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 Immunogenicity and Safety of a Purified Vero Rabies Vaccine (NCT03145766), a randomized phase 2 study. The primary outcome is Rabies Virus Neutralizing Antibody (RVNA) Geometric Mean Titers (GMTs) Against Rabies Virus at Day 0.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03145766 |
| Phase | Phase 2 |
| Condition | Rabies Virus |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 320 |
| Arms in the primary outcome | 5 |
| Lead sponsor | Sanofi Pasteur, a Sanofi Company |
| Results posted | Yes |
2. Clinical Question
Population
Healthy adults enrolled in a multicenter Phase II study. The primary endpoint used the Per-Protocol Analysis Set, defined as participants who received at least one study-vaccine dose without protocol deviations before Day 14.
Intervention
Three VRVg-2 formulations and one VRVg-1 formulation, each given by intramuscular injection on Days 0, 3, 7, 14 and 28. Each group also received human rabies immunoglobulins on Day 0.
Comparator
Imovax Rabies, given by intramuscular injection on Days 0, 3, 7, 14 and 28, with human rabies immunoglobulins on Day 0. The registry describes the study as controlled and randomized.
Primary question
What were the groups’ rabies virus neutralizing antibody geometric mean titers against rabies virus at Day 0, measured by the rapid fluorescent focus inhibition test? This is a baseline measurement, not a post-vaccination comparison.
The trial addressed the evaluation of different formulations of the Purified Vero Rabies Cell vaccine VRVg in a simulated rabies post-exposure regimen. Its registry title also identifies immunogenicity and safety as areas of interest. However, the primary endpoint reported in the results is specifically the Day 0 geometric mean titer. Since Day 0 is the first scheduled injection day, these values describe antibody levels at the start of the regimen; they do not show the antibody levels reached after the subsequent injections.
The five groups were not all different formulations of the same vaccine: the registry lists three VRVg-2 formulation groups, one VRVg-1 group and an Imovax Rabies group. All five regimens included human rabies immunoglobulins on Day 0. The primary result therefore offers baseline measurements across the groups, not evidence about comparative changes after treatment or about the effects of vaccine without immunoglobulins.
3. Trial Design
This was a completed, randomized, controlled, multicenter Phase II study with a parallel-group design. The registry records quadruple masking and describes the study in its brief summary as observer-blind. Enrollment was 320. The study began on 2017-04-17, and primary completion was recorded as 2018-01-08.
There were five groups. Group 1 received VRVg-2 Formulation 1, Group 2 received VRVg-2 Formulation 2, Group 3 received VRVg-2 Formulation 3, Group 4 received VRVg-1, and Group 5 received Imovax Rabies. Each vaccine regimen was given by intramuscular injection on Days 0, 3, 7, 14 and 28. Human rabies immunoglobulins were administered concomitantly on Day 0 in each group. This shared schedule and concomitant intervention are important context when interpreting the group results.
The primary outcome population was the Per-Protocol Analysis Set. It included participants who received at least one dose of study vaccine without protocol deviations before Day 14, described in the record as 7 days after the third vaccine injection. The outcome-specific group counts were 72 for Group 1, 75 for Group 2, 71 for Group 3, 35 for Group 4 and 34 for Group 5. These are the counts recorded for the primary outcome, not the overall enrollment total.
Further detail about randomization procedures, allocation concealment, the roles covered by masking, and the planned statistical analysis is not reported in the registry record. The posted results do not identify an adjusted or unadjusted comparison among groups. The registry records 24 outcome measures, but no secondary results are posted in the information summarized for this analysis.
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 320 participants were enrolled and vaccinated in the study.
Active Vaccination Phase (Day 0-Day 56)
| Stage | Group 1: VRVg-2 Formulation 1 | Group 2:VRVg-2 Formulation 2 | Group 3: VRVg-2 Formulation 3 | Group 4: VRVg-1 | Group 5: Imovax Rabies |
|---|---|---|---|---|---|
| STARTED | 80 | 80 | 80 | 40 | 40 |
| Vaccination 1 | 80 | 80 | 80 | 39 | 41 |
| Vaccination 2 | 77 | 81 | 80 | 39 | 39 |
| Vaccination 3 | 78 | 79 | 80 | 39 | 38 |
| Vaccination 4 | 78 | 79 | 80 | 38 | 38 |
| Vaccination 5 | 75 | 78 | 79 | 34 | 37 |
| COMPLETED | 74 | 77 | 78 | 33 | 37 |
| NOT COMPLETED | 6 | 3 | 2 | 7 | 3 |
Reasons for not completing this period:
| Reason | Group 1: VRVg-2 Formulation 1 | Group 2:VRVg-2 Formulation 2 | Group 3: VRVg-2 Formulation 3 | Group 4: VRVg-1 | Group 5: Imovax Rabies |
|---|---|---|---|---|---|
| Other Adverse Event (AE) | 1 | 1 | 0 | 1 | 2 |
| Non-compliance with the Protocol | 0 | 0 | 1 | 2 | 1 |
| Lost to Follow-up | 1 | 1 | 0 | 3 | 0 |
| Voluntary Withdrawal Not Due AE | 4 | 1 | 1 | 1 | 0 |
Follow-up Phase (Day 56 Till Month 7)
| Stage | Group 1: VRVg-2 Formulation 1 | Group 2:VRVg-2 Formulation 2 | Group 3: VRVg-2 Formulation 3 | Group 4: VRVg-1 | Group 5: Imovax Rabies |
|---|---|---|---|---|---|
| STARTED | 74 | 77 | 78 | 33 | 37 |
| COMPLETED | 67 | 75 | 73 | 30 | 34 |
| NOT COMPLETED | 7 | 2 | 5 | 3 | 3 |
Reasons for not completing this period:
| Reason | Group 1: VRVg-2 Formulation 1 | Group 2:VRVg-2 Formulation 2 | Group 3: VRVg-2 Formulation 3 | Group 4: VRVg-1 | Group 5: Imovax Rabies |
|---|---|---|---|---|---|
| Non-compliance with the Protocol | 2 | 0 | 0 | 1 | 0 |
| Lost to Follow-up | 4 | 1 | 4 | 2 | 3 |
| Voluntary Withdrawal not due to AE | 1 | 1 | 1 | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: Per-Protocol Analysis Set (PPAS): participants who received at least one dose of the study vaccine without protocol deviations before Day 14 (i.e., 7 days after the 3rd vaccine injection).
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: Analysis was performed on all randomized participants.
| Characteristic | Unit | Group 1: VRVg-2 Formulation 1 | Group 2:VRVg-2 Formulation 2 | Group 3: VRVg-2 Formulation 3 | Group 4: VRVg-1 | Group 5: Imovax Rabies | Total |
|---|---|---|---|---|---|---|---|
| Participants analysed | 80 | 80 | 80 | 40 | 40 | 320 | |
| Age, Continuous | years | 41.9 (SD 13.4) | 42.6 (SD 13.0) | 41.1 (SD 14.4) | 41.1 (SD 13.5) | 38.9 (SD 13.1) | 41.4 (SD 13.5) |
| Sex: Female, Male: Female | Participants | 44 | 35 | 41 | 16 | 22 | 158 |
| Sex: Female, Male: Male | Participants | 36 | 45 | 39 | 24 | 18 | 162 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 2 | 2 | 0 | 1 | 1 | 6 |
| Race (NIH/OMB): Asian | Participants | 1 | 2 | 3 | 0 | 1 | 7 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 18 | 18 | 22 | 13 | 7 | 78 |
| Race (NIH/OMB): White | Participants | 56 | 54 | 55 | 24 | 28 | 217 |
| Race (NIH/OMB): More than one race | Participants | 2 | 3 | 0 | 1 | 2 | 8 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 1 | 1 | 0 | 1 | 1 | 4 |
6. Primary Endpoint
The registry lists the primary outcome as Rabies Virus Neutralizing Antibody (RVNA) Geometric Mean Titers (GMTs) Against Rabies Virus at Day 0, measured over Day 0.
| Element | Registry entry |
|---|---|
| Result type | Geometric Mean |
| Measure of spread | 95% Confidence Interval |
| Unit | international units per milliliter |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the geometric mean titer (GMT) of rabies virus neutralizing antibody (RVNA) against rabies virus at Day 0. Titers are expressed in international units per milliliter and were assessed with the rapid fluorescent focus inhibition test (RFFIT) assay. The reported measure is a group-level geometric mean, accompanied by a 95% confidence interval where one is available.
Neutralizing antibodies are measured because they can quantify antibody activity directed against the virus. As a general statistical concept, a geometric mean is often used for measurements that are positive and spread over a multiplicative scale. It is obtained by averaging on a logarithmic scale and converting the result back to the original scale. This can make a group summary less dominated by very high values than an arithmetic mean would be, but the registry does not report why this summary was selected for this trial.
Timing governs what this endpoint can answer. Day 0 is the first scheduled vaccine administration day in all groups, so this endpoint describes the groups’ starting antibody levels. It is not a measurement after completion of the vaccine schedule and does not quantify a change from baseline. A baseline GMT can help characterize the enrolled groups, but by itself it cannot establish how antibody levels subsequently changed or whether those changes differed by formulation. Post-vaccination values and formal comparisons for this endpoint are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
At Day 0, the reported RVNA GMTs were 0.101 international units per milliliter for Group 1, 0.1 for Group 2, 0.102 for Group 3, 0.101 for Group 4 and 0.1 for Group 5. These are baseline group summaries. They should not be read as antibody responses to the vaccine schedule because the endpoint was measured on the first scheduled injection day.
The registry reports 95% confidence intervals for three groups: Group 1, 0.099 to 0.102; Group 3, 0.099 to 0.104; and Group 4, 0.099 to 0.103. Confidence limits for Group 2 and Group 5 are not reported in the registry record. A confidence interval describes the statistical uncertainty around an estimated group value under the method used to construct it. It does not indicate the range of individual participants’ titers, and it does not by itself test whether groups differ. Because intervals are absent for two groups, the uncertainty information is incomplete for comparisons across all five groups.
The outcome-specific sample sizes range from 34 to 75 across the groups. The group sizes are therefore not identical, and interpretation should retain the actual counts rather than assume equal contributions. The registry gives no formal comparison estimate, p-value, or analysis entry for these baseline results. Consequently, the numerical ordering of the GMTs is descriptive only. It is not evidence that one formulation produced a higher or lower response, and the small differences in displayed values should not be treated as established group effects.
The endpoint’s time point also limits what can be inferred about balance between groups. Randomization is intended, in general, to make treatment groups comparable at enrollment, but observed baseline values may still vary. The record does not report a baseline significance test or an adjusted comparison. Nor does it state whether the endpoint was intended as a comparative efficacy measure. A statistical interpretation should therefore stop at describing the reported baseline summaries and their available confidence intervals.
The safety results are distinct from this immunogenicity endpoint. The record reports serious adverse events, other adverse events and deaths by group, but does not establish that any reported event was caused by a particular vaccine. Those counts describe the posted safety observations; they do not replace a comparative safety analysis, which is not reported in the registry record.
9. Statistical Methods Explained
The reported primary outcome is a geometric mean titer with a 95% confidence interval. No formal hypothesis test or model-based comparison among the five groups is reported in the registry record. The following explanations describe general statistical concepts relevant to interpreting these measures; they should not be taken as a description of unreported trial procedures.
What does a geometric mean describe?
In general, a geometric mean summarizes positive measurements by averaging their logarithms and transforming that average back to the measurement scale. This is useful when values vary multiplicatively, such as measurements that can differ by proportional rather than fixed amounts. It differs from an arithmetic mean, which averages the original values directly. The registry reports GMTs, but does not report the distribution of individual titers or the calculation details used for the estimates.
How should a confidence interval be read?
In general, a confidence interval expresses the precision of an estimate under a stated statistical procedure. A narrower interval indicates greater precision than a wider interval for the same type of estimate. A 95% confidence interval is not a statement that a particular participant’s value lies within its bounds, nor is it a direct probability statement about the fixed group value. It also does not automatically establish a difference between two groups. Group comparisons require an appropriate comparison estimate and its uncertainty or a specified test.
For this endpoint, confidence intervals are reported for Group 1, Group 3 and Group 4, but not for Group 2 or Group 5. Without the missing intervals or a reported comparison analysis, readers cannot use the posted summaries to assess comparative precision consistently across all groups. Overlap or non-overlap between separate group intervals, even when available, is not a substitute for a formal comparison designed for the question.
Why does the analysis population matter?
The primary outcome uses the Per-Protocol Analysis Set: participants who received at least one dose of study vaccine without protocol deviations before Day 14. In general, a per-protocol population focuses on participants meeting specified adherence and protocol criteria. It can differ from an analysis of everyone randomized, because exclusions or deviations may change who contributes to the outcome. The registry does not report a corresponding intention-to-treat estimate or a comparison between analysis populations, so the impact of the population definition cannot be assessed from these results.
What does randomization contribute?
Random allocation is generally used to reduce systematic differences between treatment groups at the point of assignment. It does not guarantee that every measured baseline characteristic will be identical between groups, and it does not eliminate uncertainty. In this trial, randomization is recorded, but the sequence-generation and allocation-concealment methods are not reported in the registry record. The Day 0 titers are descriptive baseline summaries and no test of baseline differences is reported.
What can be inferred from the posted estimates?
The five GMTs and the available confidence intervals support a description of baseline antibody levels in the primary analysis population. They do not estimate a treatment effect, because no post-treatment endpoint or change from baseline is included in this primary result. The record does not report a model, covariate adjustment, testing procedure, or planned contrast for the five groups. It would be inappropriate to infer such methods from the reported summary statistics.
More generally, comparisons across multiple groups raise the possibility of multiplicity: testing many contrasts can increase the chance of at least one apparently notable result if no adjustment or prespecified strategy is used. The registry record does not report a multiplicity procedure or a formal set of pairwise tests. Since no p-values or comparative estimates are posted, the baseline values should be read as descriptive rather than as a collection of supported treatment-effect claims.
General statistical interpretation also depends on how missing measurements are handled and whether the assumptions used for estimation are reasonable. The registry does not report an imputation method, a missing-data model, or diagnostic information for this endpoint. The missing confidence limits for two group summaries further restrict assessment of precision. These omissions do not change the recorded GMT values, but they limit evaluation of how completely uncertainty and participant data were incorporated.
10. Multiplicity, Missing Data and Analysis Populations
The registry reports a primary endpoint and 24 outcome measures, but the results summarized for this analysis contain no secondary outcome results. The primary endpoint has group-level estimates, but no reported p-values, formal group comparisons, or statistical analysis entries. A multiplicity adjustment or prespecified hierarchy for testing multiple outcomes or contrasts is not reported in the registry record.
As a general principle, when many hypotheses are tested, the chance of at least one false-positive finding can increase unless the analysis plan addresses multiplicity. That concern cannot be quantified from these results because the registry does not report which comparisons, if any, were planned or performed. The Day 0 GMTs are descriptive values and should not be treated as evidence from multiple comparative tests.
The primary analysis population is defined as participants receiving at least one vaccine dose without protocol deviations before Day 14. The registry does not report the number excluded from this population, the reasons for exclusion, or a complementary analysis of all randomized participants. It also does not report how missing antibody measurements were handled, whether missingness differed by group, or whether sensitivity analyses were conducted. These details matter because the endpoint-specific counts do not by themselves explain why fewer participants contribute to the outcome than the overall enrollment total.
Accordingly, the available information supports interpretation of the reported per-protocol group summaries only. The extent to which missing observations, population exclusions, or multiplicity procedures could affect broader conclusions is not reported in the registry record.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Group 1: VRVg-2 Formulation 1 | 0 | 80 | 0.0% |
| Group 2: VRVg-2 Formulation 2 | 0 | 80 | 0.0% |
| Group 3: VRVg-2 Formulation 3 | 1 | 80 | 1.2% |
| Group 4: VRVg-1 | 0 | 39 | 0.0% |
| Group 5: Imovax Rabies | 0 | 41 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Group 1: VRVg-2 Formulation 1 | 0 of 80 |
| Group 2: VRVg-2 Formulation 2 | 0 of 80 |
| Group 3: VRVg-2 Formulation 3 | 0 of 80 |
| Group 4: VRVg-1 | 0 of 39 |
| Group 5: Imovax Rabies | 0 of 41 |
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 |
|---|---|
| Group 1: VRVg-2 Formulation 1 | 40 of 80 |
| Group 2: VRVg-2 Formulation 2 | 39 of 80 |
| Group 3: VRVg-2 Formulation 3 | 45 of 80 |
| Group 4: VRVg-1 | 22 of 39 |
| Group 5: Imovax Rabies | 28 of 41 |
Most frequent serious adverse event terms
| Event term | Organ system | Group 1: VRVg-2 Formulation 1 | Group 2: VRVg-2 Formulation 2 | Group 3: VRVg-2 Formulation 3 | Group 4: VRVg-1 | Group 5: Imovax Rabies |
|---|---|---|---|---|---|---|
| Facial Paralysis | Nervous system disorders | 0 of 80 | 0 of 80 | 1 of 80 | 0 of 39 | 0 of 41 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Group 1: VRVg-2 Formulation 1 | Group 2: VRVg-2 Formulation 2 | Group 3: VRVg-2 Formulation 3 | Group 4: VRVg-1 | Group 5: Imovax Rabies |
|---|---|---|---|---|---|---|
| Injection Site Pain | General disorders | 29 of 80 | 32 of 80 | 38 of 80 | 14 of 39 | 24 of 41 |
| Myalgia | Musculoskeletal and connective tissue disorders | 25 of 80 | 22 of 80 | 20 of 80 | 11 of 39 | 19 of 41 |
| Headache | Nervous system disorders | 26 of 80 | 12 of 80 | 21 of 80 | 10 of 39 | 15 of 41 |
| Malaise | General disorders | 26 of 80 | 13 of 80 | 17 of 80 | 11 of 39 | 16 of 41 |
| Application Site Bruise | General disorders | 0 of 80 | 1 of 80 | 1 of 80 | 2 of 39 | 1 of 41 |
Serious events with the highest arm-level rate: facial paralysis (1.2%).
For serious adverse events, the registry lists 80 participants at risk in each of the first three groups, 39 in Group 4 and 41 in Group 5. Serious adverse events affected 0 participants in Group 1, 0 in Group 2, 1 in Group 3, 0 in Group 4 and 0 in Group 5. Deaths are listed as 0 in every group. These are counts as recorded, not estimates of comparative risk.
The record identifies Facial Paralysis, with 1.2%, among the top serious adverse event terms. The available information does not establish whether that event was related to a study vaccine, to human rabies immunoglobulins, or to another cause. It also does not provide a case narrative or a comparison adjusted for differences in group size.
Other adverse events affected 40 of 80 participants in Group 1, 39 of 80 in Group 2, 45 of 80 in Group 3, 22 of 39 in Group 4 and 28 of 41 in Group 5. These counts are broader than serious adverse events and should not be conflated with the serious-event counts. A participant may also experience more than one event; the registry summary does not state whether counts represent unique participants for every event category or provide event-level detail. No causal attribution should be inferred from the group totals alone.
12. What the Result Does, and Does Not, Mean
The results establish that the registry contains Day 0 RVNA geometric mean titers for five groups in the Per-Protocol Analysis Set. The values are close in their displayed scale, and confidence intervals are available for three of the five groups. The results also document the numbers of participants included in those endpoint summaries. This provides a descriptive account of baseline antibody levels in the analyzed groups.
They do not establish the antibody levels after the regimen, the size of any change from baseline, or whether the formulations differ in post-vaccination immunogenicity. The endpoint is measured on Day 0, before the scheduled sequence of injections has been completed. The record does not report a formal comparison of group GMTs or a treatment-effect estimate. Thus, the values cannot support a claim that any one formulation performs better or worse than another.
The results also do not by themselves establish comparative safety. The reported counts indicate that one serious adverse event was recorded in Group 3, none in the other groups, and no deaths were recorded. Counts alone do not determine causality, and the record does not provide enough detail to evaluate event severity, timing, relatedness, or differences in follow-up across groups. The other adverse-event counts likewise describe recorded observations, not causal effects.
More broadly, the trial’s registry record gives a limited view of the statistical plan and the handling of missing outcome data. No multiplicity approach, imputation method, or formal analysis of the five-arm comparison is reported. The available evidence should therefore be understood as descriptive registry results rather than a complete comparative analysis of immunogenicity or safety.
13. Why This Trial Matters Statistically
This trial illustrates why the endpoint’s timing is as important as its name. “Immunogenicity” can refer broadly to immune responses, but the primary measure is a Day 0 antibody GMT. Because it is a starting measurement, it does not describe the response generated over the subsequent schedule. Recognizing that distinction prevents a baseline summary from being mistaken for a vaccine-effect estimate.
The study also shows how a multi-group design complicates interpretation when only group summaries are available. There are five regimens, including several VRVg formulations and an active vaccine comparator, with human rabies immunoglobulins included in every group. A reader needs formal comparative estimates, uncertainty and a clear analysis plan to assess differences between regimens. Those elements are not reported for the primary endpoint in the registry record.
Another statistical lesson is that an estimate and its precision are separate pieces of information. GMTs are reported for all groups, while confidence intervals are reported for only three. The missing intervals do not erase the point estimates, but they leave an incomplete account of uncertainty across groups. Similarly, endpoint-specific participant counts help describe how much data contribute, but the record does not explain exclusions or missing measurements.
Finally, safety counts require careful separation of event categories and cautious interpretation of causality. Serious and other adverse events are reported separately, and group counts are not a substitute for a comparative safety analysis. Taken together, the registry record is useful for understanding what was measured and what observations were posted, while also showing why endpoint timing, analysis populations, uncertainty and reporting completeness matter in clinical-trial interpretation.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The principal limitation is that the primary endpoint is recorded at Day 0, the first scheduled injection day. It therefore describes baseline RVNA titers rather than the immune response following the study regimens. The registry does not report post-vaccination GMTs or a change-from-baseline result within this primary outcome, so comparative immunogenicity cannot be assessed from these values.
Precision reporting is incomplete: confidence intervals are available for Groups 1, 3 and 4, but not for Groups 2 and 5. No formal comparison, p-value, adjusted estimate or analysis model is reported. The record also does not explain the missing confidence limits, provide individual-level distributions, or specify how the GMT confidence intervals were calculated.
The primary outcome is based on a per-protocol population, and the registry does not give the number or reasons for exclusions from that population. Missing-data methods and sensitivity analyses are not reported. This leaves uncertainty about how protocol deviations or unavailable measurements affected the analyzed group counts.
Further limitations include the absence of reported details on the randomization process, allocation concealment, masking roles, and planned statistical comparisons. Although the trial is recorded as quadruple-masked and observer-blind, the specific masking arrangements are not described. The posted safety summaries also lack event narratives and causal assessments. These gaps constrain interpretation of both comparative efficacy and safety without changing the descriptive details reported for the trial.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Immunogenicity and Safety of a Purified Vero Rabies Vaccine — NCT03145766.
- Registry record last updated 2022-04-19; status last verified 2022-03.
- Results first posted 2021-01-28.
- 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
The registry record describes a completed, randomized, controlled, multicenter Phase II parallel-group study of five rabies vaccine groups in healthy adults. Enrollment was 320. The vaccine schedule was intramuscular injection on Days 0, 3, 7, 14 and 28, with human rabies immunoglobulins on Day 0 in every group.
The primary outcome was the Day 0 RVNA GMT against rabies virus, measured by RFFIT in the Per-Protocol Analysis Set. Group values range from 0.1 to 0.102 international units per milliliter as reported. Confidence intervals are posted for three groups; intervals for two groups are not reported in the registry record. No formal comparison analysis or secondary outcome results are reported in the information.
Safety results list one serious adverse event in Group 3, none in the remaining groups, and 0 deaths in all groups. The record does not establish causality for the event or provide a comparative safety analysis. Details of missing-data handling, multiplicity, and the statistical analysis plan are not reported in the registry record.