Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05696080
Other study ID # V116-008
Secondary ID V116-008jRCT2061
Status Completed
Phase Phase 3
First received
Last updated
Start date February 13, 2023
Est. completion date February 16, 2024

Study information

Verified date February 2024
Source Merck Sharp & Dohme LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary objectives of this study are to evaluate the safety and tolerability of the pneumococcal 21 valent conjugate vaccine (V116), and to evaluate the serotype-specific opsonophagocytic activity (OPA) post-vaccination with V116 and PCV15 (a pneumococcal conjugate vaccine that includes 15 serotypes) + PPSV23 (comprised of the polysaccharides from 23 of the serotypes causing disease in adults) post-vaccination. within each vaccination group separately.


Recruitment information / eligibility

Status Completed
Enrollment 518
Est. completion date February 16, 2024
Est. primary completion date February 16, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 64 Years
Eligibility Inclusion Criteria: - Has documented result(s) of =1 of the following risk conditions for pneumococcal disease: diabetes mellitus, receiving treatment with =1 approved antidiabetic medication, with all Hemoglobin A1c (HbA1c) measurements =9% within 6 months before first study vaccination; compensated chronic liver disease; diagnosis of chronic obstructive pulmonary disease (COPD) managed per local guidelines; diagnosis of mild or moderate persistent asthma managed per local guidelines; confirmed diagnosis of chronic heart disease managed per local guidelines; confirmed diagnosis of chronic kidney disease (>3 months duration). - Is receiving stable medical management for the listed risk conditions for =3 months with no anticipated major change in treatment expected for the duration of the study and with =1 hospitalization directly related to the risk condition. - Female Is not a participant of childbearing potential (POCBP); or if a POCBP Uses an acceptable contraceptive method or is abstinent from penile-vaginal intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis); their medical history, menstrual history, and recent sexual activity has been reviewed by the investigator. Exclusion Criteria: - Has a history of active hepatitis. - Has a history of diabetic ketoacidosis or 2 or more episodes of severe, symptomatic hypoglycemia within 3 months before first study vaccination (Day 1). - Has a history of myocardial infarction, acute coronary syndrome, transient ischemic attack, or ischemic or hemorrhagic stroke within 3 months before first study vaccination (Day 1). - Has a history of severe pulmonary hypertension with World Health Organization (WHO) functional class =3 or history of Eisenmenger syndrome - Has a history of autoimmune related chronic kidney disease, chronic kidney failure, a reversible cause of kidney disease, nephrotic syndrome, or any ineligible Kidney Disease: Improving Global Outcomes (KDIGO)-recommended stage of glomerular filtration rate (GFR) and Albuminuria - 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 before first study vaccination (Day 1). - Has a known hypersensitivity to any component of V116, PCV15, or PPSV23, including diphtheria toxoid. - Has a known or suspected impairment of immunological function including, but not limited to, congenital or acquired immunodeficiency, documented human immunodeficiency virus (HIV) infection, functional or anatomic asplenia, or autoimmune disease. - Has a coagulation disorder contraindicating intramuscular (IM) vaccination. - Had a recent febrile illness or received antibiotic therapy for any acute illness occurring within 72 hours before receipt of any study vaccine. - Has a known malignancy that is progressing or has required active treatment <3 years before randomization. - Has planned organ transplantation (heart, liver, lung, kidney, or pancreas) or other planned major surgical procedure during the duration of this study. - Has expected survival for <1 year. - Has received any prior pneumococcal vaccine or is expected to receive any pneumococcal vaccine during the study outside the protocol. - Has 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 at Visit 2 (Day 1). - Is currently receiving systemic 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 any study vaccine or is scheduled to receive any non-live vaccine =30 days after receipt of any study vaccine. - Has received any live virus vaccine (including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) live virus vaccines) =30 days before receipt of any study vaccine or is scheduled to receive any live virus vaccine =30 days after receipt of any study vaccine - Has received a blood transfusion or blood products, including immunoglobulin =6 months before receipt of any study vaccine or is scheduled to receive a blood transfusion or blood product =30 days after receipt of any study vaccine. - Is receiving chronic home oxygen therapy.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
V116
Pneumococcal 21-valent conjugate vaccine with 4 µg of each of the following pneumococcal polysaccharides (PnPs) antigen: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20, 22F, 23A, 23B, 24F, 31, 33F, and 35B in each 0.5 mL sterile solution
Drug:
Placebo for PCV15 + PPSV23
Saline in each 0.5 mL sterile solution
Biological:
PCV15
Pneumococcal 15-valent conjugate vaccine with 2 µg of each of the following PnPs antigen: 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; and 4 µg of PnPs antigen 6B in each 0.5 mL sterile suspension
PPSV23
Pneumococcal 23-valent polyvalent vaccine with 25 µg of each of the following PnPs antigen: 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F in each 0.5 mL sterile solution

Locations

Country Name City State
Australia Royal Brisbane and Women's Hospital ( Site 0400) Brisbane Queensland
Australia Holdsworth House Medical Practice ( Site 0402) Darlinghurst New South Wales
Canada Hamilton Medical Research Group ( Site 0107) Hamilton Ontario
Canada Milestone Research Inc. ( Site 0106) London Ontario
Canada Manna Research Mirabel ( Site 0105) Mirabel Quebec
Canada G A Research Associates ( Site 0100) Moncton New Brunswick
Canada Clinique de médecine Urbaine du Quartier Latin ( Site 0111) Montreal Quebec
Canada Diex Recherche Trois-Rivieres ( Site 0110) Trois-Rivieres Quebec
Canada Diex Recherche Victoriavile Inc. ( Site 0102) Victoriaville Quebec
Chile Universidad San Sebastian - Providencia ( Site 1003) Providencia Region M. De Santiago
Chile Centro de Investigacion Clinicadela Universidad Catolica ( Site 1004) Santiago Region M. De Santiago
Chile Centro de Investigaciones Medicas Respiratorias (CIMER) ( Site 1008) Santiago Region M. De Santiago
Chile CESFAM Esmeralda ( Site 1009) Santiago Region M. De Santiago
Chile Universidad de Chile - Hospital Clínico Universidad de Chile-Cardiology ( Site 1006) Santiago Region M. De Santiago
Chile Centro de Investigación del Maule-Centro de Investigación 2 ( Site 1010) Talca Maule
Chile Hospital Dr. Hernán Henríquez Aravena ( Site 1001) Temuco Araucania
Japan Medical corporation Applied Bio-Pharmatech Kurume Clinical Pharmacology Clinic ( Site 0200) Kurume Fukuoka
Japan Shimonoseki Medical Center ( Site 0201) Shimonoseki Yamaguchi
Korea, Republic of Hallym University Sacred Heart Hospital ( Site 0303) Anyang-si Kyonggi-do
Korea, Republic of Hallym University Kangdong Sacred Heart Hospital ( Site 0301) Seoul
Korea, Republic of Konkuk University Medical Center ( Site 0302) Seoul
Korea, Republic of Korea University Anam Hospital ( Site 0305) Seoul
Korea, Republic of Seoul National University Hospital ( Site 0300) Seoul
New Zealand CGM Research Trust ( Site 0505) Christchurch Canterbury
New Zealand Pacific Clinical Research Network - Forte ( Site 0501) Christchurch Canterbury
New Zealand P3 Research - Lower Hutt ( Site 0508) Lower Hutt Wellington
New Zealand Pacific Clinical Research Network - Rotorua ( Site 0500) Rotorua Bay Of Plenty
New Zealand P3 Research - Tauranga ( Site 0507) Tauranga Bay Of Plenty
New Zealand P3 Research - Wellington ( Site 0503) Wellington
Poland Centrum Medyczne Pratia Bydgoszcz-Centrum Medyczne Pratia Bydgoszcz ( Site 0607) Bydgoszcz Kujawsko-pomorskie
Poland IN VIVO ( Site 0601) Bydgoszcz Kujawsko-pomorskie
Poland Centrum Medyczne Pratia Katowice ( Site 0604) Katowice Slaskie
Poland Clinical Medical Research ( Site 0605) Katowice Slaskie
Poland Centrum Medyczne Medyk ( Site 0602) Rzeszow Podkarpackie
Poland Clinmedica Research Sp. z. o. o. ( Site 0603) Skierniewice Lodzkie
Poland MICS Centrum Medyczne Torun ( Site 0606) Torun Kujawsko-pomorskie
United States EmVenio Research ( Site 0018) Fort Worth Texas
United States Indago Research & Health Center, Inc ( Site 0002) Hialeah Florida
United States Holston Medical Group ( Site 0010) Kingsport Tennessee
United States Aventiv Research ( Site 0022) Mesa Arizona
United States Mid Hudson Medical Research ( Site 0008) New Windsor New York
United States SKY Integrative Medical Center/SKYCRNG ( Site 0012) Ridgeland Mississippi
United States Wenatchee Valley Hospital ( Site 0019) Wenatchee Washington
United States Triple O Research Institute, P.A ( Site 0011) West Palm Beach Florida

Sponsors (1)

Lead Sponsor Collaborator
Merck Sharp & Dohme LLC

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Chile,  Japan,  Korea, Republic of,  New Zealand,  Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Participants with solicited injection-site adverse events (AEs) from Day 1 through Day 5 post-vaccination Percentage of participants with solicited injection-site AEs from Day 1 through Day 5 post-vaccination Up to Day 5
Primary Participants with solicited systemic AEs from Day 1 through Day 5 post-vaccination Percentage of participants with solicited systemic AEs from Day 1 through Day 5 post-vaccination Up to Day 5
Primary Participants with vaccine-related serious adverse events (SAEs) from Day 1 through the duration of participation in the study Percentage of participants with vaccine-related SAEs from Day 1 through the duration of participation in the study Up to Month 6
Primary Serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) post-vaccination Serotype-specific OPA GMTs post-vaccination with V116 (30 days post-vaccination [Day 30]) or PCV15 + PPSV23 (30 days post-vaccination with the final dose in the regimen [Week 12]) Up to Week 12
Secondary Serotype-specific Immunoglobulin G (IgG) geometric mean concentrations (GMCs) post-vaccination Serotype-specific IgG GMCs post-vaccination with V116 (Day 30) and PCV15 + PPSV23 (Week 12) Up to Week 12
Secondary Serotype-specific geometric mean fold rises (GMFRs) from baseline to post-vaccination with V116 and PCV15 + PPSV2 for OPA responses Serotype-specific GMFRs from baseline (Day 1) to post-vaccination with V116 (Day 30) and from baseline (Day 1) to post=vaccination with PCV15 + PPSV2 (Week 12) for OPA responses Baseline and up to Week 12
Secondary Serotype-specific GMFRs from baseline to post-vaccination with V116 and PCV15 + PPSV2 for Immunoglobulin G (IgG) responses Serotype-specific GMFRs from baseline (Day 1) to post-vaccination with V116 (Day 30) and from baseline (Day 1) to post-vaccination with PCV15 + PPSV23 (Week 12) for IgG responses Baseline and up to Week 12
Secondary Serotype-specific percentage of participants with a =4-fold rise from baseline to post-vaccination with V116 and PCV15 + PPSV2 for OPA responses Serotype-specific percentage of participants with a =4-fold rise from baseline (Day 1) to post-vaccination with V116 (Day 30) and from baseline (Day 1) to post-vaccination with PCV15 + PPSV2 (Week 12) for OPA responses Baseline and up to Week 12
Secondary Serotype-specific percentage of participants with a =4-fold rise from baseline to post-vaccination with V116 and PCV15 + PPS for IgG responsesV2 Serotype-specific proportion of participants with a =4-fold rise from baseline (Day 1) to post-vaccination with V116 (Day 30) and from baseline (Day 1) to post-vaccination with PCV15 + PPSV2 (Week 12) for IgG responses Baseline and up to Week 12
See also
  Status Clinical Trial Phase
Completed NCT02463539 - Residual Anti-pneumococcal Immunity After Pneumococcal Immunization in ANCA-associated Vasculitis N/A
Completed NCT03095326 - Pneumococcal Vaccination for Splenectomised Thalassemia Major Patients in Indonesia Phase 4
Completed NCT02260882 - Revaccination With PNEUMOVAX™ 23 in Older Japanese Adults (V110-902) Phase 4
Completed NCT02572635 - A Phase I Study to Evaluate the Safety and Immunogenicity of PnuBioVax Phase 1
Completed NCT01654263 - A Phase IIb, Open-Label, Dose Ranging Study of 13-Valent Pneumococcal Conjugate Vaccine in Adults 55 Through 74 Years of Age Previously Vaccinated With 23-Valent Pneumococcal Polysaccharide Vaccine Phase 2
Completed NCT01531322 - A Study Assessing 13-valent Pneumococcal Conjugate Vaccine in Healthy Chinese Subjects Phase 1
Completed NCT00496093 - Safety, Tolerability and Immunogenicity of Pneumovax 23 in Healthy Adults in India (V110-011) Phase 3
Completed NCT02062281 - Study of Evaluating Safety and Immunogenicity of 23-Valent Pneumococcal Polysaccharide Vaccine With Influenza Vaccine in Children and Adults Phase 4
Completed NCT00133549 - 9-valent CRM 197 Pneumococcal Phase 2
Completed NCT03467984 - A Study to Evaluate the Safety and Immunogenecity of LBVE(Multivalent Pneumococcal Conjugate Vaccine) in Healthy Infants Phase 2
Active, not recruiting NCT03489018 - The Effect of Fractional Doses of Pneumococcal Conjugate Vaccines on Immunogenicity and Carriage in Kenyan Infants Phase 4
Recruiting NCT02463578 - Immunogenicity of a Combined Anti-pneumococcal Vaccine Schedule in Patients With ANCA-associated Vasculitis N/A
Completed NCT00535730 - ZOSTAVAX™ Administered Concomitantly With PNEUMOVAX™ 23 (V211-012)(COMPLETED) Phase 3
Completed NCT02558751 - Pneumonia Vaccine in Aging HIV Positive Individuals Phase 0
Completed NCT02515240 - Immune Response to Pneumococcal Vaccination in HIV Infected Individuals Phase 0
Completed NCT00560950 - Revaccination With PNEUMOVAX(TM) 23 in Older Adults (V110-007) Phase 3
Completed NCT05425732 - Safety and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults (V116-003, STRIDE-3) Phase 3
Completed NCT03619252 - Pneumococcal Vaccination of Multiple Myeloma Patients on Novel Agents Phase 4
Not yet recruiting NCT03549208 - A Study to Evaluate the Safety and Immunogeneicity of Multivalent Pneumococcal Conjugate Vaccine in Healthy Adults Phase 1
Not yet recruiting NCT03341195 - Mobile Phone SMS Messages and Automated Calls in Improving Vaccine Coverage Among Children in Pakistan N/A