This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Study to Assess the Safety, Tolerability and Immune Response Following Vaccination With Immunose™ FLU (NCT02998996), a randomized phase 1, phase 2 study. The primary outcome is Local Tolerability - First Dose.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02998996 |
| Phase | Phase 1, Phase 2 |
| Condition | Influenza, Human |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 162 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Eurocine Vaccines AB |
| Results posted | Yes |
2. Clinical Question
The clinical question concerns the safety and tolerability of Immunose™ FLU, a quadrivalent influenza-antigen vaccine formulation based on Endocine™. The registry describes a Phase I/II study and states that its main purpose was to evaluate safety and tolerability. The official title also names immune response as an objective, but an immune-response result is not reported in the registry record.
Population
The registry lists 162 enrolled participants with influenza, human, as the condition. Participant eligibility characteristics, such as age or health status, are not reported in the registry record.
Intervention
The Immunose™ FLU formulations contained 15 µg HA/strain with either 1% or 2% Endocine™. The registry also lists 15 µg HA/strain without Endocine™ as an intervention arm.
Comparator
Listed comparators include saline placebo, an intramuscular comparator and an intranasal comparator. The registry describes the intramuscular comparator as 15 µg HA/strain; a description for the intranasal comparator is not reported in the registry record.
Primary question
The primary endpoint concerns local tolerability after the first dose: whether participants experienced at least one specified administration-site reaction during the stated assessment period. The registry record does not provide a single summarized comparison for this endpoint.
This framing identifies the study’s treatment groups and the kind of outcome it sought to assess, but it does not establish that any formulation was better or worse than a comparator. The registry includes participant counts for safety summaries, while the primary local-tolerability endpoint is described across multiple reactions and assessment times. Those details do not, by themselves, define a statistical contrast or establish the result of one.
3. Trial Design
The registry describes a randomized, parallel-group Phase I/II study with placebo control. Its official title calls it partially blinded, while the registry’s masking entry is quadruple. These descriptions are both part of the record; how the partial blinding and masking designation relate to specific study roles is not reported in the registry record. Allocation is listed as randomized, but the sequence-generation and allocation-concealment procedures are not reported.
The listed interventions comprise Immunose™ FLU with 1% Endocine™ and with 2% Endocine™, influenza antigen without Endocine™, saline placebo, an intramuscular comparator and an intranasal comparator. The listed antigen amount is 15 µg HA/strain for the formulations and for the intramuscular comparator. A description for the intranasal comparator is not reported in the registry record. The record does not describe the dosing schedule beyond the first-dose endpoint assessment or explain the rationale for the particular group structure.
The study started in 2016-09, had a primary completion date of 2017-06-01 and is marked completed. Enrollment is listed as 162. Group-level denominators in the safety summaries vary, and the registry does not explain the relationship between those denominators and total enrollment. No inference about the reasons for those group sizes or any participant flow should be drawn from the counts alone.
Study conduct details that would help readers assess the design, including eligibility criteria, sites, recruitment procedures and protocol deviations, are not reported in the registry record. The record also does not describe the randomization ratio, the planned statistical analysis, or whether any interim review occurred. These absences limit what can be concluded about the conduct and analysis beyond the design labels and intervention descriptions recorded.
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 | Immunose™ FLU 1%, | Immunose™ FLU 2%, | Influenza Antigen, | Saline (NaCl), | i.m. Comparator, | i.n. Comparator |
|---|---|---|---|---|---|---|
| STARTED | 36 | 35 | 36 | 18 | 18 | 19 |
| COMPLETED | 36 | 34 | 35 | 18 | 17 | 19 |
| NOT COMPLETED | 0 | 1 | 1 | 0 | 1 | 0 |
Reasons for not completing this period:
| Reason | Immunose™ FLU 1%, | Immunose™ FLU 2%, | Influenza Antigen, | Saline (NaCl), | i.m. Comparator, | i.n. Comparator |
|---|---|---|---|---|---|---|
| Lost to Follow-up | 0 | 0 | 1 | 0 | 0 | 0 |
| Pregnancy | 0 | 1 | 0 | 0 | 0 | 0 |
| Family reasons | 0 | 0 | 0 | 0 | 1 | 0 |
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.
Only the first 6 of 7 groups are shown.
| Characteristic | Unit | Immunose™ FLU 1%, | Immunose™ FLU 2%, | Influenza Antigen, | Saline (NaCl), | i.m. Comparator, | i.n. Comparator |
|---|---|---|---|---|---|---|---|
| Participants analysed | 36 | 35 | 36 | 18 | 18 | 19 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 36 | 35 | 36 | 18 | 18 | 19 |
| Age, Categorical: >=65 years | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Age, Continuous | years | 26.36 (SD 5.69) | 26.34 (SD 5.46) | 25.11 (SD 4.8) | 27.72 (SD 5.6) | 27.22 (SD 4.75) | 24.68 (SD 4.32) |
| Sex: Female, Male: Female | Participants | 20 | 19 | 20 | 15 | 9 | 8 |
| Sex: Female, Male: Male | Participants | 16 | 16 | 16 | 3 | 9 | 11 |
| Race/Ethnicity, Customized: Ethnicity – African descent | Participants | 0 | 2 | 0 | 1 | 0 | 0 |
| Race/Ethnicity, Customized: Ethnicity – Asian or Pacific Islander | Participants | 1 | 0 | 0 | 0 | 0 | 0 |
| Race/Ethnicity, Customized: Ethnicity – Caucasian | Participants | 35 | 32 | 34 | 17 | 17 | 19 |
| Race/Ethnicity, Customized: Ethnicity – Mixed/multi-racial | Participants | 0 | 1 | 2 | 0 | 1 | 0 |
| Region of Enrollment: Sweden | participants | 36 | 35 | 36 | 18 | 18 | 19 |
6. Primary Endpoint
The registry lists the primary outcome as Local Tolerability - First Dose, measured over Pre-dose, and 15 and 120 min after study drug administration (Visit 2)..
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is titled “Local Tolerability - First Dose.” It counts participants with at least one administration-site reaction among swelling, redness, pain and pruritus, regardless of severity. The specified assessment period is pre-dose and 15 and 120 min after study drug administration at Visit 2. This makes the endpoint a participant-level binary outcome: a participant either met the endpoint definition during the stated assessment period or did not.
As a general statistical matter, a participant-level event indicator can provide a direct summary of how often a defined event occurred in each group. Combining several qualifying reactions into an “at least one” outcome can capture whether any listed reaction occurred, while not distinguishing which reaction drove the outcome or how many reactions an affected participant experienced. The endpoint definition also does not grade severity, because reactions count regardless of severity.
The endpoint is relevant to the stated safety and tolerability objective. However, the registry does not report a single result for this composite endpoint or a comparison between groups. It notes that the primary outcome has several categories or time points and was not reduced to one comparison. The record does not specify whether the listed reactions were also analyzed separately, how observations at different assessment times were combined in an analysis, or how missing assessments were handled.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry’s available results are descriptive safety counts, not a reported statistical test of the primary endpoint. The primary outcome is defined as participants with at least one local reaction, but the record does not present one summarized result or a group comparison for that outcome. It would therefore be inappropriate to infer a treatment effect, a confidence interval, or statistical significance from the endpoint definition alone.
The serious-event counts are reported as 2 of 36 for Immunose™ FLU 1%, and 0 of 35, 0 of 36, 0 of 18, 0 of 18 and 0 of 19 for the remaining groups, respectively. The group labels are Immunose™ FLU 2%, influenza antigen, saline, intramuscular comparator and intranasal comparator. These counts describe the registry’s recorded serious-event summaries; they do not establish whether observed differences reflect a treatment effect. The registry record does not report a statistical comparison or uncertainty interval for these counts.
The counts for participants with other events are 32 of 36, 30 of 35, 26 of 36, 10 of 18, 13 of 18 and 10 of 19 across the same group order. These figures are descriptive and should not be treated as the primary local-tolerability result: the registry’s primary endpoint has its own specific reaction definition and assessment period, while the safety summaries are presented separately. A direct equivalence between these categories is not reported in the registry record.
Counts depend on both the number of participants assessed and the event definition. Different group denominators make raw counts alone especially unsuitable for ranking groups. Even where a count is zero, the record does not establish that the underlying event risk is zero. General statistical interpretation requires consideration of uncertainty as well as the observed count; no confidence intervals or formal comparisons for these safety figures are reported in the registry record.
The serious-event terms listed are “Eryipelas” and “Gastroenteritis bacterial,” each with a reported value of 2.8%. The registry does not identify the group or denominator associated with those term-level percentages in the information. They should therefore be read as terms listed in the serious-event summary, not as evidence of a group-specific rate or a comparative result.
Overall, the posted data support a limited descriptive reading of the recorded counts. They do not provide the inferential analysis needed to determine how precisely groups differ, nor do they report a primary-endpoint estimate that can be interpreted as a treatment contrast.
9. Statistical Methods Explained
The registry identifies a randomized, parallel-group study, but the record does not describe the statistical methods used to analyze its outcomes. No analysis entries are listed. The following concepts explain how results of this kind are commonly interpreted; they are general statistical explanations, not a description of methods confirmed for this trial.
What does a participant count represent?
For a binary outcome, each participant is classified according to whether the defined event occurred. A group’s event count describes how many participants met that definition, and its denominator describes how many participants were considered at risk or included in that summary. The count is not itself a rate or a comparison. A rate requires a denominator, and a comparison requires a defined contrast between groups. The registry provides counts and group denominators for the adverse-event summaries, but it does not provide a statistical contrast for them.
The primary endpoint is also binary by definition: at least one specified reaction during the assessment period. That composite definition makes the outcome straightforward to classify, but it combines different reaction types. Separate results by reaction, severity or assessment time could answer more specific questions, if analyzed and reported. The record does not report those detailed results or explain whether it used a method to account for repeated assessments.
What would a confidence interval add?
In general, a confidence interval expresses the uncertainty around an estimated quantity, such as an event proportion or a difference between groups. A narrow interval indicates greater precision under the assumptions of the chosen method; a wide interval indicates less precision. The interval does not remedy an unclear endpoint definition or an unreported comparison. No confidence intervals for the primary endpoint or the listed adverse-event counts are reported in the registry record.
When groups are compared, the analysis should specify the effect measure, the groups being contrasted and the population included. For a binary endpoint, possible effect measures include a difference in event proportions or a ratio of proportions. Which measure was selected matters to interpretation, and estimates can have different numerical values while describing the same data. The registry record does not report a selected effect measure, a prespecified contrast or an adjusted analysis for the primary endpoint. No such measures should be reconstructed from the descriptive counts.
Why does the analysis population matter?
An analysis population determines which participants contribute to an estimate. For example, a trial may define an analysis set according to assignment, treatment received, or availability of endpoint data. These approaches answer different questions and can produce different results if participants do not complete follow-up or lack measurements. The registry record does not report the analysis population for the primary endpoint or explain how participants with missing observations were treated. The group denominators in the safety summaries should not be assumed to define the primary analysis population.
How should planning illustrations be read?
The registry’s sample-size assumptions describe planning illustrations based on a fraction of the observed effect, with a two-sided significance level of 0.05, equal allocation between two arms and a normal approximation. For time-to-event outcomes, the stated convention is a total event count; for other outcomes, the convention is participants per arm. These are planning assumptions, not a record of the trial’s own design justification. The record does not report the trial’s original sample-size calculation, the effect considered clinically relevant, or whether the trial was designed around the primary endpoint.
As a general matter, a planning calculation estimates the scale of a future study under explicit assumptions about an effect and analysis. It does not describe the probability that an already completed study found an effect, and it cannot turn a descriptive result into evidence of a difference. In particular, sample-size illustrations based on an observed effect are sensitive to how that effect was estimated. They should be read as hypothetical planning scenarios, not as observed power or as proof that a planned comparison was adequately powered.
What can randomization and masking support?
In general, random allocation can help balance measured and unmeasured characteristics between groups on average, while masking can reduce some forms of expectation-related bias. These are design principles, not guarantees that bias is absent. Their contribution depends on implementation, adherence, outcome measurement and analysis. The registry records randomization and a quadruple masking designation, while the official title describes the study as partially blinded. Details of who was masked, how the assignment sequence was created, and whether masking was maintained are not reported in the registry record.
Finally, the registry’s note that the primary outcome has several categories or time points and was not reduced to one comparison is important for interpretation. Without a specified summary and contrast, neither a single effect estimate nor its uncertainty can be presented from the record. The absence of a reported analysis is not evidence that no analysis was performed outside the registry; it means that the analysis is not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The primary endpoint includes several reaction categories and assessment times. The registry explicitly notes that it has several categories or time points and was not reduced to one comparison. It does not report which comparisons, if any, were designated as primary within those categories, how multiplicity was handled, or whether adjustment for multiple testing was planned. Multiplicity matters in general because examining several outcomes or contrasts can increase the chance of a chance-positive finding if results are interpreted without an appropriate analysis plan. No conclusion about such procedures can be drawn from the record.
Missing-data handling is not reported in the registry record. The record does not state how incomplete reaction assessments, withdrawals or participants without an evaluable endpoint were handled. This matters because an event count among participants with recorded assessments can differ in interpretation from an analysis that includes all randomized participants under a defined approach. The safety denominators alone do not establish the handling of missing primary-outcome observations.
Analysis populations are also not reported. The registry does not say whether the primary endpoint was analyzed by assigned group, by treatment received, or in another defined population. It does not describe exclusions or protocol-deviation handling. These details are needed to understand what population an estimate represents and how closely it follows the randomized comparison.
These gaps do not establish that the trial lacked procedures for multiplicity, missing data or analysis populations. They mean that those procedures are not reported in the registry record, so the posted results cannot be assessed on those dimensions.
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 |
|---|---|---|---|
| Immunose™ FLU 1%, | 2 | 36 | 5.6% |
| Immunose™ FLU 2%, | 0 | 35 | 0.0% |
| Influenza Antigen, | 0 | 36 | 0.0% |
| Saline (NaCl), | 0 | 18 | 0.0% |
| i.m. Comparator, | 0 | 18 | 0.0% |
| i.n. Comparator | 0 | 19 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Immunose™ FLU 1%, | 0 of 36 |
| Immunose™ FLU 2%, | 0 of 35 |
| Influenza Antigen, | 0 of 36 |
| Saline (NaCl), | 0 of 18 |
| i.m. Comparator, | 0 of 18 |
| i.n. Comparator | 0 of 19 |
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 |
|---|---|
| Immunose™ FLU 1%, | 32 of 36 |
| Immunose™ FLU 2%, | 30 of 35 |
| Influenza Antigen, | 26 of 36 |
| Saline (NaCl), | 10 of 18 |
| i.m. Comparator, | 13 of 18 |
| i.n. Comparator | 10 of 19 |
Most frequent serious adverse event terms
| Event term | Organ system | Immunose™ FLU 1%, | Immunose™ FLU 2%, | Influenza Antigen, | Saline (NaCl), | i.m. Comparator, | i.n. Comparator |
|---|---|---|---|---|---|---|---|
| Eryipelas | Infections and infestations | 1 of 36 | 0 of 35 | 0 of 36 | 0 of 18 | 0 of 18 | 0 of 19 |
| Gastroenteritis bacterial | Infections and infestations | 1 of 36 | 0 of 35 | 0 of 36 | 0 of 18 | 0 of 18 | 0 of 19 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Immunose™ FLU 1%, | Immunose™ FLU 2%, | Influenza Antigen, | Saline (NaCl), | i.m. Comparator, | i.n. Comparator |
|---|---|---|---|---|---|---|---|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | 15 of 36 | 20 of 35 | 13 of 36 | 1 of 18 | 2 of 18 | 7 of 19 |
| Fatigue | General disorders | 13 of 36 | 13 of 35 | 14 of 36 | 5 of 18 | 8 of 18 | 4 of 19 |
| Throat irritation | Respiratory, thoracic and mediastinal disorders | 22 of 36 | 21 of 35 | 3 of 36 | 1 of 18 | 0 of 18 | 1 of 19 |
| Headache | Nervous system disorders | 10 of 36 | 10 of 35 | 14 of 36 | 3 of 18 | 5 of 18 | 6 of 19 |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | 15 of 36 | 13 of 35 | 10 of 36 | 5 of 18 | 3 of 18 | 1 of 19 |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | 15 of 36 | 12 of 35 | 7 of 36 | 3 of 18 | 3 of 18 | 4 of 19 |
| Sneezing | Respiratory, thoracic and mediastinal disorders | 9 of 36 | 8 of 35 | 12 of 36 | 2 of 18 | 2 of 18 | 4 of 19 |
| Nasal muscosal disorder | Respiratory, thoracic and mediastinal disorders | 10 of 36 | 7 of 35 | 5 of 36 | 2 of 18 | 0 of 18 | 1 of 19 |
| Cough | Respiratory, thoracic and mediastinal disorders | 8 of 36 | 6 of 35 | 8 of 36 | 1 of 18 | 1 of 18 | 0 of 19 |
| Rhinalgia | Respiratory, thoracic and mediastinal disorders | 7 of 36 | 10 of 35 | 6 of 36 | 0 of 18 | 0 of 18 | 0 of 19 |
Serious events with the highest arm-level rate: eryipelas (2.8%), gastroenteritis bacterial (2.8%).
The serious-event summaries give a count of affected participants and a group denominator. The registry reports 2 of 36 in Immunose™ FLU 1%, with zero affected participants reported among the denominators of 35, 36, 18, 18 and 19 for the other listed groups. These are counts, not formal comparisons. A zero count means no affected participant was recorded in that group’s summary; it does not establish that the event could not occur or that the underlying risk is zero.
The registry also lists “Eryipelas” and “Gastroenteritis bacterial” as serious-event terms, each at 2.8%. The group attribution and denominator for these term-level values are not reported in the registry record. They cannot be interpreted as group-specific percentages based on the information available.
The other-event counts are reported separately from the serious-event counts. They describe participants with an event in the registry’s safety summaries and are not, by themselves, the primary local-tolerability outcome. That endpoint has a defined set of administration-site reactions and a specified assessment period. No formal statistical comparison, uncertainty interval or detailed event-term breakdown for the other-event counts is reported in the registry record. These summaries should therefore be read as descriptive safety information rather than evidence of a comparative treatment effect.
12. What the Result Does, and Does Not, Mean
The registry record describes a randomized study of Immunose™ FLU formulations and comparator groups, with safety and tolerability as the stated main purpose. It defines a first-dose local-tolerability endpoint based on whether a participant experienced at least one of four administration-site reactions during the stated assessment period. It also reports serious and other adverse-event counts by group. Those details identify what was measured and what counts were recorded.
The record does not report a single primary-endpoint result or a statistical comparison between groups. Consequently, it does not show how local tolerability differed across the listed formulations and comparators, nor how precise any such difference might be. The safety counts likewise do not establish a comparative effect: the registry does not report confidence intervals or formal tests for them. The listed serious-event terms lack reported group attribution in the record described.
The official title names immune response, but an immune-response result is not reported in the registry record. The record also does not provide enough information to judge the original sample-size rationale, the analysis populations, missing-data handling or multiplicity procedures. These limitations concern the information available in the registry, not necessarily whether additional work was conducted outside it.
As a general statistical distinction, descriptive counts tell readers what was recorded in the reported groups. An inferential result additionally requires a defined comparison and an estimate of uncertainty, interpreted in light of the analysis plan and data completeness. Without those elements, the counts should not be converted into claims that one formulation is better, worse, equivalent or safe in a broader population. The appropriate conclusion is limited to the study design, endpoint definition and descriptive counts the registry records.
13. Why This Trial Matters Statistically
This study is statistically notable because its primary endpoint is a composite participant-level outcome assessed across several reaction categories and time points, while the registry does not reduce it to a single comparison. That distinction matters: an outcome definition can be clear, yet a reader still needs a prespecified summary and contrast to interpret a treatment effect. Reporting the endpoint alone does not provide that estimate.
The design also includes multiple formulations and comparator types. Such a structure can address different descriptive or comparative questions, but interpretation depends on which contrasts were planned and how multiple comparisons were handled. Those analysis details are not reported in the registry record. Without them, a reader cannot identify a reported primary contrast or evaluate whether conclusions were tied to prespecified analyses.
The safety summaries illustrate another important principle: raw counts are not comparative evidence. Counts need their denominators, a defined outcome, and an analysis that accounts for uncertainty. This is especially relevant when group denominators vary. The registry gives denominators alongside counts, but does not report inferential comparisons for the listed safety results.
Finally, the registry’s planning assumptions should be distinguished from the trial’s original design rationale. A planning illustration based on a fraction of an observed effect is a hypothetical aid for considering future studies. It is not evidence of observed power and does not substitute for a prespecified sample-size justification. The record’s limitations make transparent reporting of endpoint analyses, populations, missingness and uncertainty particularly important for readers assessing this trial.
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.
Several trial-specific details needed to interpret the results are not reported in the registry record. Eligibility criteria and participant characteristics are not described in the information available, so the population represented by the enrollment cannot be characterized beyond the listed condition. The registry does not explain the group-level safety denominators or participant flow, and those counts should not be used to infer reasons for differences in the number assessed.
The intranasal comparator has no description in the arm information. The official title describes the study as partially blinded, whereas the registry masking entry is quadruple; the record does not clarify the roles masked or reconcile these descriptions. Randomization procedures and the allocation ratio are also not reported.
For the primary endpoint, the record specifies the reaction types and timing but does not report one summary result or a group comparison. It does not state how repeated assessments or missing observations were handled. The registry also does not report analysis populations, multiplicity procedures, confidence intervals or the statistical plan. The serious-event term percentages are not linked to a group or denominator in the information recorded.
The official title includes immune response, but an immune-response result is not reported in the registry record. The record lists two outcome measures, but the additional measure’s details are not described in the information. These reporting gaps restrict interpretation of the posted results; they do not establish that additional analyses or documentation do not exist elsewhere.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Study to Assess the Safety, Tolerability and Immune Response Following Vaccination With Immunose™ FLU — NCT02998996.
- Registry record last updated 2019-02-21; status last verified 2018-10.
- Results first posted 2019-02-21.
- 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
NCT02998996 is a completed randomized, placebo-controlled, parallel-group Phase I/II study sponsored by Eurocine Vaccines AB. The registry lists quadruple masking, while the official title describes the study as partially blinded. Enrollment is listed as 162. The study started in 2016-09 and its primary completion date is 2017-06-01.
The study evaluated Immunose™ FLU formulations with 1% or 2% Endocine™, influenza antigen without Endocine™, saline placebo, an intramuscular comparator and an intranasal comparator. The primary endpoint was first-dose local tolerability, defined by at least one of four administration-site reactions during the stated assessment period.
The registry reports descriptive serious and other adverse-event counts, but does not report a single primary-endpoint comparison, confidence intervals or an immune-response result. Analysis populations, missing-data handling, multiplicity procedures and the trial’s original sample-size justification are not reported in the registry record.