Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) for All Serotypes in V116 Following Vaccination With Separate V116 Lots | Serotype-specific OPA titers for all serotypes in V116 following vaccination were determined using multiplex opsonophagocytic assay (MOPA). Serotype-specific OPA GMTs and GMT ratios with 95% confidence intervals (CIs) were calculated using a constrained longitudinal data analysis (cLDA) model. Per protocol, within-group CIs were not calculated and the PPSV23 treatment group was not included as it was not analyzed with the individual lots of V116. | Day 30 | |
| Secondary | GMTs of Serotype-specific OPA for All Serotypes in V116 Following Vaccination: Combined Lots of V116 or PPSV23 | Serotype-specific OPA titers for all serotypes in V116 following vaccination were determined using MOPA. Serotype-specific OPA GMTs and GMT ratios with 95% CI were calculated using a constrained longitudinal data analysis (cLDA) model. Per protocol, within-group CIs were not calculated. | 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 concentrations for all serotypes in V116 following vaccination were determined using pneumococcal electrochemiluminescence (PnECL). Serotype-specific pneumococcal IgG GMCs and GMC ratios with 95% confidence intervals were calculated using a cLDA model. Per protocol, within-group CIs were not calculated and the PPSV23 treatment group was not included as it was not analyzed with the individual lots of V116. | Day 30 | |
| Secondary | GMCs of Serotype-specific IgG for All Serotypes in V116 Following Vaccination: Combined Lots of V116 or PPSV23 | Serotype-specific IgG concentrations for all serotypes in V116 following vaccination were determined using PnECL. Serotype-specific pneumococcal IgG GMCs and GMC ratios with 95% confidence intervals were calculated using a cLDA model. Per protocol, within-group CIs were not calculated. | 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 were determined using MOPA. The GMFR of each pneumococcal serotype was calculated as Day 30 GMT/Day 1 GMT. The 95% CIs were calculated based on based on the t-distribution. Per protocol, the PPSV23 treatment group was not included as it was not analyzed with the individual lots of V116. | 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 | Serotype-specific OPA titer were determined using MOPA. Percentage of participants with a =4-fold rise in serotype-specific OPA for all serotypes in V116 following vaccination were reported. The 95% CIs were calculated based on the exact binomial method proposed by Clopper and Pearson. Per protocol, the PPSV23 treatment group was not included as it was not analyzed with the individual lots of V116. | 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 were determined using PnECL. The GMFR for each pneumococcal IgG serotype was calculated as Day 30 GMC/Day 1 GMC. The 95% CIs were calculated based on the t-distribution. Per protocol, the PPSV23 treatment group was not included as it was not analyzed with the individual lots of V116. | 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 | Serotype-specific IgG concentrations were determined using PnECL. Percentage of participants with a =4-fold rise in serotype-specific IgG for all serotypes in V116 were reported. The 95% CIs were calculated based on the exact binomial method proposed by Clopper and Pearson. Per protocol, the PPSV23 treatment group was not included as it was not analyzed with the individual lots of V116. | 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 titers for cross-reactive serotypes (6A, 6C, 15B, and 15C) were determined using MOPA. The 95% CIs for serotype-specific OPA GMTs were calculated based on based on the t-distribution. Per protocol, within-group CIs were not calculated. Per protocol, the PPSV23 treatment group was not included as it was not analyzed with the individual lots of V116. | Day 30 |
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