This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for A Phase I/II Trial of Tetravalent Live Attenuated Dengue Vaccine in Flavivirus Antibody Naive Infants (NCT00322049), a randomized phase 1, phase 2 study. The primary outcome is Reactogenicity in Terms of Solicited Symptoms After Dose 1 of the Dengue Vaccine vs. Control Vaccine..
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00322049 |
| Phase | Phase 1, Phase 2 |
| Condition | Dengue |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 51 |
| Arms in the primary outcome | n/a |
| Lead sponsor | U.S. Army Medical Research and Development Command |
| Results posted | Yes |
2. Clinical Question
Population
Infants described as flavivirus-antibody-naive, with vaccination beginning at 12-15 months of age. The registry gives this age range as the target for the trial and describes dengue-endemic settings as the broader context for vaccine development.
Intervention
A tetravalent live attenuated dengue vaccine candidate, F17, given in a two-dose schedule. The registry describes full-dose and 1/10-dose cohorts, with vaccination at Months 0 and 6 and booster follow-up at 3 years.
Comparator
Control vaccines listed as varicella vaccine and Haemophilus influenzae Type b conjugate vaccine. The registry's arm descriptions and adverse-event group labels do not align cleanly, so comparisons should be interpreted with that labeling limitation in mind.
Primary question
What number of local and general solicited reactogenicity events was recorded during the 21-day follow-up period after Dose 1 in the dengue-vaccine and control groups? The registry identifies this measure but does not report a numerical primary result or an analysis comparing groups.
The trial's stated aims extend beyond the primary reactogenicity measure. They include assessing dengue neutralizing antibodies to each serotype one and four years following Dose 2, in the setting of potential wild-type dengue-virus exposure, and assessing immunogenicity, safety, and reactogenicity after a booster at Year 3. The registry also lists secondary outcomes concerning dengue-specific symptoms and dengue viremia 10 days after the booster.
The clinical question is therefore broader than whether solicited symptoms occurred after the first dose. It concerns short-term safety and reactogenicity, antibody responses over follow-up, and outcomes around a later booster. The posted record does not provide numerical results for those antibody aims or the listed secondary outcomes, so their findings cannot be characterized from the registry information.
3. Trial Design
This was a randomized, double-masked, parallel Phase I/II trial. The registry lists enrollment as 51 and status as completed. The sponsor was the U.S. Army Medical Research and Development Command. The trial's listed condition was dengue.
The registry describes three cohorts: a full-dose dengue-vaccine cohort, a 1/10-dose dengue-vaccine cohort, and a control-vaccine cohort. The intervention descriptions identify the dengue candidate as a tetravalent live attenuated vaccine and list varicella vaccine and Haemophilus influenzae Type b conjugate vaccine as control vaccines. The dengue schedule is described as doses at Months 0 and 6, followed by booster follow-up at 3 years. The record also describes a primary reactogenicity follow-up period of 21 days after Dose 1.
There is an important labeling inconsistency. The arm descriptions identify Cohort A as full dose, Cohort B as control, and Cohort C as 1/10 dose. The adverse-event group labels instead identify Cohort A as 1/10 dose, Cohort B as full dose, Cohort C as full dose, and a separate control group. The primary-outcome description says that cohorts B and C were combined because both cohorts were full dose, but those labels do not match the arm descriptions. This discrepancy limits confident mapping of some posted safety figures to the described arms.
The registry gives a start date of 2004-02 and a primary completion date of 2009-06. It does not report details of the randomization procedure, concealment, masking implementation, or how participants were assigned among the dose cohorts. Those design details should not be inferred from the general labels “randomized” and “double.”
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.
Overall Study
| Stage | Cohort A - 1/10th Dose Dengue Vaccine | Cohort B - Full Dose Dengue Vaccine | Cohort C - Full Dose Dengue Vaccine | Control Group - Hib Vaccine |
|---|---|---|---|---|
| STARTED | 4 | 10 | 20 | 17 |
| COMPLETED | 4 | 9 | 20 | 16 |
| NOT COMPLETED | 0 | 1 | 0 | 1 |
Reasons for not completing this period:
| Reason | Cohort A - 1/10th Dose Dengue Vaccine | Cohort B - Full Dose Dengue Vaccine | Cohort C - Full Dose Dengue Vaccine | Control Group - Hib Vaccine |
|---|---|---|---|---|
| Moved out of area | 0 | 0 | 0 | 1 |
| Infected with Dengue during study | 0 | 1 | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: Format of results is consistent with how data was presented in the Final Clinical Study Report. Combining of cohorts B and C was due to both cohorts being full dose
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | Cohort A - 1/10th Dose Dengue Vaccine | Cohort B - Full Dose Dengue Vaccine | Cohort C - Full Dose Dengue Vaccine | Control Group - Hib Vaccine | Total |
|---|---|---|---|---|---|---|
| Participants analysed | 4 | 10 | 20 | 17 | 51 | |
| Age, Continuous | months | 14.0 (SD 0.00) | 13.3 (SD 0.82) | 13.6 (SD 0.88) | 13.6 (SD 0.79) | 13.6 (SD 0.80) |
| Sex: Female, Male: Female | Participants | 1 | 6 | 7 | 9 | 23 |
| Sex: Female, Male: Male | Participants | 3 | 4 | 13 | 8 | 28 |
| Race/Ethnicity, Customized: Southeast Asian | Participants | 4 | 10 | 20 | 17 | 51 |
| Region of Enrollment: Thailand | participants | 4 | 10 | 20 | 17 | 51 |
6. Primary Endpoint
The registry lists the primary outcome as Reactogenicity in Terms of Solicited Symptoms After Dose 1 of the Dengue Vaccine vs. Control Vaccine., measured over 21-day follow-up period after Dose 1.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | specified events |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the number of specified local and general solicited reactogenicity events after Dose 1, assessed during a 21-day follow-up period. The description says that diary cards were used to record solicited symptoms during days 0-20. In this context, a count endpoint records how many events meeting the specified criteria were observed in the follow-up window; it is not itself a measure of antibody response or protection against dengue.
Solicited symptoms are useful in a vaccine trial because they focus observation on symptoms the study intends to monitor, over a defined period after vaccination. The timing makes the endpoint directly relevant to short-term reactogenicity. The record does not provide the list of specified symptoms, how events were graded, whether repeated reports of the same symptom were counted as separate events, or whether the reported number refers to events or participants experiencing events. These details are not reported in the registry record.
The registry states that the result format follows the Final Clinical Study Report and that cohorts B and C were combined because both were full dose. However, the displayed group labels elsewhere are inconsistent with that explanation. No numerical count, group-level comparison, uncertainty estimate, or statistical test for the primary endpoint is reported in the registry record. Consequently, the endpoint can be described, but the size and precision of any difference between groups cannot be assessed from this record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The available registry information describes the trial design and the intended primary endpoint, but does not include a numerical primary-outcome result or an analysis of that outcome. There is therefore no reported estimate of the number of solicited events by group, no group contrast, and no confidence interval or test result for the primary question. A conclusion about the direction, size, or precision of a difference in primary reactogenicity cannot be drawn from this information.
The adverse-event summary contains counts of participants with serious events, other events, and deaths in the listed groups. The serious-event counts are 0 among 4 in the group labeled Cohort A: Dengue Vaccine- 1/10 Dose, 1 among 10 in the group labeled Cohort B: Full Dose, 0 among 20 in the group labeled Cohort C: Dengue Vaccine - Full Dose, and 3 among 17 in the Control Group. The registry records 0 deaths in each of these groups. These are descriptive safety counts; they are not a substitute for the missing primary reactogenicity results.
The group labels warrant caution. As described in the trial design, the arm descriptions assign treatments differently from the adverse-event labels. The primary-outcome description also refers to combining cohorts B and C as full-dose cohorts, which does not reconcile with the arm descriptions. The record does not explain this inconsistency. It is therefore safer to quote the adverse-event group labels as recorded than to relabel or combine those counts as if the treatment mapping were unambiguous.
Even when group counts are available, small counts can leave substantial uncertainty about how well they represent the event experience that might be observed in a larger or different population. General statistical interpretation distinguishes the observed count from the underlying event frequency: the count is a record of what occurred in the trial, while an estimate of frequency and its uncertainty requires a clearly defined denominator, outcome definition, and analysis. The posted safety summary does not include confidence intervals or an adjusted comparison.
The registry lists serious-event terms with percentages, including “Fracture left forearm” at 10.0%, “Acute gastroenteritis with dehydration” at 5.9%, “Acute gastroenteritis with febrile seizure” at 5.9%, and “Viral gastritis with dehydration/vomiting, fever” at 5.9%. The denominator and method used for these percentages are not reported in the registry record. They should therefore be read as listed descriptive entries, not as estimates that can be directly compared across terms or groups.
The registry identifies antibody kinetics and booster-related safety and immunogenicity as trial aims, and it lists secondary outcomes for dengue-specific symptoms and viremia after booster. Numerical results for these outcomes are not reported in the registry record. The absence of reported results in this record does not establish that an outcome did not occur or was not measured; it means its findings cannot be evaluated from the information recorded.
9. Statistical Methods Explained
What does randomization contribute?
In general, randomization is intended to make treatment assignment less dependent on participant characteristics, which can help support a fair comparison between groups. It does not guarantee that groups will be identical, particularly when group sizes are limited, and it does not remove the need to report how assignment was conducted or how outcomes were analyzed. The registry labels this trial randomized, but the specific sequence-generation and allocation procedures are not reported in the registry record.
What does double masking mean for interpretation?
In general, masking is used to reduce the influence that knowledge of assigned treatment may have on participant reporting, clinical assessment, or outcome recording. A “double” label indicates that the record classifies the trial as double-masked, but the registry does not identify which people were masked or explain the practical masking procedures. For diary-card symptoms, consistent recording and clear symptom definitions are important; those operational details are not reported in the registry record.
How should a count endpoint be understood?
A count endpoint records the number of events meeting a specified definition within a specified population and observation period. Its interpretation depends on what counts as an event, whether a participant can contribute multiple events, and how time under observation is handled. Here, the listed endpoint is the number of specified events during the 21-day period after Dose 1, with diary-card recording described for days 0-20. The record does not clarify whether repeated symptoms in one participant contribute multiple counts or whether the reported measure is instead a count of participants with at least one symptom.
General statistical methods for count outcomes may account for the possibility that variability exceeds what a simple count model expects; this is often called over-dispersion. Whether that issue arose or what model might address it depends on the observed data and analysis plan. No model, dispersion assessment, or primary-outcome analysis is reported in the registry record, so no particular method should be attributed to this trial.
What would an uncertainty interval add?
In general, a confidence interval gives a range of values compatible with the data and the statistical method under its assumptions. It communicates precision as well as the direction and size of an estimate. A narrow interval generally indicates greater precision than a wide interval, while neither an interval nor a test result alone establishes clinical importance. No interval for the primary endpoint or the adverse-event counts is reported in the registry record.
A p-value, when reported, describes how compatible the observed data are with a specified null model under the assumptions of the test. It does not measure the probability that a treatment is effective, nor does it describe the size of an effect. The registry record does not report a primary-outcome p-value or an analysis comparing the groups. It would be inappropriate to infer one from the descriptive counts, especially given the group-label inconsistency and the absence of a stated analysis.
What do the planning illustrations represent?
The record describes sample-size planning illustrations based on a fraction of an observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. These are planning illustrations, not observed power and not evidence that the trial was designed using those assumptions. The record does not report the trial's own sample-size justification. Since the primary endpoint has several categories or time points and was not reduced to one comparison, no single primary comparison is represented by the planning output. The illustrations should not be read as a reconstruction of the original design or as a result of the trial.
In general, a planning calculation asks what sample size might be needed under stated assumptions; it does not establish what effect was observed or what precision the completed trial achieved. A calculation using a fraction of an observed effect is especially dependent on the effect chosen as its starting point. It is not a substitute for a clearly reported estimate and uncertainty interval for the trial outcome.
How does the endpoint fit within the wider aims?
The primary endpoint concerns solicited symptoms after Dose 1. Other stated aims concern neutralizing antibodies to each dengue serotype at later follow-up, and a booster at Year 3. These outcomes address different questions and require outcome-specific definitions and analyses. A symptom count cannot be treated as an antibody result, and antibody kinetics cannot be inferred from a reactogenicity endpoint. The registry lists seven outcome measures and zero analyses, but does not provide the numerical results or statistical methods needed to interpret those additional aims.
In general, interpretation also depends on the analysis population: for example, whether all randomized participants, participants who received a dose, or participants with available outcome data are included. The registry does not specify the population used for the primary endpoint or for the safety summaries. It likewise does not describe missing-data handling, protocol deviations, or whether analyses followed assigned treatment. These omissions prevent assessment of how those choices may have affected the reported results.
10. Multiplicity, Missing Data and Analysis Populations
The trial record identifies several outcome areas: solicited symptoms after Dose 1, dengue neutralizing antibodies over follow-up, booster-related safety and immunogenicity, dengue-specific symptoms, and viremia after booster. When a study evaluates multiple outcomes or several time points, the chance of at least one apparently unusual result can increase if many tests are interpreted without a prespecified approach. General methods for addressing multiplicity include prioritizing outcomes, adjusting inference, or clearly treating some results as exploratory. The registry does not report a multiplicity strategy, hierarchy among secondary outcomes, or a statistical analysis plan.
Missing-data handling is also not reported in the registry record. It does not state how incomplete diary cards, missed visits, unavailable antibody measurements, or withdrawal from follow-up were handled. For a diary-based endpoint, incomplete recording could affect the observed count; the direction and extent of any such effect depend on why observations are missing and on the analysis approach. No assumptions about those issues can be made from the posted record.
Analysis populations are not specified. The record does not say whether the primary analysis included all randomized participants, only those vaccinated, or another defined group. It also does not report how protocol deviations or participants without outcome measurements were treated. The distinction matters because different populations can answer different questions, and their results need not coincide.
The record lists seven outcome measures and zero analyses. This does not establish what analyses may have been conducted outside the registry; it means the registry does not report them. Without a reported analysis plan, outcome-specific estimates, and missing-data details, the results cannot be assessed for selective reporting or for sensitivity to analysis choices.
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 |
|---|---|---|---|
| Cohort A: Dengue Vaccine- 1/10 Dose (T-DEN F17 ) | 0 | 4 | 0.0% |
| Cohort B: Full Dose (T-DEN F17 ) | 1 | 10 | 10.0% |
| Cohort C: Dengue Vaccine - Full Dose (T-DEN F17 ) | 0 | 20 | 0.0% |
| Control Group | 3 | 17 | 17.6% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Cohort A: Dengue Vaccine- 1/10 Dose (T-DEN F17 ) | 0 of 4 |
| Cohort B: Full Dose (T-DEN F17 ) | 0 of 10 |
| Cohort C: Dengue Vaccine - Full Dose (T-DEN F17 ) | 0 of 20 |
| Control Group | 0 of 17 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Cohort A: Dengue Vaccine- 1/10 Dose (T-DEN F17 ) | 4 of 4 |
| Cohort B: Full Dose (T-DEN F17 ) | 10 of 10 |
| Cohort C: Dengue Vaccine - Full Dose (T-DEN F17 ) | 20 of 20 |
| Control Group | 6 of 17 |
Most frequent serious adverse event terms
| Event term | Organ system | Cohort A: Dengue Vaccine- 1/10 Dose (T-DEN F17 ) | Cohort B: Full Dose (T-DEN F17 ) | Cohort C: Dengue Vaccine - Full Dose (T-DEN F17 ) | Control Group |
|---|---|---|---|---|---|
| Fracture left forearm | Injury, poisoning and procedural complications | 0 of 4 | 1 of 10 | 0 of 20 | 0 of 17 |
| Acute gastroenteritis with dehydration | Gastrointestinal disorders | 0 of 4 | 0 of 10 | 0 of 20 | 1 of 17 |
| Acute gastroenteritis with febrile seizure | Gastrointestinal disorders | 0 of 4 | 0 of 10 | 0 of 20 | 1 of 17 |
| Viral gastritis with dehydration/vomiting, fever | Gastrointestinal disorders | 0 of 4 | 0 of 10 | 0 of 20 | 1 of 17 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Cohort A: Dengue Vaccine- 1/10 Dose (T-DEN F17 ) | Cohort B: Full Dose (T-DEN F17 ) | Cohort C: Dengue Vaccine - Full Dose (T-DEN F17 ) | Control Group |
|---|---|---|---|---|---|
| Redness | Skin and subcutaneous tissue disorders | 2 of 4 | 7 of 10 | 14 of 20 | 1 of 17 |
| Swelling | General disorders | 1 of 4 | 5 of 10 | 11 of 20 | 2 of 17 |
| Redness | Skin and subcutaneous tissue disorders | 1 of 4 | 1 of 10 | 12 of 20 | 3 of 17 |
| Pain | General disorders | 1 of 4 | 2 of 10 | 11 of 20 | 2 of 17 |
| Pain | General disorders | 1 of 4 | 3 of 10 | 8 of 20 | 3 of 17 |
| Swelling | General disorders | 1 of 4 | 0 of 10 | 8 of 20 | 1 of 17 |
Serious events with the highest arm-level rate: fracture left forearm (10.0%), acute gastroenteritis with dehydration (5.9%), acute gastroenteritis with febrile seizure (5.9%), viral gastritis with dehydration/vomiting, fever (5.9%).
The adverse-event summary reports serious events, other events, and deaths by its own group labels. It records serious events for 0 among 4 in Cohort A: Dengue Vaccine- 1/10 Dose, 1 among 10 in Cohort B: Full Dose, 0 among 20 in Cohort C: Dengue Vaccine - Full Dose, and 3 among 17 in the Control Group. Deaths are recorded as 0 in every listed group. Other events are recorded for 4 among 4, 10 among 10, 20 among 20, and 6 among 17, respectively, using those same labels.
These counts describe what the registry records; they do not establish that an event was caused by a vaccine. The record does not report an adjudication method or a causal assessment for the listed events. Nor does it give confidence intervals or a formal comparative safety analysis. The small group counts mean that the observed counts alone offer limited information about how precisely event frequencies are estimated.
The listed serious-event terms include fracture and acute gastroenteritis-related entries, each accompanied by a percentage. The percentage denominator is not reported in the registry record. In addition, the arm descriptions and adverse-event group labels are inconsistent, so treatment assignment should not be inferred by silently reconciling them. The group names and numbers should be retained as recorded, with this limitation in mind.
12. What the Result Does, and Does Not, Mean
The registry establishes that a randomized, double-masked Phase I/II trial of a tetravalent live attenuated dengue vaccine was conducted in infants described as flavivirus-antibody-naive. It records an enrollment of 51 and identifies solicited symptoms after Dose 1 as the primary endpoint. It also describes planned assessment of antibody responses, booster-related outcomes, dengue-specific symptoms, and viremia.
What the record does not establish is the numerical result for the primary endpoint. It does not report a count of solicited events by treatment group, an estimate of a group difference, an uncertainty interval, or a statistical test. The serious and other adverse-event counts are descriptive and have a separate purpose; they do not fill in the missing primary result. The inconsistencies between arm descriptions and adverse-event group labels further limit interpretation of group-specific safety figures.
More generally, an observed count in a trial is not by itself a precise estimate of the frequency that would apply in other settings. Precision depends on the amount and completeness of observed data, the event definition, and the statistical analysis. The registry does not report confidence intervals, the primary analysis population, or missing-data methods. Its serious-event percentages also lack a reported denominator basis.
The record therefore supports a description of the trial's aims, design labels, endpoint definition, and listed adverse-event counts, but not a conclusion about the size or precision of a primary-outcome difference. It also does not provide the numerical antibody or booster results needed to characterize those aims. A lack of reported results in the registry should not be interpreted as evidence that an outcome was absent, nor as evidence for or against a treatment effect.
The sample-size calculations described by the record are planning illustrations under stated assumptions. They are not observed power, do not supply the trial's missing outcome estimates, and are not a substitute for the trial's own design rationale, which is not reported in the registry record.
13. Why This Trial Matters Statistically
This trial illustrates why design labels and outcome reporting need to be considered together. Randomization and double masking are useful features to identify, but interpretation also depends on knowing how allocation was carried out, what exactly was measured, who contributed data, and how comparisons were analyzed. Those operational and analytical details are not reported in the registry record.
It also demonstrates the difference between an endpoint description and an outcome result. The record defines a 21-day period for solicited symptoms after Dose 1 and identifies diary cards as the recording method. That information clarifies what the primary question concerns, but it cannot answer the question without group-level counts and an analysis. Clear reporting of event definitions, denominators, estimates, and uncertainty is necessary for readers to judge how informative a result is.
The label mismatch across arm descriptions and adverse-event groups is a further statistical reporting concern. If group identities cannot be mapped confidently, even correctly recorded counts may be difficult to interpret as treatment-specific evidence. Preserving the labels as recorded, rather than combining or relabeling groups without support, is essential to avoid overstating what the data show.
Finally, this record sets out several distinct aims, ranging from short-term symptoms to antibody measurements and booster outcomes. Those endpoints address different questions and should not be treated as interchangeable. Reporting each with its population, time point, estimate, and uncertainty would allow a more complete assessment. The record's limited results and methods information makes transparent description, rather than strong comparative claims, the appropriate statistical approach.
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 registry record does not report a numerical result for the primary endpoint, a group comparison, or an uncertainty estimate. Although the endpoint is described as a number of specified events, the symptom list and event-counting rules are not reported. The record does not clarify whether it counts all events or participants with symptoms.
There is an inconsistency between the arm descriptions and adverse-event group labels. The primary-outcome description says cohorts B and C were combined because both were full dose, while the arm descriptions identify Cohort B as control and Cohort C as 1/10 dose. The adverse-event labels assign different treatments to those cohort names. The registry does not explain the discrepancy, preventing confident reconciliation of the group-specific safety counts.
The statistical analysis plan, sample-size justification, randomization procedure, masking implementation, analysis populations, and missing-data approach are not reported in the registry record. Nor are there reported confidence intervals or tests for the primary endpoint. The sample-size information is described as a planning illustration based on an observed effect and specified assumptions, rather than the trial's own design justification.
The record lists aims and secondary outcomes related to antibody kinetics, booster outcomes, dengue-specific symptoms, and viremia, but does not report numerical results for them. The denominator basis for the percentages attached to serious-event terms is also not reported. These limitations restrict interpretation to the design descriptions and descriptive counts actually recorded; they do not show that unreported outcomes were not measured.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Phase I/II Trial of Tetravalent Live Attenuated Dengue Vaccine in Flavivirus Antibody Naive Infants — NCT00322049.
- Registry record last updated 2018-01-19; status last verified 2017-12.
- Results first posted 2017-07-19.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
NCT00322049 is a completed randomized, double-masked, parallel Phase I/II trial sponsored by the U.S. Army Medical Research and Development Command. The registry lists enrollment as 51 and describes a tetravalent live attenuated dengue vaccine candidate, including full-dose and 1/10-dose cohorts, with varicella and Haemophilus influenzae Type b conjugate vaccines as controls.
The primary endpoint concerns the number of solicited local and general reactogenicity events during the 21-day period after Dose 1. The registry does not report a numerical result or statistical analysis for that endpoint. It lists serious-event and other-event counts, but group labels conflict with the arm descriptions. Antibody and booster-related aims are described without numerical results in the registry record.