Safety and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults 50 Years of Age or Older (V116-010, STRIDE-10)
- Registration Number
- NCT05569954
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1484
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description V116 V116 Participants will receive a single intramuscular (IM) vaccination of 0.5 mL of V116 on Day 1. PPSV23 PPSV23 Participants will receive a single IM vaccination of 0.5 mL of PPSV23 on Day 1.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Solicited Injection-Site Adverse Events (AEs) Up to 5 days postvaccination 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. 95% confidence intervals (CIs) for between-group differences are provided using the Miettinen \& Nurminen method.
Percentage of Participants With Solicited Systemic AEs Up to 5 days postvaccination 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 the following: fatigue (tiredness), headache, myalgia (muscle aches), and pyrexia (maximum temperature ≥ 100.4 °F/38.0 °C). 95% confidence intervals (CIs) for between-group differences are provided using the Miettinen \& Nurminen method.
Percentage of Participants With Vaccine-Related Serious Adverse Events (SAEs) Up to 6 months postvaccination 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 are summarized. 95% confidence intervals (CIs) for between-group differences are provided using the Miettinen \& Nurminen method.
Serotype-Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) for All Serotypes in V116 Day 30 postvaccination 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), and they hypothesis test (1-sided p-value), were calculated using a constrained longitudinal data analysis (cLDA) model. Per protocol, within-group CIs, or any other method of dispersion were not planned or calculated.
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-Specific OPAs for Serotypes Unique to V116 Baseline (Day 1) and Day 30 postvaccination The percentage of participants with ≥4-fold rise from baseline in serotype-specific OPAs for the unique pneumococcal serotypes contained in V116 was determined. The 9 unique pneumococcal serotypes in V116 are as follows: 6A, 15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B. Per protocol, within-group CIs, or any other method of dispersion were not planned or calculated.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-Specific Cross-Reactive OPAs Baseline (Day 1) and Day 30 postvaccination OPA induced by serotypes 6A and 15C in V116 but cross-reactive to serotypes 6C and 15B, respectively, were measured. The percentage of participants with ≥4-fold rise from baseline in serotype-specific cross-reactive OPAs was determined. Point estimate, 95% CI, and p-value are based on the Clopper-Pearson method. Per protocol, this outcome measure was not planned or analyzed in the PPSV23 study arm.
Serotype-Specific Geometric Mean Fold Rise (GMFR) of OPA GMTs for All Serotypes in V116 Baseline (Day 1) and Day 30 postvaccination The GMFR from baseline in serotype-specific OPA GMTs for all serotypes in V116 was determined using MOPA. The within-group 95% CIs are obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution.
Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for All Serotypes in V116 Day 30 postvaccination The GMCs for serotype-specific IgG antibodies for all serotypes in V116 were determined using pneumococcal electrochemiluminescence (PnECL). The GMC ratio estimation and 95% CI were calculated using a cLDA method. Per protocol, within-group CIs, or any other method of dispersion were not planned or calculated.
Serotype-Specific GMFR of IgG GMCs for All Serotypes in V116 Baseline (Day 1) and Day 30 postvaccination The GMFR from baseline in GMCs for serotype-specific IgG antibodies for all serotypes in V116 was determined using PnECL. The within-group 95% CIs are obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution.
Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific OPA GMTs for All Serotypes in V116 Baseline (Day 1) and Day 30 postvaccination The percentage of participants with ≥4-fold rise from baseline in serotype-specific OPA GMTs for all serotypes in V116 was determined with MOPA. The within-group CIs were calculated based on the Clopper-Pearson method.
Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific IgG GMCs for All Serotypes in V116 Baseline (Day 1) and Day 30 postvaccination The percentage of participants with ≥4-fold rise from baseline in serotype-specific IgG GMCs for all serotypes in V116 was determined using PnECL. The within-group CIs were calculated based on the Clopper-Pearson method.
Trial Locations
- Locations (55)
Fundacion Estudios Clinicos ( Site 0200)
🇦🇷Rosario, Santa Fe, Argentina
Paratus Clinical Research Western Sydney ( Site 1500)
🇦🇺Blacktown, New South Wales, Australia
Northern Beaches Clinical Research ( Site 1502)
🇦🇺Brookvale, New South Wales, Australia
Paratus Clinical Research Brisbane ( Site 1501)
🇦🇺Albion, Queensland, Australia
IPS Centro Científico Asistencial S.A.S ( Site 0407)
🇨🇴Barranquilla, Atlantico, Colombia
Fundacion Valle del Lili- CIC ( Site 0415)
🇨🇴Cali, Valle Del Cauca, Colombia
klinikum rechts der isar der technischen universität münchen ( Site 0904)
🇩🇪München, Bayern, Germany
InfektioResearch ( Site 0903)
🇩🇪Frankfurt am Main, Hessen, Germany
Medizentrum Essen Borbeck ( Site 0902)
🇩🇪Essen, Nordrhein-Westfalen, Germany
Universitaetsklinikum Koeln ( Site 0900)
🇩🇪Köln, Nordrhein-Westfalen, Germany
Scroll for more (45 remaining)Fundacion Estudios Clinicos ( Site 0200)🇦🇷Rosario, Santa Fe, Argentina