A Clinical Study of the V116 Vaccine for Children and Teenagers (V116-013) (STRIDE-13)

Merck Sharp & Dohme (MSD)

Status and phase: Enrolling; Phase 3

Conditions: Pneumococcal Infection

Treatments: Biological: V116; Biological: PPSV23

Study type: Interventional

Funder types: Industry

Identifiers

NCT06177912

jRCT2031230559 (Registry Identifier)

V116-013 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of V116 compared to PPSV23 in children 2 through 17 years of age. Researchers want to learn if V116 is as good as, or is better than the PPSV23 vaccine in terms of the antibody immune response. V116 and PPSV23 will be studied in children and teenagers who have a higher risk of getting invasive pneumococcal disease (IPD).

Enrollment: 820 estimated patients

Sex: All

Ages: 2 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Has a diagnosis and stable medical management (for at least 3 months) of one of the following risk conditions for pneumococcal disease: Diabetes mellitus, chronic compensated liver disease, chronic lung disease, chronic heart disease, or chronic kidney disease.
• Has completed pneumococcal conjugate vaccine regimen (PCV7, PCV10, or PCV13) at least 8 weeks before study enrollment.

Exclusion criteria

• Has previously received PPSV23 vaccine
• Has a history of active hepatitis within 3 months before study vaccination
• History of invasive pneumococcal disease within 3 years before study vaccination

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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820 participants in 2 patient groups

V116

Experimental group

Description:

Participants will receive a single 0.5 mL intramuscular (IM) injection of V116 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