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.
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
- Type of treatment
- Vaccines, Injection or infusion
- 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
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
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
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
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
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
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
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
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
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
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
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
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
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
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).
- Conditions
- Pneumococcal Infection
- 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 group | Role | What they receive |
|---|---|---|
| V116 | Experimental | Participants will receive a single 0.5 mL intramuscular (IM) injection of V116 on Day 1 Receives: Biological: V116 |
| PPSV23 | Active comparator | Participants 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.
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
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
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
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)
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
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
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
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
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.
- First posted20 Dec 2023
- Study start18 Jan 2024
- Primary completion26 Feb 2025
- Study completion26 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pneumococcal InfectionStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
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
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf