A Study to Evaluate the Safety, Tolerability, Immunogenicity, and Lot Consistency of V116 in Adults 18 to 49 Years of Age (V116-004, STRIDE-4)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Pneumococcal Disease

Treatments: Biological: PPSV23; Biological: V116

Study type: Interventional

Funder types: Industry

Identifiers

NCT05464420

V116-004

2022-000265-41 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 2,162 patients

Sex: All

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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2,162 participants in 4 patient groups

V116 Lot 1

Experimental group

Description:

Participants will receive a single 0.5 mL intramuscular (IM) dose of V116 Lot 1 on Day 1.

Treatment:

Biological: V116

V116 Lot 2

Experimental group

Description:

Participants will receive a single 0.5 mL IM dose of V116 Lot 2 on Day 1.

Treatment:

Biological: V116

V116 Lot 3

Experimental group

Description:

Participants will receive a single 0.5 mL IM dose of V116 Lot 3 on Day 1.

Treatment:

Biological: V116

PPSV23

Active Comparator group

Description:

Participants will receive a single 0.5 mL IM dose of PPSV23 on Day 1.

Treatment:

Biological: PPSV23