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, Tolerability and Immunogenicity of V114 in Healthy Adults and Infants (V114-004) (NCT02037984), a randomized phase 1, phase 2 study. The primary outcome is Percentage of Adult Participants Experiencing ≥1 Adverse Event (AE).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02037984 |
| Phase | Phase 1, Phase 2 |
| Condition | Streptococcus Pneumoniae Infection, Pneumococcal Infections |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Triple |
| Enrollment | 341 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Merck Sharp & Dohme LLC |
| Results posted | Yes |
2. Clinical Question
Population
Healthy adults in Period 1 were assessed for the primary endpoint. The study also enrolled healthy infants in Period 2, but the primary endpoint concerns adults who received V114. The registry record reports 341 participants enrolled overall.
Intervention
Adults received a single vaccination on Day 1. The adult formulations were V114 1x:1x:1x and V114 2x:2x:2x. Infant participants received one of several V114 formulations according to a four-vaccination schedule.
Comparator
For the primary adult endpoint, the posted results compare the two V114 adult formulation groups. The primary endpoint population description includes adults who received V114. The registry record also lists Prevnar 13® as an intervention in the broader study, including an infant arm.
Primary question
What percentage of adult participants in each V114 group experienced at least one adverse event up to 14 days? The posted results report 100.0% in each adult group, with 20 participants in each group. The registry record does not report a primary endpoint comparison between V114 and Prevnar 13®.
3. Trial Design
This completed study is registered as a Phase I-II randomized, triple-masked, parallel-group trial. It evaluated safety, tolerability, and immunogenicity across five V114 formulations in healthy adults and infants. The overall enrollment was 341. The registry record lists Streptococcus Pneumoniae Infection and Pneumococcal Infections as conditions.
The study was organized in two periods. Adults were enrolled in Period 1, and infants were enrolled in Period 2; the record states that Period 1 would complete before Period 2 began. Adults received a single vaccination on Day 1. Infant participants received four vaccinations at 2, 4, 6, and 12 to 15 months of age. The posted primary endpoint is restricted to adults, while several listed secondary outcomes concern infant antibody responses after later doses.
The intervention list includes Prevnar 13® and five V114 formulations: 1x:1x:1x, 2x:2x:2x, 2x:1x:2x, 1x:1x:2x, and 0.5x:0.5x:2x. Adult arms are listed for the first two formulations; infant arms are listed for all five formulations and Prevnar 13®. The primary results label the second adult arm as Adult V114: 2x.2x.2x, while the arm description uses 2x:2x:2x. The record does not explain this difference in punctuation.
The study is marked completed. Its start date is 2014-01-28 and its primary completion date is 2016-07-01. The registry record does not report the randomization method, allocation ratio, masking procedures, or detailed protocol sequence beyond the two-period description. It also does not report a sample-size justification for the trial.
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.
Only the first 6 of 8 groups are shown.
Overall Study
| Stage | Adult V114: 1x:1x:1x | Adult V114: 2x.2x.2x | Infant V114: 1x:1x:1x | Infant V114: 2x:1x:2x | Infant V114: 2x:2x:2x | Infant V114: 0.5x:0.5x:2x |
|---|---|---|---|---|---|---|
| STARTED | 20 | 20 | 50 | 51 | 50 | 49 |
| COMPLETED | 19 | 20 | 38 | 30 | 38 | 37 |
| NOT COMPLETED | 1 | 0 | 12 | 21 | 12 | 12 |
Reasons for not completing this period:
| Reason | Adult V114: 1x:1x:1x | Adult V114: 2x.2x.2x | Infant V114: 1x:1x:1x | Infant V114: 2x:1x:2x | Infant V114: 2x:2x:2x | Infant V114: 0.5x:0.5x:2x |
|---|---|---|---|---|---|---|
| Lack of Efficacy | 0 | 0 | 3 | 10 | 2 | 2 |
| Lost to Follow-up | 1 | 0 | 3 | 5 | 2 | 2 |
| Physician Decision | 0 | 0 | 0 | 0 | 0 | 0 |
| Protocol Violation | 0 | 0 | 0 | 0 | 0 | 1 |
| Technical Problems | 0 | 0 | 3 | 3 | 2 | 3 |
| Withdrawal by Parent/Guardian | 0 | 0 | 3 | 2 | 5 | 1 |
| Withdrawal by Subject | 0 | 0 | 0 | 1 | 1 | 3 |
Analysis population for the primary outcome, as defined in the registry: Adult participants who received V114 are included.
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.
Population: All randomized and treated participants are included. One participant in the Infant V114: 0.5x:0.5x:2x arm was enrolled and randomized but did not receive any study treatment.
Only the first 6 of 9 groups are shown.
| Characteristic | Unit | Adult V114: 1x:1x:1x | Adult V114: 2x.2x.2x | Infant V114: 1x:1x:1x | Infant V114: 2x:1x:2x | Infant V114: 2x:2x:2x | Infant V114: 0.5x:0.5x:2x |
|---|---|---|---|---|---|---|---|
| Participants analysed | 20 | 20 | 50 | 51 | 50 | 48 | |
| Age, Continuous | Years | 31.3 (SD 8.9) | 31.6 (SD 8.1) | — | — | — | — |
| Age, Continuous | Weeks | — | — | 8.9 (SD 1.4) | 8.7 (SD 1.2) | 8.9 (SD 1.3) | 8.5 (SD 1.5) |
| Sex: Female, Male: Female | Participants | 15 | 12 | 30 | 26 | 23 | 18 |
| Sex: Female, Male: Male | Participants | 5 | 8 | 20 | 25 | 27 | 30 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 1 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 1 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 1 | 0 | 1 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 3 | 4 | 3 | 5 | 4 | 8 |
| Race (NIH/OMB): White | Participants | 15 | 15 | 42 | 44 | 41 | 35 |
| Race (NIH/OMB): More than one race | Participants | 0 | 1 | 4 | 2 | 4 | 5 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Percentage of Adult Participants Experiencing ≥1 Adverse Event (AE), measured over Up to 14 days.
| 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 adult participants experiencing at least one adverse event, with a timeframe of up to 14 days. The registry definition describes an adverse event as an untoward medical occurrence in a participant administered a pharmaceutical product; a causal relationship with treatment is not required. Thus, the endpoint counts an event after vaccination without establishing that vaccination caused it.
The posted results include adults who received V114. Each adult formulation group had 20 participants, and the reported percentage experiencing at least one adverse event was 100.0% in both groups. The endpoint is a binary participant-level outcome: each participant either experienced at least one event during the stated timeframe or did not. It does not convey how many events an individual experienced, how severe those events were, or whether they were considered related to treatment.
Such an endpoint is used to describe short-term event occurrence during a specified observation period. It offers a broad safety summary, but interpretation depends on the event definition, follow-up duration, population, and completeness of event collection. The record does not report a separate causal assessment for the primary endpoint. Serious adverse events are listed separately in the safety results, so the primary endpoint should not be read as a count of serious events.
7. Results Posted in the Registry
- Adult V114: 2x.2x.2x: 100.0% (20/20) versus 100.0% (20/20) on control; risk difference 0.0 percentage points (95% CI 0.0 to 0.0), risk ratio 1.00 (1.00–1.00); unadjusted two-proportion z-test p = n/a.
Risk difference: Adult V114: 2x.2x.2x
95% CI: 0.0 to 0.0 percentage points
Recalculated from the posted summary statistics
8. Statistical Interpretation
The adult primary endpoint results are identical as reported: 20 participants were included in each formulation group, and 100.0% in each group experienced at least one adverse event up to 14 days. The reported risk difference is 0.0, with a confidence interval from 0.0 to 0.0. The posted results therefore show no observed difference in this endpoint between these two adult groups. They do not establish that the formulations have identical safety profiles or that no meaningful difference could exist in other populations, time periods, or outcomes.
The result is a broad measure of any adverse event, not a measure of treatment-related events alone. The endpoint definition explicitly does not require a causal relationship. It also does not distinguish event types or severity. The separate safety listing reports serious adverse events and deaths by group, and those figures should be considered as distinct summaries rather than as details implied by the primary endpoint.
The scope of the comparison is narrow. Both reported groups are adult V114 groups, and the primary endpoint population description specifies adults who received V114. Although the full study included infant groups and a Prevnar 13® arm, the posted primary result does not compare the adult endpoint against Prevnar 13® or report an adult-versus-infant comparison. Infant antibody outcomes listed in the registry address immunogenicity, not the adult primary safety endpoint.
All participants in both adult groups being recorded with at least one event leaves no observed variation in the binary endpoint within either group. That pattern does not show that all events were serious, related to V114, or alike in clinical importance. It also limits the endpoint’s ability to distinguish the groups in this small adult comparison. The registry record does not provide event-level descriptions for the adult primary endpoint, nor does it report the statistical method used to calculate the comparison interval.
The results should be read as descriptive registry findings for the recorded endpoint and timeframe. The record does not report a primary endpoint hypothesis, a prespecified margin for comparing formulations, or a conclusion about equivalence or noninferiority. The confidence interval as posted is 0.0 to 0.0, but its calculation method is not reported in the registry record. It should not be treated as proof that uncertainty about all relevant safety differences is absent.
9. Statistical Methods Explained
The primary outcome is a percentage of participants with an event. In general, this type of outcome reduces each participant’s experience during the specified period to whether at least one qualifying event occurred. The registry reports 20 participants and 100.0% for each adult formulation group. It also reports a risk difference of 0.0 and a confidence interval from 0.0 to 0.0. A risk difference expresses the contrast between two event proportions; the posted estimate indicates no observed difference on that scale.
What the endpoint captures
Because the endpoint counts any adverse event and does not require a causal relationship, it is useful as a broad account of events occurring after administration. It is not, by itself, an estimate of events caused by the intervention. Nor does a single participant-level percentage show event frequency, duration, severity, or recurrence. Those questions require more detailed outcome definitions and event data than this primary endpoint provides.
What a confidence interval communicates
In general, a confidence interval describes the statistical uncertainty around an estimated effect under the assumptions of the method used. Its width is often informative about precision: narrower intervals indicate less uncertainty under that method, while wider intervals indicate more. Here, the posted interval runs from 0.0 to 0.0. The registry record does not state how the interval was calculated, so the method and assumptions behind that particular interval cannot be evaluated from the record alone. The displayed values should be described as posted, not as an independently verified analysis.
How to interpret a binary comparison
A binary endpoint records whether an event occurred for each participant. In general, comparisons can be expressed as a risk difference or a relative measure such as a risk ratio. A risk difference is expressed on an absolute scale, while a risk ratio compares the proportions relative to one another. The posted comparison includes a risk difference and a risk ratio, but the primary interpretation can remain focused on the reported event percentages and risk difference. Since all participants in both adult groups are reported as having at least one event, the observed proportions are the same.
The registry record does not report the inferential test, confidence-interval construction, adjustment variables, or a statistical analysis plan. It does not say whether the analysis was prespecified as superiority, equivalence, or noninferiority. Consequently, the result cannot be interpreted as a formal demonstration of any of those claims. General statistical methods can explain the meaning of the outcome and effect scale, but cannot fill in an undocumented analysis plan.
How to read planning illustrations
Planning sample sizes are different from observed trial results. The planning assumptions described for the registry-based illustration use a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The target effect is expressed as a stated fraction of the observed effect. The illustration is based on the observed effect and is not the trial’s own design justification. It does not describe the trial’s achieved power, and a calculated planning count should not be interpreted as an observed participant count or as evidence that the trial was adequately powered.
General sample-size planning depends on the effect to be detected, variability or event rates, chosen error thresholds, allocation, and analysis method. For a binary endpoint, the assumed event proportions matter. When an observed endpoint shows the same reported percentage in both groups, planning from that observed contrast requires particular caution: it does not supply an independent clinical target or justify a claim about the study’s original design. The registry record does not report the original sample-size assumptions or rationale.
The primary outcome is adult-only, whereas the trial also includes infant safety and immunogenicity outcomes. Analyses across distinct populations and outcomes should not be collapsed into one overall result. The registry lists 21 outcome measures and 150 analyses, but does not report which analyses were primary to a full analysis plan or how the family of analyses was handled statistically. The primary endpoint can therefore be interpreted on its own terms, with the limitations of the available analysis description kept in view.
10. Confidence Intervals and Precision
The posted adult endpoint estimate is 100.0% in both groups, with 20 participants in each. The reported risk difference is 0.0, and its confidence interval is 0.0 to 0.0. These are the recorded values for the adult primary endpoint comparison. The record does not state the confidence-interval method, so the interval’s construction and assumptions are not reported in the registry record.
In general, precision refers to how tightly an estimate is determined by the data under a statistical method. Confidence intervals communicate uncertainty around an estimate, but their interpretation depends on the method and assumptions used. A point estimate alone does not show how much uncertainty remains. Here, the interval as posted has no displayed width, but that should not be taken as evidence that all uncertainty is absent. The registry record does not explain how an interval with these endpoints was obtained or whether it reflects a particular convention for this outcome pattern.
Both adult groups have the same reported percentage, and every participant in each group is recorded as having at least one event. This leaves no observed variation in the endpoint between participants within either group. The result therefore provides a limited basis for distinguishing event proportions between the two formulations in this sample. The endpoint also summarizes any adverse event, without indicating event severity or causality, and covers only the stated period of up to 14 days.
Precision for this adult comparison should not be generalized to the infant groups, other outcomes, or longer follow-up. The registry record does not provide an adult primary endpoint comparison with Prevnar 13®, nor does it give an analysis plan or the method used for the reported interval. Those omissions constrain how fully the numerical precision can be assessed.
11. Multiplicity, Missing Data and Analysis Populations
The registry lists 21 outcome measures and 150 analyses; 10 secondary outcomes are posted. The secondary outcome descriptions include infant serotype-specific IgG threshold results after doses 3 and 4 and an infant geometric mean concentration outcome. These are distinct questions from the adult primary endpoint and involve multiple formulations, serotypes, and timepoints as described in the registry.
When many outcomes or comparisons are examined, the chance of observing a nominally notable result somewhere among them can increase. General approaches to multiplicity include prespecifying a primary comparison, controlling an error rate, or treating analyses as exploratory. The registry record does not report a multiplicity adjustment, a hierarchy among outcomes, or a detailed plan for interpreting the analyses collectively. The number of listed analyses alone does not show which adjustment, if any, was used.
The adult primary endpoint population is described as adults who received V114. The record does not give a more detailed analysis-population definition, such as rules for exclusions or how participants with incomplete endpoint information were handled. Missing-data procedures, imputation, and the amount of missing primary endpoint data are not reported in the registry record. The posted group denominators are 20 and 20, but they do not by themselves explain whether all randomized adults were included or whether any participants were excluded before analysis.
The registry record also does not report interim analyses, stopping rules, or a complete statistical analysis plan. Without those details, readers cannot determine from the record whether all analyses followed a prespecified plan or how multiplicity and missing information were addressed. This does not establish that these procedures were absent; it means they are not reported in the registry record.
12. 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 |
|---|---|---|---|
| Adult: V114-1x:1x:1x | 0 | 20 | 0.0% |
| Adult: V114-2x:2x:2x | 0 | 20 | 0.0% |
| Infant: V114-1x:1x:1x | 1 | 50 | 2.0% |
| Infant: V114-2x:1x:2x | 4 | 51 | 7.8% |
| Infant: V114-2x:2x:2x | 3 | 50 | 6.0% |
| Infant: V114-0.5x:0.5x:2x | 3 | 48 | 6.2% |
| Infant: V114-1x:1x:2x | 0 | 50 | 0.0% |
| Infant: Prevnar 13 | 5 | 51 | 9.8% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Adult: V114-1x:1x:1x | 0 of 20 |
| Adult: V114-2x:2x:2x | 0 of 20 |
| Infant: V114-1x:1x:1x | 0 of 50 |
| Infant: V114-2x:1x:2x | 0 of 51 |
| Infant: V114-2x:2x:2x | 0 of 50 |
| Infant: V114-0.5x:0.5x:2x | 0 of 48 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Adult: V114-1x:1x:1x | 20 of 20 |
| Adult: V114-2x:2x:2x | 20 of 20 |
| Infant: V114-1x:1x:1x | 49 of 50 |
| Infant: V114-2x:1x:2x | 51 of 51 |
| Infant: V114-2x:2x:2x | 48 of 50 |
| Infant: V114-0.5x:0.5x:2x | 46 of 48 |
Most frequent serious adverse event terms
| Event term | Organ system | Adult: V114-1x:1x:1x | Adult: V114-2x:2x:2x | Infant: V114-1x:1x:1x | Infant: V114-2x:1x:2x | Infant: V114-2x:2x:2x | Infant: V114-0.5x:0.5x:2x |
|---|---|---|---|---|---|---|---|
| Bronchiolitis | Infections and infestations | 0 of 20 | 0 of 20 | 0 of 50 | 0 of 51 | 2 of 50 | 0 of 48 |
| Viral infection | Infections and infestations | 0 of 20 | 0 of 20 | 0 of 50 | 0 of 51 | 2 of 50 | 0 of 48 |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | 0 of 20 | 0 of 20 | 0 of 50 | 0 of 51 | 0 of 50 | 1 of 48 |
| Anal abscess | Infections and infestations | 0 of 20 | 0 of 20 | 0 of 50 | 1 of 51 | 0 of 50 | 0 of 48 |
| Bacteraemia | Infections and infestations | 0 of 20 | 0 of 20 | 0 of 50 | 1 of 51 | 0 of 50 | 0 of 48 |
| Gastroenteritis viral | Infections and infestations | 0 of 20 | 0 of 20 | 1 of 50 | 0 of 51 | 0 of 50 | 0 of 48 |
| Respiratory syncytial virus infection | Infections and infestations | 0 of 20 | 0 of 20 | 0 of 50 | 1 of 51 | 0 of 50 | 0 of 48 |
| Viral upper respiratory tract infection | Infections and infestations | 0 of 20 | 0 of 20 | 0 of 50 | 1 of 51 | 0 of 50 | 0 of 48 |
| Skull fracture | Injury, poisoning and procedural complications | 0 of 20 | 0 of 20 | 0 of 50 | 1 of 51 | 0 of 50 | 0 of 48 |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | 0 of 20 | 0 of 20 | 0 of 50 | 0 of 51 | 0 of 50 | 1 of 48 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Adult: V114-1x:1x:1x | Adult: V114-2x:2x:2x | Infant: V114-1x:1x:1x | Infant: V114-2x:1x:2x | Infant: V114-2x:2x:2x | Infant: V114-0.5x:0.5x:2x |
|---|---|---|---|---|---|---|---|
| Injection site pain | General disorders | 20 of 20 | 20 of 20 | 47 of 50 | 46 of 51 | 40 of 50 | 37 of 48 |
| Irritability | Psychiatric disorders | 0 of 20 | 0 of 20 | 47 of 50 | 49 of 51 | 47 of 50 | 40 of 48 |
| Somnolence | Nervous system disorders | 0 of 20 | 0 of 20 | 42 of 50 | 43 of 51 | 42 of 50 | 36 of 48 |
| Injection site erythema | General disorders | 7 of 20 | 6 of 20 | 22 of 50 | 33 of 51 | 26 of 50 | 29 of 48 |
| Decreased appetite | Metabolism and nutrition disorders | 0 of 20 | 0 of 20 | 23 of 50 | 31 of 51 | 32 of 50 | 27 of 48 |
| Injection site swelling | General disorders | 7 of 20 | 6 of 20 | 19 of 50 | 28 of 51 | 21 of 50 | 25 of 48 |
| Injection site induration | General disorders | 0 of 20 | 0 of 20 | 21 of 50 | 27 of 51 | 19 of 50 | 26 of 48 |
| Pyrexia | General disorders | 0 of 20 | 3 of 20 | 13 of 50 | 16 of 51 | 17 of 50 | 13 of 48 |
| Upper respiratory tract infection | Infections and infestations | 0 of 20 | 0 of 20 | 3 of 50 | 7 of 51 | 7 of 50 | 9 of 48 |
| Myalgia | Musculoskeletal and connective tissue disorders | 13 of 20 | 11 of 20 | 0 of 50 | 0 of 51 | 0 of 50 | 0 of 48 |
Serious events with the highest arm-level rate: bronchiolitis (4.0%), viral infection (4.0%), gastrooesophageal reflux disease (2.1%), respiratory distress (2.1%), tachypnoea (2.1%).
The serious adverse event summary reports 0 affected participants among 20 adults in each V114 group. Among the infant groups, the recorded serious adverse event counts are 1 of 50 for V114 1x:1x:1x, 4 of 51 for V114 2x:1x:2x, 3 of 50 for V114 2x:2x:2x, 3 of 48 for V114 0.5x:0.5x:2x, 0 of 50 for V114 1x:1x:2x, and 5 of 51 for Prevnar 13®. Deaths are reported as 0 in every listed group.
These figures describe the number of participants recorded with serious adverse events in each group. They are not the primary endpoint, which counts participants with at least one adverse event of any type up to 14 days in adults. The serious-event group summaries do not establish whether an event was caused by an intervention. The registry record does not provide a comparative statistical analysis of serious adverse events.
The record lists Bronchiolitis and Viral infection at 4.0% each among the most frequent serious terms, and Gastrooesophageal reflux disease, Respiratory distress, and Tachypnoea at 2.1% each; Gastroenteritis viral is listed at 2.0%. These are the reported term percentages. They should be read as event listings, not as evidence of causal association or as a substitute for group-specific comparative analysis. The registry record does not further describe the denominator convention for these listed terms.
13. What the Result Does, and Does Not, Mean
The posted adult result establishes a descriptive finding: the two V114 groups each had 20 participants, and the recorded percentage experiencing at least one adverse event up to 14 days was 100.0% in each group. The reported risk difference is 0.0, with a confidence interval from 0.0 to 0.0. The result does not show an observed difference on this endpoint between the two adult formulations.
That finding is not a general conclusion about all safety outcomes. The endpoint includes any untoward medical occurrence and does not require the event to be related to treatment. It does not indicate how many events occurred, whether participants experienced the same event types, or whether the events had similar severity. Serious adverse events are summarized separately, and those counts should not be inferred from the primary endpoint’s 100.0% values.
The result also does not establish equivalence or noninferiority. The registry record does not report a margin for either claim, a formal hypothesis framework, or the statistical method used for the posted interval. An identical observed percentage is not, by itself, proof that the underlying event probabilities are identical. The primary result concerns adults receiving V114, not infants, not all five V114 formulations, and not a comparison with the infant Prevnar 13® group.
The study’s infant outcomes address immunogenicity, including threshold attainment for serotype-specific IgG and geometric mean concentrations. These measures answer different questions from the adult adverse-event endpoint. They should not be treated as interchangeable evidence or combined into one overall treatment conclusion.
Planning illustrations based on observed effects are also not trial results. They describe assumptions for a hypothetical future design, not the number of participants observed in this study and not the trial’s achieved power. The registry record does not report the trial’s original sample-size justification. Overall, the posted figures can be used to describe the recorded outcomes and their stated scope, while broader conclusions remain limited by the endpoint, population, follow-up, and analysis details reported in the registry.
14. Why This Trial Matters Statistically
This trial is statistically informative because it places a broad safety endpoint alongside infant immunogenicity outcomes in a study with distinct adult and infant periods. Keeping the populations and endpoints separate is essential: the adult primary endpoint measures occurrence of any adverse event over a short stated period, while infant secondary outcomes concern antibody thresholds and concentrations after specified doses.
The adult endpoint produces a strikingly uniform observed result: both groups report 100.0% with at least one adverse event, among 20 participants per group. That uniformity makes clear why a percentage alone is not a complete account of safety. Event type, seriousness, causal assessment, and follow-up duration all affect interpretation, and the registry reports some of those details separately rather than within the primary outcome.
The posted risk difference and confidence interval also illustrate the importance of understanding how a statistic was obtained. The estimate is 0.0 and the interval is 0.0 to 0.0, but the method is not reported. Statistical interpretation depends not only on numerical results but also on the analysis plan and assumptions. A reader should distinguish a posted interval from a fully documented inferential analysis.
Finally, the record lists many outcome measures and analyses, while leaving multiplicity procedures and missing-data handling undocumented. This makes transparent reporting especially important. The trial record supports a focused description of the adult endpoint and the listed safety counts; it does not support treating the many distinct outcomes as one unified test or assuming that unreported methods were used in a particular way.
15. 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.
- Participant counts were reconstructed from posted percentages and arm sizes, so small rounding differences are possible.
The primary endpoint covers adults who received V114 and a timeframe of up to 14 days. It does not describe longer-term safety, infant primary safety outcomes, or event rates for the full study population. The primary result reports 20 participants per adult formulation group, while overall enrollment was 341; the registry record does not explain the flow from total enrollment to the primary endpoint denominators.
The endpoint counts any adverse event regardless of causal relationship. It therefore cannot distinguish events considered related to vaccination from events that occurred for other reasons. The registry record does not provide event-level details for the adult primary outcome, such as event type, severity, duration, or recurrence. The separate serious adverse event summary gives participant counts, but no comparative statistical analysis is reported for those counts.
The posted adult comparison is limited to two V114 formulations. Although Prevnar 13® is listed as an intervention for infants, the primary endpoint results do not provide an adult comparison with that intervention. The record also contains a punctuation difference in the second adult group label: the primary results use 2x.2x.2x, while the arm description uses 2x:2x:2x. The record does not clarify the labeling discrepancy.
Important analysis details are not reported in the registry record. These include the confidence-interval method, missing-data handling, detailed analysis-population rules, multiplicity adjustment, interim analyses, and the trial’s sample-size rationale. The record does not report whether outcome assessment was adjusted for covariates or which inferential framework was prespecified. These limitations constrain interpretation without showing that any particular procedure was or was not performed.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: Safety, Tolerability and Immunogenicity of V114 in Healthy Adults and Infants (V114-004) — NCT02037984.
- Registry record last updated 2019-06-24; status last verified 2019-06.
- Results first posted 2019-04-30.
- 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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19. Record Summary
NCT02037984 is a completed Phase I-II randomized, triple-masked, parallel-group study of V114 safety, tolerability, and immunogenicity in healthy adults and infants. Overall enrollment was 341. Adults were enrolled in Period 1 and infants in Period 2. Adult participants received a single vaccination on Day 1; infant participants received four vaccinations at 2, 4, 6, and 12 to 15 months of age.
The primary endpoint was the percentage of adult participants experiencing at least one adverse event up to 14 days. The posted result is 100.0% in each of two adult groups, with 20 participants in each group. The reported risk difference is 0.0, with a confidence interval from 0.0 to 0.0. Serious adverse events and deaths are summarized separately by group. The registry record does not report the confidence-interval method, detailed missing-data procedures, multiplicity approach, or original sample-size justification.