V116 Vaccine for Pneumococcal Disease

(STRIDE-13 Trial)

No longer recruiting at 109 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines a new vaccine, V116, to determine if it matches or surpasses the existing PPSV23 vaccine in boosting the immune response against pneumococcal disease. The focus is on children and teenagers aged 2 to 17 who are at higher risk for this disease, such as those with stable conditions like diabetes or chronic heart or lung issues. Participants must have completed a previous pneumococcal vaccine regimen at least eight weeks before starting the trial to be eligible. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking advancements in vaccine development.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that V116 is generally safe and functions similarly to current vaccines in preventing pneumococcal infections. In studies with adults, V116 effectively prevented serious pneumococcal diseases. Most participants experienced no severe side effects, suggesting the vaccine's safety. While this indicates V116 might also be safe for children and teenagers, further research is needed to confirm this for these age groups. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for pneumococcal disease?

Researchers are excited about V116 because it offers a new approach to protecting against pneumococcal disease. Unlike the standard PPSV23 vaccine, V116 is designed to target a broader range of pneumococcal strains, potentially offering enhanced protection. This expanded coverage is crucial in fighting against the diverse and evolving pneumococcal bacteria, which can cause serious infections. By potentially addressing a wider array of strains, V116 could provide more comprehensive protection than current vaccines.

What evidence suggests that this trial's treatments could be effective for pneumococcal disease?

This trial will compare the V116 vaccine with the PPSV23 vaccine for preventing serious pneumococcal infections. Research has shown that the V116 vaccine, which participants in this trial may receive, could help prevent serious pneumococcal infections, especially in adults. Studies suggest that V116 might work better against these infections than some current vaccines. It is designed to protect against bacteria that can cause serious illnesses like pneumonia. Although the data mainly focuses on adults, the strong immune response from the vaccine suggests it might also be effective for children and teens at high risk for these infections. ^{2 6 7 8 9}

Who Is on the Research Team?

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11582112/

Cost-Effectiveness Analysis of the Use of V116, a 21- ... Based on the inputs and assumptions used, the results indicated that the V116 strategy prevented 27,766 and 32,387 disease cases/deaths and ...

2. merck.com merck.com/news/merck-announces-positive-data-for-v116-an-investigational-21-valent-pneumococcal-conjugate-vaccine-specifically-designed-for-adults/

Merck Announces Positive Data for V116, an ... These positive results show that V116 has the potential to help prevent invasive pneumococcal disease among adult populations.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S147330992400344X

Safety, tolerability, and immunogenicity of an adult ... ... data for the vaccine serotypes, suggest that V116 has the potential to be more effective against adult pneumococcal disease than currently licensed vaccines.

4. nature.com nature.com/articles/s43856-025-01106-z

Cross reactivity within pneumococcal serogroups 6 and 15 ... V116 is a vaccine designed for adults to prevent bacterial infections caused by pneumococcus, such as pneumonia and meningitis. Following ...

5. cdc.gov cdc.gov/mmwr/volumes/74/wr/mm7401a1.htm

Expanded Recommendations for Use of Pneumococcal ... This report describes CDC's updated pneumococcal conjugate vaccine recommendation for all adults aged ≥50 years who are PCV-naïve or who ...

6. cdc.gov cdc.gov/acip/downloads/slides-2024-02-28-29/04-Pneumococcal-Platt-508.pdf

V116 V116 is well-tolerated with a safety profile generally comparable to currently licensed pneumococcal vaccines. V116 is the first adult specific ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40953572/

Safety, tolerability, and immunogenicity of an adult-specific ... Interpretation: V116 was well tolerated and immunogenic for all 21 serotypes, supporting the use of this vaccine in adults living with HIV.

8. academic.oup.com academic.oup.com/cid/article/79/6/1366/7724740

Phase 3 Clinical Study to Evaluate the Safety, Tolerability, and ... V116 is well tolerated with a safety profile comparable to currently licensed pneumococcal vaccines and generates IgG and functional immune ...

9. thelancet.com thelancet.com/journals/laninf/article/PIIS1473-3099(24)00344-X/abstract

Safety, tolerability, and immunogenicity of an adult ... Immune responses successfully immunobridged between younger and older adults for all serotypes in V116. V116 was generally well tolerated with ...