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 Trial of the Immunogenicity, Safety, and Tolerability of rF1V Vaccine With CpG 1018® Adjuvant Compared With rF1V Vaccine in Adults 18 to 55 Years of Age (NCT05506969), a randomized phase 2 study. The primary outcome is Rates of Reactogenicity and Safety.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05506969 |
| Phase | Phase 2 |
| Condition | Plague, Pneumonic, Plague, Vaccine-Preventable Diseases |
| Allocation | Randomized |
| Design model | Sequential |
| Masking | Double |
| Enrollment | 200 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Dynavax Technologies Corporation |
| Results posted | Yes |
2. Clinical Question
Population
Adults 18 to 55 years of age. The registry record lists plague and vaccine-preventable diseases among the conditions associated with the trial. The safety analysis population is defined as participants who received at least 1 study injection and had any post-baseline safety data.
Intervention
Two rF1V vaccine regimens included CpG 1018® adjuvant: co-administration of the vaccine and adjuvant, and bedside mixing of the vaccine and adjuvant. Each was administered as 2 injections.
Comparator
rF1V vaccine alone, administered as 3 injections. This was the active-control regimen; the registry record describes no placebo arm.
Primary question
What were the rates of solicited local and systemic post-injection reactions and other specified safety outcomes from Day 1 to Week 56? The registry record lists these outcomes but does not report a single summary comparison across the outcome categories and time points.
The clinical question is therefore about observed safety and reactogenicity across the three regimens, rather than a single event or one overall treatment effect. Solicited reactions are events specifically sought after injection, while the listed safety outcomes also include adverse events, severe adverse events, serious adverse events, adverse events of special interest, and deaths. The registry record does not report a separate immunogenicity outcome measure, despite immunogenicity appearing in the trial title.
Interpretation depends on keeping the groups distinct. The two adjuvanted regimens differ in how the vaccine and adjuvant were prepared, while the vaccine-only group received a different injection regimen. The posted safety counts can describe events recorded in each group, but they do not by themselves establish why an event occurred or whether one regimen caused more events than another. No single statistical contrast or adjusted comparison is reported for the primary outcome.
3. Trial Design
This was a phase 2, randomized, active-controlled, observer-blinded, multicenter trial. The registry record also identifies the study as double-masked and sequential. Enrollment was 200 participants. The trial was listed as completed, with a start date of 2022-08-09 and primary completion on 2023-10-03.
Three regimen groups are described. The co-administered group received rF1V vaccine and CpG 1018® adjuvant as 2 injections. The bedside-mix group received the vaccine and adjuvant mixed at bedside, also as 2 injections. The vaccine-only group received rF1V vaccine as 3 injections. The active control was therefore another vaccine regimen, not an untreated or placebo group.
Random allocation means that assignment was intended to occur by chance, a design feature that can support fair comparisons when allocation is implemented as planned. The registry record does not report the allocation ratio, the randomization procedure, or how the sequential model affected trial conduct. It also does not explain which trial personnel were masked or how masking was maintained. Those details are not reported in the registry record.
The primary outcome was a set of rates covering solicited local and systemic post-injection reactions and several additional safety categories. Its stated timeframe was Day 1 to Week 56. The safety analysis population included participants who received at least 1 study injection and had any post-baseline safety data. Although the study title includes immunogenicity, the registry record lists one outcome measure, describing safety; immunogenicity results are not reported in the registry record.
A completed status indicates that the registry lists the trial as completed; it does not, on its own, establish that every planned outcome or analysis is posted. No analysis entries are listed for the primary outcome. Consequently, the available record supports description of the posted safety counts, but not a complete account of the trial’s inferential 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.
Overall Study
| Stage | rF1V-1018 Co-Administered | rF1V-1018 Bedside Mix | rF1V Vaccine Only |
|---|---|---|---|
| STARTED | 21 | 90 | 89 |
| COMPLETED | 18 | 81 | 77 |
| NOT COMPLETED | 3 | 9 | 12 |
Analysis population for the primary outcome, as defined in the registry: Safety analysis population: All participants who received at least 1 study injection and had any post-baseline safety data
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: Safety analysis population: All participants who received at least 1 study injection and had any post-baseline safety data
| Characteristic | Unit | rF1V-1018 Co-Administered | rF1V-1018 Bedside Mix | rF1V Vaccine Only | Total |
|---|---|---|---|---|---|
| Participants analysed | 21 | 90 | 89 | 200 | |
| Age, Customized: Mean (SD) | Years | 39.1 (SD 8.17) | 40.0 (SD 9.2) | 37.9 (SD 9.91) | 39.0 (SD 9.76) |
| Age, Customized: 18-39 | Participants | 12 | 42 | 46 | 100 |
| Age, Customized: 40+ | Participants | 9 | 48 | 43 | 100 |
| Sex: Female, Male: Female | Participants | 9 | 34 | 36 | 79 |
| Sex: Female, Male: Male | Participants | 12 | 56 | 53 | 121 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 | 8 | 10 | 18 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 21 | 77 | 77 | 175 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 5 | 2 | 7 |
| Race/Ethnicity, Customized: White | Participants | 14 | 62 | 62 | 138 |
| Race/Ethnicity, Customized: Black or African American | Participants | 4 | 19 | 20 | 43 |
| Race/Ethnicity, Customized: American Indian or Alaska Native | Participants | 1 | 1 | 0 | 2 |
| Race/Ethnicity, Customized: Asian | Participants | 1 | 2 | 2 | 5 |
| Race/Ethnicity, Customized: Native Hawaiian or Other Pacific Islander | Participants | 0 | 1 | 2 | 3 |
| Race/Ethnicity, Customized: Other | Participants | 1 | 5 | 3 | 9 |
| Body mass index | (kg/m^2) | 26.5 (SD 2.46) | 25.9 (SD 3.04) | 25.5 (SD 3.16) | 25.8 (SD 3.04) |
6. Primary Endpoint
The registry lists the primary outcome as Rates of Reactogenicity and Safety, measured over Day 1 to Week 56.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary outcome is titled Rates of Reactogenicity and Safety and is measured in participants. It covers solicited local and systemic reactions after injection, as well as adverse events, severe adverse events, serious adverse events, adverse events of special interest, and deaths. The timeframe is Day 1 to Week 56.
These categories address different aspects of tolerability and safety. Solicited reactions are specifically monitored events, whereas broader adverse-event reporting can capture events outside a prespecified list of reactions. Severity and seriousness are distinct classifications: severity describes how intense an event is, while seriousness is a regulatory classification based on consequences such as hospitalization or other specified outcomes. A severe event is not automatically a serious event, and an event classified as serious need not be the most intense symptom.
Counting participants with an event is a useful way to describe how many people experienced an outcome within a group. It is not the same as counting all event episodes, since one participant may have more than one event. For a broad safety endpoint, separate categories can also be more informative than combining everything into one number: common short-term reactions and uncommon serious events have different meanings for interpretation.
The registry record does not provide the category-by-category outcome results across all time points or a single reduced comparison. It notes that the primary outcome has several categories or time points and is not reduced to one comparison. Thus, the endpoint definition clarifies what was intended to be measured, but the posted record does not allow a complete assessment of each specified component.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted adverse-event counts distinguish serious adverse events, other adverse events, and deaths across the three regimen groups. In the co-administered group, 1 of 21 participants at risk was listed as affected by a serious adverse event, and 18 of 21 were listed as affected by other adverse events; deaths were 0. In the bedside-mix group, the corresponding counts were 0 of 90 for serious adverse events and 77 of 90 for other adverse events; deaths were 0. In the vaccine-only group, 3 of 89 participants were listed as affected by serious adverse events and 69 of 89 by other adverse events; deaths were 1.
These are descriptive counts, not estimates of a treatment effect. They do not include a reported statistical comparison, confidence interval, or adjustment for differences among groups. The counts alone cannot establish whether apparent differences reflect a regimen, chance variation, differences in participant characteristics, or other influences. No causal attribution for the events is reported in the registry record.
The serious-event entries are based on relatively small numbers of affected participants in each group. General statistical principle: when events are uncommon, estimates of their frequency can be imprecise, and a small change in the observed count can materially affect the apparent pattern. A lack of reported events in a group does not prove that the underlying risk is zero. The record does not give confidence intervals for these counts or a formal comparison between groups.
The registry separately lists serious-event terms and percentages: Cor Pulmonale Acute, 4.8%; Pulmonary Embolism, 4.8%; Deep Vein Thrombosis, 4.8%; Complicated Appendicitis, 1.1%; Appendicitis, 1.1%; and Toxicity to Various Agents, 1.1%. The record does not provide enough context alongside these terms to interpret the percentages as group-specific rates or to establish their denominators. They should therefore be read as listed event information, not as a direct comparison among regimens.
The primary outcome is broader than the posted counts alone. It includes solicited local and systemic reactions and multiple safety categories over Day 1 to Week 56, but no analysis entries are listed and the record says the outcome has multiple categories or time points rather than one comparison. The adverse-event counts consequently do not substitute for a complete analysis of the primary outcome. They describe the safety information that is posted, without supporting a conclusion about comparative safety across the full endpoint.
The registry record reports 200 enrolled participants, while the safety counts are presented with group-specific numbers at risk. The record does not explain any difference between enrollment and the numbers contributing to particular safety summaries. Nor does it report missing-data handling or whether the posted counts include all participants with any safety follow-up. Those omissions limit how completely the counts can be linked to the planned safety population.
9. Statistical Methods Explained
General statistical principle: a randomized trial uses chance-based assignment to make groups comparable, on average, with respect to both measured and unmeasured characteristics. This supports an interpretable comparison, but it does not remove uncertainty, guarantee that groups are identical, or replace reporting of the analysis. The registry identifies this study as randomized, but details of the allocation procedure and the statistical analysis are not reported in the registry record.
What does a participant count measure?
The posted safety data use counts of participants with events. This is a person-level summary: each participant is counted as affected or not affected for the relevant category, regardless of how many separate episodes they experienced. General statistical principle: a participant count and an event count answer different questions. A participant-level measure describes how many people experienced an event; an event-level measure describes the total number of episodes, which may include repeated events in the same person.
The serious-event and other-event counts are reported separately. They should not be merged into one total without a prespecified definition and a clear understanding of whether categories overlap. The registry record does not state whether participants could appear in both categories or how overlapping events were handled in any summary. It also does not provide separate posted results for every solicited reaction, severity category, special-interest event, or time point included in the primary outcome.
How should uncertainty be understood?
General statistical principle: a confidence interval expresses the range of effect sizes reasonably compatible with the data under a specified statistical model. It conveys precision as well as direction and magnitude. A point estimate alone does not show how uncertain a result is. No confidence intervals or formal primary-outcome estimates are reported in the registry record, so the precision of a between-group contrast cannot be assessed from the posted counts.
General statistical principle: inference from sparse event data is particularly uncertain. When counts are small, standard large-sample approximations can be unreliable, and methods designed for rare outcomes may be considered. The registry record does not report the statistical method used for safety comparisons, if any, and no analysis entries are listed. No method should be inferred from the counts themselves.
Why do outcome categories matter?
The primary outcome combines several kinds of information: solicited local reactions, solicited systemic reactions, adverse events, severe adverse events, serious adverse events, adverse events of special interest, and deaths. These outcomes differ in definition, clinical meaning, and likely frequency. General statistical principle: a single composite summary can conceal variation among its components, while many separate comparisons create a multiplicity problem. The record does not report a prespecified strategy for combining or separately testing these categories.
The registry states that the primary outcome has several categories or time points and is not reduced to one comparison. This matters because there is no single reported estimate that can represent all aspects of the endpoint. The available counts should not be treated as a complete test of the primary outcome or as a proxy for unreported categories.
What does the design description establish?
The trial is described as phase 2, randomized, active-controlled, observer-blinded, multicenter, double-masked, and sequential. These labels identify broad design features, but do not give the operational details needed to reproduce an analysis. The allocation ratio, masking procedures, analysis model, covariate adjustments, and handling of repeated observations are not reported in the registry record. No interim analyses or stopping rules are reported in the registry record.
General statistical principle: if measurements are collected repeatedly over time, their correlation within a participant may matter for analysis. Treating repeated measurements as independent can misstate uncertainty. The registry provides a timeframe of Day 1 to Week 56, but does not report the detailed schedule of assessments or a model for repeated observations. It is therefore not possible to determine how time-specific results were handled statistically.
The record gives a safety analysis population definition: participants who received at least 1 study injection and had any post-baseline safety data. General statistical principle: defining the analysis population is essential because excluding participants or observations can alter the interpretation of a randomized comparison. The record does not report whether a separate intention-to-treat population was used, how participants with incomplete follow-up were handled, or whether any sensitivity analyses were conducted.
The stated sample-size assumptions describe an illustration 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 described as a stated fraction of the observed effect. Such planning illustrations are not observed power and are not evidence that the trial was designed to detect a particular effect. The registry record does not report the trial’s own sample-size justification or the assumptions used in its original design.
10. Multiplicity, Missing Data and Analysis Populations
The primary outcome includes several categories and time points. The registry record explicitly indicates that it is not reduced to one comparison, and no analysis entries are listed. No multiplicity procedure, hierarchy of hypotheses, or strategy for interpreting multiple comparisons is reported in the registry record. General statistical principle: when many outcomes or time points are tested, the chance of at least one apparently unusual result can increase unless the analysis accounts for the number and relationship of the tests. The record does not show whether such adjustment was planned or used.
Missing-data methods are not reported in the registry record. In particular, the record does not describe how participants with incomplete safety follow-up were handled, whether missing observations were imputed, or whether sensitivity analyses assessed the effect of missing information. The safety analysis population requires at least 1 study injection and any post-baseline safety data, but the record does not state how many participants were excluded from that population or why.
The defined safety analysis population is the only analysis population described in the posted outcome information. A separate intention-to-treat or per-protocol population is not reported in the registry record. The record also does not explain how participants were assigned to the safety summaries, whether analyses followed randomized assignment, or how protocol deviations were treated.
These omissions affect interpretation of both the event counts and any unreported comparisons. They do not establish that a particular method was or was not used in trial conduct; they mean only that the method is not reported in the registry record. Without a stated analysis plan and transparent handling of missing data and multiple outcomes, the posted counts should be interpreted descriptively.
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 |
|---|---|---|---|
| rF1V-1018 Co-Administered | 1 | 21 | 4.8% |
| rF1V-1018 Bedside Mix | 0 | 90 | 0.0% |
| rF1V Vaccine Only | 3 | 89 | 3.4% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| rF1V-1018 Co-Administered | 0 of 21 |
| rF1V-1018 Bedside Mix | 0 of 90 |
| rF1V Vaccine Only | 1 of 89 |
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 |
|---|---|
| rF1V-1018 Co-Administered | 18 of 21 |
| rF1V-1018 Bedside Mix | 77 of 90 |
| rF1V Vaccine Only | 69 of 89 |
Most frequent serious adverse event terms
| Event term | Organ system | rF1V-1018 Co-Administered | rF1V-1018 Bedside Mix | rF1V Vaccine Only |
|---|---|---|---|---|
| Cor Pulmonale Acute | Cardiac disorders | 1 of 21 | 0 of 90 | 0 of 89 |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | 1 of 21 | 0 of 90 | 0 of 89 |
| Deep Vein Thrombosis | Vascular disorders | 1 of 21 | 0 of 90 | 0 of 89 |
| Complicated Appendicitis | Infections and infestations | 0 of 21 | 0 of 90 | 1 of 89 |
| Appendicitis | Infections and infestations | 0 of 21 | 0 of 90 | 1 of 89 |
| Toxicity to Various Agents | Injury, poisoning and procedural complications | 0 of 21 | 0 of 90 | 1 of 89 |
Most frequent non-serious adverse event terms
| Event term | Organ system | rF1V-1018 Co-Administered | rF1V-1018 Bedside Mix | rF1V Vaccine Only |
|---|---|---|---|---|
| Injection Site Pain | General disorders | 16 of 21 | 66 of 90 | 56 of 89 |
| Fatigue | General disorders | 10 of 21 | 43 of 90 | 30 of 89 |
| Headache | Nervous system disorders | 8 of 21 | 34 of 90 | 25 of 89 |
| Myalgia | Musculoskeletal and connective tissue disorders | 9 of 21 | 23 of 90 | 22 of 89 |
| Malaise | General disorders | 6 of 21 | 25 of 90 | 21 of 89 |
| Diarrhoea | Gastrointestinal disorders | 7 of 21 | 15 of 90 | 12 of 89 |
| Injection Site Pruritus | General disorders | 2 of 21 | 17 of 90 | 13 of 89 |
| Chills | General disorders | 3 of 21 | 13 of 90 | 14 of 89 |
| Nausea | Gastrointestinal disorders | 4 of 21 | 13 of 90 | 12 of 89 |
| Vomiting | Gastrointestinal disorders | 0 of 21 | 5 of 90 | 3 of 89 |
Serious events with the highest arm-level rate: cor pulmonale acute (4.8%), pulmonary embolism (4.8%), deep vein thrombosis (4.8%), complicated appendicitis (1.1%), appendicitis (1.1%).
Serious adverse events are listed as participants affected among those at risk. The co-administered group had 1 of 21 affected, the bedside-mix group had 0 of 90, and the vaccine-only group had 3 of 89. These are counts, not a reported comparison, and the registry record gives no confidence intervals or test results for differences between groups.
Other adverse events are presented separately: 18 of 21 in the co-administered group, 77 of 90 in the bedside-mix group, and 69 of 89 in the vaccine-only group. The record lists 0 deaths in the co-administered group, 0 in the bedside-mix group, and 1 in the vaccine-only group. These figures describe the posted observations; they do not identify whether an event was caused by a vaccine regimen.
The serious-event terms are listed with percentages, but the record does not specify the relevant denominator or whether each percentage refers to a particular group. They should not be interpreted as group-specific rates without that context. General statistical principle: the absence of a recorded serious event in a group does not establish zero underlying risk, particularly when the number of observed participants and events is limited. These data are best read as descriptive safety information, not as a definitive ranking of the regimens.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a randomized phase 2 trial evaluated three rF1V vaccine regimens in adults 18 to 55 years of age and reports selected safety counts. It identifies a vaccine-only active-control regimen and two regimens using CpG 1018® adjuvant. The posted counts give a descriptive account of serious adverse events, other adverse events, and deaths in the groups.
Those counts do not provide a complete answer to the primary safety question. The outcome includes solicited local and systemic reactions and additional safety categories over Day 1 to Week 56. The registry record does not post a single summary comparison, and no analysis entries are listed. It also does not provide confidence intervals or formal comparison results. The magnitude and precision of any between-group differences therefore cannot be established from the available record.
The counts do not show that any event was caused by a study regimen, nor do they establish that a regimen is safer or less safe than another. A randomized design can support comparison when analyzed appropriately, but the group counts alone do not account for uncertainty, follow-up, missing data, or possible differences in how outcomes were assessed. No causal attribution or detailed statistical method is reported in the registry record.
The trial title refers to immunogenicity, but the listed outcome measure describes rates of reactogenicity and safety. Immunogenicity results are not reported in the registry record. The posted information therefore does not support conclusions about immune response. It also should not be treated as evidence about clinical protection against plague, since that outcome is not among the reported results described in the record.
General statistical principle: results from a phase 2 trial and a particular study population do not automatically generalize to other populations or settings. The registry describes adults aged 18 to 55; information about other ages or populations is not reported in the registry record. The appropriate reading is narrow: the record provides selected safety observations in the described trial groups, while leaving important outcome details and inferential analyses unreported.
13. Why This Trial Matters Statistically
This trial raises several statistical issues that are important in safety studies. First, the primary outcome is not one event but a set of categories and time points. That structure affects what a result means: a count for one category cannot stand in for the full collection, and a single overall summary could hide differences among its components.
Second, the record includes three regimens, with two adjuvanted approaches and a vaccine-only active control. The two adjuvanted groups differ in preparation and are described as separate regimens. A valid comparative interpretation would need to identify which contrasts were planned and how multiple comparisons were handled. Those details are not reported in the registry record.
Third, safety outcomes can include uncommon but important events. General statistical principle: rare-event estimates are often imprecise, so raw counts should be considered alongside uncertainty intervals and clear denominators. The posted record gives serious-event counts and lists serious-event terms, but does not report confidence intervals or a formal comparative analysis. The small event counts cannot by themselves establish a stable ordering among groups.
Finally, the registry record distinguishes enrollment from the safety population definition and reports group-specific numbers at risk for safety summaries. Clear reporting of the analysis population, follow-up, and missing-data handling is necessary to understand how observed counts relate to all randomized participants. The record does not provide those details. These features make the study a useful example of why outcome definitions, denominators, analysis plans, and uncertainty reporting are essential to interpreting randomized safety data.
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 lists one primary outcome measure, but that outcome covers multiple types of reactions and safety events across Day 1 to Week 56. It states that the outcome has several categories or time points and is not reduced to one comparison. Detailed category-specific results across the full timeframe are not reported in the registry record.
No analysis entries are listed for the primary outcome. The record therefore does not provide a formal between-group estimate, confidence interval, hypothesis test, or adjustment strategy. The statistical analysis plan, including any covariate adjustment or method for repeated measurements, is not reported in the registry record. Multiplicity procedures and interim analyses are also not reported.
The safety counts are not accompanied by a full explanation of follow-up completeness, missing observations, or the number of participants excluded from the defined safety analysis population. The record does not state how missing data were handled or whether sensitivity analyses were performed. The group-specific counts at risk do not, by themselves, explain how the enrolled population contributed to each reported summary.
The serious-event terms are accompanied by percentages, but the relevant denominator and group attribution are not stated alongside them. The percentages therefore cannot be interpreted confidently as group-specific rates. The record also does not report event causality assessments or detail how repeated events within participants were summarized.
Finally, although immunogenicity appears in the trial title, the registry record describes a safety outcome and does not report immunogenicity results. The available posted information is consequently limited to selected safety observations and cannot support a complete interpretation of all outcomes named in the trial title.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Trial of the Immunogenicity, Safety, and Tolerability of rF1V Vaccine With CpG 1018® Adjuvant Compared With rF1V Vaccine in Adults 18 to 55 Years of Age — NCT05506969.
- Registry record last updated 2025-07-29; status last verified 2025-07.
- Results first posted 2025-07-29.
- 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
NCT05506969 is a completed phase 2 randomized, active-controlled, observer-blinded, multicenter trial in adults 18 to 55 years of age. Enrollment was 200. The trial compared rF1V vaccine alone with two regimens using CpG 1018® adjuvant: co-administration and bedside mixing.
The primary outcome covers solicited local and systemic reactions and other safety categories from Day 1 to Week 56. The registry record defines a safety analysis population and posts counts for serious adverse events, other adverse events, and deaths. It does not report a single reduced comparison, analysis entries, confidence intervals, or a statistical test for the primary outcome.
Results for immunogenicity, the detailed analysis plan, missing-data handling, and multiplicity procedures are not reported in the registry record. The posted safety counts are descriptive and do not establish causal attribution or comparative safety.