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 Study on a MenACYW Conjugate Vaccine Administered as a Single Dose in Participants Aged 12 Months and Older in Vietnam (NCT06228586), a na phase 3 study. The primary outcome is Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT06228586 |
| Phase | Phase 3 |
| Condition | Meningococcal Infection, Healthy Volunteers |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 447 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Sanofi Pasteur, a Sanofi Company |
| Results posted | Yes |
2. Clinical Question
Population
Participants aged 12 months and older in Vietnam. The study concerned meningococcal infection and included healthy volunteers. Enrollment was 447. The registry record describes age-based safety groups, but does not give detailed eligibility criteria in the information available for this study summary.
Intervention
A single injection of MenACYW conjugate vaccine on Day 1. The vaccine is described as a quadrivalent meningococcal polysaccharide vaccine conjugated to tetanus toxoid, targeting serogroups A, C, W, and Y.
Comparator
There was no concurrent control group. This was a single-group, open-label study, and the allocation field is recorded as NA. The age-based groups used for safety reporting are not randomized treatment groups and should not be interpreted as a like-for-like comparison.
Primary question
How did geometric mean titers of functional antibodies against serogroups A, C, Y, and W compare before vaccination on Day 1 and 30 days after vaccination, on Day 31? The study also aimed to describe the safety profile after the single dose. Numerical primary endpoint results are not reported in the registry record, so the size and precision of the antibody response cannot be assessed from the available record.
The question is descriptive rather than a test of whether vaccination outperforms another intervention. The study can describe measured antibody levels at the specified timepoints among participants included in the relevant analyses. Without a concurrent comparator, it cannot separate changes over time from effects attributable to the vaccine, nor can it estimate a treatment contrast against an alternative. The registry record describes the planned immunogenicity and safety objectives, but does not report numerical antibody estimates, confidence intervals, or the detailed statistical analysis used to produce them.
3. Trial Design
This was a Phase III, open-label, single-center study conducted in Vietnam. It enrolled 447 participants aged 12 months and older and is marked completed in the registry record. The recorded study start date is 2024-01-18, and the primary completion date is 2024-03-31. Participants were assigned to a single group receiving one dose of MenACYW conjugate vaccine; the intervention description specifies a single injection on Day 1. The registry record gives an expected participation duration of approximately 30 to 44 days.
Open-label means that the study was not masked. The masking field is NONE, and the allocation field is NA. This is not a randomized comparison: the age-based safety groups do not provide a vaccine-versus-control contrast. The study therefore has a descriptive structure, with antibody measurements planned before vaccination and 30 days after the dose, alongside safety monitoring. The record identifies the vaccine as a quadrivalent conjugate targeting meningococcal serogroups A, C, W, and Y.
The primary endpoint is geometric mean titers measured using a serum bactericidal assay with human complement. The stated timepoints are Day 1 before vaccination and Day 31, described as 30 days post-vaccination on Day 1. The primary endpoint analysis was performed on the per-protocol analysis set, described as a subset of the full analysis set. The full analysis set included participants who received the study vaccine and had a valid post-vaccination serology result. The criteria used to define the per-protocol set are not reported in the registry record.
The study aimed to describe both immunogenicity and safety. The registry record lists 8 outcome measures, but does not report numerical geometric mean titers or their confidence intervals in the information. It also does not report a detailed statistical analysis plan, justification for the enrollment target, interim analysis procedures, or other protocol details. The results should therefore be read as an incomplete account of the study’s statistical evidence, not as a full presentation of its analyses.
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: A total of 447 participants (223 participants aged 12-23 months and 224 participants aged \>=24 months) were enrolled in this study.
Overall Study
| Stage | MenACYW Conjugate Vaccine: 12-23 Months of Age | MenACYW Conjugate Vaccine: 24 Months of Age and Above |
|---|---|---|
| STARTED | 223 | 224 |
| Vaccinated | 223 | 223 |
| COMPLETED | 220 | 223 |
| NOT COMPLETED | 3 | 1 |
Reasons for not completing this period:
| Reason | MenACYW Conjugate Vaccine: 12-23 Months of Age | MenACYW Conjugate Vaccine: 24 Months of Age and Above |
|---|---|---|
| Withdrawal by Participant or Parent/Guardian | 3 | 1 |
Analysis population for the primary outcome, as defined in the registry: Analysis was performed on the per-protocol analysis set (PPAS) which was a subset of the full analysis set (FAS). The FAS included participants who received the study vaccine and had a valid post-vaccination serology result.
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: Enrolled study participants were participants that had their eligibility evaluation and passed screening.
| Characteristic | Unit | MenACYW Conjugate Vaccine: 12-23 Months of Age | MenACYW Conjugate Vaccine: 24 Months of Age and Above | Total |
|---|---|---|---|---|
| Participants analysed | 223 | 224 | 447 | |
| Age, Categorical: <=18 years | Participants | 223 | 121 | 344 |
| Age, Categorical: Between 18 and 65 years | Participants | 0 | 88 | 88 |
| Age, Categorical: >=65 years | Participants | 0 | 15 | 15 |
| Sex: Female, Male: Female | Participants | 118 | 130 | 248 |
| Sex: Female, Male: Male | Participants | 105 | 94 | 199 |
| Race and Ethnicity Not Collected | Participants | — | — | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W, measured over Day 1 (pre-vaccination) and Day 31 (30 days post-vaccination on Day 1).
| Element | Registry entry |
|---|---|
| Result type | Geometric Mean |
| Measure of spread | 95% Confidence Interval |
| Unit | titer |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the geometric mean titer (GMT) of antibodies against meningococcal serogroups A, C, Y, and W. Antibody activity was measured with a serum bactericidal assay using human complement, or hSBA. The stated measurements were taken on Day 1 before vaccination and on Day 31, 30 days after the Day 1 dose. The analysis population for this endpoint was the per-protocol analysis set, a subset of the full analysis set.
A titer summarizes the level of measurable antibody activity in the assay. A geometric mean is used when values are positive and may be distributed unevenly across a wide range: it averages on a logarithmic scale and expresses the result back on the original scale. This is a general statistical description of the measure, not a report of the observed study results. A confidence interval describes the uncertainty around an estimated quantity under the analysis assumptions. The endpoint specifies a 95% confidence interval, but the numerical GMT estimates and confidence limits are not reported in the registry record.
The use of hSBA makes the endpoint a measure of functional antibody activity rather than simply an antibody concentration. Reporting measurements before and after vaccination can describe how observed titers vary over the study period. In a single-group study, however, the comparison is within participants over time rather than against a concurrent untreated or alternative-treatment group. The endpoint alone therefore does not establish why a change occurred. The posted record does not include enough numerical result information to assess the magnitude, variability, or precision of the titers at either timepoint.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The trial’s principal statistical question concerns antibody titers before and after a single dose, not a randomized contrast between vaccine and control. The registry record identifies the endpoint, assay, timepoints, and analysis population, but does not report the numerical GMT values or their 95% confidence intervals. Consequently, the posted information does not allow a reader to quantify the titers at Day 1 or Day 31, compare their magnitude, or judge the precision of either estimate.
This absence of numerical endpoint results is important. A study objective is not itself a result, and the statement that a response was to be described does not establish what was observed. Without the estimates and uncertainty intervals, the direction and size of any change cannot be characterized from this record. It is also not possible to assess whether the results are consistent across the four serogroups or whether estimates differ in precision. Those details are not reported in the registry record.
The design further limits interpretation of any before-and-after difference, even if the numerical values were available. In a single-group study, time and intervention occur in sequence for the same group, so a change cannot be compared with what would have happened over the same period under a concurrent control condition. The study is open-label, and there is no randomized control group. The age-based safety groups do not serve as such a comparator: they are defined by age and are both described as receiving the vaccine. They should not be treated as evidence of a controlled treatment effect.
The primary endpoint is specified as a geometric mean titer with a 95% confidence interval. In general, confidence intervals communicate the statistical uncertainty around an estimate under the chosen analysis. Their interpretation depends on the statistical model and analysis population. The registry record names the per-protocol analysis set and says it is a subset of the full analysis set, but does not give the per-protocol criteria or numerical estimates. Thus, neither the exact precision nor the sensitivity of the findings to population definitions can be evaluated from the posted information.
For safety, the record lists age-based groups with denominators of 223 and counts of participants affected by serious and other adverse events. These figures describe the registry’s safety summaries; they do not establish that an event was caused by vaccination. The serious adverse event counts are small in absolute terms, but interpreting their frequency or comparing age groups requires caution. No randomized comparator is available, and the registry record does not report the event definitions, observation details, or a causal assessment. The listed serious-event terms and percentages should likewise be read as registry descriptions, not as evidence of causation.
Overall, this record establishes the study’s descriptive design and intended measurements but gives limited numerical evidence for interpreting immunogenicity. It supports a clear statement of what was measured and when, and it reports selected safety figures. It does not support a quantified estimate of the antibody response or a treatment-effect conclusion. Additional numerical results and analysis details are not reported in the registry record.
9. Statistical Methods Explained
The study’s primary measure is a geometric mean titer. Titers are measurements of antibody activity from the hSBA, an assay using human complement. The registry describes functional activity against serogroups A, C, Y, and W. A geometric mean is a way to summarize positive measurements that may be skewed or spread across a wide range. In general, the calculation takes the average after transforming values to a logarithmic scale, then transforms that average back to the original scale. This can make the summary more representative than an arithmetic mean when high values would otherwise exert substantial influence. This explanation is general; the registry record does not report the individual titers or the calculation details.
The planned timepoints were Day 1 before vaccination and Day 31, 30 days after the dose administered on Day 1. Comparing summaries at these timepoints can describe the pattern of measured titers over time. A paired analysis can account for the fact that measurements may come from the same participants, but the registry record does not state whether the primary analysis used paired individual-level measurements, a particular transformation, or a specific statistical model. Those details are not reported in the registry record.
The stated dispersion measure is a 95% confidence interval. In general, a confidence interval gives a range of estimates compatible with the observed data under the assumptions of the statistical procedure. It reflects statistical uncertainty, not the range of individual participants’ values, and it does not by itself address systematic errors such as selection or measurement bias. The numerical intervals for the primary endpoint are not reported in the registry record, so their width and the precision of the GMT estimates cannot be assessed.
The registry says that the primary endpoint analysis was performed on the per-protocol analysis set, which was a subset of the full analysis set. It describes the full analysis set as participants who received the vaccine and had a valid post-vaccination serology result. The criteria for inclusion in the per-protocol set are not reported. In general, per-protocol analyses may exclude participants who do not meet specified protocol requirements. The impact of such exclusions depends on who is excluded and why; without the criteria and participant flow, the potential for selection effects cannot be assessed. The full analysis set definition also means that a valid post-vaccination serology result is part of eligibility for that set, so the analysis does not necessarily represent everyone enrolled.
The study is single-group and open-label. This design is suited to descriptive reporting of measured responses and events, but it does not provide a randomized treatment comparison. A comparison between Day 1 and Day 31 is a within-study time comparison, not a contrast against a concurrent control. In general, randomization helps balance prognostic factors across treatment groups, while a concurrent control helps distinguish changes associated with treatment from changes that may occur over time for other reasons. Neither feature is present in the study design described by the registry. The age-based safety groupings do not change this design: they are not reported as randomized, and both groups received the same vaccine.
The registry contains 8 outcome measures and lists zero analyses. This does not give enough detail to reconstruct the analytic procedures or determine how all outcomes were handled. A detailed statistical analysis plan, including any prespecified transformations, model specifications, covariate adjustments, handling of unusual values, or criteria for excluding observations, is not reported in the registry record. The method for dealing with missing or invalid serology results is also not reported. These omissions limit reproducibility and make it difficult to assess whether analysis choices were prespecified.
Multiplicity arises when a study makes multiple statistical assessments, such as examining several endpoints, timepoints, or serogroups. In general, the more inferences made, the greater the chance that at least one apparently notable result occurs by chance if no adjustment or prespecified hierarchy is used. This study names four serogroups in its primary endpoint and lists multiple outcome measures, but the registry record does not report a multiplicity strategy, a hierarchy of tests, or adjusted significance criteria. It would be inappropriate to infer that adjustments were or were not performed beyond what is documented.
The record also includes sample-size planning illustrations based on an observed effect, with 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. These are planning illustrations, not evidence of the trial’s original design rationale, and they do not constitute observed power. The registry record does not report the protocol’s sample-size justification. Because this trial is single-group, planning calculations based on equal allocation between two arms should not be mistaken for a randomized two-arm design or for a control comparison in this study.
In general, over-dispersion occurs when observed variability exceeds what a statistical model assumes. If ignored, standard errors and uncertainty intervals may be too small, which can make estimates appear more precise than they are. The registry record does not say whether over-dispersion was relevant to any outcome or whether a model addressing it was used. More broadly, no specific statistical model for the primary endpoint or safety outcomes is described in the information available in the registry record. Statistical interpretation should therefore distinguish the endpoint definition from unreported analysis details.
10. Multiplicity, Missing Data and Analysis Populations
The primary objective covers antibody activity against serogroups A, C, Y, and W, measured before vaccination and on Day 31. The registry record also lists 8 outcome measures. When several endpoints, serogroups, timepoints, or analyses are considered, multiplicity can affect the chance of a statistically notable finding arising by chance. In general, investigators may address this through prespecified primary and secondary outcomes, testing hierarchies, or adjustment procedures. The registry record does not report a multiplicity strategy, an inferential hierarchy, or whether any adjustments were made. No conclusion about the handling of multiple assessments should be inferred from silence in the record.
The record identifies the per-protocol analysis set for the primary endpoint and describes it as a subset of the full analysis set. The full analysis set includes participants who received the study vaccine and had a valid post-vaccination serology result. The per-protocol eligibility criteria and participant flow into the analysis sets are not reported in the registry record. The record also does not report how missing measurements, invalid tests, or other unavailable data were handled. It is therefore not possible to assess the amount or pattern of missing data or the possible effect of exclusions on the endpoint estimates.
A detailed statistical analysis plan is not reported in the registry record. Specific methods for dealing with missing data, sensitivity analyses, interim analyses, and prespecified analysis choices are also not reported. The record lists 8 outcome measures and zero analyses, but that listing does not establish which methods were used or whether they were prespecified. These gaps matter because the reliability and interpretation of estimates depend on the analysis population, missing-data handling, and the number and type of statistical assessments. Numerical primary endpoint estimates and confidence intervals are not reported in the registry record, preventing direct evaluation of those results.
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 |
|---|---|---|---|
| MenACYW Conjugate Vaccine: 12-23 Months of Age | 3 | 223 | 1.3% |
| MenACYW Conjugate Vaccine: 24 Months of Age and Above | 2 | 223 | 0.9% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| MenACYW Conjugate Vaccine: 12-23 Months of Age | 0 of 223 |
| MenACYW Conjugate Vaccine: 24 Months of Age and Above | 0 of 223 |
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 |
|---|---|
| MenACYW Conjugate Vaccine: 12-23 Months of Age | 59 of 223 |
| MenACYW Conjugate Vaccine: 24 Months of Age and Above | 39 of 223 |
Most frequent serious adverse event terms
| Event term | Organ system | MenACYW Conjugate Vaccine: 12-23 Months of Age | MenACYW Conjugate Vaccine: 24 Months of Age and Above |
|---|---|---|---|
| Pneumonia | Infections and infestations | 3 of 223 | 0 of 223 |
| Appendicitis | Infections and infestations | 0 of 223 | 1 of 223 |
| Anaphylactic Reaction | Immune system disorders | 1 of 223 | 0 of 223 |
| Rib Fracture | Injury, poisoning and procedural complications | 0 of 223 | 1 of 223 |
Most frequent non-serious adverse event terms
| Event term | Organ system | MenACYW Conjugate Vaccine: 12-23 Months of Age | MenACYW Conjugate Vaccine: 24 Months of Age and Above |
|---|---|---|---|
| Injection Site Pain | General disorders | 26 of 223 | 23 of 223 |
| Upper Respiratory Tract Infection | Infections and infestations | 22 of 223 | 2 of 223 |
| Injection Site Erythema | General disorders | 13 of 223 | 11 of 223 |
| Pyrexia | General disorders | 16 of 223 | 7 of 223 |
| Decreased Appetite | Metabolism and nutrition disorders | 17 of 223 | 0 of 223 |
| Myalgia | Musculoskeletal and connective tissue disorders | 0 of 223 | 15 of 223 |
| Crying | General disorders | 13 of 223 | 0 of 223 |
| Malaise | General disorders | 0 of 223 | 13 of 223 |
Serious events with the highest arm-level rate: pneumonia (1.3%), appendicitis (0.4%), anaphylactic reaction (0.4%), rib fracture (0.4%).
The safety summaries are presented for two age-based groups: participants 12-23 months of age and participants 24 months of age and above. Each group has a reported at-risk denominator of 223. The serious adverse event counts are 3 and 2, respectively; the counts for other adverse events are 59 and 39. No deaths are reported in either group. These are group-specific registry figures and should not be combined or treated as a randomized comparison. Both groups are described as receiving the same vaccine, and the study has no concurrent control group.
The record lists pneumonia at 1.3%, appendicitis at 0.4%, anaphylactic reaction at 0.4%, and rib fracture at 0.4% among the top serious terms. These listed terms and percentages describe what appears in the registry record; they do not establish that the events were caused by vaccination. A serious adverse event is not necessarily an event judged related to an intervention. The registry information does not report event-level timing, individual causality assessments, or definitions sufficient to interpret each term in detail.
Safety counts depend on the observation period, event definitions, and how events were collected. The record states an expected participant duration of approximately 30 to 44 days, but does not provide further detail on the safety assessment procedures in this summary. Small counts should be interpreted as limited descriptive evidence, not as a precise estimate of rare-event risk. The absence of reported deaths in these groups is a registry observation and should not be generalized beyond the recorded study.
12. What the Result Does, and Does Not, Mean
The record establishes that a completed Phase III, open-label, single-center study in Vietnam was designed to describe antibody responses and safety after one dose of MenACYW conjugate vaccine in participants aged 12 months and older. It specifies the antibody assay, the four serogroups, and the before-and-after measurement schedule. It also reports age-group safety counts and selected serious-event terms. These details clarify what investigators intended to measure and the broad structure of the study.
However, the numerical primary endpoint results are not reported in the registry record. Without the GMT values and 95% confidence intervals, the magnitude and precision of the measured antibody titers cannot be evaluated. The study objective cannot be substituted for the results, and no quantitative statement about changes in antibody activity can be made from the available record. The full set of reported immunogenicity results and the detailed analysis methods are not reported in the registry record.
The single-group design also defines what the study can and cannot establish. It can describe observed measurements in the analyzed participants. It does not provide a randomized comparison against an untreated group or another vaccine, and it cannot isolate a treatment effect from other influences on measurements over time. Age-based safety groups are not substitutes for treatment controls. Since the study was open-label, it was not masked, and no masked comparison is described.
The safety data should likewise be interpreted as descriptive counts and listed terms. They do not by themselves establish causation, and the absence of reported deaths does not rule out uncommon risks or speak to outcomes outside the reported observation. The record does not provide enough detail to assess event attribution, missing safety observations, or the statistical precision of the event summaries.
Accordingly, the registry record provides information about study design, intended endpoints, analysis population definitions, and selected safety summaries, but it does not offer enough numerical immunogenicity results for a complete statistical assessment. It does not establish a controlled treatment effect, and it does not support a conclusion about whether an intervention should be used. Those interpretations would require fuller results and analysis details, which are not reported in the registry record.
13. Why This Trial Matters Statistically
This trial is statistically instructive because its design makes the distinction between descriptive evidence and comparative evidence clear. A single-group study can characterize measurements in participants who receive an intervention, but it does not estimate a randomized contrast with a control group. Here, antibody titers were intended to be described at baseline and 30 days after vaccination. That is a useful way to define the study’s measurement question, while leaving causal interpretation limited by the absence of a concurrent comparator.
The endpoint also illustrates why an estimate needs its uncertainty measure. A GMT communicates a central summary of assay titers, while a 95% confidence interval conveys statistical precision under the analysis assumptions. The registry record specifies both the summary and the intended interval, but does not report their numerical values. This gap means readers cannot judge whether estimates were precise, how they varied across serogroups, or how strongly the data support any description of the observed response.
Analysis populations are another key issue. The full analysis set is defined by receipt of vaccine and a valid post-vaccination serology result, while the primary analysis uses a per-protocol subset. The criteria for that subset are not reported. Transparent definitions and participant flow are important because exclusions can affect which participants contribute to an estimate. Without those details, readers cannot evaluate the representativeness of the analyzed set or the sensitivity of results to population choices.
The record also highlights the value of complete reporting. It identifies outcome measures and selected safety summaries, yet does not report primary numerical endpoint results, multiplicity procedures, or a detailed analysis plan. These omissions prevent a reader from reconstructing the statistical analysis or evaluating the uncertainty around the intended immunogenicity measures. The safety counts can be read descriptively, but not as controlled comparisons or proof of causation.
For clinical researchers and statisticians, the central lesson is to distinguish a well-defined measurement plan from a fully assessable results record. Study design, analysis population, endpoint definition, precision estimates, missing-data handling, and multiplicity procedures all contribute to interpretation. In this record, some design and endpoint details are available, while key results and methods remain unreported.
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 numerical primary endpoint results are not reported in the registry record. The GMT estimates and 95% confidence intervals are specified as the endpoint but are not available in the record. The antibody measurements therefore cannot be quantified, and their precision cannot be assessed. It is also not possible to compare reported titers across the four serogroups or evaluate how the estimates changed between the stated timepoints.
The study is single-group, open-label, and single-center. It has no randomized control group, so before-and-after measurements do not form a controlled treatment contrast. The record describes an age-based division for safety reporting, but these groups are not described as randomized comparators. Findings from one center in Vietnam may not reflect other settings or populations; the extent of generalizability cannot be assessed from the information reported.
The registry identifies a per-protocol analysis set but does not report its eligibility criteria. It defines the full analysis set as participants who received the vaccine and had a valid post-vaccination serology result, but does not provide participant flow, the number contributing to the primary analysis, or details about invalid and missing measurements. The approach to missing data is not reported. These omissions limit assessment of selection and missingness effects.
The registry record does not report the detailed statistical analysis plan, the handling of multiplicity, the model used for the GMT estimates, or whether sensitivity analyses were conducted. It also does not report a protocol-based sample-size justification or interim analysis details. The listed safety figures lack further information about event ascertainment and causality assessment in this summary. Consequently, the record supports a description of the study structure and selected safety observations, but not a complete evaluation of immunogenicity, precision, or analytic robustness.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Study on a MenACYW Conjugate Vaccine Administered as a Single Dose in Participants Aged 12 Months and Older in Vietnam — NCT06228586.
- Registry record last updated 2025-09-17; status last verified 2025-08.
- Results first posted 2025-09-17.
- 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
NCT06228586 is a completed Phase III, open-label, single-center, single-group study of one dose of MenACYW conjugate vaccine in participants aged 12 months and older in Vietnam. Enrollment was 447. The recorded study start date is 2024-01-18, and the primary completion date is 2024-03-31.
The primary endpoint is geometric mean antibody titers against meningococcal serogroups A, C, Y, and W, measured by hSBA before vaccination on Day 1 and on Day 31, 30 days after the dose. The primary analysis population was the per-protocol analysis set, described as a subset of the full analysis set.
The record reports age-based safety group summaries, including serious and other adverse event counts, and selected serious-event terms. Numerical primary endpoint results, a detailed statistical analysis plan, multiplicity procedures, and missing-data methods are not reported in the registry record. The single-group design provides no randomized control comparison.