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 A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Two Lots of V114 in Healthy Infants (V114-008) (NCT02987972), a randomized phase 2 study. The primary outcome is Percentage of Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 µg/mL for the 13 Common Serotypes in V114 and Prevnar 13™: 1 Month Post Vaccination 3.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02987972 |
| Phase | Phase 2 |
| Condition | Pneumococcal Infections |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Triple |
| Enrollment | 1051 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Merck Sharp & Dohme LLC |
| Results posted | Yes |
2. Clinical Question
Population
Healthy infants aged 6 to 12 weeks, defined in the registry record as at least 42 days and at most 90 days old, were eligible. The primary endpoint analysis population was narrower: participants not considered protocol violators who had endpoint data available. The registry record gives examples of possible violations, including not receiving the correct scheduled doses within the specified timeframe and lacking valid serology results in the stated post-dose window.
Intervention
Infants were assigned to V114 Lot 1 or V114 Lot 2. Each lot was scheduled as a 0.5 mL intramuscular injection at 2, 4, 6, and 12-15 months of age. The study evaluated safety, tolerability, and immunogenicity, including antibody responses after the third vaccination.
Comparator
The comparator was Prevnar 13™. Its scheduled administration was also a 0.5 mL intramuscular injection at 2, 4, 6, and 12-15 months of age. The trial therefore included two V114 lot groups and a vaccine comparator group.
Primary question
The primary hypothesis concerned the proportion of participants reaching a serotype-specific pneumococcal IgG concentration of at least 0.35 µg/mL one month after Dose 3. This was assessed for each of the 13 serotypes common to V114 and Prevnar 13™. The stated objective was to evaluate whether the proportion for V114 was non-inferior to the proportion for Prevnar 13™. The non-inferiority margin and the primary endpoint results are not reported in the registry record.
The question is about an immune-response threshold, not a direct comparison of clinical disease outcomes. The threshold classifies whether each participant's measured antibody concentration reaches a specified level for a given serotype. Group proportions then describe how frequently that criterion was met. The registry record also lists geometric mean concentration outcomes, which describe antibody levels on a different scale, but the primary question is based on the proportion above the threshold.
3. Trial Design
This was a Phase II, randomized, double-blind, multicenter, parallel-group trial. The registry record lists an enrollment of 1051 and a completed status. The trial began on 2017-03-21, with primary completion on 2018-10-04. Merck Sharp & Dohme LLC is listed as the sponsor.
Participants were assigned to V114 Lot 1, V114 Lot 2, or Prevnar 13™. All three groups had the same scheduled injection volume, route, and visit ages: a 0.5 mL intramuscular injection at 2, 4, 6, and 12-15 months. The two V114 groups made it possible to evaluate responses associated with the separate lots; the Prevnar 13™ group served as the active comparator. The registry describes triple masking, but the specific parties kept unaware of assignments are not reported in the registry record.
The primary assessment was one month after Dose 3, identified as Month 5. The endpoint was the percentage of participants meeting a serotype-specific pneumococcal IgG threshold for each of the 13 common serotypes. The registry also lists geometric mean concentration outcomes before the fourth vaccination and one month after the fourth vaccination, alongside other outcome measures. These additional measures capture antibody concentration at other times and use a different summary from the primary threshold-based proportion.
The trial focused on immunogenicity and safety in healthy infants. The registry record does not report a clinical disease endpoint or a detailed account of how allocation sequences were generated, how assignments were concealed, or how the stated non-inferiority objective was operationalized. Those details should not be inferred from the randomized, double-blind labels alone.
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.
Overall Study
| Stage | V114 Lot 1 | V114 Lot 2 | Prevnar 13™ |
|---|---|---|---|
| STARTED | 351 | 350 | 350 |
| Vaccination 1 | 350 | 347 | 347 |
| Vaccination 2 | 333 | 335 | 335 |
| Vaccination 3 | 330 | 331 | 332 |
| Vaccination 4 | 310 | 306 | 311 |
| COMPLETED | 308 | 305 | 308 |
| NOT COMPLETED | 43 | 45 | 42 |
Reasons for not completing this period:
| Reason | V114 Lot 1 | V114 Lot 2 | Prevnar 13™ |
|---|---|---|---|
| Adverse Event | 1 | 1 | 0 |
| Death | 1 | 0 | 0 |
| Lack of Efficacy | 9 | 12 | 12 |
| Lost to Follow-up | 7 | 8 | 4 |
| Physician Decision | 1 | 6 | 0 |
| Protocol Violation | 2 | 1 | 5 |
| Withdrawal by Subject | 22 | 17 | 21 |
Analysis population for the primary outcome, as defined in the registry: Participants not considered as protocol violators and had data available for endpoint. Violations could include but were not limited to: failure to receive the scheduled correct doses within scheduled timeframe and lack of valid serology results available from 28 to 42 days following the dose being analyzed.
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 | V114 Lot 1 | V114 Lot 2 | Prevnar 13™ | Total |
|---|---|---|---|---|---|
| Participants analysed | 351 | 350 | 350 | 1051 | |
| Age, Customized: Infants and toddlers (28 days-23 months) | Participants | 351 | 350 | 350 | 1051 |
| Sex: Female, Male: Female | Participants | 164 | 186 | 173 | 523 |
| Sex: Female, Male: Male | Participants | 187 | 164 | 177 | 528 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 3 | 1 | 2 | 6 |
| Race (NIH/OMB): Asian | Participants | 3 | 1 | 3 | 7 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 3 | 2 | 1 | 6 |
| Race (NIH/OMB): Black or African American | Participants | 34 | 24 | 33 | 91 |
| Race (NIH/OMB): White | Participants | 290 | 296 | 289 | 875 |
| Race (NIH/OMB): More than one race | Participants | 18 | 25 | 22 | 65 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 1 | 0 | 1 |
| Ethnicity: Hispanic Or Latino | Participants | 49 | 36 | 53 | 138 |
| Ethnicity: Not Hispanic Or Latino | Participants | 300 | 313 | 294 | 907 |
| Ethnicity: Not Reported | Participants | 0 | 0 | 2 | 2 |
| Ethnicity: Unknown | Participants | 2 | 1 | 1 | 4 |
6. Primary Endpoint
The registry lists the primary outcome as Percentage of Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 µg/mL for the 13 Common Serotypes in V114 and Prevnar 13™: 1 Month Post Vaccination 3, measured over 1 month post vaccination 3 (Month 5).
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | 95% Confidence Interval |
| Unit | Percentage of Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the percentage of participants whose serotype-specific pneumococcal IgG concentration reached at least 0.35 µg/mL one month after Dose 3. The registry record says antibody was measured with the Meso-Scale Discovery Pneumococcal electrochemiluminescence assay. The percentage was summarized separately for each of the 13 common serotypes in V114 and Prevnar 13™.
This threshold-based endpoint turns a measured concentration into a participant-level classification: meeting or not meeting the criterion for a particular serotype. The group percentage then communicates the proportion meeting that criterion. Such a measure can be useful for comparing the distribution of immune responses across treatment groups using a common threshold, while retaining serotype-specific information rather than collapsing all serotypes into one outcome.
The endpoint does not describe the size of antibody concentrations among participants who meet the threshold, and a percentage can conceal variation in concentrations on either side of the cutoff. The registry also lists geometric mean concentration outcomes, which address antibody levels as a continuous measurement. Those measures complement, rather than replace, the primary proportion endpoint. The primary endpoint results themselves are not reported in the registry record, so the observed group proportions and their precision cannot be described from that record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record states the intended comparison: for each of the 13 common serotypes, the proportion reaching the antibody threshold after Dose 3 was to be evaluated for V114 against Prevnar 13™ under a non-inferiority hypothesis. That is a description of the research question, not evidence that the criterion was met. The endpoint estimates, confidence intervals, non-inferiority margin, and formal hypothesis-test results are not reported in the registry record.
Without those results, it is not possible to characterize the observed antibody proportions, compare the groups' response levels, or determine how precisely any difference was estimated. It is also not possible to establish whether the two V114 lots had similar results or how they compared separately with Prevnar 13™. The registry lists 124 analyses and 8 outcome measures, but these counts do not reveal the results or the analysis structure for the primary comparison.
In general, a confidence interval represents a range of values compatible with the data and the statistical procedure used. For a group proportion, its width helps convey the precision of the estimate; for a comparison, the interval can show the uncertainty around the group contrast. In a non-inferiority analysis, interpretation depends on the prespecified margin and on whether the estimated contrast and its uncertainty satisfy the trial's decision rule. The margin and decision rule are not reported in the registry record, so no non-inferiority conclusion can be reconstructed from the stated objective alone.
The endpoint has multiple serotype-specific categories. A result for one serotype would not, by itself, establish the pattern across the others. The registry record's note that the primary outcome has several categories or time points and was not reduced to one comparison is consistent with treating those results as a collection rather than inventing a single summary contrast. However, the actual estimates for those categories are not reported in the registry record.
The safety record lists serious-event counts of 18 among 350 participants in V114 Lot 1, 19 among 347 in V114 Lot 2, and 15 among 347 in Prevnar 13™. It also lists 1 death in V114 Lot 1 and 0 in each of the other groups. These counts are descriptive; the registry record does not report enough context to establish causes, timing, attribution, or comparative statistical uncertainty. Serious adverse event terms and their listed percentages are also recorded, but those summaries should not be treated as proof of a causal relationship or as a complete account of safety.
Overall, the registry record makes the trial's intended immunogenicity comparison clear but does not supply the primary outcome estimates needed to judge the observed results. Interpretation should therefore distinguish the protocol question from reported evidence: the former is available, while the latter is not reported in the registry record.
9. Statistical Methods Explained
The trial's primary endpoint is a binary participant-level classification for each serotype: the measured IgG concentration either reaches the stated threshold or does not. Group results are then expressed as percentages. The registry record identifies the assay and the assessment time, one month after Dose 3, but does not report the statistical model or the exact inferential procedure used for the primary comparisons.
What does a percentage describe?
A percentage describes the share of participants meeting a specified criterion within an analysis group. It is not the average antibody concentration. Participants with values well above the threshold and participants with values just at the threshold both count as meeting it. Likewise, a group percentage does not show the full distribution of individual measurements. The registry separately lists geometric mean concentration outcomes, which provide a summary of antibody levels rather than the fraction exceeding a cutoff.
When comparing groups, it is important to distinguish each group's percentage from the contrast between those percentages. The registry record does not give the observed percentages or the comparison estimates. No difference, ratio, or other contrast can therefore be described from the record. It also does not specify whether the primary analysis used a particular adjustment, confidence-interval method, or test.
How should confidence intervals be read?
The primary endpoint identifies a 95% confidence interval as its dispersion measure. In general, a confidence interval communicates statistical uncertainty around an estimate under the method used to construct it. A narrower interval indicates greater precision than a wider interval, but precision alone does not determine the importance of a finding. Interpretation also depends on the question, the endpoint scale, and—in a non-inferiority analysis—the prespecified margin and decision rule.
The registry record does not report the confidence-interval limits for the primary endpoint. It also does not report the non-inferiority margin. Consequently, the uncertainty around the group estimates and the basis for a formal non-inferiority conclusion are not available in the registry record. A reader should not infer a result from the study's stated hypothesis or its completed status.
What is special about a non-inferiority question?
In general, a non-inferiority design asks whether the intervention's outcome is not worse than the comparator by more than a prespecified amount. That amount is the non-inferiority margin. The result must be evaluated against that margin using the stated analysis and uncertainty measure; merely observing similar point estimates would not establish non-inferiority. The registry describes the objective as non-inferiority for each common serotype but does not report the margin, analysis plan, or primary estimates. No conclusion about whether the objective was achieved can therefore be made from the registry record.
For outcomes evaluated across several serotypes, interpretation also involves the pattern across the set of results. In general, multiple statistical comparisons can increase the chance of at least one apparently unusual result when all are considered together. Approaches to controlling or interpreting multiplicity vary with the scientific objective and prespecified plan. The registry record does not report how multiplicity was addressed, so no adjustment method or family-level error rate should be assumed.
Why can analysis populations matter?
The registry describes the primary population as participants who were not considered protocol violators and had endpoint data available. It lists examples of potential violations, including failure to receive scheduled correct doses within the required timeframe and lack of valid serology results in the stated post-dose period. This definition means the primary analysis population is not necessarily identical to everyone enrolled or randomized. Excluding participants can affect the group represented by the analysis, and the reasons for exclusion may matter when interpreting an estimate.
The population description in the registry record is incomplete: its text ends while describing the validity window. Further detail about exclusions, missing observations, handling of values outside the assay range, and the number analyzed in each group is not reported in the registry record. In general, missing-data methods can affect estimates when missingness is related to response or treatment group. The registry does not provide enough information to assess that possibility or determine whether sensitivity analyses were conducted.
The registry includes 124 analyses and 8 outcome measures, but those counts alone do not identify which results belong to which analysis population or how repeated outcomes were handled. The analysis plan, interim analyses, and sample-size justification are not reported in the registry record. Any planning illustration based on observed effects should be understood as a planning exercise, not as observed power or as evidence about the trial's original design. The registry's listed planning assumptions describe a two-sided significance level of 0.05, equal allocation, and a normal approximation, but no numeric planning outputs are reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The primary question covers 13 common serotypes, with response assessed separately for each. The registry record also lists other immunogenicity outcomes at additional time points and reports 8 outcome measures and 124 analyses. Considering multiple serotypes, outcomes, or times creates a multiplicity issue: in general, the more comparisons examined, the greater the opportunity for some estimates to appear noteworthy by chance. The appropriate approach depends on the prespecified objectives and analysis plan.
The registry record does not report whether the primary serotype-specific comparisons were adjusted for multiplicity, whether a hierarchy of hypotheses was used, or whether the conclusions were intended to apply separately to each serotype or jointly across the set. The number of analyses alone does not establish that a particular adjustment was performed. The statistical plan and any interim analyses are not reported in the registry record.
The primary analysis population is described as participants who were not considered protocol violators and had endpoint data available. The record gives examples of protocol violations but the population description is incomplete. The numbers with available primary endpoint data in each group, the extent and pattern of missing data, and the methods used to handle missing measurements are not reported in the registry record. In general, missingness can affect both the population represented by an analysis and the precision of its estimates.
The record does not describe whether sensitivity analyses assessed alternative analysis populations or assumptions about missing values. Nor does it report the full criteria for a valid serology result. These omissions limit assessment of robustness, particularly for a non-inferiority question, where analysis population and missing-data choices can be relevant. They do not establish that a particular method was or was not used; those details are simply not reported in the registry record.
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 |
|---|---|---|---|
| V114 Lot 1 | 18 | 350 | 5.1% |
| V114 Lot 2 | 19 | 347 | 5.5% |
| Prevnar 13™ | 15 | 347 | 4.3% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| V114 Lot 1 | 1 of 350 |
| V114 Lot 2 | 0 of 347 |
| Prevnar 13™ | 0 of 347 |
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 |
|---|---|
| V114 Lot 1 | 333 of 350 |
| V114 Lot 2 | 337 of 347 |
| Prevnar 13™ | 330 of 347 |
Most frequent serious adverse event terms
| Event term | Organ system | V114 Lot 1 | V114 Lot 2 | Prevnar 13™ |
|---|---|---|---|---|
| Bronchiolitis | Infections and infestations | 2 of 350 | 2 of 347 | 1 of 347 |
| Gastroenteritis viral | Infections and infestations | 2 of 350 | 1 of 347 | 2 of 347 |
| Pneumonia | Infections and infestations | 0 of 350 | 0 of 347 | 3 of 347 |
| Viral infection | Infections and infestations | 0 of 350 | 1 of 347 | 2 of 347 |
| Dehydration | Metabolism and nutrition disorders | 1 of 350 | 2 of 347 | 0 of 347 |
| Vomiting | Gastrointestinal disorders | 0 of 350 | 1 of 347 | 1 of 347 |
| Bronchitis | Infections and infestations | 0 of 350 | 1 of 347 | 1 of 347 |
| Respiratory syncytial virus bronchiolitis | Infections and infestations | 0 of 350 | 1 of 347 | 1 of 347 |
| Supraventricular tachycardia | Cardiac disorders | 1 of 350 | 0 of 347 | 0 of 347 |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | 1 of 350 | 0 of 347 | 0 of 347 |
Most frequent non-serious adverse event terms
| Event term | Organ system | V114 Lot 1 | V114 Lot 2 | Prevnar 13™ |
|---|---|---|---|---|
| Irritability | Psychiatric disorders | 295 of 350 | 301 of 347 | 294 of 347 |
| Somnolence | Nervous system disorders | 221 of 350 | 241 of 347 | 233 of 347 |
| Injection site pain | General disorders | 198 of 350 | 200 of 347 | 162 of 347 |
| Decreased appetite | Metabolism and nutrition disorders | 158 of 350 | 175 of 347 | 154 of 347 |
| Injection site erythema | General disorders | 151 of 350 | 164 of 347 | 153 of 347 |
| Pyrexia | General disorders | 115 of 350 | 128 of 347 | 141 of 347 |
| Injection site induration | General disorders | 117 of 350 | 109 of 347 | 113 of 347 |
| Injection site swelling | General disorders | 98 of 350 | 100 of 347 | 91 of 347 |
| Diarrhoea | Gastrointestinal disorders | 39 of 350 | 44 of 347 | 52 of 347 |
| Vomiting | Gastrointestinal disorders | 27 of 350 | 23 of 347 | 34 of 347 |
Serious events with the highest arm-level rate: pneumonia (0.9%), bronchiolitis (0.6%), gastroenteritis viral (0.6%), viral infection (0.6%), dehydration (0.6%).
The registry lists serious adverse event counts and the number of participants at risk in each group: V114 Lot 1 had 18 among 350, V114 Lot 2 had 19 among 347, and Prevnar 13™ had 15 among 347. The record also lists 1 death for V114 Lot 1 and 0 for each of the other groups. These are counts from the registry record and should be read as descriptive safety information, not as adjusted comparisons.
Listed serious-event terms include pneumonia at 0.9%, bronchiolitis at 0.6%, viral gastroenteritis at 0.6%, viral infection at 0.6%, dehydration at 0.6%, and intussusception at 0.3%. The record does not make clear in these summary figures how event terms overlap within participants or provide details about timing, duration, severity, or attribution. A term appearing in a group does not by itself show that vaccination caused the event.
In general, safety counts are most informative when interpreted alongside event definitions, follow-up duration, exposure, participant characteristics, and the method used to collect events. Those details are not reported in the registry record. The listed counts alone do not establish whether there are meaningful differences between groups, and they should not be treated as a complete safety assessment.
12. What the Result Does, and Does Not, Mean
The registry record identifies a randomized comparison of two V114 lots with Prevnar 13™ in healthy infants, focused on antibody responses and safety. Its primary objective was to compare the proportion meeting a serotype-specific IgG threshold one month after Dose 3, with a stated non-inferiority hypothesis for each common serotype. This defines what the study set out to examine.
The registry record does not report the primary endpoint estimates, confidence intervals, non-inferiority margin, or formal test results. It therefore does not support a conclusion about the observed immune responses or whether the stated non-inferiority objective was met. The study's completed status and its stated objective cannot substitute for those results. The listed secondary geometric mean concentration outcomes likewise do not include results in the registry record.
The recorded serious adverse event counts and death counts offer limited descriptive information. Without detail about event timing, attribution, follow-up, or statistical comparisons, those counts cannot establish a causal relationship or a definitive difference in safety between groups. The listed serious-event terms also should not be interpreted as a comprehensive inventory of every event experienced by participants.
In general, an immunogenicity endpoint measures an immune response and is not itself a measure of disease incidence or clinical protection. A threshold-based proportion also does not describe the full distribution of antibody concentrations. These distinctions matter when interpreting what an endpoint can answer. The registry record presents an immunogenicity question in healthy infants; it does not report clinical disease outcomes or establish what the results imply beyond the measured endpoints.
Accordingly, the record supports a description of the study design, population, endpoint, and selected safety counts, but not a conclusion about comparative efficacy, immunogenicity findings, or overall safety. Additional result estimates and analysis details are not reported in the registry record.
13. Why This Trial Matters Statistically
This trial is statistically notable for separating two questions that can otherwise be conflated: whether immune responses are observed for each serotype, and whether a new vaccine's response is sufficiently close to an active comparator under a non-inferiority framework. The primary endpoint turns assay measurements into threshold-based proportions, so interpretation depends both on the cutoff and on the comparison rule.
Evaluating 13 serotypes separately preserves information about serotype-specific responses but creates a collection of related estimates to interpret. In general, this raises questions about multiplicity, consistency of effects, and how a joint conclusion should be supported. The registry record states the serotype-specific objective but does not report the multiplicity strategy or the results needed to evaluate the pattern.
The trial also distinguishes lot-specific evaluation from comparison with the active comparator. Having separate V114 Lot 1 and V114 Lot 2 groups makes the lot assignments explicit, while the primary question describes V114 in relation to Prevnar 13™. Interpretation of lot consistency would require the corresponding estimates and analysis plan, neither of which is reported in the registry record.
Finally, the record illustrates why a stated hypothesis and a completed trial are not equivalent to a reported statistical conclusion. Without the estimates, confidence intervals, margin, analysis populations, and missing-data information, the strength and precision of the evidence cannot be assessed. The safety counts can be described, but they do not resolve those missing inferential details. This distinction between design intent and available results is central to careful reading of a clinical trial record.
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 registry record does not report the primary endpoint estimates, their confidence intervals, or the non-inferiority margin. These are essential to interpreting the stated primary objective. The record also does not provide a detailed statistical analysis plan, the exact method used to compare groups, or the decision rule for declaring non-inferiority.
The primary population description is incomplete and appears to end during its explanation of the valid-serology window. Group-specific numbers analyzed for the endpoint, reasons for exclusions, and missing-data handling are not reported in the registry record. The registry also does not state how multiplicity across serotypes and other outcomes was addressed. These gaps prevent a full assessment of the robustness and precision of the primary analysis.
Although the trial is described as randomized, double-blind, and multicenter, details about sequence generation, allocation concealment, masking roles, site distribution, and implementation are not reported in the registry record. The record lists the scheduled vaccination ages but does not report adherence, deviations, or the distribution of follow-up time across participants.
Safety information is limited to selected counts and listed serious-event terms. The registry record does not report event-level timing, duration, attribution, exposure-adjusted comparisons, or a fuller account of collection and adjudication. It also does not provide clinical disease outcomes. The enrollment count alone does not show how many participants contributed data to each analysis.
These limitations concern what can be determined from the registry record; they do not establish that the trial lacked analyses or procedures that are not described there. Further statistical and clinical interpretation would require the results and methods that are not reported in the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Two Lots of V114 in Healthy Infants (V114-008) — NCT02987972.
- Registry record last updated 2019-10-23; status last verified 2019-09.
- Results first posted 2019-10-23.
- 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
NCT02987972 is a completed Phase II, randomized, double-blind, multicenter, parallel-group trial sponsored by Merck Sharp & Dohme LLC. It enrolled 1051 healthy infants and compared V114 Lot 1 and V114 Lot 2 with Prevnar 13™. All groups were scheduled to receive 0.5 mL intramuscular injections at 2, 4, 6, and 12-15 months of age.
The primary endpoint was the percentage reaching a serotype-specific pneumococcal IgG concentration of at least 0.35 µg/mL one month after Dose 3, assessed for 13 common serotypes. The stated primary hypothesis was non-inferiority of V114 relative to Prevnar 13™. Primary endpoint results, confidence intervals, the non-inferiority margin, and detailed statistical methods are not reported in the registry record.
The record lists serious-event counts of 18 among 350 for V114 Lot 1, 19 among 347 for V114 Lot 2, and 15 among 347 for Prevnar 13™, with 1 death in V114 Lot 1 and 0 in each other group. These are descriptive counts and do not by themselves establish causal or comparative safety conclusions.