This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Safety and Immunogenicity of 2 or 3 Doses of MenACWY Conjugate Vaccine in Healthy Infants and the Effects of a Booster Dose of MenACWY Administered in the Second Year of Life (NCT01214837), a randomized phase 3 study. The primary outcome is Percentage of Subjects With hSBA ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following 4-Dose and 3-Dose Schedule of Men ACWY Vaccination..
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01214837 |
| Phase | Phase 3 |
| Condition | Meningococcal Disease, Meningococcal Meningitis |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 751 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Novartis Vaccines |
| Results posted | Yes |
2. Clinical Question
Population
Healthy infants enrolled in a phase 3 randomized study. Enrollment was 751. The primary analysis population is identified as Toddler PPS, but the registry record does not report the detailed criteria used to define that population or the number included in it.
Intervention
MenACWY vaccination on the schedule described as MenACWY4: a primary series at 2, 4 and 6 months of age, followed by a toddler dose at 12 months of age. The primary endpoint description refers to this as a 4-dose schedule.
Comparator
MenACWY vaccination on the schedule described as MenACWY3: doses at 2 and 4 months of age, followed by a toddler dose at 12 months of age. A routine-vaccines-only group was also included in the study, but the primary endpoint is framed as a comparison of the two MenACWY schedules.
Primary question
At 13 months of age, what percentage of participants had hSBA titers of at least 1:8 against N. meningitidis serogroups A, C, W and Y after the MenACWY4 and MenACWY3 schedules? The registry record describes the measure but does not report the corresponding percentages or confidence intervals.
The central question concerns immune response after different infant vaccination schedules, rather than the occurrence of meningococcal disease. The primary measure is the proportion meeting a specified hSBA threshold for each of four serogroups at the stated assessment age. Secondary outcomes extend the immune-response assessment across earlier ages, after different numbers of infant doses, and after completion of the toddler dose. They also include immune responses to PCV-13 antigens when vaccines were administered concomitantly.
The study also included safety monitoring. Its registry record lists serious and other adverse-event counts for the three study groups, alongside several serious-event terms. Those safety summaries are separate from the primary immunogenicity question. The registry record does not report the primary immune-response results, so the relative responses of the schedules cannot be described from this record.
3. Trial Design
This was a phase 3, randomized, open-label, multicenter, parallel-group study. The registry record reports enrollment of 751 healthy infants and identifies Novartis Vaccines as the sponsor. The study status is completed; the recorded start was 2010-10 and primary completion was 2012-04. The registry record does not report further details about the sites or the allocation procedure.
Participants were assigned to MenACWY3, MenACWY4, or routine vaccines. MenACWY3 comprised MenACWY doses at 2 and 4 months of age and a toddler dose at 12 months. MenACWY4 comprised doses at 2, 4 and 6 months and a toddler dose at 12 months. The routine-vaccines group received routine vaccines, including PCV-13, at 2, 4 and 6 months and a toddler dose at 12 months. The registry record does not give the number randomized to each group in the trial-design description; the safety summary separately lists group-specific numbers at risk.
Open-label means the study was not masked, as recorded in the registry. This describes the trial structure, not the objectivity of every measurement. The primary endpoint is a laboratory-based immune-response measure, while safety outcomes rely on adverse-event recording. The registry record does not report operational details about laboratory blinding, event review, or allocation concealment.
The study's stated purpose was to assess immunogenicity of a 3-dose versus 4-dose infant vaccination schedule, including the kinetics of immune response during early phases of the series. The secondary outcomes reflect that purpose: they include hSBA thresholds and geometric mean titers at several ages, responses following different numbers of infant doses, and responses after the toddler dose. They also include immune responses to PCV-13 antigens during concomitant administration. The primary endpoint focuses on the percentage meeting the hSBA threshold at 13 months of age.
Enrollment is not the same as the number contributing to every analysis. The primary analysis population is called Toddler PPS, but the number in that population and the handling of participants without measurements are not reported in the registry record. The recorded design therefore establishes the groups, schedules, and stated outcome framework, but does not by itself show how many participants contributed to each result.
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: All the enrolled subjects were included in the trial.
Overall Study
| Stage | MenACWY3 | MenACWY4 | Routine Vaccines |
|---|---|---|---|
| STARTED | 249 | 256 | 246 |
| COMPLETED | 195 | 192 | 184 |
| NOT COMPLETED | 54 | 64 | 62 |
Reasons for not completing this period:
| Reason | MenACWY3 | MenACWY4 | Routine Vaccines |
|---|---|---|---|
| Death | 0 | 0 | 1 |
| Adverse Event | 1 | 2 | 1 |
| Withdrawal by Subject | 27 | 36 | 28 |
| Lost to Follow-up | 20 | 15 | 21 |
| Inappropriate Enrolment | 0 | 1 | 2 |
| Administrative Reason | 2 | 6 | 4 |
| Protocol Violation | 3 | 1 | 5 |
| Unable to Classify | 1 | 3 | 0 |
Analysis population for the primary outcome, as defined in the registry: Analysis was done on the Toddler Per Protocol Population (PPS) - all subjects who received all doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol violation as defined prior to unblinding through 13 month timepoint.
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 enrolled population- All subjects who had signed an informed consent, undergone screening procedure(s) and were randomized.
| Characteristic | Unit | MenACWY3 | MenACWY4 | Routine Vaccines | Total |
|---|---|---|---|---|---|
| Participants analysed | 249 | 256 | 246 | 751 | |
| Age, Continuous | Days | 66.4 (SD 7.1) | 66.7 (SD 7.4) | 66.7 (SD 7.0) | 66.6 (SD 7.2) |
| Sex: Female, Male: Female | Participants | 126 | 123 | 106 | 355 |
| Sex: Female, Male: Male | Participants | 123 | 133 | 140 | 396 |
6. Primary Endpoint
The registry lists the primary outcome as Percentage of Subjects With hSBA ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following 4-Dose and 3-Dose Schedule of Men ACWY Vaccination., measured over 13 months of age.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | 95% Confidence Interval |
| Unit | Percentage of subjects |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the percentage of subjects with hSBA titers of at least 1:8 against N. meningitidis serogroups A, C, W and Y at 13 months of age, following the MenACWY4 and MenACWY3 schedules. The registry record identifies the unit as percentage of subjects and specifies a 95% confidence interval. It names Toddler PPS as the analysis population.
hSBA is an assay-based measure of serum bactericidal activity using human complement. A threshold endpoint classifies each participant according to whether the measured titer reaches the stated level. The percentage then describes the share of the analyzed group meeting that criterion. This kind of endpoint is useful for describing the proportion with an immune response at a prespecified threshold, while a geometric mean titer summarizes the distribution of titers on a different scale.
As general statistical context, a confidence interval conveys uncertainty around an estimated percentage: narrower intervals indicate greater precision, while wider intervals indicate less precision. Intervals also help readers assess how much uncertainty remains when comparing groups. The registry record does not report the endpoint percentages or their confidence intervals, so neither the response levels nor the precision of the estimates can be described from this record.
The endpoint is an immunogenicity measure, not a count of meningococcal disease cases. It can characterize laboratory immune responses under the study's schedules, but the registry record does not establish from this endpoint alone whether participants experienced fewer clinical infections. The stated primary assessment is at 13 months of age; outcomes at other ages are listed as secondary measures.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record sets out a direct immunogenicity question: compare the percentage meeting the hSBA threshold at 13 months after MenACWY4 and MenACWY3. It does not report the observed percentages or the confidence intervals for that primary endpoint. Consequently, the direction, magnitude, and precision of the primary comparison are not reported in the registry record. No conclusion about which schedule had a higher observed response can be drawn from the endpoint definition alone.
The endpoint is defined separately for serogroups A, C, W and Y. That structure matters because an immune-response estimate for one serogroup does not stand in for the estimate for another. The registry record identifies four serogroups but does not provide their individual primary results. Nor does it report an overall combined response measure. Without the group-specific estimates and intervals, the record cannot show whether responses were similar across serogroups or how uncertain each estimate was.
The trial included three groups, but the primary endpoint description frames the main comparison as MenACWY4 versus MenACWY3. The routine-vaccines-only group is relevant to the broader study context and is included in safety summaries, but the registry record does not state that this group is part of the primary endpoint comparison. It should not be treated as a primary comparator without a reported analysis specifying that role.
Secondary outcomes included threshold proportions and geometric mean hSBA titers at baseline and later ages; responses after 2 and 3 infant doses; titers after completion of 3- and 4-dose series; and four-fold titer increases between 12 and 13 months. Other outcomes concerned immune responses to PCV-13 antigens. These measures could describe timing and breadth of the immune response, but their numerical results are not reported in the registry record. The record lists 13 outcome measures and 56 analyses, without enough result detail to characterize the findings across those outcomes.
Safety information is reported separately. The record lists serious-event counts of 11 among 242 at risk in MenACWY3, 19 among 252 at risk in MenACWY4, and 11 among 239 at risk in the routine-vaccines group. It also lists other adverse-event counts. These descriptive counts do not establish that a schedule caused an event or that differences between groups are statistically meaningful. The record does not report comparative safety estimates, confidence intervals, or a causal assessment.
Overall, the posted record documents a randomized study with defined schedules and outcomes, but it does not report the main immunogenicity estimates. Interpretation should therefore distinguish the prespecified measurement framework from findings: the endpoint tells readers what was to be measured, not what the comparison showed. The safety summaries provide event counts and selected terms, not a complete comparative evaluation.
9. Statistical Methods Explained
Randomization is a design method for assigning participants to study groups by chance. In general, it can reduce systematic differences between groups at the start of a trial, although the registry record does not report the allocation sequence, concealment procedures, or baseline characteristics needed to assess those features. The study is described as randomized and parallel-group, with participants assigned to vaccination schedules or routine vaccines. Parallel-group means the assigned groups are followed as distinct groups rather than each participant receiving every schedule in sequence.
The study was open-label, meaning masking was recorded as absent. In general, lack of masking can influence behavior, reporting, and some assessments. Laboratory endpoints may be less subjective than participant-reported outcomes, but the registry record does not state whether laboratory personnel were masked to assignment. It also does not describe how adverse events were elicited or adjudicated. Those details should not be inferred from the open-label designation.
The primary endpoint is a binary threshold outcome at the participant level: a participant either meets the hSBA criterion or does not, for each serogroup. The group percentage is the proportion meeting the criterion among the analyzed participants. A confidence interval gives a range of values compatible with the estimate under the interval's statistical assumptions. It expresses uncertainty about the population quantity, rather than indicating that individual participant results vary within that range. The registry record specifies a 95% confidence interval but does not report the intervals or the calculation method.
Geometric mean titers, listed among the secondary outcomes, summarize antibody titers using a geometric rather than arithmetic scale. In general, this is useful for positive measurements that can be strongly skewed, because multiplicative differences are often more natural than additive differences. The registry record does not provide those titer estimates or explain the transformations, handling of values below assay limits, or interval calculations. Such implementation details are not reported in the registry record.
Comparisons of group percentages can be presented as differences, ratios, or model-based contrasts, depending on the analysis plan. Each approach answers a distinct question and can have different assumptions. The registry record does not report the primary comparison method, adjustment variables, hypothesis-testing procedure, or exact estimand beyond its description of the endpoint and population. No test statistic or p-value for the primary comparison is reported in the registry record.
General statistical context: multiple endpoints and repeated assessments create multiplicity. When many hypotheses are tested, the chance of at least one apparently unusual result can increase if every test is interpreted using the same threshold without adjustment. This does not mean every analysis is invalid; it means readers need to know which comparisons were primary, which were exploratory, and whether any multiplicity strategy was prespecified. The registry lists 13 outcome measures and 56 analyses, but multiplicity handling is not reported in the registry record.
Repeated measurements across ages can describe how an immune response changes over time. They are not independent observations when they come from the same participant. General methods for repeated data account for within-participant correlation; treating all observations as independent can make uncertainty appear too small. The registry record lists assessments at multiple ages but does not report the statistical model used to analyze repeated measurements or whether the same participants contributed at each age.
Missing data can affect estimates if participants without measurements differ from those measured. General approaches include analyzing available observations, imputing missing values under stated assumptions, or conducting sensitivity analyses. The registry record does not report the amount or pattern of missing outcome data, the missing-data assumptions, or any imputation or sensitivity method. It is therefore not possible to evaluate how missing measurements may have affected the posted estimates.
The primary analysis population is identified as Toddler PPS. In general, a per-protocol population includes participants who meet specified protocol requirements, but the precise inclusion and exclusion rules vary by study. The registry record does not define the Toddler PPS criteria or report its size. It also does not report whether an intention-to-treat analysis was conducted or how results from different analysis populations were compared.
Planning calculations are not observed outcomes. The stated planning illustration uses a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is expressed as a fraction of the observed effect. Such calculations can illustrate how sample size relates to an assumed effect and target power, but they do not show the power actually achieved in the completed trial. The record does not report the trial's own sample-size justification or its design assumptions. Any planning illustration should therefore be read as a hypothetical calculation, not as evidence about the observed result or as the original protocol rationale.
10. Multiplicity, Missing Data and Analysis Populations
The study evaluates several related immune-response outcomes across serogroups, ages, dose schedules, and vaccine combinations. The registry record lists 13 outcome measures and 56 analyses. This creates a multiplicity issue: when numerous outcomes or comparisons are examined, chance findings can occur even if there is no underlying difference for a particular measure. The registry record does not report a multiplicity adjustment, a hierarchy among secondary outcomes, or a distinction between confirmatory and exploratory analyses.
The primary outcome is defined as a threshold proportion for four serogroups at 13 months of age. The registry record does not report how the four serogroup-specific comparisons were handled statistically, whether any overall claim required a result across all serogroups, or whether confidence intervals were adjusted for multiple comparisons. Without those details and the numerical results, the strength of evidence across the set of outcomes cannot be assessed.
The primary analysis population is named Toddler PPS, but its membership rules and size are not reported in the registry record. The record also does not report the amount of missing outcome data, reasons for missingness, or methods for handling it. These details matter because an analysis limited to participants meeting protocol criteria may answer a different question from an analysis including all randomized participants, and because missing measurements can affect the represented population.
The registry record does not report whether there were sensitivity analyses for missing data, protocol deviations, or alternative analysis populations. These absences do not show that such methods were not used; they mean the methods are not reported in the registry record. The available description is insufficient to assess how robust the estimates are to analysis choices or incomplete follow-up.
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 |
|---|---|---|---|
| MenACWY3 | 11 | 242 | 4.5% |
| MenACWY4 | 19 | 252 | 7.5% |
| Routine Vaccines | 11 | 239 | 4.6% |
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 |
|---|---|
| MenACWY3 | 238 of 242 |
| MenACWY4 | 233 of 252 |
| Routine Vaccines | 228 of 239 |
Most frequent serious adverse event terms
| Event term | Organ system | MenACWY3 | MenACWY4 | Routine Vaccines |
|---|---|---|---|---|
| Respiratory synctial virus bronchiolitis | Infections and infestations | 2 of 242 | 5 of 252 | 2 of 239 |
| Bronchiolitis | Infections and infestations | 2 of 242 | 2 of 252 | 4 of 239 |
| Gastroenteritis | Infections and infestations | 1 of 242 | 0 of 252 | 1 of 239 |
| Pneumonia | Infections and infestations | 1 of 242 | 1 of 252 | 0 of 239 |
| Convulsion | Nervous system disorders | 0 of 242 | 2 of 252 | 0 of 239 |
| Cardio-respiratory arrest | Cardiac disorders | 0 of 242 | 0 of 252 | 1 of 239 |
| Congenital megacolon | Congenital, familial and genetic disorders | 0 of 242 | 0 of 252 | 1 of 239 |
| Krabbe's disease | Congenital, familial and genetic disorders | 1 of 242 | 0 of 252 | 0 of 239 |
| Laryngomalacia | Congenital, familial and genetic disorders | 0 of 242 | 0 of 252 | 1 of 239 |
| Anal fissure | Gastrointestinal disorders | 0 of 242 | 0 of 252 | 1 of 239 |
Most frequent non-serious adverse event terms
| Event term | Organ system | MenACWY3 | MenACWY4 | Routine Vaccines |
|---|---|---|---|---|
| Irritability | General disorders | 181 of 242 | 179 of 252 | 157 of 239 |
| Somnolence | Nervous system disorders | 162 of 242 | 154 of 252 | 158 of 239 |
| Injection site pain | General disorders | 137 of 242 | 140 of 252 | 138 of 239 |
| Crying | General disorders | 140 of 242 | 138 of 252 | 112 of 239 |
| Upper respiratory tract infection | Infections and infestations | 105 of 242 | 107 of 252 | 106 of 239 |
| Eating disorder | Psychiatric disorders | 104 of 242 | 104 of 252 | 93 of 239 |
| Diarrhea | Gastrointestinal disorders | 103 of 242 | 78 of 252 | 80 of 239 |
| Otitis media | Infections and infestations | 94 of 242 | 77 of 252 | 89 of 239 |
| Injection site erythema | General disorders | 87 of 242 | 80 of 252 | 89 of 239 |
| Pyrexia | General disorders | 88 of 242 | 87 of 252 | 69 of 239 |
Serious events with the highest arm-level rate: respiratory synctial virus bronchiolitis (2.0%), bronchiolitis (1.7%), convulsion (0.8%), cardio-respiratory arrest (0.4%), congenital megacolon (0.4%).
The safety summary lists serious adverse events by study group. MenACWY3 had 11 serious adverse events among 242 participants at risk; MenACWY4 had 19 among 252; and Routine Vaccines had 11 among 239. The record also lists other adverse events: 238 among 242 at risk in MenACWY3, 233 among 252 in MenACWY4, and 228 among 239 in Routine Vaccines. These are counts, not comparative effect estimates.
The registry record names Respiratory synctial virus bronchiolitis at 2.0%, Bronchiolitis at 1.7%, Convulsion at 0.8%, Cardio-respiratory arrest at 0.4%, Congenital megacolon at 0.4%, and Laryngomalacia at 0.4% among the top serious-event terms. It does not identify these terms by study group in the listed summary, so the percentages should not be attributed to a particular schedule.
Event counts alone do not establish causation or show whether group differences are statistically meaningful. The registry record does not report comparative safety analyses, confidence intervals, event definitions, exposure-adjusted rates, or deaths; deaths are not reported in the registry record. The summaries therefore describe recorded events in the listed groups but do not support a complete assessment of relative safety.
12. What the Result Does, and Does Not, Mean
The study addresses how immune-response measurements differed, or might differ, across infant MenACWY schedules. Its primary endpoint is a clearly specified threshold proportion at 13 months of age for serogroups A, C, W and Y. However, the registry record does not report the observed primary endpoint values or their confidence intervals. The central statistical result is therefore not available in this record, and no direction or size of the primary comparison can be stated.
Even when reported, an hSBA threshold proportion would describe the share of analyzed participants meeting a laboratory criterion. It would not, by itself, count clinical meningococcal disease or establish the schedules' effects on disease occurrence. The registry record's stated primary measure is immunogenicity. Its secondary outcomes broaden the immune-response description, including geometric mean titers and response measures at other ages, but those results are not reported in the registry record.
The randomized design supports a structured comparison of assigned groups, but interpretation still depends on the analysis population, missing-data handling, outcome measurement, and prespecified statistical methods. The registry record identifies Toddler PPS but does not define its criteria. It also does not report the primary analysis method, multiplicity handling, or missing-data approach. These omissions limit assessment of how the reported analyses, if available elsewhere, were constructed.
Safety counts should likewise be read descriptively. The registry record reports adverse-event counts and selected serious-event terms, but these summaries do not alone establish that events were caused by a vaccine or that the schedules differ in safety. Comparative estimates and their uncertainty are not reported in the registry record.
The record therefore establishes the question, study structure, schedules, and outcome framework, while leaving key outcome estimates and analysis details unreported. It does not support a conclusion about which schedule produced a greater immune response, nor does it establish clinical protection or a comparative safety effect. Those questions require the relevant result estimates, uncertainty measures, and fuller analysis information.
13. Why This Trial Matters Statistically
This trial is statistically notable for comparing schedules that differ in the number and timing of infant MenACWY doses, while measuring immune responses at multiple points in early life and after a toddler dose. That design raises questions about both the level of response at a particular age and its development over time. The listed secondary outcomes include threshold proportions, geometric mean titers, and four-fold increases, which capture different features of the immune-response data.
The primary endpoint also illustrates the distinction between a biological measurement and a clinical outcome. A percentage meeting an hSBA threshold is a laboratory-based summary. It can be informative about immunogenicity, but it is not itself a count of disease cases. Keeping those outcome types separate is essential when interpreting a trial's claims and limits.
Statistically, the study's many outcomes and assessments make transparent reporting especially important. The registry lists 13 outcome measures and 56 analyses. Readers need estimates, uncertainty intervals, analysis-population details, and multiplicity methods to understand how the evidence across these measurements fits together. Those result and method details are not reported in the registry record.
The trial also demonstrates why the name of an analysis population matters. Toddler PPS is specified for the primary outcome, but its criteria and size are not reported. Without those details, readers cannot fully determine which participants the primary analysis represents or assess the possible effect of exclusions and missing measurements.
Finally, the design combines immunogenicity objectives with safety monitoring. The safety summary provides group-specific counts and selected serious-event terms, while the primary endpoint focuses on immune response. These are complementary but distinct evidence streams. A clear statistical interpretation needs to preserve that distinction and avoid treating descriptive safety counts or endpoint definitions as conclusions about comparative effects.
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 most important limitation of the registry record for interpretation is that it does not report the primary immunogenicity estimates or their confidence intervals. Although the endpoint and analysis population are specified, the actual percentages for the MenACWY4 and MenACWY3 schedules are not reported in the registry record. The main comparison's magnitude, direction, and precision therefore cannot be assessed.
The record lists 13 outcome measures and 56 analyses, but it does not report how multiplicity was handled or how primary and secondary analyses were prioritized. It also does not give numerical results for the listed secondary immune-response outcomes. This limits interpretation of the breadth and consistency of the findings.
Important analysis details are not reported in the registry record: the exact Toddler PPS criteria and size, the primary statistical method, the handling of missing data, and the treatment of protocol deviations. The record does not provide enough information to evaluate whether participants with measurements differed from those without measurements or how analysis choices may have influenced estimates.
The study was open-label. The registry record does not report whether laboratory assessments were masked or provide further safeguards against assessment or reporting differences. It also does not describe allocation concealment, baseline group characteristics, or detailed adverse-event ascertainment. These items should be treated as unreported rather than assumed absent.
For safety, the record provides group counts and selected serious-event terms, but no comparative estimates or confidence intervals. Deaths are not reported in the registry record. The listed summaries therefore do not establish event causality or quantify uncertainty around between-group differences. Finally, the primary endpoint is immunogenicity rather than clinical disease incidence, so it cannot by itself describe disease outcomes.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Safety and Immunogenicity of 2 or 3 Doses of MenACWY Conjugate Vaccine in Healthy Infants and the Effects of a Booster Dose of MenACWY Administered in the Second Year of Life — NCT01214837.
- Registry record last updated 2018-10-09; status last verified 2018-09.
- Results first posted 2014-10-02.
- 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
NCT01214837 is a completed phase 3, randomized, open-label, multicenter, parallel-group study sponsored by Novartis Vaccines. Enrollment was 751. The recorded start was 2010-10, and primary completion was 2012-04. Healthy infants were assigned to MenACWY3, MenACWY4, or routine vaccines.
The primary endpoint is the percentage with hSBA titers of at least 1:8 against N. meningitidis serogroups A, C, W and Y at 13 months of age, in the Toddler PPS population. The registry record does not report the primary endpoint results or confidence intervals. It lists 13 outcome measures and 56 analyses, including additional immune-response measures and responses to PCV-13 antigens.
Safety summaries list serious and other adverse-event counts by group and selected serious-event terms. The registry record does not report comparative safety estimates or deaths. The study description establishes its design and measurement aims, but the main immunogenicity results and several analysis details are not reported in the registry record.