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 of Pneumococcal Conjugate Vaccine (V114) Compared to a Marketed Vaccine (V114-003) (NCT01215188), a randomized phase 2 study. The primary outcome is Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific ≥0.35 μg/mLThreshold Value for Postvaccination 3.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01215188 |
| Phase | Phase 2 |
| Condition | Pneumococcal Infections |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 1152 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Merck Sharp & Dohme LLC |
| Results posted | Yes |
2. Clinical Question
Population
Healthy infants were enrolled in a randomized trial. For the primary endpoint, the analysis population included infants without a protocol violation that could have affected the validity of antibody responses. The registry record does not give further demographic details or describe how many enrolled infants were included in that analysis.
Intervention
The trial included aluminum-adjuvanted V114 and non-adjuvanted V114. Each was given as four intramuscular doses at 0.5 mL, scheduled at 2, 4, 6, and 12 to 15 months of age.
Comparator
The comparator was Prevnar 13®, also given as four intramuscular doses at 0.5 mL on the same schedule. The study was randomized, quadruple-masked, and used a parallel-group design.
Primary question
The primary endpoint measured the percentage of participants reaching an IgG concentration of at least 0.35 μg/mL for specified pneumococcal serotypes one month after dose 3. The study summary describes evaluating whether either V114 formulation was non-inferior to Prevnar 13® based on responses to the 13 serotypes the vaccines have in common. The endpoint description also includes two serotypes not in common with Prevnar 13®. The registry record does not report a non-inferiority margin or a posted comparison result.
3. Trial Design
This was a randomized, quadruple-masked, parallel-group phase 2 study of pneumococcal conjugate vaccines in healthy infants. The registry record names the trial V114-003 and gives its official title as a multicenter study of safety, tolerability, and immunogenicity of V114 compared with Prevnar 13®. It lists an enrollment of 1152. The record describes three intervention groups: aluminum-adjuvanted V114, non-adjuvanted V114, and Prevnar 13®.
Each group was assigned four intramuscular doses of 0.5 mL. The scheduled ages were 2, 4, 6, and 12 to 15 months. The primary immune endpoint was assessed one month after dose 3. The registry record also lists secondary antibody outcomes after doses 3 and 4, including the percentage with an OPA titer at least 8, OPA geometric mean titers, and percentages meeting specified IgG thresholds after dose 4.
The study began on 2010-10-14, reached primary completion on 2012-07-31, and is listed as completed. The stated condition is pneumococcal infections. Although the trial summary describes non-inferiority as the question for antibody responses to the 13 serotypes in common, the registry record does not report the non-inferiority margin, the randomization procedure, or the statistical analysis plan. It also does not report how masking was maintained in practice or whether any interim analyses were planned.
The record lists zero analyses. Consequently, the design information establishes the intended comparison and outcome framework, but does not establish the numerical immune-response findings or the conclusions drawn from them.
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: There were 1152 participants randomized into the study. The 1142 participants included in this study excluded 4 subjects who each received a combination of vaccines and who each had a final disposition of completed and excludes an additional 6 subjects who were randomized but never vaccinated.
Overall Study
| Stage | V114 Adjuvanted | V114 Nonadjuvanted | PREVNAR 13® |
|---|---|---|---|
| STARTED | 378 | 386 | 378 |
| COMPLETED | 320 | 327 | 326 |
| NOT COMPLETED | 58 | 59 | 52 |
Reasons for not completing this period:
| Reason | V114 Adjuvanted | V114 Nonadjuvanted | PREVNAR 13® |
|---|---|---|---|
| Lost to Follow-up | 22 | 22 | 16 |
| Adverse Event | 1 | 1 | 3 |
| Physician Decision | 2 | 1 | 0 |
| Lack of Efficacy | 0 | 0 | 1 |
| Protocol Violation | 1 | 1 | 1 |
| Withdrawal by Subject | 32 | 34 | 31 |
Analysis population for the primary outcome, as defined in the registry: The analysis population included all infant participants who did not have a protocol violation that could have impacted the validity of the antibody responses.
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 Adjuvanted | V114 Nonadjuvanted | PREVNAR 13® | Total |
|---|---|---|---|---|---|
| Participants analysed | 378 | 386 | 378 | 1142 | |
| Age, Customized | Weeks | 8.9 (SD 1.2) | 8.8 (SD 1.2) | 8.7 (SD 1.1) | 8.8 (SD 1.2) |
| Sex: Female, Male: Female | Participants | 177 | 189 | 179 | 545 |
| Sex: Female, Male: Male | Participants | 201 | 197 | 199 | 597 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 70 | 77 | 79 | 226 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 308 | 309 | 299 | 916 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 28 | 31 | 25 | 84 |
| Race (NIH/OMB): Asian | Participants | 10 | 5 | 7 | 22 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 1 | 0 | 0 | 1 |
| Race (NIH/OMB): Black or African American | Participants | 44 | 43 | 40 | 127 |
| Race (NIH/OMB): White | Participants | 268 | 288 | 275 | 831 |
| Race (NIH/OMB): More than one race | Participants | 27 | 18 | 31 | 76 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 1 | 0 | 1 |
6. Primary Endpoint
The registry lists the primary outcome as Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific ≥0.35 μg/mLThreshold Value for Postvaccination 3, measured over One month postvaccination 3.
| 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 meeting a serotype-specific IgG reference level one month after postvaccination dose 3. The threshold is at least 0.35 μg/mL, measured using the pneumococcal polysaccharide electrochemiluminescence assay. The description relates this reference level to the World Health Organization enzyme-linked immunosorbent assay threshold of at least 0.35 μg/mL.
The endpoint covers the 13 serotypes in common with Prevnar 13®—serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F—and two serotypes not in common with Prevnar 13®, serotypes 22F and 33F. It is a binary-response summary: for each participant and serotype, the concentration either meets the specified threshold or does not. The reported measure would be the percentage meeting the threshold, with a 95% confidence interval listed as the endpoint’s dispersion measure.
As a general statistical concept, a threshold-based response is useful because it gives an interpretable summary of how many participants reached a defined antibody level. It also simplifies a continuous concentration measurement into a response category, so it does not describe the full distribution of antibody concentrations. The registry record does not report endpoint values, confidence intervals, or a single comparison result. It therefore does not establish how responses differed between groups.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies an immunogenicity endpoint and the intended vaccine comparisons, but it does not include a posted analysis of the primary outcome. It describes the percentage meeting the IgG threshold for each specified serotype and notes that a 95% confidence interval was the planned way to express dispersion. However, it gives no group percentages, confidence interval bounds, treatment contrasts, p-values, or other numerical primary results. No conclusion about the relative antibody responses can be drawn from the record’s endpoint description alone.
The study summary frames the question as whether either V114 formulation is non-inferior to Prevnar 13® for responses to the 13 serotypes the vaccines have in common. A non-inferiority conclusion depends on comparing an estimated treatment difference with a prespecified margin. The registry record does not report that margin, an estimated difference, or an analysis against the margin. The fact that non-inferiority is the stated question is not evidence that the criterion was met.
The endpoint description covers 15 serotypes: the 13 in common and two not in common. The summary’s non-inferiority question is specifically framed around the common serotypes. The registry record does not present a single collapsed comparison across these serotypes, and the outcome is identified as having several categories or time points rather than being reduced to one comparison. Because there are no posted analyses, it is not possible to determine how results varied by serotype or whether any prespecified aggregate was used.
The enrollment entry is 1152, but that number does not tell the reader how many participants contributed data to each endpoint, serotype, or treatment comparison. The primary analysis population is described in terms of excluding participants with protocol violations that could have affected antibody-response validity, but the record does not report the resulting analysis counts. Nor does it give missing outcome counts or their handling.
Safety figures are listed separately for serious and other adverse events, along with deaths and selected serious-event terms. These are descriptive counts and listed percentages, not a comparative safety analysis with uncertainty estimates. They do not by themselves establish whether events were caused by vaccination, or whether differences between groups are meaningful. The registry record is therefore informative about the intended design, endpoint definitions, and selected event counts, but is insufficient for a statistical assessment of comparative efficacy or safety.
9. Statistical Methods Explained
What does a percentage meeting a threshold represent?
The primary endpoint is a binary response summarized as a percentage. Each participant’s measured IgG concentration for a serotype is classified according to whether it reaches the specified threshold. A group percentage describes the share of participants who meet that criterion; it does not show how far above or below the threshold individual measurements lie. Two groups could have similar percentages while having different distributions of concentrations, or different percentages despite broadly overlapping distributions.
As a general statistical concept, a confidence interval expresses uncertainty around an estimate under the assumptions of the analysis. A 95% confidence interval is listed for this endpoint. Its width would depend in part on the number of usable observations and the variability in responses. Narrower intervals generally indicate more precise estimates, while wider intervals indicate greater uncertainty. The registry record does not report the actual interval bounds or the group estimates, so their precision cannot be assessed.
How does non-inferiority differ from a test for any difference?
In a non-inferiority study, the question is whether the candidate treatment’s outcome is not worse than the comparator by more than a prespecified amount considered acceptable for the study. That amount is the non-inferiority margin. The analysis compares the estimated group difference and its uncertainty with that margin. A non-significant test for a difference is not, on its own, evidence of non-inferiority: failure to detect a difference can also reflect imprecision.
The trial summary states that non-inferiority was the intended question for immune responses to the 13 serotypes shared with Prevnar 13®. The margin, contrast definition, and decision rule are not reported in the registry record. There are also no posted effect estimates or confidence intervals. As a result, the non-inferiority framework can be described, but its application and outcome cannot be evaluated from the record.
Why do multiple serotypes matter?
The primary endpoint description names 13 serotypes shared with the comparator and two additional serotypes. Responses are serotype-specific: a result for one serotype does not automatically describe responses to another. Reporting many serotype-level results raises a multiplicity issue. When numerous hypotheses are tested, the chance of at least one apparently unusual result can increase if no adjustment or interpretive strategy is used. As a general statistical concept, multiplicity can be handled through a prespecified hierarchy, adjustment, or a clearly defined descriptive interpretation. The registry record does not report which approach, if any, was used for the primary or secondary outcomes.
The record lists secondary outcomes after postvaccination doses 3 and 4. These include threshold-based OPA responses, OPA geometric mean titers, and IgG threshold responses. These outcomes describe different features of immune response and are not interchangeable. A percentage above a threshold summarizes the frequency of a defined response; a geometric mean titer summarizes titer levels on a multiplicative scale. The record does not post results for these outcomes or explain how their multiplicity was addressed.
What role does the analysis population play?
The primary analysis population is defined as infant participants without a protocol violation that could have affected antibody-response validity. This is a population definition, not a count. Excluding participants can affect the interpretation of a randomized comparison if the exclusions differ across groups or relate to outcomes. The registry record does not report the number excluded, the reasons by group, or whether another analysis population was used as a sensitivity analysis.
Missing outcome data can also affect a percentage estimate. For example, the denominator may depend on which participants have a usable assay result for a given serotype and time point. As a general concept, methods for missing data should be described because different assumptions can lead to different estimates. The registry record does not report missing-data counts, imputation methods, or sensitivity analyses.
What can be inferred from the safety counts?
Adverse-event counts are descriptive unless accompanied by a specified analysis that accounts for follow-up, event definitions, and uncertainty. The registry record lists serious-event and other-event counts with at-risk denominators, as well as deaths. It does not report comparative effect estimates or confidence intervals for these outcomes. Counts alone cannot establish causality or quantify the precision of between-group differences.
The registry record also does not report a statistical analysis plan, the exact methods used for the antibody comparisons, or whether analyses were adjusted for any covariates. General statistical principles can explain why these details matter, but they cannot substitute for a trial-specific method description. In particular, the posted design and endpoint definitions do not reveal whether the reported analyses, if any, followed a prespecified plan.
10. Multiplicity, Missing Data and Analysis Populations
The primary outcome covers multiple serotypes, and the registry record also lists multiple secondary outcomes at different postvaccination time points. Such a collection of comparisons raises multiplicity questions: without a prespecified strategy, interpreting isolated results can overstate the strength of evidence. The record does not report a multiplicity adjustment, a testing hierarchy, or another method for controlling or interpreting multiple comparisons. It also does not report which outcomes, if any, were designated for confirmatory testing beyond the listed primary endpoint.
The endpoint analysis population includes infant participants without a protocol violation that could have affected antibody-response validity. The definition does not specify how many participants met it or how exclusions were distributed across groups. The registry record does not report missing assay results, incomplete follow-up, or the method used to handle missing endpoint data. It also does not report sensitivity analyses assessing the effect of exclusions or missing measurements.
These omissions matter because a percentage is interpreted in relation to the participants who contribute to its denominator. If the available measurements differ across groups or serotypes, estimates may not be directly comparable. This is a general statistical concern, not evidence that such imbalance occurred in this trial.
The registry record lists zero analyses. It therefore does not provide enough information to judge how multiplicity, missing observations, or the stated analysis-population rule were handled in practice. The analysis population definition is available, but details of its implementation and the resulting endpoint estimates are 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 | 25 | 368 | 6.8% |
| V114 Non-Adjuvanted | 27 | 382 | 7.1% |
| Prevnar | 29 | 376 | 7.7% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| V114 | 1 of 368 |
| V114 Non-Adjuvanted | 1 of 382 |
| Prevnar | 2 of 376 |
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 | 345 of 368 |
| V114 Non-Adjuvanted | 348 of 382 |
| Prevnar | 347 of 376 |
Most frequent serious adverse event terms
| Event term | Organ system | V114 | V114 Non-Adjuvanted | Prevnar |
|---|---|---|---|---|
| Respiratory syncytial virus bronchiolitis | Infections and infestations | 6 of 368 | 7 of 382 | 6 of 376 |
| Bronchiolitis | Infections and infestations | 5 of 368 | 6 of 382 | 4 of 376 |
| Gastroenteritis | Infections and infestations | 4 of 368 | 1 of 382 | 1 of 376 |
| Cellulitis | Infections and infestations | 1 of 368 | 0 of 382 | 3 of 376 |
| Pneumonia | Infections and infestations | 2 of 368 | 0 of 382 | 2 of 376 |
| Gastroenteritis viral | Infections and infestations | 0 of 368 | 1 of 382 | 2 of 376 |
| Influenza | Infections and infestations | 2 of 368 | 1 of 382 | 0 of 376 |
| Upper respiratory tract infection | Infections and infestations | 0 of 368 | 2 of 382 | 1 of 376 |
| Pyrexia | General disorders | 0 of 368 | 0 of 382 | 2 of 376 |
| Sudden infant death syndrome | General disorders | 1 of 368 | 0 of 382 | 1 of 376 |
Most frequent non-serious adverse event terms
| Event term | Organ system | V114 | V114 Non-Adjuvanted | Prevnar |
|---|---|---|---|---|
| Irritability | General disorders | 315 of 368 | 311 of 382 | 306 of 376 |
| Injection site pain | General disorders | 264 of 368 | 280 of 382 | 271 of 376 |
| Somnolence | Nervous system disorders | 263 of 368 | 281 of 382 | 265 of 376 |
| Decreased appetite | Metabolism and nutrition disorders | 212 of 368 | 195 of 382 | 196 of 376 |
| Injection site erythema | General disorders | 217 of 368 | 179 of 382 | 201 of 376 |
| Injection site swelling | General disorders | 181 of 368 | 132 of 382 | 165 of 376 |
| Injection site induration | General disorders | 163 of 368 | 112 of 382 | 160 of 376 |
| Pyrexia | General disorders | 123 of 368 | 86 of 382 | 110 of 376 |
| Diarrhoea | Gastrointestinal disorders | 36 of 368 | 26 of 382 | 36 of 376 |
| Upper respiratory tract infection | Infections and infestations | 30 of 368 | 41 of 382 | 26 of 376 |
Serious events with the highest arm-level rate: respiratory syncytial virus bronchiolitis (1.8%), bronchiolitis (1.6%), gastroenteritis (1.1%), cellulitis (0.8%), gastritis viral (0.5%).
The registry record lists three safety groups: V114, V114 Non-Adjuvanted, and Prevnar. For serious adverse events, the listed counts and at-risk denominators are 25 of 368 for V114, 27 of 382 for V114 Non-Adjuvanted, and 29 of 376 for Prevnar. For other adverse events, the listed counts and denominators are 345 of 368, 348 of 382, and 347 of 376, respectively. The record also lists deaths as 1, 1, and 2 across those groups. These are registry counts; they are not recalculated into percentages or comparative estimates.
The listed serious-event terms and percentages include respiratory syncytial virus bronchiolitis at 1.8%, bronchiolitis at 1.6%, gastroenteritis at 1.1%, cellulitis at 0.8%, gastritis viral at 0.5%, and influenza at 0.5%. The registry record does not provide further context for interpreting these terms, such as event-level timing or a comparative analysis.
Counts do not show whether events were caused by a vaccine. Nor do they account, by themselves, for uncertainty in comparisons. The record does not report confidence intervals or adjusted analyses for these safety outcomes.
12. What the Result Does, and Does Not, Mean
The registry record establishes that this was a randomized, quadruple-masked phase 2 comparison of two V114 formulations with Prevnar 13® in healthy infants. It defines an antibody-response endpoint based on the percentage reaching an IgG threshold after dose 3 and describes the study’s non-inferiority question for shared serotypes. These details explain what investigators intended to compare; they do not provide the comparative results.
No primary outcome analyses are posted in the registry record. There are no reported response percentages, confidence intervals, or treatment contrasts from which to judge the size or precision of any difference. The record therefore does not establish whether either V114 formulation met a non-inferiority criterion. It also does not establish the direction or consistency of responses across individual serotypes.
The endpoint is a threshold-based measure, not a direct description of all antibody concentrations. Even if a percentage result were available, it would need to be interpreted alongside the assay, the chosen threshold, the uncertainty interval, and the intended comparison. The trial summary’s non-inferiority framing also requires the margin and analysis rule, neither of which is reported in the registry record.
The safety entries describe observed event counts and selected serious-event terms. They do not prove that a vaccine caused an event, and the counts alone do not show whether apparent differences are precise or meaningful. The registry record does not report a comparative safety analysis or uncertainty estimates for these entries.
These limits are specific to the information in the registry record. They do not imply that analyses were never conducted elsewhere; they mean that the registry record does not report them. A reader should distinguish the trial’s planned questions and recorded event counts from evidence that would require posted outcome analyses.
13. Why This Trial Matters Statistically
This trial illustrates why a randomized design and a clearly defined endpoint are only part of the information needed to interpret a clinical study. Randomization, quadruple masking, and parallel groups describe important features of the planned comparison. The antibody endpoint further specifies the measurement, threshold, assessment time, and analysis population. Those features help define the question but cannot answer it without outcome estimates.
The non-inferiority framing is also statistically important. It requires more than observing that two groups appear similar: the margin and uncertainty around the treatment contrast determine whether the data support the stated objective. The registry record describes the objective but does not report the margin or analysis result. This makes the distinction between a trial’s purpose and its evidence especially clear.
Serotype-specific outcomes create another interpretive challenge. Immune responses may need to be considered across multiple serotypes, while the study summary focuses its non-inferiority question on the 13 shared serotypes and the primary endpoint description includes two additional serotypes. Without posted estimates and a stated strategy for multiple comparisons, readers cannot assess the pattern or consistency of results.
Finally, the record’s safety counts show why event descriptions need context. Denominators and counts are useful descriptive information, but a comparative interpretation also requires attention to definitions, follow-up, uncertainty, and causality. The registry entry therefore provides a useful outline of the statistical questions while also demonstrating the limits of interpretation when analyses are not reported.
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 main limitation for statistical interpretation is that the registry record lists zero analyses. The primary endpoint is described, but no group estimates, confidence intervals, treatment contrasts, or p-values are reported. This prevents assessment of the size, direction, or precision of immune-response differences. The non-inferiority margin and the method used to assess non-inferiority are also not reported.
The primary outcome involves several serotypes, while the study summary frames the non-inferiority question around the 13 serotypes in common with Prevnar 13®. The endpoint description additionally includes serotypes 22F and 33F, which are not in common. The registry record does not explain how these distinct sets were combined or interpreted, and it does not report serotype-level results. The listed secondary outcomes span additional measures and time points, but their results and any multiplicity strategy are not reported.
The primary analysis population excludes participants with protocol violations that could have affected antibody-response validity. The record does not give the number meeting that definition, the exclusions by group, or the amount of missing assay data. It does not describe missing-data methods or sensitivity analyses. Enrollment is reported as 1152, but that does not identify the analysis denominator for each outcome.
For safety, event counts and selected serious-event terms are listed without comparative uncertainty estimates or further information on timing and attribution. These limitations concern what the registry record reports; they do not establish that additional trial analyses or documentation do not exist elsewhere.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Study of Pneumococcal Conjugate Vaccine (V114) Compared to a Marketed Vaccine (V114-003) — NCT01215188.
- Registry record last updated 2019-04-30; status last verified 2019-04.
- 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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18. Record Summary
NCT01215188 is a completed randomized, quadruple-masked, parallel-group phase 2 study comparing aluminum-adjuvanted V114, non-adjuvanted V114, and Prevnar 13® in healthy infants. The registry record lists enrollment of 1152 and a four-dose intramuscular schedule at 2, 4, 6, and 12 to 15 months of age.
The primary endpoint is the percentage reaching the serotype-specific IgG threshold of at least 0.35 μg/mL one month after dose 3. The study summary describes a non-inferiority question for the 13 serotypes shared with Prevnar 13®. The endpoint description also includes two additional serotypes.
The record lists safety counts and secondary outcome definitions but lists zero analyses. Primary endpoint estimates, confidence intervals, the non-inferiority margin, missing-data methods, and multiplicity methods are not reported in the registry record. The trial began on 2010-10-14, reached primary completion on 2012-07-31, and is listed as completed.