V116 Vaccine for Pneumococcal Disease

(STRIDE-13 Trial)

Recruiting at 94 trial locations

Overseen By Toll Free Number

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Merck Sharp & Dohme LLC

Disqualifiers: Hepatitis, Pneumococcal disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

882 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

Research Team

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Eligibility Criteria

This trial is for children and teenagers aged 2 to 17 who've finished their pneumococcal conjugate vaccine series. They must have stable chronic conditions like diabetes, liver, lung, heart, or kidney disease for at least three months.

Inclusion Criteria

I have a stable condition like diabetes or heart disease for at least 3 months.

I have completed my pneumococcal vaccine course more than 8 weeks ago.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single 0.5 mL intramuscular injection of either V116 or PPSV23 on Day 1

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after vaccination, including assessment of adverse events and immune response

6 months

Multiple visits (in-person and virtual)

Treatment Details

Interventions

• PPSV23
• V116

Trial Overview The study compares two vaccines: V116 and PPSV23. It aims to see if V116 triggers a better or equal immune response against pneumococcal infections in kids with higher risk of invasive disease.

Participant Groups

Group I: V116 Experimental Treatment 1 Intervention

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

Group II: PPSV23 Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Merck Sharp & Dohme LLC

Lead Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University