This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Safety and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults 50 Years of Age or Older (V116-010, STRIDE-10) (NCT05569954), a randomized phase 3 study. The primary outcome is Percentage of Participants With Solicited Injection-Site Adverse Events (AEs).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05569954 |
| Phase | Phase 3 |
| Condition | Pneumococcal Disease |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Triple |
| Enrollment | 1484 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Merck Sharp & Dohme LLC |
| Results posted | Yes |
2. Clinical Question
Population
Pneumococcal vaccine-naïve adults 50 years of age or older with pneumococcal disease as the registry-listed condition. The registry describes the trial population as adults who had not previously received a pneumococcal vaccine.
Intervention
A single intramuscular vaccination of 0.5 mL of V116 on Day 1. The study assesses safety, tolerability, and immune responses after vaccination.
Comparator
A single intramuscular vaccination of 0.5 mL of PPSV23 on Day 1. PPSV23 is the active comparator and is described as a polyvalent 23-valent pneumococcal vaccine.
Primary question
What percentage of participants experience solicited injection-site adverse events up to 5 days postvaccination, and how do the groups compare? The registry also describes hypotheses about immune responses at 30 days postvaccination: noninferiority for the 12 serotypes common to both vaccines, and superiority for the 9 serotypes unique to V116.
The registry’s primary outcome is the percentage of participants with solicited injection-site adverse events. The specified events are pain or tenderness, redness or erythema, and swelling. The primary endpoint is therefore a short-term tolerability measure, not a direct measure of protection against pneumococcal disease.
The immune-response hypotheses address a different question. They concern serotype-specific opsonophagocytic activity geometric mean titers and, for unique V116 serotypes, the percentage of participants with at least a four-fold rise from baseline. These are stated hypotheses rather than results. The numerical immunogenicity comparisons are not reported in the registry record.
3. Trial Design
NCT05569954 is a completed phase 3 randomized, active-comparator-controlled study. The registry describes a parallel-group design and records masking as triple. The official title and brief summary describe the study as double-blind. The registry record does not explain the difference between those masking descriptions or identify which roles were masked.
The planned enrollment was 1484. Participants were pneumococcal vaccine-naïve adults 50 years of age or older. The two interventions were V116 and PPSV23, with each arm receiving a single intramuscular vaccination of 0.5 mL on Day 1. PPSV23 served as the active comparator. The study was sponsored by Merck Sharp & Dohme LLC.
The registry lists the start date as 2022-11-07 and the primary completion date as 2023-10-30. Its status is completed. The primary safety endpoint covers solicited injection-site adverse events up to 5 days postvaccination. The stated immunogenicity hypotheses concern assessment at 30 days postvaccination, including noninferiority for 12 shared serotypes and superiority for 9 serotypes unique to V116.
The adverse-event record distinguishes the base study from an immunogenicity substudy and a PBMC sub-study. For the base study, the listed at-risk counts are 739 for V116 and 741 for PPSV23. The immunogenicity substudy lists 349 for V116 and 348 for PPSV23; the PBMC sub-study lists 41 and 39, respectively. These subgroup counts describe the registry’s safety listings and should not be substituted for the planned enrollment or treated as the analysis population for every endpoint.
The registry lists 11 outcome measures and 61 analyses. It does not report the protocol’s sample-size justification, detailed allocation procedure, or the roles covered by masking.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: 1484 participants were randomized in the base study. Additionally, a subgroup of the first 700 participants randomized in the base study to either V116 or PPSV23 were followed for an additional 18 months after completing Visit 5 as part of an immunogenicity substudy extension. 80 participants enrolled at selected study sites were followed for an additional 6 months after completing Visit 5 as part of a PBMC substudy extension. These substudies investigated exploratory objectives.
Base Study
| Stage | V116 | PPSV23 |
|---|---|---|
| STARTED | 741 | 743 |
| Vaccinated | 739 | 741 |
| COMPLETED | 733 | 735 |
| NOT COMPLETED | 8 | 8 |
Reasons for not completing this period:
| Reason | V116 | PPSV23 |
|---|---|---|
| Lost to Follow-up | 3 | 4 |
| Protocol Violation | 1 | 2 |
| Withdrawal by Subject | 4 | 2 |
Immunogenicity Substudy Extension
| Stage | V116 | PPSV23 |
|---|---|---|
| STARTED | 350 | 350 |
| Vaccinated | 349 | 348 |
| COMPLETED | 335 | 338 |
| NOT COMPLETED | 15 | 12 |
Reasons for not completing this period:
| Reason | V116 | PPSV23 |
|---|---|---|
| Lost to Follow-up | 3 | 4 |
| Randomized by mistake without study treatment | 0 | 2 |
| Withdrawal by Subject | 12 | 5 |
| Non-Study pneumococcal vaccine administered | 0 | 1 |
PBMC Substudy Extension
| Stage | V116 | PPSV23 |
|---|---|---|
| STARTED | 41 | 39 |
| Vaccinated | 41 | 39 |
| COMPLETED | 39 | 39 |
| NOT COMPLETED | 2 | 0 |
Reasons for not completing this period:
| Reason | V116 | PPSV23 |
|---|---|---|
| Withdrawal by Subject | 2 | 0 |
Analysis population for the primary outcome, as defined in the registry: All randomized participants that received a vaccination. Participants are included in the group corresponding to the vaccination received.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | Base Study: V116 | Base Study: PPSV23 | Total |
|---|---|---|---|---|
| Participants analysed | 741 | 743 | 1484 | |
| Age, Continuous | Years | 63.9 (SD 8.4) | 63.7 (SD 8.3) | 63.8 (SD 8.3) |
| Sex: Female, Male: Female | Participants | 332 | 333 | 665 |
| Sex: Female, Male: Male | Participants | 409 | 410 | 819 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 151 | 162 | 313 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 579 | 571 | 1150 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 11 | 10 | 21 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 4 | 5 | 9 |
| Race (NIH/OMB): Asian | Participants | 151 | 140 | 291 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 9 | 3 | 12 |
| Race (NIH/OMB): Black or African American | Participants | 2 | 2 | 4 |
| Race (NIH/OMB): White | Participants | 455 | 469 | 924 |
| Race (NIH/OMB): More than one race | Participants | 119 | 124 | 243 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 1 | 0 | 1 |
6. Primary Endpoint
The registry lists the primary outcome as Percentage of Participants With Solicited Injection-Site Adverse Events (AEs), measured over Up to 5 days postvaccination.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | Percentage of Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the percentage of participants with solicited injection-site adverse events up to 5 days postvaccination. The solicited events are pain or tenderness, redness or erythema, and swelling. The endpoint captures symptoms that are specifically sought during a defined period after vaccination, rather than relying only on events that participants happen to report without prompting.
A percentage expresses how common an event was within the defined vaccinated population. Because the outcome is whether a participant experienced one or more specified events, it is a binary participant-level outcome: each participant either meets the endpoint definition or does not. The registry states that the primary population includes all randomized participants who received a vaccination, with participants grouped according to the vaccination received.
This endpoint is used to describe short-term injection-site tolerability and to compare the two randomized groups. It does not, by itself, measure the immune response or demonstrate prevention of pneumococcal disease. The registry specifies 95% confidence intervals for between-group differences using the Miettinen and Nurminen method. A confidence interval conveys the uncertainty around an estimated difference; it is not a guarantee that the true difference lies within the interval.
The posted record does not present one reduced primary comparison because the primary outcome has several categories or time points. Consequently, a single primary endpoint percentage or between-group estimate cannot be stated from the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The trial’s primary question is comparative: it concerns the percentage of vaccinated participants with solicited injection-site adverse events after V116 versus PPSV23. The registry defines the event types and the observation period, and specifies a method for confidence intervals around between-group differences. However, the primary result is not available as one reduced comparison in the registry record. The direction and size of a primary difference, together with its precision, therefore cannot be characterized from the listed primary outcome description alone.
The study’s immune-response aims should also be kept separate from the primary safety endpoint. The brief summary states hypotheses of noninferiority for 12 serotypes shared by the vaccines and superiority for 9 serotypes unique to V116, with assessments described at 30 days postvaccination. It also describes a superiority hypothesis for the percentage of participants with at least a four-fold rise from baseline in unique-serotype OPA GMTs. Hypotheses identify planned questions; they do not establish that a criterion was met. Numerical immunogenicity results and their uncertainty are not reported in the registry record.
The safety listings report 22 serious adverse events among 739 participants at risk in the base-study V116 group and 18 among 741 at risk in the base-study PPSV23 group. The immunogenicity substudy lists 0 among 349 at risk for V116 and 0 among 348 at risk for PPSV23. The PBMC sub-study lists 0 among 41 at risk for V116 and 0 among 39 at risk for PPSV23. Deaths are listed as 0 in each of these groups. These are descriptive registry counts, not adjusted comparisons or evidence of a statistically established difference.
The record lists several serious-event terms at 0.1% each: extrasystoles, mitral valve incompetence, sinus bradycardia, thyroid mass, abdominal wall haematoma, and chest pain. The displayed listings do not establish whether an event was caused by vaccination. Nor do these serious-event figures replace the solicited injection-site endpoint, which covers a different set of events and a specified short postvaccination period.
Interpretation is limited by the absence of a posted primary estimate and confidence interval, and by the absence of detailed immune-response estimates in the registry record. Without those quantities, readers cannot assess the magnitude or precision of the principal comparisons from these listings.
9. Statistical Methods Explained
The methods described in the registry concern different kinds of outcomes. The primary endpoint is a percentage of participants with an event, while the immunogenicity aims concern serotype-specific immune measurements and changes from baseline. These outcomes require distinct summaries and should not be treated as if one statistical method answers every question.
What does a percentage compare?
For a binary endpoint, the observed participant count is classified according to whether the defined event occurred. Dividing the number of participants who meet the event definition by the relevant analysis population gives a proportion, which may be expressed as a percentage. A between-group difference compares the proportions in the two vaccination groups. The registry specifies 95% confidence intervals for the primary between-group differences and names the Miettinen and Nurminen method.
In general, a confidence interval gives a range of values compatible with the data under the method’s assumptions. Its width reflects precision: broader intervals indicate more uncertainty about the size of the difference. The interval is not a statement that every value in the range is equally likely, and it does not by itself establish clinical importance. The registry’s description states the confidence level and method but does not provide a single primary estimate or interval in the record.
What is the Miettinen and Nurminen method used for?
In general, the Miettinen and Nurminen approach is used to construct confidence intervals for differences between proportions. A method for the interval is not the same as a report of the resulting estimate. To interpret the primary comparison, the observed group proportions, the estimated difference, and its confidence interval would need to be available. Those numerical primary results are not reported as one reduced comparison in the registry record.
How do the immune-response questions differ?
The study summary describes serotype-specific OPA geometric mean titers and IgG geometric mean concentrations among its immune-response measures. A geometric mean summarizes positive measurements on a multiplicative scale and can be useful when measurements are skewed. A geometric mean fold rise describes change relative to baseline on that scale. These general definitions explain the measure types; they do not provide the trial’s estimates. The registry record does not report the numerical immune-response comparisons needed to judge the size or precision of those effects.
Noninferiority and superiority are different inferential questions. In general, a noninferiority analysis asks whether the data exclude an unacceptable loss relative to a comparator, according to a prespecified margin. A superiority analysis asks whether the data support a difference in a specified direction. The summary states the trial’s hypotheses but does not report the noninferiority margin, the detailed statistical plan, or whether any hypothesis was met. Those details are not reported in the registry record.
What do planning illustrations represent?
Any sample-size illustrations associated with these results are planning illustrations based on an observed effect, not observed power. The stated assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation; the effect to detect is described as a stated fraction of the observed effect. For non-time-to-event outcomes, such illustrations are expressed as participants per arm. They are not the trial’s observed enrollment, and they do not show that the study had a particular probability of detecting an effect after it was conducted.
In general, a planning calculation depends on the assumed effect, variability or event frequency, significance criterion, and design assumptions. Changing an assumed effect changes the number of participants indicated by the calculation. Such an illustration can help frame future planning, but it does not establish the rationale used when this trial was designed. The protocol’s sample-size justification is not reported in the registry record, and no sample-size value from a planning illustration should be read as an observed outcome.
Why do analysis populations matter?
The primary endpoint description defines its population as all randomized participants who received a vaccination, analyzed according to the vaccination received. This is a specific vaccinated population, not automatically every randomized participant. The registry’s safety listings also distinguish the base study, immunogenicity substudy, and PBMC sub-study. Different outcomes may use different populations, so denominators need to be read with the endpoint and group label rather than assumed to apply uniformly across the trial.
In general, missing measurements can affect the population used for an analysis and can introduce uncertainty if the reasons for missingness are related to outcomes. The registry record does not describe missing-data methods for the primary endpoint or immunogenicity outcomes. Statistical methods such as imputation or sensitivity analyses should not be presumed when they are not reported.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 11 outcome measures and 61 analyses. The study summary also describes multiple serotype-specific immune-response questions, including noninferiority for shared serotypes, superiority for unique serotypes, and a rise-from-baseline outcome. With multiple endpoints and analyses, the interpretation of individual statistical findings can depend on how the analysis plan handled multiplicity.
In general, multiplicity arises when several statistical hypotheses are tested. If each test is interpreted without regard to the others, the chance of at least one apparently positive result across a family of tests can increase. A prespecified testing sequence, adjustment procedure, or defined family of hypotheses can help clarify how evidence should be interpreted. The registry record does not report a multiplicity adjustment, testing hierarchy, or the detailed statistical plan. Their use or absence should not be inferred from the number of listed analyses.
The primary endpoint description identifies the population as randomized participants who received a vaccination, grouped according to the vaccination received. That population definition is reported for the primary endpoint; it does not establish the analysis population for every secondary or immunogenicity outcome. The record lists separate safety cohorts for the base study and two substudies.
Missing-data handling is not reported in the registry record. The record does not describe how participants without endpoint assessments were handled, whether any imputation was used, or whether sensitivity analyses were conducted. These details matter because complete-case analyses and methods that account for missing measurements can rely on different assumptions. No such methods or assumptions should be attributed to the trial without a registry report.
The protocol’s sample-size justification and detailed statistical analysis plan are also not reported. Planning illustrations based on observed effects do not fill that gap and should not be interpreted as observed power or as evidence about the original design rationale.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Base Study: V116 | 22 | 739 | 3.0% |
| Base Study: PPSV23 | 18 | 741 | 2.4% |
| Immunogenicity Substudy: V116 | 0 | 349 | 0.0% |
| Immunogenicity Substudy: PPSV23 | 0 | 348 | 0.0% |
| PBMC Sub-study: V116 | 0 | 41 | 0.0% |
| PBMC Sub-study: PPSV23 | 0 | 39 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Base Study: V116 | 0 of 741 |
| Base Study: PPSV23 | 0 of 743 |
| Immunogenicity Substudy: V116 | 0 of 349 |
| Immunogenicity Substudy: PPSV23 | 0 of 348 |
| PBMC Sub-study: V116 | 0 of 41 |
| PBMC Sub-study: PPSV23 | 0 of 39 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Base Study: V116 | 399 of 739 |
| Base Study: PPSV23 | 364 of 741 |
| Immunogenicity Substudy: V116 | 0 of 349 |
| Immunogenicity Substudy: PPSV23 | 0 of 348 |
| PBMC Sub-study: V116 | 0 of 41 |
| PBMC Sub-study: PPSV23 | 0 of 39 |
Most frequent serious adverse event terms
| Event term | Organ system | Base Study: V116 | Base Study: PPSV23 | Immunogenicity Substudy: V116 | Immunogenicity Substudy: PPSV23 | PBMC Sub-study: V116 | PBMC Sub-study: PPSV23 |
|---|---|---|---|---|---|---|---|
| Thyroid mass | Endocrine disorders | 1 of 739 | 1 of 741 | 0 of 349 | 0 of 348 | 0 of 41 | 0 of 39 |
| Chest pain | General disorders | 1 of 739 | 1 of 741 | 0 of 349 | 0 of 348 | 0 of 41 | 0 of 39 |
| Acute myocardial infarction | Cardiac disorders | 0 of 739 | 1 of 741 | 0 of 349 | 0 of 348 | 0 of 41 | 0 of 39 |
| Extrasystoles | Cardiac disorders | 1 of 739 | 0 of 741 | 0 of 349 | 0 of 348 | 0 of 41 | 0 of 39 |
| Mitral valve incompetence | Cardiac disorders | 1 of 739 | 0 of 741 | 0 of 349 | 0 of 348 | 0 of 41 | 0 of 39 |
| Sinus bradycardia | Cardiac disorders | 1 of 739 | 0 of 741 | 0 of 349 | 0 of 348 | 0 of 41 | 0 of 39 |
| Vertigo | Ear and labyrinth disorders | 0 of 739 | 1 of 741 | 0 of 349 | 0 of 348 | 0 of 41 | 0 of 39 |
| Abdominal wall haematoma | Gastrointestinal disorders | 1 of 739 | 0 of 741 | 0 of 349 | 0 of 348 | 0 of 41 | 0 of 39 |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | 0 of 739 | 1 of 741 | 0 of 349 | 0 of 348 | 0 of 41 | 0 of 39 |
| Cholecystitis | Hepatobiliary disorders | 1 of 739 | 0 of 741 | 0 of 349 | 0 of 348 | 0 of 41 | 0 of 39 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Base Study: V116 | Base Study: PPSV23 | Immunogenicity Substudy: V116 | Immunogenicity Substudy: PPSV23 | PBMC Sub-study: V116 | PBMC Sub-study: PPSV23 |
|---|---|---|---|---|---|---|---|
| Injection site pain | General disorders | 301 of 739 | 261 of 741 | 0 of 349 | 0 of 348 | 0 of 41 | 0 of 39 |
| Fatigue | General disorders | 122 of 739 | 118 of 741 | 0 of 349 | 0 of 348 | 0 of 41 | 0 of 39 |
| Headache | Nervous system disorders | 124 of 739 | 105 of 741 | 0 of 349 | 0 of 348 | 0 of 41 | 0 of 39 |
| Injection site erythema | General disorders | 58 of 739 | 47 of 741 | 0 of 349 | 0 of 348 | 0 of 41 | 0 of 39 |
| Myalgia | Musculoskeletal and connective tissue disorders | 43 of 739 | 46 of 741 | 0 of 349 | 0 of 348 | 0 of 41 | 0 of 39 |
| Injection site swelling | General disorders | 48 of 739 | 32 of 741 | 0 of 349 | 0 of 348 | 0 of 41 | 0 of 39 |
Serious events with the highest arm-level rate: extrasystoles (0.1%), mitral valve incompetence (0.1%), sinus bradycardia (0.1%), thyroid mass (0.1%), abdominal wall haematoma (0.1%).
The registry’s safety listings separate the base study from the immunogenicity and PBMC sub-studies. In the base study, the V116 group lists 22 serious adverse events among 739 participants at risk, while the PPSV23 group lists 18 among 741. In the immunogenicity substudy, the listings are 0 among 349 for V116 and 0 among 348 for PPSV23. In the PBMC sub-study, they are 0 among 41 for V116 and 0 among 39 for PPSV23. Deaths are listed as 0 in each group.
These counts are descriptive. They do not show whether an event was caused by vaccination, and the raw counts alone do not account for differences in follow-up, event timing, or other features of the data. The registry record does not provide a statistical comparison or confidence interval for these serious adverse-event figures. The top listed serious-event terms—extrasystoles, mitral valve incompetence, sinus bradycardia, thyroid mass, abdominal wall haematoma, and chest pain—are each reported at 0.1%.
Serious adverse events are distinct from the primary endpoint, which concerns solicited injection-site symptoms up to 5 days postvaccination. The serious-event listings therefore should not be used as a substitute for the primary endpoint results, which are not reported as one reduced comparison in the registry record.
12. What the Result Does, and Does Not, Mean
The registry record establishes the question and structure of the trial: a randomized phase 3 comparison of V116 with PPSV23 in pneumococcal vaccine-naïve adults 50 years of age or older. It specifies a short-term solicited injection-site endpoint and describes immune-response hypotheses. The record also contains descriptive serious adverse-event listings for the base study and two substudies.
It does not establish the magnitude or precision of the primary comparison. The primary outcome has several categories or time points and is not reduced to one comparison in the registry record. The primary between-group estimate and its confidence interval are therefore not available as a single result to interpret. The numerical immune-response results are also not reported in the registry record, so the stated noninferiority and superiority hypotheses cannot be treated as findings.
The serious adverse-event counts describe events recorded in the listed groups, but counts alone do not establish causation or a statistically meaningful difference between vaccines. The registry does not report a formal comparison for those figures. Likewise, the listed zero deaths describe the recorded groups; they do not resolve all safety questions or replace detailed outcome reporting.
In general, a clinical trial’s interpretation depends on the endpoint definition, analysis population, estimate, uncertainty, and analysis plan. For a noninferiority question, the margin and confidence interval are central to judging the result. For superiority, the direction and precision of the estimate matter. The relevant margin, detailed plan, and numerical immune-response comparisons are not reported in the registry record.
Accordingly, the record supports a description of what was studied and what safety counts were listed, but not a conclusion about whether one vaccine had a more favorable primary endpoint or immune response. It also does not support a conclusion about prevention of pneumococcal disease from the information reported for these outcomes.
13. Why This Trial Matters Statistically
This trial raises several statistical issues that are common in clinical vaccine studies. The randomized active-comparator design frames a direct comparison between two vaccination groups, while the primary endpoint is a participant-level percentage for solicited injection-site events. Making the event definition, observation window, and vaccinated analysis population explicit is important: the resulting percentage answers a specific short-term tolerability question rather than a broader question about disease prevention.
The registry also describes several immune-response aims across serotypes. The distinction between shared and unique serotypes leads to different hypotheses—noninferiority for 12 common serotypes and superiority for 9 unique serotypes. This is statistically important because the hypotheses have different decision criteria, and several outcomes or analyses may raise multiplicity questions. The detailed testing strategy and multiplicity handling are not reported in the registry record.
Precision is another key issue. A point estimate alone would not describe how uncertain a group comparison is; confidence intervals provide information about that uncertainty. The registry names a method for confidence intervals on the primary between-group difference, but the primary result is not reported as one reduced comparison. This illustrates why a stated method and an outcome definition do not substitute for the estimate and its interval.
Finally, subgroup safety listings need careful interpretation. The base study, immunogenicity substudy, and PBMC sub-study have different listed at-risk counts. Reading each figure with its group and population prevents subgroup counts from being mistaken for the entire enrolled population. The record’s descriptive counts can inform how safety information was organized, but without comparative estimates and fuller methods they cannot establish a causal or statistically supported difference.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The primary endpoint is described, but its result is not presented as one reduced comparison because the outcome has several categories or time points. The registry record therefore does not report a single primary estimate and confidence interval for interpretation. Detailed numerical immunogenicity results are also not reported in the registry record, despite the stated hypotheses about shared and unique serotypes.
The registry records triple masking, whereas the official title and brief summary describe the study as double-blind. The record does not explain this difference or specify which participants, investigators, or other roles were masked. The allocation procedure beyond randomized allocation is not reported.
The listed serious adverse-event counts are descriptive, and the record does not include a formal comparison or confidence interval for them. Safety listings are divided among the base study and two substudies, so their group counts do not represent one interchangeable denominator for all outcomes. The registry record also does not report missing-data procedures or detailed analysis populations for every outcome.
The multiplicity approach, detailed statistical analysis plan, and sample-size justification are not reported in the registry record. Planning illustrations based on an observed effect are not a substitute for the original design rationale and are not observed power. These reporting gaps limit assessment of how the many outcomes and analyses were intended to support formal conclusions.
The information described in the record focuses on safety and immunogenicity. It does not report a clinical disease-prevention result that would allow those outcomes to be interpreted as direct evidence about prevention of pneumococcal disease.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Safety and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults 50 Years of Age or Older (V116-010, STRIDE-10) — NCT05569954.
- Registry record last updated 2026-03-02; status last verified 2026-02.
- Results first posted 2024-10-31.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
NCT05569954 is a completed randomized phase 3 active-comparator study of V116 versus PPSV23 in pneumococcal vaccine-naïve adults 50 years of age or older. Planned enrollment was 1484. Each group received a single intramuscular vaccination of 0.5 mL on Day 1. The registry describes a parallel-group design and records triple masking, while the title and summary describe the trial as double-blind.
The primary endpoint is the percentage of participants with solicited injection-site adverse events up to 5 days postvaccination. The registry specifies 95% confidence intervals for between-group differences using the Miettinen and Nurminen method, but the primary outcome is not reduced to one comparison. Immune-response hypotheses concern the 12 shared serotypes and 9 serotypes unique to V116; numerical immune-response results are not reported in the registry record.
For the base study, serious adverse events are listed as 22 among 739 at risk for V116 and 18 among 741 for PPSV23; deaths are listed as 0. The record also lists separate immunogenicity and PBMC sub-study safety groups. The multiplicity approach, missing-data methods, and sample-size justification are not reported in the registry record.