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CompletedNCT06177912STRIDE-13Updated Mar 11, 2026Results posted

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

A Phase 3 interventional study of V116 and PPSV23 in Pneumococcal Infection, sponsored by Merck Sharp & Dohme LLC. Completed at 92 sites in 13 countries. Open to participants aged 2 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-03-11.

Sponsored by Merck Sharp & Dohme LLC · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
882
Allocation
Randomized
Ages
2 Years to 17 Years
Sex
All
01

Study 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. 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).

02

Conditions studied

  • Pneumococcal Infection
03

In context

Pneumococcal Infections

281 studies on the registry are indexed under Pneumococcal Infections; 27 are open to participants now.

This study's enrollment of 882 is above the median of 379 across 230 interventional studies indexed under Pneumococcal Infections.

Browse Pneumococcal Infections studies →

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.

Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
882 participants (actual)

Study arms

  • Experimental
    V116

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

    Biological: V116

  • Active comparator
    PPSV23

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

    Biological: PPSV23

Interventions

  • BiologicalV116

    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

    Also known as: Pneumococcal 21-valent Conjugate Vaccine

  • BiologicalPPSV23

    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

    Also known as: PNEUMOVAX™23

06

What researchers measure

Primary outcomes

  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.

    Time frame: 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).

    Time frame: 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.

    Time frame: 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.

    Time frame: 30 days postvaccination

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: Baseline (Day 1) and Day 30 postvaccination

07

Results

Posted Mar 11, 2026

Participant flow

Participant flow — Overall Study
MilestoneV116PPSV23
Started531351
Vaccinated528348
Safety analysis population527347
Completed522345
Not completed96
Withdrew: Death02
Withdrew: Lost to follow-up20
Withdrew: Randomized by mistake without study treatment11
Withdrew: Withdrawal by parent/guardian53
Withdrew: Randomized by mistake with study treatment10

Outcome measures

PrimaryPercentage 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.

Time frame:
Up to 5 days postvaccination
Reported as:
Number · Percentage of Participants
Percentage of Participants With Solicited Injection-site Adverse Events (AEs)
Percentage of ParticipantsV116PPSV23
Injection site erythema24.316.4
Injection site pain67.754.5
Injection site swelling18.818.2
Statistical analysis
  • V116 vs PPSV23 · Difference in percentage: 7.9 · 95% CI 2.4 to 13.1
  • V116 vs PPSV23 · Difference in percentage: 13.3 · 95% CI 6.7 to 19.8
  • V116 vs PPSV23 · Difference in percentage: 0.6 · 95% CI -4.8 to 5.8
PrimaryPercentage 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).

Time frame:
Up to 5 days post vaccination
Reported as:
Number · Percentage of Participants
Percentage of Participants With Solicited Systemic AEs
Percentage of ParticipantsV116PPSV23
Arthralgia4.45.5
Fatigue20.121.0
Headache17.115.3
Irritability11.611.0
Malaise13.39.2
Myalgia6.35.2
Pyrexia4.65.8
Somnolence9.59.2
Urticaria2.71.7
Statistical analysis
  • V116 vs PPSV23 · Difference in percentage: -1.1 · 95% CI -4.4 to 1.8
  • V116 vs PPSV23 · Difference in percentage: -0.9 · 95% CI -6.5 to 4.5
  • V116 vs PPSV23 · Difference in percentage: 1.8 · 95% CI -3.3 to 6.7
  • V116 vs PPSV23 · Difference in percentage: 0.6 · 95% CI -3.8 to 4.8
  • V116 vs PPSV23 · Difference in percentage: 4.1 · 95% CI -0.3 to 8.2
  • V116 vs PPSV23 · Difference in percentage: 1.1 · 95% CI -2.3 to 4.2
  • V116 vs PPSV23 · Difference in percentage: -1.2 · 95% CI -4.5 to 1.7
  • V116 vs PPSV23 · Difference in percentage: 0.3 · 95% CI -3.9 to 4.1
  • V116 vs PPSV23 · Difference in percentage: 0.9 · 95% CI -1.3 to 2.9
PrimaryPercentage 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.

Time frame:
Up to approximately 6 months
Reported as:
Number · Percentage of Participants
Percentage of Participants With Vaccine-related Serious Adverse Events (SAEs)
Percentage of ParticipantsV116PPSV23
Percentage of Participants With Vaccine-related Serious Adverse Events (SAEs)0.20.6
Statistical analysis
  • V116 vs PPSV23 · Difference in percentage: -0.4 · 95% CI -1.9 to 0.6
PrimaryGeometric 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.

Time frame:
30 days postvaccination
Reported as:
Geometric mean · Titers
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Responses
TitersV116PPSV23
Serotype 3526.6 (NA to NA)517.0 (NA to NA)
Serotype 7F20618.1 (NA to NA)14207.2 (NA to NA)
Serotype 812294.5 (NA to NA)8966.9 (NA to NA)
Serotype 9N35556.8 (NA to NA)18587.8 (NA to NA)
Serotype 10A13719.7 (NA to NA)5363.8 (NA to NA)
Serotype 11A10396.3 (NA to NA)3129.8 (NA to NA)
Serotype 12F14752.0 (NA to NA)4820.1 (NA to NA)
Serotype 17F40011.8 (NA to NA)11267.4 (NA to NA)
Serotype 19A9009.8 (NA to NA)9797.6 (NA to NA)
Serotype 20A37532.2 (NA to NA)14787.0 (NA to NA)
Serotype 22F20162.7 (NA to NA)7770.3 (NA to NA)
Serotype 33F73201.8 (NA to NA)40609.0 (NA to NA)
Serotype 6A16910.9 (NA to NA)5653.8 (NA to NA)
Serotype 15A69527.8 (NA to NA)5332.2 (NA to NA)
Serotype 15C34539.1 (NA to NA)4398.4 (NA to NA)
Serotype 16F31544.9 (NA to NA)5449.7 (NA to NA)
Serotype 23A28591.7 (NA to NA)4882.0 (NA to NA)
Serotype 23B5988.2 (NA to NA)370.5 (NA to NA)
Serotype 24F11102.2 (NA to NA)2771.8 (NA to NA)
Serotype 3146163.7 (NA to NA)2563.0 (NA to NA)
Serotype 35B40102.8 (NA to NA)7812.5 (NA to NA)
Statistical analysis
  • V116 vs PPSV23 · cLDA model · p = < 0.001 (P-value is estimated from a cLDA model.) · Gmt ratio: 1.02 · 95% CI 0.89 to 1.17
  • V116 vs PPSV23 · cLDA model · p = < 0.001 (P-value is estimated from a cLDA model.) · Gmt ratio: 1.45 · 95% CI 1.24 to 1.70
  • V116 vs PPSV23 · cLDA model · p = < 0.001 (P-value is estimated from a cLDA model.) · Gmt ratio: 1.37 · 95% CI 1.20 to 1.56
  • V116 vs PPSV23 · cLDA model · p = < 0.001 (P-value is estimated from a cLDA model.) · Gmt ratio: 1.91 · 95% CI 1.64 to 2.23
  • V116 vs PPSV23 · cLDA model · p = < 0.001 (P-value is estimated from a cLDA model.) · Gmt ratio: 2.56 · 95% CI 2.18 to 3.00
  • V116 vs PPSV23 · cLDA model · p = < 0.001 (P-value is estimated from a cLDA model.) · Gmt ratio: 3.32 · 95% CI 2.80 to 3.95
  • V116 vs PPSV23 · cLDA model · p = < 0.001 (P-value is estimated from a cLDA model.) · Gmt ratio: 3.06 · 95% CI 2.62 to 3.58
  • V116 vs PPSV23 · cLDA model · p = < 0.001 (P-value is estimated from a cLDA model.) · Gmt ratio: 3.55 · 95% CI 3.02 to 4.17
  • V116 vs PPSV23 · cLDA model · p = < 0.001 · Gmt ratio: 0.92 · 95% CI 0.78 to 1.08
  • V116 vs PPSV23 · cLDA model · p = < 0.001 · Gmt ratio: 2.54 · 95% CI 2.13 to 3.02
  • V116 vs PPSV23 · cLDA model · p = < 0.001 · Gmt ratio: 2.59 · 95% CI 2.21 to 3.04
  • V116 vs PPSV23 · cLDA model · p = < 0.001 · Gmt ratio: 1.80 · 95% CI 1.54 to 2.11
  • V116 vs PPSV23 · cLDA model · p = < 0.001 · Gmt ratio: 2.99 · 95% CI 2.46 to 3.64
  • V116 vs PPSV23 · cLDA model · p = < 0.001 · Gmt ratio: 13.04 · 95% CI 11.13 to 15.27
  • V116 vs PPSV23 · cLDA model · p = < 0.001 · Gmt ratio: 7.85 · 95% CI 6.29 to 9.81
  • V116 vs PPSV23 · cLDA model · p = < 0.001 · Gmt ratio: 5.79 · 95% CI 5.01 to 6.69
  • V116 vs PPSV23 · cLDA model · p = < 0.001 · Gmt ratio: 5.86 · 95% CI 4.88 to 7.03
  • V116 vs PPSV23 · cLDA model · p = < 0.001 · Gmt ratio: 16.16 · 95% CI 12.03 to 21.72
  • V116 vs PPSV23 · cLDA model · p = < 0.001 · Gmt ratio: 4.01 · 95% CI 3.40 to 4.72
  • V116 vs PPSV23 · cLDA model · p = < 0.001 · Gmt ratio: 18.01 · 95% CI 15.09 to 21.50
  • V116 vs PPSV23 · cLDA model · p = < 0.001 · Gmt ratio: 5.13 · 95% CI 4.45 to 5.93
SecondaryGeometric 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.

Time frame:
30 days postvaccination
Reported as:
Geometric mean · μg/mL
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) After Vaccination
μg/mLV116PPSV23
Serotype 31.56 (NA to NA)1.88 (NA to NA)
Serotype 7F7.33 (NA to NA)7.37 (NA to NA)
Serotype 813.68 (NA to NA)17.86 (NA to NA)
Serotype 9N7.11 (NA to NA)9.41 (NA to NA)
Serotype 10A8.47 (NA to NA)4.69 (NA to NA)
Serotype 11A7.47 (NA to NA)4.32 (NA to NA)
Serotype 12F1.78 (NA to NA)1.38 (NA to NA)
Serotype 17F14.75 (NA to NA)6.13 (NA to NA)
Serotype 19A13.50 (NA to NA)15.97 (NA to NA)
Serotype 20A9.09 (NA to NA)5.75 (NA to NA)
Serotype 22F14.20 (NA to NA)10.23 (NA to NA)
Serotype 33F6.75 (NA to NA)9.34 (NA to NA)
Serotype 6A11.98 (NA to NA)6.25 (NA to NA)
Serotype 15A12.00 (NA to NA)1.24 (NA to NA)
Serotype 15C13.54 (NA to NA)2.55 (NA to NA)
Serotype 16F2.35 (NA to NA)0.18 (NA to NA)
Serotype 23A7.17 (NA to NA)1.05 (NA to NA)
Serotype 23B6.47 (NA to NA)1.29 (NA to NA)
Serotype 24F2.39 (NA to NA)0.22 (NA to NA)
Serotype 314.67 (NA to NA)0.27 (NA to NA)
Serotype 35B8.96 (NA to NA)0.89 (NA to NA)
Statistical analysis
  • V116 vs PPSV23 · Gmc ratio: 0.83 · 95% CI 0.72 to 0.95
  • V116 vs PPSV23 · Gmc ratio: 0.99 · 95% CI 0.86 to 1.15
  • V116 vs PPSV23 · Gmc ratio: 0.77 · 95% CI 0.67 to 0.87
  • V116 vs PPSV23 · Gmc ratio: 0.76 · 95% CI 0.65 to 0.88
  • V116 vs PPSV23 · Gmc ratio: 1.81 · 95% CI 1.50 to 2.17
  • V116 vs PPSV23 · Gmc ratio: 1.73 · 95% CI 1.49 to 2.01
  • V116 vs PPSV23 · Gmc ratio: 1.28 · 95% CI 1.07 to 1.54
  • V116 vs PPSV23 · Gmc ratio: 2.41 · 95% CI 2.06 to 2.81
  • V116 vs PPSV23 · Gmc ratio: 0.85 · 95% CI 0.71 to 1.00
  • V116 vs PPSV23 · Gmc ratio: 1.58 · 95% CI 1.34 to 1.87
  • V116 vs PPSV23 · Gmc ratio: 1.39 · 95% CI 1.17 to 1.64
  • V116 vs PPSV23 · Gmc ratio: 0.72 · 95% CI 0.61 to 0.85
  • V116 vs PPSV23 · Gmc ratio: 1.92 · 95% CI 1.59 to 2.31
  • V116 vs PPSV23 · Gma ratio: 9.67 · 95% CI 8.07 to 11.60
  • V116 vs PPSV23 · Gmc ratio: 5.32 · 95% CI 4.35 to 6.50
  • V116 vs PPSV23 · Gmc ratio: 12.97 · 95% CI 11.04 to 15.24
  • V116 vs PPSV23 · Gmc ratio: 6.84 · 95% CI 5.56 to 8.43
  • V116 vs PPSV23 · Gmc ratio: 5.03 · 95% CI 4.18 to 6.04
  • V116 vs PPSV23 · Gmc ratio: 10.72 · 95% CI 8.83 to 13.01
  • V116 vs PPSV23 · Gmc ratio: 17.38 · 95% CI 14.92 to 20.24
  • V116 vs PPSV23 · Gmc ratio: 10.10 · 95% CI 8.72 to 11.70
SecondaryGeometric 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.

Time frame:
Baseline (Day 1) and 30 days postvaccination
Reported as:
Geometric mean · Ratio
Geometric Mean Fold Rise (GMFR) From Baseline in Serotype-specific OPA GMTs
RatioV116PPSV23
Serotype 37.9 (6.8 to 9.1)7.6 (6.4 to 9.0)
Serotype 7F15.8 (13.7 to 18.3)10.5 (9.0 to 12.4)
Serotype 830.5 (25.9 to 36.0)21.7 (17.8 to 26.4)
Serotype 9N13.9 (12.1 to 15.9)8.0 (6.8 to 9.3)
Serotype 10A15.4 (12.5 to 19.0)6.0 (4.7 to 7.5)
Serotype 11A18.6 (14.9 to 23.4)5.9 (4.5 to 7.8)
Serotype 12F452.7 (378.6 to 541.4)149.3 (122.1 to 182.6)
Serotype 17F33.3 (28.3 to 39.2)9.9 (8.2 to 11.8)
Serotype 19A6.6 (5.6 to 7.7)7.2 (6.1 to 8.7)
Serotype 20A10.4 (9.0 to 12.0)4.1 (3.5 to 4.9)
Serotype 22F22.2 (18.3 to 26.8)8.4 (6.8 to 10.3)
Serotype 33F18.2 (16.1 to 20.5)10.0 (8.6 to 11.6)
Serotype 6A22.1 (17.8 to 27.4)7.1 (5.6 to 9.0)
Serotype 15A26.6 (23.3 to 30.4)2.0 (1.8 to 2.3)
Serotype 15C124.5 (95.0 to 163.3)13.4 (10.2 to 17.7)
Serotype 16F7.6 (6.7 to 8.6)1.5 (1.3 to 1.6)
Serotype 23A14.2 (11.7 to 17.2)2.2 (1.8 to 2.7)
Serotype 23B92.9 (70.3 to 122.8)6.2 (4.5 to 8.4)
Serotype 24F4.4 (3.8 to 5.1)1.1 (0.9 to 1.3)
Serotype 3128.8 (24.1 to 34.4)1.6 (1.3 to 1.8)
Serotype 35B6.0 (5.3 to 6.8)1.3 (1.2 to 1.4)
SecondaryPercentage 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.

Time frame:
Baseline (Day 1) and Day 30 postvaccination
Reported as:
Number · Percentage of Participants
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPAs GMTs
Percentage of ParticipantsV116PPSV23
Serotype 364.6 (59.8 to 69.3)66.1 (60.1 to 71.6)
Serotype 7F84.2 (80.3 to 87.5)79.7 (74.4 to 84.3)
Serotype 892.3 (89.2 to 94.8)90.6 (86.3 to 93.9)
Serotype 9N82.8 (78.8 to 86.3)71.7 (65.9 to 77.0)
Serotype 10A73.5 (68.7 to 77.9)47.5 (41.2 to 53.8)
Serotype 11A76.2 (71.7 to 80.4)46.2 (39.9 to 52.6)
Serotype 12F96.7 (94.5 to 98.2)96.0 (93.0 to 98.0)
Serotype 17F92.4 (89.3 to 94.8)74.0 (68.2 to 79.3)
Serotype 19A57.8 (52.9 to 62.7)64.0 (58.0 to 69.7)
Serotype 20A77.8 (73.2 to 82.0)48.0 (41.8 to 54.4)
Serotype 22F84.1 (80.1 to 87.5)65.3 (59.2 to 71.0)
Serotype 33F88.9 (85.5 to 91.8)74.2 (68.5 to 79.3)
Serotype 6A76.3 (71.7 to 80.5)55.7 (49.2 to 62.0)
Serotype 15A91.3 (88.0 to 93.8)22.8 (17.9 to 28.3)
Serotype 15C90.7 (87.2 to 93.5)68.9 (62.6 to 74.7)
Serotype 16F67.5 (62.7 to 72.1)13.5 (9.6 to 18.3)
Serotype 23A75.2 (70.2 to 79.8)27.4 (21.6 to 33.8)
Serotype 23B78.2 (73.8 to 82.2)42.7 (36.4 to 49.2)
Serotype 24F47.6 (42.3 to 52.9)7.9 (4.7 to 12.4)
Serotype 3189.9 (86.4 to 92.7)13.6 (9.6 to 18.5)
Serotype 35B60.7 (55.7 to 65.6)7.8 (4.8 to 11.8)
SecondaryGMFR 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.

Time frame:
Baseline (Day 1) and Day 30 postvaccination
Reported as:
Geometric mean · Ratio
GMFR From Baseline in Serotype-specific IgG GMCs
RatioV116PPSV23
Serotype 35.8 (5.0 to 6.6)6.6 (5.5 to 7.9)
Serotype 7F23.0 (20.4 to 26.0)23.3 (20.2 to 26.9)
Serotype 834.5 (30.4 to 39.1)40.5 (34.4 to 47.7)
Serotype 9N22.5 (19.5 to 26.0)31.5 (26.4 to 37.7)
Serotype 10A20.4 (17.9 to 23.2)12.3 (10.3 to 14.8)
Serotype 11A13.7 (11.7 to 16.0)7.5 (6.2 to 8.9)
Serotype 12F22.6 (20.1 to 25.3)17.5 (14.8 to 20.6)
Serotype 17F41.6 (36.6 to 47.4)16.7 (14.2 to 19.7)
Serotype 19A8.1 (6.9 to 9.5)9.3 (7.5 to 11.4)
Serotype 20A11.4 (10.1 to 12.9)7.1 (6.1 to 8.3)
Serotype 22F41.8 (34.7 to 50.4)35.7 (28.5 to 44.8)
Serotype 33F19.9 (17.7 to 22.3)26.3 (22.1 to 31.2)
Serotype 6A25.9 (21.7 to 31.0)13.1 (10.8 to 15.9)
Serotype 15A32.0 (27.8 to 36.9)3.3 (2.8 to 3.9)
Serotype 15C42.4 (36.8 to 48.9)7.4 (6.2 to 9.0)
Serotype 16F15.4 (13.6 to 17.5)1.4 (1.2 to 1.5)
Serotype 23A28.8 (24.8 to 33.5)4.1 (3.4 to 4.8)
Serotype 23B18.3 (15.3 to 21.9)3.4 (2.9 to 4.1)
Serotype 24F12.6 (10.8 to 14.7)1.1 (1.0 to 1.2)
Serotype 3125.3 (22.4 to 28.6)1.5 (1.4 to 1.7)
Serotype 35B10.1 (8.8 to 11.5)1.0 (1.0 to 1.1)
SecondaryPercentage 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.

Time frame:
Baseline (Day 1) and Day 30 postvaccination
Reported as:
Number · Percentage of Participants
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs
Percentage of ParticipantsV116PPSV23
Serotype 359.3 (54.1 to 64.5)62.2 (55.6 to 68.5)
Serotype 7F92.5 (89.2 to 95.0)97.4 (94.4 to 99.0)
Serotype 894.4 (91.5 to 96.6)94.8 (91.1 to 97.3)
Serotype 9N88.0 (84.2 to 91.2)92.2 (87.9 to 95.3)
Serotype 10A88.0 (84.2 to 91.2)80.9 (75.2 to 85.7)
Serotype 11A77.2 (72.5 to 81.4)63.9 (57.3 to 70.1)
Serotype 12F93.3 (90.2 to 95.7)88.7 (83.9 to 92.5)
Serotype 17F95.5 (92.8 to 97.4)87.4 (82.4 to 91.4)
Serotype 19A63.8 (58.6 to 68.8)67.0 (60.5 to 73.0)
Serotype 20A78.8 (74.2 to 82.9)66.1 (59.6 to 72.2)
Serotype 22F85.5 (81.4 to 89.0)87.0 (81.9 to 91.0)
Serotype 33F91.1 (87.6 to 93.8)91.3 (86.9 to 94.6)
Serotype 6A83.8 (79.6 to 87.5)76.5 (70.5 to 81.8)
Serotype 15A92.8 (89.6 to 95.2)37.4 (31.1 to 44.0)
Serotype 15C94.2 (91.2 to 96.3)63.9 (57.3 to 70.1)
Serotype 16F85.8 (81.7 to 89.2)7.0 (4.0 to 11.1)
Serotype 23A89.4 (85.8 to 92.4)43.9 (37.4 to 50.6)
Serotype 23B76.0 (71.3 to 80.4)39.6 (33.2 to 46.2)
Serotype 24F75.2 (70.4 to 79.6)3.0 (1.2 to 6.2)
Serotype 3193.3 (90.2 to 95.7)7.4 (4.4 to 11.6)
Serotype 35B76.6 (71.9 to 80.9)0.9 (0.1 to 3.1)

Adverse events

Collected over Up to approximately 6 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
V1160/531 (0%)29/527 (5.5%)408/527 (77.4%)
PPSV232/351 (0.6%)25/347 (7.2%)237/347 (68.3%)
Most frequent serious events
Showing 10 of 46
Most frequent serious events
EventV116PPSV23
Urinary tract infectionInfections and infestations4/5270/347
AsthmaRespiratory, thoracic and mediastinal disorders4/5272/347
Anaphylactic reactionImmune system disorders0/5272/347
Respiratory tract infection viralInfections and infestations1/5272/347
PneumoniaInfections and infestations3/5271/347
Diabetic ketoacidosisMetabolism and nutrition disorders3/5271/347
Cardiogenic shockCardiac disorders2/5270/347
Dengue feverInfections and infestations2/5271/347
Pneumonia viralInfections and infestations2/5270/347
Cardiopulmonary failureCardiac disorders0/5271/347
Most frequent other events
Showing 10 of 12
Most frequent other events
EventV116PPSV23
Injection site painGeneral disorders357/527189/347
Injection site erythemaGeneral disorders130/52757/347
FatigueGeneral disorders107/52773/347
Injection site swellingGeneral disorders99/52763/347
HeadacheNervous system disorders94/52753/347
MalaiseGeneral disorders70/52733/347
IrritabilityPsychiatric disorders61/52738/347
SomnolenceNervous system disorders50/52732/347
PyrexiaGeneral disorders33/52725/347
MyalgiaMusculoskeletal and connective tissue disorders34/52718/347

Baseline characteristics

Age, Continuous
Age, Continuous(Years)V116PPSV23Total
Mean8.2 ± 4.17.8 ± 3.88.0 ± 4.0
Sex: Female, Male
Sex: Female, Male(Participants)V116PPSV23Total
Female220142362
Male311209520
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)V116PPSV23Total
Hispanic or Latino233158391
Not Hispanic or Latino298192490
Unknown or Not Reported011
Race (NIH/OMB)
Race (NIH/OMB)(Participants)V116PPSV23Total
American Indian or Alaska Native484391
Asian483785
Native Hawaiian or Other Pacific Islander000
Black or African American312051
White322203525
More than one race8248130
Unknown or Not Reported000
08

Study locations

92 sites
  • Central Research Associates ( Site 0145)
    Birmingham, Alabama 35205, United States
  • Velocity Clinical Research, Phoenix ( Site 0122)
    Phoenix, Arizona 85006, United States
  • Madera Family Medical Group ( Site 0120)
    Madera, California 93637, United States
  • Optumcare Colorado Springs, LLC ( Site 0113)
    Colorado Springs, Colorado 80922, United States
  • Accel Research Sites Network- Nona Pediatric Center ( Site 0109)
    Orlando, Florida 32829, United States
  • University of South Florida-Department of Pediatrics ( Site 0110)
    Tampa, Florida 33606, United States
  • Velocity Clinical Research at Primary Pediatrics, Macon ( Site 0128)
    Macon, Georgia 31210, United States
  • Bingham Memorial Hospital ( Site 0149)
    Blackfoot, Idaho 83221, United States
  • Clinical Research Prime ( Site 0105)
    Idaho Falls, Idaho 83404, United States
  • Clinical Research Prime Rexburg ( Site 0104)
    Rexburg, Idaho 83440, United States
  • University of Louisville, Norton Children's Research Institute ( Site 0148)
    Louisville, Kentucky 40202, United States
  • Velocity Clinical Research, Lafayette ( Site 0103)
    Lafayette, Louisiana 70508, United States
  • Velocity Clinical Research, Gulfport ( Site 0115)
    Gulfport, Mississippi 39503, United States
  • Velocity Clinical Research, Hastings ( Site 0114)
    Hastings, Nebraska 68901, United States
  • Midwest Children's Health Research Institute ( Site 0117)
    Lincoln, Nebraska 68504, United States
  • Midwest Children's Health Research Institute ( Site 0106)
    Lincoln, Nebraska 68505, United States
  • Midwest Children's Health Research Institute-Research ( Site 0119)
    Lincoln, Nebraska 68516, United States
  • Midwest Children's Health Research Institute-Research ( Site 0102)
    Lincoln, Nebraska 68522, United States
  • Velocity Clinical Research, Albuquerque ( Site 0112)
    Albuquerque, New Mexico 87107, United States
  • Velocity Clinical Research, Vestal ( Site 0121)
    Vestal, New York 13850, United States
  • Epic Medical Research - Oklahoma ( Site 0134)
    Chickasha, Oklahoma 73018, United States
  • Tribe Clinical Research, LLC-Pediatrics ( Site 0118)
    Greenville, South Carolina 29607, United States
  • Tribe Clinical Research - Spartanburg ( Site 0108)
    Spartanburg, South Carolina 29301, United States
  • Velocity Clinical Research, Austin ( Site 0129)
    Austin, Texas 78759, United States
  • PanAmerican Clinical Research ( Site 0132)
    Brownsville, Texas 78521, United States
  • Epic Medical Research ( Site 0133)
    DeSoto, Texas 75115, United States
  • Epic Medical Research - Mesquite ( Site 0144)
    Mesquite, Texas 75150, United States
  • Alliance for Multispecialty Research, LLC ( Site 0140)
    Layton, Utah 84041, United States
  • Velocity Clinical Research, Salt Lake City ( Site 0124)
    West Jordan, Utah 84088, United States
  • Canadian Center for Vaccinology ( Site 0004)
    Halifax, Nova Scotia B3K6R8, Canada
  • Premier Clinical Trial Network ( Site 0008)
    Hamilton, Ontario L8L 5G4, Canada
  • Children's Hospital of Eastern Ontario ( Site 0001)
    Ottawa, Ontario K1H 8L1, Canada
  • CHU Sainte-Justine ( Site 0007)
    Montreal, Quebec H3T 1C5, Canada
  • McGill University Health Centre - Vaccine Study Centre ( Site 0005)
    Pierrefonds, Quebec H9H 4Y6, Canada
  • CHU de Québec-Université Laval ( Site 0006)
    Québec, Quebec G1E 7G9, Canada
  • Hospital Dr. Hernán Henríquez Aravena ( Site 0208)
    Temuco, Araucania 4781151, Chile
  • Centro de Estudios Clínicos (ICIM, Facultad de Medicina Clínica Alemana Universidad del Desarrollo)
    Santiago, Region M. de Santiago 7590943, Chile
  • Pontificia Universidad Catolica de Chile-Pediatric Infectious Diseases and Immunology ( Site 0209)
    Santiago, Region M. de Santiago 8330077, Chile
  • Hospital Roberto del Río-Infectología Pediátrica ( Site 0200)
    Santiago, Region M. de Santiago 8380418, Chile
  • Hospital Padre Hurtado-NEONATOLOGY/PEDIATRICS ( Site 0204)
    Santiago, Region M. de Santiago 8880465, Chile
  • Clinica Somer ( Site 0405)
    Rionegro, Antioquia 054040, Colombia
  • Oncomedica S.A.S ( Site 0402)
    Montería, Departamento de Córdoba 230001, Colombia
  • Fundación Valle del Lili ( Site 0404)
    Cali, Valle del Cauca Department 760032, Colombia
  • CEIP - Centro de Estudios en Infectología Pediátrica ( Site 0401)
    Cali, Valle del Cauca Department 760042, Colombia
  • FVR, Kokkolan rokotetutkimusklinikka ( Site 0602)
    Kokkola, Keski-Pohjanmaa 67100, Finland
  • FVR, Oulun rokotetutkimusklinikka ( Site 0600)
    Oulu, North Ostrobothnia 90220, Finland
  • FVR, Tampereen rokotetutkimusklinikka ( Site 0603)
    Tampere, Pirkanmaa 33100, Finland
  • FVR, Seinäjoen rokotetutkimusklinikka ( Site 0604)
    Seinäjoki, South Ostrobothnia 60100, Finland
  • FVR, Turun rokotetutkimusklinikka ( Site 0606)
    Turku, Southwest Finland 20520, Finland
  • FVR, Espoon rokotetutkimusklinikka ( Site 0608)
    Espoo, Uusimaa 02230, Finland
  • MeVac - Meilahti Vaccine Research Center ( Site 0609)
    Helsinki, Uusimaa 00290, Finland
  • Centre Hospitalier Universitaire de Caen - Hôpital Côte de N-Centre de Recherche Clinique Pédiatriq
    Caen, Calvados 14033, France
  • Hôpital Jeanne de Flandre ( Site 0702)
    Lille, Nord 59037, France
  • Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Robert Debre - Centre Hospitalo Universita
    Paris, 75019, France
  • Rambam Health Care Campus ( Site 0900)
    Haifa, 3109601, Israel
  • Hadassah Mount Scopus Medical Centre ( Site 0902)
    Jerusalem, 9124001, Israel
  • Schneider Children's Medical Center ( Site 0903)
    Petah Tikva, 4920235, Israel
  • Saiseikai Yokohamashi Tobu Hospital ( Site 1714)
    Yokohama, Kanagawa 230-0012, Japan
  • Okinawa Prefectural Nanbu Medical Center and Children's Medical Center ( Site 1701)
    Kanegusuku, Okinawa 901-1193, Japan
  • Juntendo University Hospital ( Site 1700)
    Bunkyo-ku, Tokyo 113-8431, Japan
  • Aquakids Clinic ( Site 1709)
    Edogawa-ku, Tokyo 133-0056, Japan
  • Miyazaki Prefectural Miyazaki Hospital ( Site 1711)
    Miyazaki, 880-8510, Japan
  • University of Miyazaki Hospital ( Site 1705)
    Miyazaki, 889-1692, Japan
  • National Hospital Organization Okayama Medical Center ( Site 1713)
    Okayama, 701-1192, Japan
  • Saitama Prefectural Children's Medical Center ( Site 1702)
    Saitama, 330-8777, Japan
  • IN VIVO ( Site 1006)
    Bydgoszcz, Kuyavian-Pomeranian Voivodeship 85-048, Poland
  • Centrum Medyczne Pratia Bydgoszcz ( Site 1004)
    Bydgoszcz, Kuyavian-Pomeranian Voivodeship 85-796, Poland
  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckieg-Klinika Pediatrii i Chorob Infekcyjnyc
    Wroclaw, Lower Silesian Voivodeship 50-368, Poland
  • SZPZOZ im. Dzieci Warszawy w Dziekanowie Lesnym ( Site 1007)
    Łomianki, Masovian Voivodeship 05-092, Poland
  • Gravita Diagnostyka i Leczenie Niepłodności ( Site 1005)
    Lodz, Łódź Voivodeship 91-347, Poland
  • Hospital Germans Trias i Pujol ( Site 1104)
    Badalona, Barcelona 08916, Spain
  • Hospital Sant Joan de Déu ( Site 1113)
    Esplugues de Llobregat, Barcelona 08950, Spain
  • Hospital Universitari Vall d'Hebron ( Site 1115)
    Barcelona, Catalonia 08035, Spain
  • CHUS - Hospital Clinico Universitario-Servicio de Pediatría ( Site 1111)
    Santiago de Compostela, La Coruna 15706, Spain
  • Hospital Universitario Severo Ochoa ( Site 1114)
    Leganés, Madrid 28911, Spain
  • Hospital Universitario La Paz-Pediatria y Enfermedades Infecciosas ( Site 1105)
    Madrid, Madrid, Comunidad de 28046, Spain
  • Hospital Universitario 12 de Octubre-Unidad Pediátrica de Investigación y Ensayos Clínicos ( Site 11
    Madrid, 28041, Spain
  • HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO ( Site 1112)
    Seville, 41013, Spain
  • CTC Karolinska ( Site 1201)
    Solna, Stockholm County 171 64, Sweden
  • Norrlands universitetssjukhus ( Site 1200)
    Umeå, Västerbotten County 901 85, Sweden
  • CTC GoCo ( Site 1202)
    Mölndal, Västra Götaland County 431 53, Sweden
  • Faculty of Medicine Siriraj Hospital-Pediatric Infectious Diseases ( Site 1601)
    Bangkoknoi, Bangkok 10700, Thailand
  • Chulalongkorn University-Pediatrics ( Site 1602)
    Pathumwan, Bangkok 10330, Thailand
  • Faculty of Tropical Medicine, Mahidol University - Vaccine Trial Centre ( Site 1604)
    Ratchathewi, Bangkok 10400, Thailand
  • Songklanagarind hospital-Department of Pediatrics ( Site 1603)
    Hat Yai, Changwat Songkhla 90110, Thailand
  • Çukurova Üniversitesi Tıp Fakültesi Adana Hastanesi-Pediatric Infection ( Site 1302)
    Sarçam, Adana 01250, Turkey (Türkiye)
  • Hacettepe Universite Hastaneleri ( Site 1300)
    Ankara, 06230, Turkey (Türkiye)
  • Ankara Universitesi Tip Fakultesi Hastanesi ( Site 1304)
    Ankara, 06590, Turkey (Türkiye)
  • Ankara Bilkent Şehir Hastanesi-Infectious Disease and Clinical Microbiology ( Site 1301)
    Ankara, 06800, Turkey (Türkiye)
  • Sisli Etfal Training and Research Hospital ( Site 1305)
    Istanbul, 34360, Turkey (Türkiye)
  • Ege Universitesi Hastanesi ( Site 1306)
    Izmir, 35100, Turkey (Türkiye)
  • Erciyes Universitesi Tıp Fakultesi Hastaneleri-pediatric infection ( Site 1303)
    Kayseri, 38039, Turkey (Türkiye)
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Feb 20, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT06177912
Lead sponsor
Merck Sharp & Dohme LLC
Responsible party
Sponsor
First posted
Dec 20, 2023
Start date
Jan 18, 2024
Primary completion
Feb 26, 2025
Completion
Feb 26, 2025
Results posted
Mar 11, 2026
Last update
Mar 11, 2026

Study contacts

Medical Director
study director · Merck Sharp & Dohme LLC

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
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