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 V419 in Healthy Infants When Given at 2, 3, 4 and 12 Months (V419-007) (NCT01341639), a randomized phase 3 study. The primary outcome is Percentage of Participants Vaccinated With PR5I Compared With INFANRIX™ Hexa With Acceptable Ab Response to Haemophilus Influenzae Type b, Diphtheria, Tetanus, and Poliovirus Types 1, 2 & 3, at 5 Months.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01341639 |
| Phase | Phase 3 |
| Condition | Bacterial Infections, Virus Diseases |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 1250 |
| Arms in the primary outcome | n/a |
| Lead sponsor | MCM Vaccines B.V. |
| Results posted | Yes |
2. Clinical Question
The trial asks whether healthy infants receiving V419 at 2, 3, 4, and 12 months have an acceptable immune response, and whether that response is similar to the response in infants receiving a licensed vaccine control. The primary endpoint focuses on antibody responses to Haemophilus influenzae type b, diphtheria, tetanus, and poliovirus types 1, 2, and 3 at 5 months, one month after post-dose 3 of PRI5.
The comparison is between the PR5I regimen—V419 with RotaTeq, Prevenar 13, and ProQuad—and INFANRIX™ hexa with RotaTeq, Prevenar 13, and ProQuad. The registry describes a randomized, double-blind, active-comparator controlled trial. Its primary outcome is a set of response percentages across several antigens or response categories, rather than one single summary comparison. Numerical response estimates and the corresponding comparison results are not reported in the registry record.
Population
Healthy infants. The primary analysis population is further restricted to participants meeting inclusion criteria, not identified as protocol violators, vaccinated within acceptable day ranges, and with serology results in the stated post-dose window. Participants from site 0048 were excluded from that population.
Intervention
V419 given at 2, 3, 4, and 12 months, with RotaTeq, Prevenar 13, and ProQuad in the PR5I arm.
Comparator
INFANRIX™ hexa with RotaTeq, Prevenar 13, and ProQuad. The registry describes this as a licensed vaccine control.
Primary question
What proportion of participants met the stated antibody titre criteria for the specified antigens at 5 months, and how did the response compare between the two regimens?
3. Trial Design
This was a Phase III, randomized, double-blind, parallel-group, active-comparator controlled trial. The registry lists an enrollment of 1250 and a completed status. The study began on 2011-05-26, with primary completion on 2013-03-13. MCM Vaccines B.V. is listed as sponsor.
The two arm descriptions define the active regimens: PR5I consists of V419, RotaTeq, Prevenar 13, and ProQuad; the comparator consists of INFANRIX™ hexa, RotaTeq, Prevenar 13, and ProQuad. Thus, the comparison is between vaccine regimens that share the listed accompanying vaccines but differ in the listed primary vaccine. The registry’s brief summary frames the objective as assessing whether the V419 response is acceptable and similar to that with the licensed control.
Random allocation is intended, in general, to reduce systematic differences between treatment groups at the point of assignment. Double masking is intended, in general, to limit the influence of treatment knowledge on participant care, outcome assessment, or reporting. The registry identifies these design features, but details of sequence generation, allocation concealment, and the practical masking procedures are not reported in the registry record.
The primary endpoint is measured one month after post-dose 3, at 5 months old. Other listed outcomes include antibody responses to measles, mumps, rubella, and varicella after the toddler dose of ProQuad, as well as injection-site and systemic adverse events in specified observation windows. These outcomes address different immune responses and safety observations; they should not be treated as interchangeable measures.
The registry lists 10 outcome measures and 37 analyses. The number of reported analyses does not by itself reveal which comparisons were prespecified, how outcomes were prioritized, or whether a multiplicity procedure was used. Those details are not reported in the registry record.
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.
Infant Series
| Stage | PR5I | INFANRIX™ Hexa |
|---|---|---|
| STARTED | 628 | 622 |
| Site 0048 Excluded | 611 | 606 |
| Treated | 610 | 605 |
| COMPLETED | 599 | 590 |
| NOT COMPLETED | 29 | 32 |
Reasons for not completing this period:
| Reason | PR5I | INFANRIX™ Hexa |
|---|---|---|
| Protocol Violation | 1 | 0 |
| Not Vaccinated | 0 | 1 |
| Adverse Event | 0 | 5 |
| Withdrawal by Subject | 11 | 8 |
| Lost to Follow-up | 0 | 2 |
| Site 0048 Participants | 17 | 16 |
Interim Period
| Stage | PR5I | INFANRIX™ Hexa |
|---|---|---|
| STARTED | 599 | 590 |
| COMPLETED | 591 | 581 |
| NOT COMPLETED | 8 | 9 |
Reasons for not completing this period:
| Reason | PR5I | INFANRIX™ Hexa |
|---|---|---|
| Withdrawal by Subject | 6 | 7 |
| Lost to Follow-up | 2 | 0 |
| Physician Decision | 0 | 1 |
| Protocol Violation | 0 | 1 |
Toddler Dose
| Stage | PR5I | INFANRIX™ Hexa |
|---|---|---|
| STARTED | 590 | 582 |
| COMPLETED | 539 | 548 |
| NOT COMPLETED | 51 | 34 |
Post-Treatment
| Stage | PR5I | INFANRIX™ Hexa |
|---|---|---|
| STARTED | 539 | 548 |
| COMPLETED | 539 | 545 |
| NOT COMPLETED | 0 | 3 |
Reasons for not completing this period:
| Reason | PR5I | INFANRIX™ Hexa |
|---|---|---|
| Withdrawal by Subject | 0 | 1 |
| Adverse Event | 0 | 2 |
Analysis population for the primary outcome, as defined in the registry: All participants in the PR5I group who met inclusion criteria, were not protocol violators, received vaccinations within acceptable day ranges, and who had serology results within revised windows (RW) of Days 28 to 51 Post-Dose 3. Participants from site 0048 were excluded. Participants in the INFANRIX™ hexa group were not 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.
Population: All randomized participants excluding participants from site 0048.
| Characteristic | Unit | PR5I | INFANRIX™ Hexa | Total |
|---|---|---|---|---|
| Participants analysed | 611 | 606 | 1217 | |
| Age, Continuous | Days | 61.4 (SD 6.9) | 61.5 (SD 6.9) | 61.5 (SD 6.9) |
| Sex: Female, Male: Female | Participants | 291 | 290 | 581 |
| Sex: Female, Male: Male | Participants | 320 | 316 | 636 |
6. Primary Endpoint
The registry lists the primary outcome as Percentage of Participants Vaccinated With PR5I Compared With INFANRIX™ Hexa With Acceptable Ab Response to Haemophilus Influenzae Type b, Diphtheria, Tetanus, and Poliovirus Types 1, 2 & 3, at 5 Months, measured over One month after post-dose 3 of PRI5 (5 months old).
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | Percentage of participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint measures the percentage of participants who met specified antibody titre criteria for Haemophilus influenzae type b, diphtheria, tetanus, and poliovirus types 1, 2, and 3. Antibody titres were measured using RIA for PRP, MIT for diphtheria and poliovirus, and ELISA for tetanus. The response criteria include an antibody titre of at least 0.15 μg/mL for Hib (PRP), at least 0.01 IU/mL for diphtheria and tetanus, and at least 8 (1/dil) for inactivated poliovirus types 1, 2, and 3. These criteria define the binary response outcome: each participant either meets the relevant threshold or does not.
Such thresholds are used to turn a laboratory measurement into a clinically interpretable response classification. A percentage can describe how common threshold attainment was in each arm, while a comparison can quantify the difference in response rates. The registry says the estimated response rates are based on the Miettinen and Nurminen method, stratified by country.
The endpoint is assessed at 5 months, one month after post-dose 3 of PRI5. Because it covers several antigens and criteria, it is not one undifferentiated response. The registry record does not report the numerical response rates, interval estimates, or the corresponding results for the comparison between regimens. It therefore does not establish from the posted primary endpoint information how large or precise any between-arm difference was.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry describes a trial designed to compare antibody response percentages between infants receiving PR5I and infants receiving INFANRIX™ hexa with the listed accompanying vaccines. It specifies the primary endpoint’s laboratory measures, response thresholds, assessment time, and a stratified method for estimating response rates. However, numerical primary endpoint results are not reported in the registry record. The size, direction, and precision of the primary comparison therefore cannot be characterized from the registry information.
The endpoint is binary for each response criterion: a participant meets a threshold or does not. In general, a response percentage is a group-level summary of how often that criterion was met. It does not describe every individual antibody titre, and it does not show how far above or below the threshold an individual result lies. Since several antigens are included, each response estimate pertains to a particular antigen or criterion; one response should not be generalized to all the others.
The registry identifies the Miettinen and Nurminen method stratified by country for estimated response rates. In general, stratification accounts for the specified grouping factor when estimating a comparison, rather than treating all observations as if they came from one unstructured group. The registry does not report the estimates or confidence intervals needed to assess the uncertainty around this comparison. A confidence interval, in general, describes a range of values compatible with the data and the specified statistical method; its width conveys precision, not certainty that a particular value is true.
The purpose described in the brief summary includes assessing whether the response is acceptable and similar to the licensed control. Similarity is not established merely because a difference is not statistically significant. In general, a similarity or non-inferiority conclusion depends on a prespecified margin and an analysis that evaluates the result against that margin. The margin, decision rule, and primary endpoint results are not reported in the registry record, so no such conclusion can be drawn from the information available.
The registry includes secondary immune-response outcomes after the toddler dose of ProQuad and several adverse-event outcomes. These provide distinct questions and observation windows. Their presence does not substitute for missing primary endpoint estimates, and the registry record does not provide numerical results for those secondary outcomes in the listed information.
The posted adverse-event counts describe serious adverse events in each arm, and the registry lists selected serious-event terms with percentages. These are descriptive safety data. Without details on event definitions, follow-up completeness, comparative estimates, and uncertainty, raw counts or listed percentages should not be used to infer a causal difference between regimens. The registry lists no deaths in either arm, but the available figures alone do not resolve other safety questions.
Overall, the record gives important design and endpoint details but does not include the numerical efficacy or immunogenicity results required to judge the primary comparison. Interpretation should remain limited to what is specified: the trial’s question, its response criteria, its analysis population description, and the posted safety counts.
9. Statistical Methods Explained
The statistical information in the registry record is sufficient to identify the type of primary outcome and one stated estimation method, but not to reconstruct the full analysis. The endpoint is a percentage of participants with a binary response, and response is defined by antibody titre thresholds. The registry states that estimated response rates use the Miettinen and Nurminen method stratified by country.
What does a response percentage represent?
General: A binary outcome assigns each participant to one of two categories, such as meeting or not meeting a threshold. The response percentage describes the proportion in the applicable analysis group meeting that criterion. It is not the average antibody titre and does not retain the full information in each measured titre. Converting a continuous laboratory value into a threshold-based outcome can make a result easier to interpret against a defined criterion, but it also means that results just on opposite sides of a threshold are classified differently even if their measured values are close.
For this trial, the criteria differ by antigen and assay. The registry specifies an antibody titre of at least 0.15 μg/mL for Hib (PRP), at least 0.01 IU/mL for diphtheria and tetanus, and at least 8 (1/dil) for poliovirus types 1, 2, and 3. Each criterion should be interpreted in relation to its corresponding measurement; a response classification for one antigen does not stand in for another.
What does stratification by country do?
General: Stratification divides an analysis into groups defined by a factor, then accounts for those groups in the estimate. When country is the stratification factor, the method takes country into account in estimating the response comparison. This can be useful when the distribution of participants across countries or the outcome patterns differ by country. The registry does not describe the number of countries, the country-specific estimates, or how any country-specific information contributed to the final estimates.
The registry names the Miettinen and Nurminen method for the response-rate estimates. It does not provide the equations, confidence level, interval estimates, test results, or any additional model specification. Those details are not reported in the registry record. The method name alone does not permit calculation of the reported comparison without the underlying response counts and analysis details.
Why are confidence intervals useful?
General: A confidence interval gives an uncertainty range for an estimated quantity under a specified statistical procedure. For a comparison of response rates, it helps show which values remain compatible with the observed data and method. An interval estimate is usually more informative than a point estimate alone because it communicates precision. A narrow interval indicates greater precision than a wide interval, but neither guarantees that the estimate is unbiased or that the analysis assumptions are correct.
No primary response estimates or confidence intervals are reported in the registry record. Consequently, the precision of the primary comparison cannot be evaluated from the listed information. The registry also does not report a p-value for this endpoint in the information available.
Why does the analysis population matter?
The primary outcome description defines an analysis population that includes participants who met inclusion criteria, were not protocol violators, received vaccinations within acceptable day ranges, and had serology results within the stated window of Days 28 to 51 post-dose 3. Participants from site 0048 were excluded. This is a restricted analysis population, not simply everyone enrolled. In general, restricting an analysis based on protocol adherence or observed laboratory results can change the group being analyzed and may affect how broadly the result applies. The registry does not report how many participants met each criterion or the reasons participants were excluded.
The registry does not state whether additional analysis populations were used, such as an intention-to-treat population, nor does it report how departures from assigned treatment were handled. These details are not reported in the registry record. They matter because different analysis populations can answer different questions: an analysis of participants as randomized preserves the initial assignment comparison, while a restricted population can focus on those meeting specified conditions, but may be more vulnerable to selection effects.
What does over-dispersion mean for binary outcomes?
General: Over-dispersion arises when observed variation is greater than a statistical model expects. In binary-outcome analyses, model-based standard errors can be too small if the model fails to account for extra variation or dependence. This issue is relevant when models make assumptions about how outcomes vary across participants or groups. The registry does not report a model-based approach or an over-dispersion assessment for the primary endpoint, so no claim can be made about whether it was considered.
How should planning calculations be read?
General: Sample-size planning calculations explore how many participants might be needed to detect a specified effect under stated assumptions. The record’s planning illustration uses a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation; the effect to detect is described as a stated fraction of the observed effect. These calculations are planning illustrations, not observed power and not evidence that a trial had a particular probability of success after the results were observed. The registry does not identify these illustrations as the trial’s own design justification. The trial’s original sample-size justification is not reported in the registry record.
For time-to-event outcomes, the planning note describes total events; for other outcomes, it describes participants per arm. The primary endpoint in this record is a binary percentage outcome, but no planning result is needed to interpret the missing primary response estimates. Planning calculations cannot supply the absent trial outcome or replace its confidence interval and analysis results.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 10 outcome measures and 37 analyses. The primary endpoint itself includes responses for several antigens and criteria, and the listed secondary outcomes include additional immune-response and adverse-event questions. When many outcomes or comparisons are examined, the chance of finding at least one apparently noteworthy result by chance can increase. General: multiplicity procedures may control or otherwise address that risk, but the appropriate approach depends on which outcomes are confirmatory and how the comparisons are organized.
The registry information does not report whether the trial used a multiplicity adjustment, a prespecified testing hierarchy, or another procedure to control interpretation across outcomes. It also does not identify which of the listed analyses were primary, secondary, exploratory, or prespecified in the statistical analysis plan. These details are not reported in the registry record. The number of analyses alone is not evidence that a particular adjustment was or was not used.
The primary analysis population is described as participants meeting inclusion criteria, not protocol violators, vaccinated within acceptable day ranges, and with serology results within the specified post-dose window; site 0048 participants were excluded. This description indicates that the primary endpoint analysis depends on protocol and serology criteria. The registry does not report the resulting analysis counts, the reasons for missing serology, or the handling of participants lacking outcome measurements.
Missing-data methods, including any imputation, sensitivity analysis, or assumptions about missing outcomes, are not reported in the registry record. The handling of withdrawals and participants with incomplete vaccination is also not reported. In general, missingness can affect a percentage estimate if the participants with observed results differ systematically from those without results. Without information on the extent and handling of missing data, the potential impact cannot be assessed.
The registry also does not report a complete statistical analysis plan or interim-analysis details. Those details are not reported in the registry record and should not be inferred from the listed endpoint methods.
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 |
|---|---|---|---|
| PR5I | 23 | 610 | 3.8% |
| INFANRIX Hexa | 22 | 605 | 3.6% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| PR5I | 0 of 610 |
| INFANRIX Hexa | 0 of 605 |
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 |
|---|---|
| PR5I | 603 of 610 |
| INFANRIX Hexa | 599 of 605 |
Most frequent serious adverse event terms
| Event term | Organ system | PR5I | INFANRIX Hexa |
|---|---|---|---|
| Respiratory syncytial virus bronchiolitis | Infections and infestations | 3 of 610 | 7 of 605 |
| Bronchiolitis | Infections and infestations | 3 of 610 | 2 of 605 |
| Pyrexia | General disorders | 2 of 610 | 2 of 605 |
| Pyelonephritis | Infections and infestations | 2 of 610 | 2 of 605 |
| Concussion | Injury, poisoning and procedural complications | 3 of 610 | 1 of 605 |
| Bronchitis | Infections and infestations | 2 of 610 | 1 of 605 |
| Benign familial neonatal convulsions | Congenital, familial and genetic disorders | 0 of 610 | 1 of 605 |
| Inguinal hernia | Gastrointestinal disorders | 1 of 610 | 0 of 605 |
| Oesophagitis | Gastrointestinal disorders | 0 of 610 | 1 of 605 |
| Swollen tongue | Gastrointestinal disorders | 0 of 610 | 1 of 605 |
Most frequent non-serious adverse event terms
| Event term | Organ system | PR5I | INFANRIX Hexa |
|---|---|---|---|
| Irritability | General disorders | 537 of 610 | 518 of 605 |
| Crying | General disorders | 523 of 610 | 531 of 605 |
| Somnolence | Nervous system disorders | 470 of 610 | 485 of 605 |
| Pyrexia | General disorders | 471 of 610 | 472 of 605 |
| Injection site pain | General disorders | 469 of 610 | 456 of 605 |
| Injection site erythema | General disorders | 459 of 610 | 430 of 605 |
| Decreased appetite | Metabolism and nutrition disorders | 401 of 610 | 408 of 605 |
| Injection site swelling | General disorders | 384 of 610 | 347 of 605 |
| Vomiting | Gastrointestinal disorders | 205 of 610 | 194 of 605 |
| Injection site induration | General disorders | 106 of 610 | 127 of 605 |
Serious events with the highest arm-level rate: respiratory syncytial virus bronchiolitis (1.2%), bronchiolitis (0.5%), concussion (0.5%), pyrexia (0.3%), pyelonephritis (0.3%).
The registry lists serious adverse events for each arm. In the PR5I arm, 23 of 610 participants at risk were affected; in the INFANRIX Hexa arm, 22 of 605 participants at risk were affected. The registry lists 0 deaths in each arm. These are descriptive counts and denominators, not by themselves a full comparison of safety between regimens.
The listed serious-event terms are respiratory syncytial virus bronchiolitis (1.2%), bronchiolitis (0.5%), concussion (0.5%), pyrexia (0.3%), pyelonephritis (0.3%), and bronchitis (0.3%). The registry information does not assign these listed percentages to a specific arm, so they should not be interpreted as arm-specific estimates.
General: Counts depend on the event definition, follow-up period, and completeness of reporting. A difference between raw counts does not by itself establish a treatment-related difference; a comparative analysis would also need to account for denominators, uncertainty, and the trial’s safety analysis methods. Those methods and comparative estimates are not reported in the registry record. Serious-event counts should also be distinguished from the broader listed outcomes for solicited and unsolicited injection-site or systemic adverse events, which use their own observation windows.
12. What the Result Does, and Does Not, Mean
The record identifies a randomized comparison of two infant vaccine regimens and describes a primary immunogenicity question. It gives the response thresholds, assays, assessment time, and an estimation method stratified by country. Those details clarify what the primary endpoint was designed to measure. They do not, in the absence of numerical primary results, show how often participants met the thresholds or how the response rates compared between arms.
The word “similar” appears in the trial’s stated objective, but similarity cannot be concluded from the objective alone. General: Similarity or non-inferiority assessments require a defined comparison framework, often including a margin and a decision criterion. The registry does not report the margin, decision rule, or numerical comparison results, so the available record does not support a conclusion about similarity.
The response thresholds classify antibody measurements into response categories. They do not describe every feature of immune response, and they do not directly report clinical outcomes such as disease prevention. The registry lists bacterial infections and virus diseases as conditions, but the primary endpoint described is antibody response. The record does not provide a numerical estimate of disease incidence or a clinical efficacy result.
The safety information includes serious-event counts, selected event terms, and no listed deaths in either arm. These data describe what is reported in the registry; they do not establish that a regimen caused or prevented any particular event. Nor do the listed figures alone characterize all safety outcomes, since the registry also describes other adverse-event measures with specified windows.
The trial’s completed status and enrollment are administrative and design details. They do not establish whether the primary objective was met. The appropriate interpretation is therefore limited: the registry outlines a comparison and its planned measurement framework, while numerical primary endpoint findings and important analysis details are not reported in the registry record.
13. Why This Trial Matters Statistically
This trial illustrates why endpoint definitions and analysis populations matter in immunogenicity research. A response percentage can look straightforward, but its meaning depends on the antigen, assay, threshold, time point, and participants included in the analysis. Here, the endpoint combines several antigen-specific criteria, with measurements specified for PRP, diphtheria, tetanus, and poliovirus. Treating that set as a single undifferentiated result would obscure the distinct questions being asked.
The design also illustrates the role of an active comparator and shared co-administered vaccines. The two arms are described as V419 or INFANRIX™ hexa, with RotaTeq, Prevenar 13, and ProQuad in both regimens. The comparison is therefore framed around the specified regimens rather than an untreated group. Randomization and double masking are important design features, but they do not substitute for reporting estimates and uncertainty.
Statistically, the registry names the Miettinen and Nurminen method stratified by country, which makes clear that the response comparison is intended to account for country strata. It also describes a restricted primary analysis population and excludes participants from site 0048. Such details can materially shape which observations contribute to an endpoint estimate, so transparent reporting of the population and missing-data handling is essential.
The record includes many outcomes and analyses, making clear why multiplicity and prespecification are relevant questions. Without reported numerical results, confidence intervals, and a documented analysis strategy, readers cannot assess the precision or strength of the primary comparison. The statistical importance of this record is therefore not a conclusion about the vaccine response, but the need to connect a clearly specified endpoint and analysis population to complete, interpretable results.
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 principal limitation for interpreting the primary question is that numerical response rates and between-arm estimates are not reported in the registry record. Confidence intervals, p-values, and the details needed to evaluate the comparison are also not reported. The endpoint description therefore identifies what was measured but does not reveal the observed response pattern or its precision.
The primary analysis population is restricted by inclusion criteria, protocol-violation status, acceptable vaccination day ranges, and the availability and timing of serology. Participants from site 0048 were excluded. The registry does not state the number excluded for each reason, the characteristics of excluded participants, or how these restrictions affected the analysis. General: exclusions based on post-randomization events or observed results can reduce comparability if the groups remaining for analysis differ in relevant ways.
The record lists 10 outcome measures and 37 analyses, but does not report the multiplicity strategy, full statistical analysis plan, or which analyses were confirmatory. Missing-data methods and sensitivity analyses are also not reported. As a result, the robustness of any unlisted or unreported outcome findings cannot be assessed from the registry information.
The safety information is limited to posted serious-event counts, selected terms, and deaths. The registry information does not give event-level timing, detailed follow-up completeness, comparative uncertainty, or attribution methods. The percentages listed for serious-event terms are not assigned to a specific arm in the available information.
Finally, the record’s stated objective includes acceptable and similar immune response, but the acceptance criteria for the overall comparison and any non-inferiority margin are not reported in the registry record. Conclusions about clinical outcomes, beyond the described antibody-response endpoint, are not supported by the endpoint information listed.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 3, 4 and 12 Months (V419-007) — NCT01341639.
- Registry record last updated 2019-04-30; status last verified 2019-04.
- Results first posted 2019-04-10.
- 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
NCT01341639 is a completed Phase III randomized, double-blind, parallel-group active-comparator trial sponsored by MCM Vaccines B.V. The registry lists an enrollment of 1250. It compares V419 with INFANRIX™ hexa, with RotaTeq, Prevenar 13, and ProQuad included in both arm descriptions.
The primary endpoint is the percentage meeting specified antibody titre criteria for Hib, diphtheria, tetanus, and poliovirus types 1, 2, and 3 at 5 months. The registry specifies assays, thresholds, a restricted analysis population, and the Miettinen and Nurminen method stratified by country. Numerical primary endpoint results and key details on multiplicity and missing-data handling are not reported in the registry record.
Posted safety information includes serious-event counts of 23 of 610 in PR5I and 22 of 605 in INFANRIX Hexa, with 0 deaths in each arm. These figures are descriptive and do not by themselves establish a comparative safety effect.