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Pneumococcal InfectionPhase 3STRIDE-13NCT06177912

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

A Phase 3 study testing V116 and PPSV23 in people with Pneumococcal Infection, run by Merck Sharp & Dohme LLC at 92 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of V116 compared to PPSV23 in children and teenagers 2 through 17 years of age, who had completed routine pneumococcal vaccine as infants/toddlers. Read more about this study

Who is it for?
Ages 2 to 17 years
Conditions the study is for
Pneumococcal Infection
What is being tested?
V116 and PPSV23
Could I receive a placebo?
No, everyone receives an active treatment
How many people
882 participants
Where
92 sitesin 13 countries
Study dates
18 Jan 2024to 26 Feb 2025
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • Had a curative procedure/surgery for chronic heart disease and does not require medication, follow-up, additional interventions, or further management per local guidelines.
  • Has a history of active hepatitis within 3 months before study vaccination.
  • Has a history of diabetic ketoacidosis or 2 or more episodes of severe, symptomatic hypoglycemia within 3 months before study vaccination.
  • Has a history of severely decreased kidney function dialysis, autoimmune related chronic kidney disease, nephrotic syndrome of any cause, or an acute/reversible cause of kidney disease.
  • Has a history of severe pulmonary hypertension or history of Eisenmenger syndrome.
  • History of invasive pneumococcal disease within 3 years before study vaccination.

Trial locations and contacts

92 sites in 13 countries.

92 sites in 13 countries

United States29 sites

  • Velocity Clinical Research, Albuquerque ( Site 0112)

    Albuquerque, New Mexico, 87107

  • Velocity Clinical Research, Austin ( Site 0129)

    Austin, Texas, 78759

  • Central Research Associates ( Site 0145)

    Birmingham, Alabama, 35205

  • Bingham Memorial Hospital ( Site 0149)

    Blackfoot, Idaho, 83221

  • PanAmerican Clinical Research ( Site 0132)

    Brownsville, Texas, 78521

  • Epic Medical Research - Oklahoma ( Site 0134)

    Chickasha, Oklahoma, 73018

  • Optumcare Colorado Springs, LLC ( Site 0113)

    Colorado Springs, Colorado, 80922

  • Epic Medical Research ( Site 0133)

    DeSoto, Texas, 75115

  • Tribe Clinical Research, LLC-Pediatrics ( Site 0118)

    Greenville, South Carolina, 29607

  • Velocity Clinical Research, Gulfport ( Site 0115)

    Gulfport, Mississippi, 39503

  • Velocity Clinical Research, Hastings ( Site 0114)

    Hastings, Nebraska, 68901

  • Clinical Research Prime ( Site 0105)

    Idaho Falls, Idaho, 83404

  • Velocity Clinical Research, Lafayette ( Site 0103)

    Lafayette, Louisiana, 70508

  • Alliance for Multispecialty Research, LLC ( Site 0140)

    Layton, Utah, 84041

  • Midwest Children's Health Research Institute ( Site 0117)

    Lincoln, Nebraska, 68504

  • Midwest Children's Health Research Institute ( Site 0106)

    Lincoln, Nebraska, 68505

  • Midwest Children's Health Research Institute-Research ( Site 0119)

    Lincoln, Nebraska, 68516

  • Midwest Children's Health Research Institute-Research ( Site 0102)

    Lincoln, Nebraska, 68522

  • University of Louisville, Norton Children's Research Institute ( Site 0148)

    Louisville, Kentucky, 40202

  • Velocity Clinical Research at Primary Pediatrics, Macon ( Site 0128)

    Macon, Georgia, 31210

  • Madera Family Medical Group ( Site 0120)

    Madera, California, 93637

  • Epic Medical Research - Mesquite ( Site 0144)

    Mesquite, Texas, 75150

  • Accel Research Sites Network- Nona Pediatric Center ( Site 0109)

    Orlando, Florida, 32829

  • Velocity Clinical Research, Phoenix ( Site 0122)

    Phoenix, Arizona, 85006

  • Clinical Research Prime Rexburg ( Site 0104)

    Rexburg, Idaho, 83440

  • Tribe Clinical Research - Spartanburg ( Site 0108)

    Spartanburg, South Carolina, 29301

  • University of South Florida-Department of Pediatrics ( Site 0110)

    Tampa, Florida, 33606

  • Velocity Clinical Research, Vestal ( Site 0121)

    Vestal, New York, 13850

  • Velocity Clinical Research, Salt Lake City ( Site 0124)

    West Jordan, Utah, 84088

Other trials in United States

Japan8 sites

  • Juntendo University Hospital ( Site 1700)

    Bunkyo-ku, Tokyo, 113-8431

  • Aquakids Clinic ( Site 1709)

    Edogawa-ku, Tokyo, 133-0056

  • Okinawa Prefectural Nanbu Medical Center and Children's Medical Center ( Site 1701)

    Kanegusuku, Okinawa, 901-1193

  • Miyazaki Prefectural Miyazaki Hospital ( Site 1711)

    Miyazaki, 880-8510

  • University of Miyazaki Hospital ( Site 1705)

    Miyazaki, 889-1692

  • National Hospital Organization Okayama Medical Center ( Site 1713)

    Okayama, 701-1192

  • Saitama Prefectural Children's Medical Center ( Site 1702)

    Saitama, 330-8777

  • Saiseikai Yokohamashi Tobu Hospital ( Site 1714)

    Yokohama, Kanagawa, 230-0012

Other trials in Japan

Spain8 sites

  • Hospital Germans Trias i Pujol ( Site 1104)

    Badalona, Barcelona, 08916

  • Hospital Universitari Vall d'Hebron ( Site 1115)

    Barcelona, Catalonia, 08035

  • Hospital Sant Joan de Déu ( Site 1113)

    Esplugues de Llobregat, Barcelona, 08950

  • Hospital Universitario Severo Ochoa ( Site 1114)

    Leganés, Madrid, 28911

  • Hospital Universitario La Paz-Pediatria y Enfermedades Infecciosas ( Site 1105)

    Madrid, Madrid, Comunidad de, 28046

  • Hospital Universitario 12 de Octubre-Unidad Pediátrica de Investigación y Ensayos Clínicos ( Site 11

    Madrid, 28041

  • CHUS - Hospital Clinico Universitario-Servicio de Pediatría ( Site 1111)

    Santiago de Compostela, La Coruna, 15706

  • HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO ( Site 1112)

    Seville, 41013

Other trials in Spain

Finland7 sites

  • FVR, Espoon rokotetutkimusklinikka ( Site 0608)

    Espoo, Uusimaa, 02230

  • MeVac - Meilahti Vaccine Research Center ( Site 0609)

    Helsinki, Uusimaa, 00290

  • FVR, Kokkolan rokotetutkimusklinikka ( Site 0602)

    Kokkola, Keski-Pohjanmaa, 67100

  • FVR, Oulun rokotetutkimusklinikka ( Site 0600)

    Oulu, North Ostrobothnia, 90220

  • FVR, Seinäjoen rokotetutkimusklinikka ( Site 0604)

    Seinäjoki, South Ostrobothnia, 60100

  • FVR, Tampereen rokotetutkimusklinikka ( Site 0603)

    Tampere, Pirkanmaa, 33100

  • FVR, Turun rokotetutkimusklinikka ( Site 0606)

    Turku, Southwest Finland, 20520

Other trials in Finland

Turkey (Türkiye)7 sites

  • Hacettepe Universite Hastaneleri ( Site 1300)

    Ankara, 06230

  • Ankara Universitesi Tip Fakultesi Hastanesi ( Site 1304)

    Ankara, 06590

  • Ankara Bilkent Şehir Hastanesi-Infectious Disease and Clinical Microbiology ( Site 1301)

    Ankara, 06800

  • Sisli Etfal Training and Research Hospital ( Site 1305)

    Istanbul, 34360

  • Ege Universitesi Hastanesi ( Site 1306)

    Izmir, 35100

  • Erciyes Universitesi Tıp Fakultesi Hastaneleri-pediatric infection ( Site 1303)

    Kayseri, 38039

  • Çukurova Üniversitesi Tıp Fakültesi Adana Hastanesi-Pediatric Infection ( Site 1302)

    Sarçam, Adana, 01250

Other trials in Turkey (Türkiye)

Canada6 sites

  • Canadian Center for Vaccinology ( Site 0004)

    Halifax, Nova Scotia, B3K6R8

  • Premier Clinical Trial Network ( Site 0008)

    Hamilton, Ontario, L8L 5G4

  • CHU Sainte-Justine ( Site 0007)

    Montreal, Quebec, H3T 1C5

  • Children's Hospital of Eastern Ontario ( Site 0001)

    Ottawa, Ontario, K1H 8L1

  • McGill University Health Centre - Vaccine Study Centre ( Site 0005)

    Pierrefonds, Quebec, H9H 4Y6

  • CHU de Québec-Université Laval ( Site 0006)

    Québec, Quebec, G1E 7G9

Other trials in Canada

Chile5 sites

  • Centro de Estudios Clínicos (ICIM, Facultad de Medicina Clínica Alemana Universidad del Desarrollo)

    Santiago, Region M. de Santiago, 7590943

  • Pontificia Universidad Catolica de Chile-Pediatric Infectious Diseases and Immunology ( Site 0209)

    Santiago, Region M. de Santiago, 8330077

  • Hospital Roberto del Río-Infectología Pediátrica ( Site 0200)

    Santiago, Region M. de Santiago, 8380418

  • Hospital Padre Hurtado-NEONATOLOGY/PEDIATRICS ( Site 0204)

    Santiago, Region M. de Santiago, 8880465

  • Hospital Dr. Hernán Henríquez Aravena ( Site 0208)

    Temuco, Araucania, 4781151

Other trials in Chile

Poland5 sites

  • IN VIVO ( Site 1006)

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-048

  • Centrum Medyczne Pratia Bydgoszcz ( Site 1004)

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796

  • Gravita Diagnostyka i Leczenie Niepłodności ( Site 1005)

    Lodz, Łódź Voivodeship, 91-347

  • SZPZOZ im. Dzieci Warszawy w Dziekanowie Lesnym ( Site 1007)

    Łomianki, Masovian Voivodeship, 05-092

  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckieg-Klinika Pediatrii i Chorob Infekcyjnyc

    Wroclaw, Lower Silesian Voivodeship, 50-368

Other trials in Poland

Colombia4 sites

  • Fundación Valle del Lili ( Site 0404)

    Cali, Valle del Cauca Department, 760032

  • CEIP - Centro de Estudios en Infectología Pediátrica ( Site 0401)

    Cali, Valle del Cauca Department, 760042

  • Oncomedica S.A.S ( Site 0402)

    Montería, Departamento de Córdoba, 230001

  • Clinica Somer ( Site 0405)

    Rionegro, Antioquia, 054040

Other trials in Colombia

Thailand4 sites

  • Faculty of Medicine Siriraj Hospital-Pediatric Infectious Diseases ( Site 1601)

    Bangkoknoi, Bangkok, 10700

  • Songklanagarind hospital-Department of Pediatrics ( Site 1603)

    Hat Yai, Changwat Songkhla, 90110

  • Chulalongkorn University-Pediatrics ( Site 1602)

    Pathumwan, Bangkok, 10330

  • Faculty of Tropical Medicine, Mahidol University - Vaccine Trial Centre ( Site 1604)

    Ratchathewi, Bangkok, 10400

Other trials in Thailand

France3 sites

  • Centre Hospitalier Universitaire de Caen - Hôpital Côte de N-Centre de Recherche Clinique Pédiatriq

    Caen, Calvados, 14033

  • Hôpital Jeanne de Flandre ( Site 0702)

    Lille, Nord, 59037

  • Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Robert Debre - Centre Hospitalo Universita

    Paris, 75019

Other trials in France

Israel3 sites

  • Rambam Health Care Campus ( Site 0900)

    Haifa, 3109601

  • Hadassah Mount Scopus Medical Centre ( Site 0902)

    Jerusalem, 9124001

  • Schneider Children's Medical Center ( Site 0903)

    Petah Tikva, 4920235

Other trials in Israel

Sweden3 sites

  • CTC GoCo ( Site 1202)

    Mölndal, Västra Götaland County, 431 53

  • CTC Karolinska ( Site 1201)

    Solna, Stockholm County, 171 64

  • Norrlands universitetssjukhus ( Site 1200)

    Umeå, Västerbotten County, 901 85

Other trials in Sweden

About this study

Official title: A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Children and Adolescents With Increased Risk of Pneumococcal Disease

The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of V116 compared to PPSV23 in children and teenagers 2 through 17 years of age, who had completed routine pneumococcal vaccine as infants/toddlers. 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 pneumococcal disease (PD).

Being tested
V116, PPSV23
Medical subject headings
Pneumococcal Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • V116Biological

    Also called Pneumococcal 21-valent Conjugate Vaccine

    Pneumococcal 21-valent conjugate vaccine with 4 μg of each of the following pneumococcal polysaccharides (PnPs) antigen: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B in each 0.5 mL sterile solution

  • PPSV23Biological

    Also called PNEUMOVAX™23

    Pneumococcal 23-valent conjugate vaccine with 25 μg of each of the following PnPs antigen: 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F in each 0.5 mL sterile solution

Study groups in NCT06177912
Study groupRoleWhat they receive
V116ExperimentalParticipants will receive a single 0.5 mL intramuscular (IM) injection of V116 on Day 1
Receives: Biological: V116
PPSV23Active comparatorParticipants will receive a single 0.5 mL IM dose of PPSV23 on Day 1.
Receives: Biological: PPSV23

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Solicited Injection-site Adverse Events (AEs)

    An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs included pain/tenderness, redness/erythema, and swelling.

    Measured: Up to 5 days postvaccination

  2. Percentage of Participants With Solicited Systemic AEs

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited systemic AEs included muscle aches all over the body (myalgia), headache, tiredness (fatigue), hives or welts (urticaria), irritability, joint pain (arthralgia), drowsiness (somnolence), feeling sick (malaise), and fever (pyrexia).

    Measured: Up to 5 days post vaccination

  3. Percentage of Participants With Vaccine-related Serious Adverse Events (SAEs)

    A vaccine-related SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event.

    Measured: Up to approximately 6 months

  4. Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Responses

    Opsonophagocytic activity (OPA) for the serotypes in V116 will be determined using a multiplexed opsonophagocytic assay (MOPA). Serotype-specific OPA GMTs and GMT ratios with 95% confidence intervals (CIs) were calculated using a constrained longitudinal data analysis (cLDA) model. The 12 common pneumococcal serotypes in both V116 and PPSV23 were as follows: 3, 7F, 8, 9N, 10A, 11A, 12F, 17F, 19A, 20A, 22F, and 33F. The 9 unique pneumococcal serotypes in V116 were as follows: 6A, 15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B.

    Measured: 30 days postvaccination

Secondary outcomes (5)

  1. Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) After Vaccination

    The GMCs for serotype-specific IgG antibodies will be determined using pneumococcal electrochemiluminescence (PnECL). Serotype-specific IgGs and GMC ratios with 95% CIs were calculated using a cLDA model. The 12 common pneumococcal serotypes in both V116 and PPSV23 were as follows: 3, 7F, 8, 9N, 10A, 11A, 12F, 17F, 19A, 20A, 22F, and 33F. The 9 unique pneumococcal serotypes in V116 were as follows: 6A, 15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B.

    Measured: 30 days postvaccination

  2. Geometric Mean Fold Rise (GMFR) From Baseline in Serotype-specific OPA GMTs

    The GMFR from baseline in serotype-specific OPA GMTs was determined using MOPA at baseline and 30 days postvaccination and derived from a cLDA model. The GMFR (Day 30 GMT/Day 1 GMT) from baseline (Day 1) to Day 30 of each pneumococcal OPA serotype was calculated. The 12 common pneumococcal serotypes in both V116 and PPSV23 were as follows: 3, 7F, 8, 9N, 10A, 11A, 12F, 17F, 19A, 20A, 22F, and 33F. The 9 unique pneumococcal serotypes in V116 were as follows: 6A, 15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B.

    Measured: Baseline (Day 1) and 30 days postvaccination

  3. Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPAs GMTs

    The percentage of participants with ≥4-fold rise from baseline (Day 1) to Day 30 in GMTs of each pneumococcal serotype was calculated. Titer levels were determined by the MOPA and derived from a cLDA model. The 12 common pneumococcal serotypes in both V116 and PPSV23 were as follows: 3, 7F, 8, 9N, 10A, 11A, 12F, 17F, 19A, 20A, 22F, and 33F. The 9 unique pneumococcal serotypes in V116 were as follows: 6A, 15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B.

    Measured: Baseline (Day 1) and Day 30 postvaccination

  4. GMFR From Baseline in Serotype-specific IgG GMCs

    The GMFR from baseline in serotype-specific IgG GMCs was determined using PnECL at baseline and 30 days postvaccination and derived from a cLDA model. The GMFR (Day 30 GMT/Day 1 GMT) from baseline (Day 1) to Day 30 of each pneumococcal IgG serotype was calculated. The 12 common pneumococcal serotypes in both V116 and PPSV23 were as follows: 3, 7F, 8, 9N, 10A, 11A, 12F, 17F, 19A, 20A, 22F, and 33F.

    Measured: Baseline (Day 1) and Day 30 postvaccination

  5. Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs

    The percentage of participants with ≥4-fold rise from baseline (Day 1) to Day 30 in GMCs of each pneumococcal serotype was calculated. Titer levels were determined by PnECL and derived from a cLDA model. The 12 common pneumococcal serotypes in both V116 and PPSV23 were as follows: 3, 7F, 8, 9N, 10A, 11A, 12F, 17F, 19A, 20A, 22F, and 33F. The 9 unique pneumococcal serotypes in V116 were as follows: 6A, 15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B.

    Measured: Baseline (Day 1) and Day 30 postvaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Dec 2023
  2. Study start18 Jan 2024
  3. Primary completion26 Feb 2025
  4. Study completion26 Feb 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
882 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06177912
Sponsor's protocol ID
V116-013
Other IDs
V116-013, jRCT2031230559, 2023-506236-32, U1111-1293-4944, 2023
Acronym
STRIDE-13
Status last verified
Mar 2026
First submitted
11 Dec 2023
Last updated
11 Mar 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing V116 and PPSV23 in people with Pneumococcal Infection, run by Merck Sharp & Dohme LLC at 92 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 92 sites in United States, Japan, Spain, Finland, Turkey (Türkiye) and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Solicited Injection-site Adverse Events (AEs) (time frame: Up to 5 days postvaccination). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06177912.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.

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