Safety and Immunogenicity of V116 in Adults With Increased Risk for Pneumococcal Disease (V116-008)

NCT05696080 | Completed Phase 3 Results DMC FDA Drug

• 4 other identifiers: V116-008jRCT20612201062022-502791-22-01U1111-1282- 1460
• Study Type: interventional
• Target: 518
• Locations: 8 countries
• Sites: 44

Brief 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.

Conditions

Pneumococcal Infection

Outcome Measures

Primary Outcomes (4)

• Percentage of Participants With Solicited Injection-site Adverse Events (AEs) From Day 1 Through Day 5 Post-vaccination

  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. The percentage of participants with solicited injection-site AEs was assessed following any vaccination. Solicited injection-site AEs consist of the following: pain/tenderness, redness/erythema, and swelling.

  Up to 5 days following each vaccination

• Participants With Solicited Systemic AEs From Day 1 Through Day 5 Post-vaccination

  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. The percentage of participants with solicited systemic AEs was assessed following any vaccination. Solicited systemic AEs consist of the following: fatigue (tiredness), headache, myalgia (muscle aches), and pyrexia (maximum temperature \>= 100.4 °F/38.0 °C).

  Up to 5 days following each vaccination

• Participants With Vaccine-related Serious Adverse Events (SAEs) From Day 1 Through The Duration of Participation in The Study

  A vaccine-related SAE is any untoward medical consequence 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 another important medical event, which is determined by the investigator to be related to the vaccine. The percentage of participants with SAEs was assessed following any vaccination.

  Up to 194 days following Visit 2 (Day 1)

• Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Pneumococcal Serotypes Contained in V116

  The serotype specific OPA GMTs for the pneumococcal serotypes were determined using the multiplex opsonophagocytic assay (MOPA). The point estimate was calculated by exponentiating the estimates of the mean of the natural log values and within-group 95% CIs were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution. The 13 common pneumococcal serotypes in both V116 and PCV15 + PPSV23 were as follows: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 17F, 19A, 20A, 22F, and 33F. The 8 unique pneumococcal serotypes in V116 were as follows: 15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B.

  30 days following V116 [Day 30] for the V116 + Placebo group and 30 days following PPSV23 [Week 12] for the PCV15 + PPSV23 group.

Secondary Outcomes (5)

• Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Pneumococcal Serotypes Contained in V116

  30 days following V116 [Day 30] for the V116 + Placebo group and 30 days following PPSV23 [Week 12] for the PCV15 + PPSV23 group.

• Serotype-specific Geometric Mean Fold Rises (GMFRs) for OPA Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23

  Baseline (Day 1) and postvaccination (30 days following V116 [Day 30] for the V116 + Placebo group and 30 days following PPSV23 [Week 12] for the PCV15 + PPSV23 group)

• Serotype-specific GMFRs for IgG Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23

  Baseline (Day 1) and postvaccination (30 days following V116 [Day 30] for the V116 + Placebo group and 30 days following PPSV23 [Week 12] for the PCV15 + PPSV23 group)

• Percentage of Participants With ≥4-fold Change From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 in Serotype Specific OPA Responses for Pneumococcal Serotypes Contained in V116

  Baseline (Day 1) and postvaccination (30 days following V116 [Day 30] for the V116 + Placebo group and 30 days following PPSV23 [Week 12] for the PCV15 + PPSV23 group)

• Percentage of Participants With ≥4-fold Change From Baseline to Post-Vaccination With V116 and PCV15 + PPSV23 in Serotype Specific IgG Responses for Pneumococcal Serotypes Contained in V116

  Baseline (Day 1) and postvaccination (30 days following V116 [Day 30] for the V116 + Placebo group and 30 days following PPSV23 [Week 12] for the PCV15 + PPSV23 group)

Study Arms (2)

V116 + Placebo

EXPERIMENTAL

Participants administered a single intramuscular (IM) dose of V116 on Day 1, and single IM dose of placebo on Week 8.

Biological: V116; Biological: Placebo

PCV15 + PPSV23

ACTIVE COMPARATOR

Participants administered a single IM dose of PCV15 on Day 1, and a single IM dose of PPSV23 on Week 8.

Biological: PCV15; Biological: PPSV23

Interventions

V116 BIOLOGICAL

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

Also known as: Pneumococcal 21-valent Conjugate Vaccine

V116 + Placebo

Placebo BIOLOGICAL

Saline in each 0.5 mL sterile solution

V116 + Placebo

PCV15 BIOLOGICAL

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

Also known as: VAXNEUVANCE™

PCV15 + PPSV23

PPSV23 BIOLOGICAL

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

Also known as: PNEUMOVAX™23

PCV15 + PPSV23

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (44)

Aventiv Research ( Site 0022)

Mesa, Arizona, 85206, United States

Location

Indago Research & Health Center, Inc ( Site 0002)

Hialeah, Florida, 33012, United States

Location

Triple O Research Institute, P.A ( Site 0011)

West Palm Beach, Florida, 33407, United States

Location

SKY Integrative Medical Center/SKYCRNG ( Site 0012)

Ridgeland, Mississippi, 39157, United States

Location

Mid Hudson Medical Research ( Site 0008)

New Windsor, New York, 12553, United States

Location

Holston Medical Group ( Site 0010)

Kingsport, Tennessee, 37660, United States

Location

EmVenio Research ( Site 0018)

Fort Worth, Texas, 27713, United States

Location

Wenatchee Valley Hospital ( Site 0019)

Wenatchee, Washington, 98801, United States

Location

Holdsworth House Medical Practice ( Site 0402)

Darlinghurst, New South Wales, 2010, Australia

Location

Royal Brisbane and Women's Hospital ( Site 0400)

Brisbane, Queensland, 4029, Australia

Location

G A Research Associates ( Site 0100)

Moncton, New Brunswick, E1G 1A7, Canada

Location

Hamilton Medical Research Group ( Site 0107)

Hamilton, Ontario, L8M 1K7, Canada

Location

Milestone Research Inc. ( Site 0106)

London, Ontario, N5W 6A2, Canada

Location

Manna Research Mirabel ( Site 0105)

Mirabel, Quebec, J7J 2K8, Canada

Location

Clinique de médecine Urbaine du Quartier Latin ( Site 0111)

Montreal, Quebec, H2L 4E9, Canada

Location

Diex Recherche Trois-Rivieres ( Site 0110)

Trois-Rivières, Quebec, G9A 4P3, Canada

Location

Diex Recherche Victoriavile Inc. ( Site 0102)

Victoriaville, Quebec, G6P 6P6, Canada

Location

Centro de Investigación del Maule-Centro de Investigación 2 ( Site 1010)

Talca, Maule Region, 3460000, Chile

Location

Universidad San Sebastian - Providencia ( Site 1003)

Providencia, Region M. de Santiago, 7500000, Chile

Location

Centro de Investigaciones Medicas Respiratorias (CIMER) ( Site 1008)

Santiago, Region M. de Santiago, 7500692, Chile

Location

Centro de Investigacion Clinicadela Universidad Catolica ( Site 1004)

Santiago, Region M. de Santiago, 8330034, Chile

Location

Universidad de Chile - Hospital Clínico Universidad de Chile-Cardiology ( Site 1006)

Santiago, Region M. de Santiago, 8380420, Chile

Location

CESFAM Esmeralda ( Site 1009)

Santiago, Region M. de Santiago, 9340000, Chile

Location

Hospital Dr. Hernán Henríquez Aravena ( Site 1001)

Temuco, Región de la Araucanía, 4781151, Chile

Location

Medical corporation Applied Bio-Pharmatech Kurume Clinical Pharmacology Clinic ( Site 0200)

Kurume, Fukuoka, 830-0011, Japan

Location

Shimonoseki Medical Center ( Site 0201)

Shimonoseki, Yamaguchi, 750-0061, Japan

Location

Pacific Clinical Research Network - Rotorua ( Site 0500)

Rotorua, Bay of Plenty, 3010, New Zealand

Location

P3 Research - Tauranga ( Site 0507)

Tauranga, Bay of Plenty, 3110, New Zealand

Location

CGM Research Trust ( Site 0505)

Christchurch, Canterbury, 8011, New Zealand

Location

Pacific Clinical Research Network - Forte ( Site 0501)

Christchurch, Canterbury, 8013, New Zealand

Location

P3 Research - Lower Hutt ( Site 0508)

Lower Hutt, Wellington Region, 5010, New Zealand

Location

P3 Research - Wellington ( Site 0503)

Wellington, 6021, New Zealand

Location

IN VIVO ( Site 0601)

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-048, Poland

Location

Centrum Medyczne Pratia Bydgoszcz-Centrum Medyczne Pratia Bydgoszcz ( Site 0607)

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796, Poland

Location

MICS Centrum Medyczne Torun ( Site 0606)

Torun, Kuyavian-Pomeranian Voivodeship, 87-100, Poland

Location

Centrum Medyczne Medyk ( Site 0602)

Rzeszów, Podkarpackie Voivodeship, 35-055, Poland

Location

Centrum Medyczne Pratia Katowice ( Site 0604)

Katowice, Silesian Voivodeship, 40-081, Poland

Location

Clinical Medical Research ( Site 0605)

Katowice, Silesian Voivodeship, 40-156, Poland

Location

Clinmedica Research Sp. z. o. o. ( Site 0603)

Skierniewice, Łódź Voivodeship, 96-100, Poland

Location

Hallym University Sacred Heart Hospital ( Site 0303)

Anyang-si, Kyonggi-do, 14068, South Korea

Location

Korea University Anam Hospital ( Site 0305)

Seoul, 02841, South Korea

Location

Seoul National University Hospital ( Site 0300)

Seoul, 03080, South Korea

Location

Konkuk University Medical Center ( Site 0302)

Seoul, 05030, South Korea

Location

Hallym University Kangdong Sacred Heart Hospital ( Site 0301)

Seoul, 05355, South Korea

Location

Related Publications (1)

• Scott PT, Pathirana J, Kato A, Tytus R, Perez CM, Gilchrist NL, Kanou H, Ha Yoo K, Kania G, Nissen M, Russell AF, Fernsler D, Waleed M, Li J, Buchwald UK, Platt HL. A Phase 3, Randomized Trial Investigating the Safety, Tolerability, and Immunogenicity of V116, an Adult-Specific Pneumococcal Conjugate Vaccine, in Pneumococcal Vaccine-Naive Adults 18-64 Years of Age at Increased Risk of Pneumococcal Disease, STRIDE-8. Clin Infect Dis. 2026 Feb 25;82(2):e217-e226. doi: 10.1093/cid/ciaf604.

  PMID: 41208546 RESULT

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Pneumococcal Infections

Interventions

23-valent pneumococcal capsular polysaccharide vaccine

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme LLC

ClinicalTrialsDisclosure@msd.com

1-800-672-6372

Study Officials

• Clinical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2023
• First Posted: January 25, 2023
• Study Start: February 13, 2023
• Primary Completion: February 16, 2024
• Study Completion: February 16, 2024
• Last Updated: March 3, 2026
• Results First Posted: February 26, 2025

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

AU (2); JP (2); CA (7); PL (7); US (8); CL (7); NZ (6); KR (5)