A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-experienced Adults (V116-006, STRIDE-6)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Pneumonia, Pneumococcal

Treatments: Biological: PCV15; Biological: V116; Biological: PPSV23

Study type: Interventional

Funder types: Industry

Identifiers

NCT05420961

2021-006679-41 (EudraCT Number)

jRCT2071220025 (Registry Identifier)

V116-006

Details and patient eligibility

About

This a study of V116 in adults ≥50 years of age who previously received a pneumococcal vaccination ≥1 year before enrollment. The primary objectives of this study are to evaluate the safety, tolerability, and immunogenicity of V116.

Full description

Participants will be randomized to 1 of 3 cohorts depending upon prior vaccinations. Prior vaccinations by cohort include: PPSV23 (pneumococcal vaccine, polyvalent [23-valent], PNEUMOVAX™23) for Cohort 1; PCV13 (pneumococcal 13-valent conjugate vaccine; PREVNAR 13™) for Cohort 2; PCV15 (pneumococcal 15-valent conjugate vaccine; VAXNEUVANCE™), PCV20 (pneumococcal 20-valent conjugate vaccine; PREVNAR 20™), PCV13+PPSV23, PCV15+PPSV23, or PPSV23+PCV13 for Cohort 3.

Enrollment: 717 patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

The main inclusion and exclusion criteria include but are not limited to the following:

Inclusion Criteria:

• Has received pneumococcal vaccine >= 1 year before enrollment (PCV13, PCV15, PCV20, PPSV23, PCV13+PPSV23, PPSV23+PCV13, or PCV15+PPSV23).

Exclusion Criteria:

• Has a history of invasive pneumococcal disease (IPD).
• Has a known hypersensitivity to any component of V116, PCV15, PCV20, 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 intramuscular vaccination.
• Has a known malignancy that is progressing or has required active treatment.
• Has received PPSV23 followed by either PCV15 or PCV20.
• Received systemic corticosteroids (prednisone equivalent of ≥20 mg/day).
• 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 any study vaccine.
• Has 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.
• Has 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 post-vaccination blood draw is complete.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

717 participants in 5 patient groups

Cohort 1: V116

Experimental group

Description:

Participants will receive a single 0.5 mL intramuscular (IM) injection of V116 on Day 1. Participants in this arm received PPSV23 prior to the enrollment.

Treatment:

Biological: V116

Cohort 1: PCV15

Active Comparator group

Description:

Participants will receive a single 0.5 mL IM injection of PCV15 on Day 1. Participants in this arm received PPSV23 prior to the enrollment.

Treatment:

Biological: PCV15

Cohort 2: V116

Experimental group

Description:

Participants will receive a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV13 prior to the enrollment.

Treatment:

Biological: V116

Cohort 2: PPSV23

Active Comparator group

Description:

Participants will receive a single 0.5 mL IM injection of PPSV23 on Day 1. Participants in this arm received PCV13 prior to the enrollment.

Treatment:

Biological: PPSV23

Cohort 3: V116

Experimental group

Description:

Participants will receive a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV15, PCV20, PCV13+PPSV23, PCV15+PPSV23, or PPSV23+PCV13 prior to the enrollment.

Treatment:

Biological: V116