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 Safety and Immunogenicity of Three Influenza Vaccines Adults Ages 18 and Older (NCT01992094), a randomized phase 3 study. The primary outcome is 1.Geometric Mean Titres (GMT) in Subjects After Receiving One Dose of Either QIVc, TIV1c or TIV2c.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01992094 |
| Phase | Phase 3 |
| Condition | Influenza |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 2680 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Novartis Vaccines |
| Results posted | Yes |
2. Clinical Question
The trial asks whether the antibody response after vaccination with QIVc is non-inferior to the response after vaccination with the relevant trivalent comparator. The primary measure is the geometric mean titre (GMT) of hemagglutination-inhibition (HI) antibodies, assessed three weeks after a dose of vaccine. Comparisons are strain-specific: QIVc is compared with TIV1c for H1N1, H3N2 and B1, and with TIV2c for the alternate B strain, B2.
The non-inferiority rule is expressed as a ratio of comparator GMT to QIVc GMT. Non-inferiority was defined when the upper bound of the two-sided 95% confidence interval for that ratio did not exceed 1.5. The registry record describes this criterion, but does not report the numerical GMTs, ratios, confidence intervals or the resulting non-inferiority conclusions. Those primary outcome results are not reported in the registry record.
Population
Adults aged ≥18 years. The primary immunogenicity analysis is described as using the Per Protocol population, consisting of eligible Full Analysis Set efficacy/immunogenicity participants who received the vaccine correctly and were not excluded under the stated criteria.
Intervention
QIVc, a cell-based quadrivalent subunit influenza virus vaccine.
Comparator
TIV1c or TIV2c, the cell-based trivalent vaccine comparators. Which comparator is used depends on the influenza strain being assessed.
Primary question
Does the upper bound of the two-sided 95% confidence interval for the comparator-to-QIVc GMT ratio meet the stated non-inferiority margin of 1.5 for the specified strains?
3. Trial Design
The registry describes a Phase III, stratified, randomized, double-blind, multicenter, non-inferiority study. Its design fields identify quadruple masking and a parallel-group model. It evaluates three biological interventions: QIVc, TIV1c and TIV2c. The study concerns influenza and enrolled adults aged 18 years and older. The listed enrollment is 2680.
The study began in 2013-11, reached primary completion in 2014-07 and is recorded as completed. The registry identifies Novartis Vaccines as the sponsor. These design and administrative details describe the planned and registered study; they do not establish what the immunogenicity results were.
The primary outcome is GMT after one dose, measured three weeks after vaccination at Day 22. Its comparisons are not a single pooled comparison across every vaccine and strain. For H1N1, H3N2 and B1, the record specifies QIVc versus TIV1c; for B2, it specifies QIVc versus TIV2c. This strain-specific structure matters because each comparison contributes to the assessment of the overall immunogenicity question.
The listed secondary outcomes include seroconversion, the proportion reaching an HI titre of at least 1:40, geometric mean ratios and geometric mean titres. Some are defined within age cohorts, and some concern particular B strains. The registry lists 13 outcome measures and 12 analyses. The primary outcome itself includes several categories or time points and is not reduced to a single comparison in the posted results. Numerical primary endpoint findings are not reported in the registry record.
Randomization and masking are design features intended to limit bias in allocation and assessment. The registry does not report further details of the randomization procedure, masking implementation or stratification factors. Such details should not be inferred from the design labels alone.
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: All enrolled subjects were included in the trial
Overall Study
| Stage | QIVc (≥18 Years) | TIV1c (≥18 Years) | TIV2c (≥18 Years) |
|---|---|---|---|
| STARTED | 1335 | 676 | 669 |
| COMPLETED | 1285 | 652 | 648 |
| NOT COMPLETED | 50 | 24 | 21 |
Reasons for not completing this period:
| Reason | QIVc (≥18 Years) | TIV1c (≥18 Years) | TIV2c (≥18 Years) |
|---|---|---|---|
| ADMINISTRATIVE REASON | 6 | 7 | 1 |
| Adverse Event | 1 | 0 | 0 |
| Death | 5 | 5 | 2 |
| Lost to Follow-up | 26 | 9 | 13 |
| OTHER | 4 | 0 | 0 |
| Protocol Violation | 1 | 0 | 1 |
| Withdrawal by Subject | 7 | 3 | 4 |
Analysis population for the primary outcome, as defined in the registry: Analysis was done on Per Protocol (PP) Population i.e. all subjects in the Full Analysis Set (FAS) efficacy/immunogenicity population correctly receive the vaccine, have no major protocol deviations leading to exclusion as defined prior to unblinding/analysis and are not excluded due to other reasons defined prior to unblinding or analysis
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | QIVc (≥18 Years) | TIV1c (≥18 Years) | TIV2c (≥18 Years) | Total |
|---|---|---|---|---|---|
| Participants analysed | 1335 | 676 | 669 | 2680 | |
| Age, Continuous | year | 57.4 (SD 17.8) | 57.2 (SD 18.0) | 57.1 (SD 18.1) | 57.3 (SD 17.9) |
| Sex: Female, Male: Female | Participants | 732 | 392 | 392 | 1516 |
| Sex: Female, Male: Male | Participants | 603 | 284 | 277 | 1164 |
6. Primary Endpoint
The registry lists the primary outcome as 1.Geometric Mean Titres (GMT) in Subjects After Receiving One Dose of Either QIVc, TIV1c or TIV2c, measured over Three weeks post vaccination (Day 22).
| Element | Registry entry |
|---|---|
| Result type | Geometric Mean |
| Measure of spread | 95% Confidence Interval |
| Unit | Titer |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the geometric mean titre of HI antibodies measured three weeks after one dose of QIVc, TIV1c or TIV2c. The HI assay measures antibody activity against specified influenza strains. The endpoint is used to compare the antibody responses elicited by the vaccine groups, rather than to measure clinical influenza illness.
A geometric mean summarizes titre values on a multiplicative scale. In general, this approach is useful for measurements that are positive and can vary substantially, because the mean is calculated through a logarithmic transformation and then returned to the original scale. A GMT comparison is therefore interpreted as a relative response, expressed in the registry’s comparator-to-QIVc ratio, rather than as an absolute difference in titres.
The stated non-inferiority criterion requires the upper bound of the two-sided 95% confidence interval for the comparator-to-QIVc GMT ratio to be no greater than 1.5. A confidence interval describes the uncertainty around an estimated quantity under the analysis assumptions. For a non-inferiority assessment, the interval’s upper bound is compared with the prespecified margin; the point estimate alone would not establish whether the criterion was met.
The registry does not report the strain-specific GMT estimates, ratios, confidence intervals or endpoint conclusions. Thus the endpoint definition and decision rule are available, but the primary outcome’s numerical evidence is not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record provides the primary endpoint’s definition and non-inferiority rule, but not the numerical findings needed to apply that rule. It reports no strain-specific GMT estimates, comparator-to-QIVc ratios, confidence intervals or conclusions about whether the margin was met. Accordingly, the posted record does not allow a statistical reader to verify the primary non-inferiority assessment.
The relevant comparison is not simply whether the observed GMTs look similar. Under the stated rule, the upper bound of the two-sided 95% confidence interval for the comparator-to-QIVc ratio must not exceed 1.5. The interval matters because it reflects uncertainty in the estimated relative response. If the estimate is near the margin, uncertainty may affect whether the criterion is satisfied; a point estimate without its interval would not resolve that question.
The ratio is oriented as comparator GMT divided by QIVc GMT. That orientation should be kept in view when interpreting the margin: it is the upper confidence bound for that particular ratio that is compared with 1.5. The record specifies different comparator assignments by strain. H1N1, H3N2 and B1 are compared with TIV1c, while B2 is compared with TIV2c. Results from one strain-comparator pairing cannot be substituted for another.
The primary analysis population is described as Per Protocol. It includes participants in the Full Analysis Set efficacy/immunogenicity population who received the vaccine correctly and had no major protocol deviations leading to exclusion, as defined before unblinding or analysis, and who were not excluded for another reason. This definition is important because it identifies the population used for the stated endpoint assessment; the record does not provide the number analyzed in that population or the numerical outcomes.
The posted safety counts are separate from the immunogenicity endpoint. They describe participants affected by serious adverse events and other adverse events within the registry’s listed groups. These counts do not supply evidence about the GMT comparison, and the immunogenicity endpoint does not itself establish clinical effects on influenza illness.
Overall, the record supports a description of the question, design and decision rule, but not a conclusion about whether non-inferiority was demonstrated. That conclusion is not reported in the registry record. No recalculated primary estimate or confidence interval is available in the listed details.
9. Statistical Methods Explained
The statistical methods described by the registry center on comparing geometric mean HI antibody titres and applying a non-inferiority margin. The record gives the endpoint, assessment timing, comparison orientation, margin and analysis population. It does not report the complete statistical analysis plan or the numerical endpoint results.
What does a geometric mean represent?
In general, a geometric mean is a summary suited to measurements that are positive and whose variation is more naturally understood multiplicatively. The values are transformed to a logarithmic scale, averaged, and transformed back. As a result, a ratio of geometric means is a natural way to describe relative levels. Here, the registry defines the ratio as the comparator GMT divided by the QIVc GMT.
This type of summary does not describe every participant’s titre or the spread of individual responses. It provides a group-level estimate. The registry identifies the unit as Titer and the dispersion measure as a 95% confidence interval. The actual estimates and intervals are not reported in the registry record.
How is non-inferiority assessed?
In general, a non-inferiority analysis asks whether the data rule out an unacceptable loss relative to a comparator, using a prespecified margin. It is not enough to find no statistically significant difference in a conventional superiority test. The margin and the direction of the ratio define the decision rule. In this trial, the stated rule is that the upper bound of the two-sided 95% confidence interval for the comparator-to-QIVc GMT ratio must not exceed 1.5.
The confidence interval is relevant because the observed ratio is an estimate subject to sampling uncertainty. The interval describes a range of values compatible with the data under the analysis assumptions. For this rule, an upper bound beyond the margin would not satisfy the stated criterion, even if the point estimate were below the margin. The registry does not provide the interval bounds, so the criterion cannot be checked from the registry entries.
Why are there strain-specific comparisons?
The trial’s primary description assigns QIVc versus TIV1c comparisons to H1N1, H3N2 and B1, and assigns QIVc versus TIV2c to B2. These are separate vaccine-strain pairings. A result for one pairing would answer only that part of the immunogenicity question. The registry notes that the primary outcome has several categories or time points and is not reduced to one comparison. The set of numerical primary findings is not reported in the registry record.
What does the analysis population mean?
The primary outcome is described as analyzed in the Per Protocol population. The record defines this as participants in the Full Analysis Set efficacy/immunogenicity population who correctly received the vaccine, had no major protocol deviations leading to exclusion under criteria defined before unblinding or analysis, and were not excluded for another reason. In general, a per-protocol analysis focuses on participants meeting specified protocol conditions. Exclusions can affect who contributes information, so the population definition is part of interpreting the estimate. The record does not report the number analyzed or provide participant-level data.
The description does not say whether another analysis population was used to support the non-inferiority assessment, or how any differences between populations were handled. Those details are not reported in the registry record.
What can be said about planning calculations?
The planning assumptions described for the separate sample-size illustration are a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect defined as a stated fraction of the observed effect. These are planning assumptions, not evidence about the observed trial result. Any such sample-size estimate is an illustration under its assumptions; it is not observed power. The numerical planning illustrations are not reported in the registry record, and the registry does not establish that these assumptions were the trial’s own design justification.
In general, a normal approximation uses an idealized distribution to estimate uncertainty or plan a study. Equal allocation is an assumption for dividing participants between comparison groups in that illustration. Neither assumption should be treated as a description of actual analyzed group sizes unless the record reports those sizes for the relevant analysis. The registry’s listed enrollment and safety denominators refer to different recorded quantities and should not be silently substituted for analysis-population counts.
The registry record does not report whether interim analyses were conducted, a full multiplicity strategy, the treatment of missing endpoint measurements, or the detailed model used to estimate the GMT ratios and confidence intervals. Those elements cannot be reconstructed from the endpoint definition alone.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 13 outcome measures and 12 analyses. The primary endpoint includes multiple categories or time points, and the posted material does not reduce it to one comparison. The record also lists multiple secondary immunogenicity outcomes, including seroconversion, HI titres of at least 1:40, geometric mean ratios and geometric mean titres across age cohorts and particular strains. These multiple comparisons create a multiplicity question: when several hypotheses are assessed, the chance of at least one apparently favorable finding can differ from the chance associated with a single prespecified test.
The registry record does not report a multiplicity adjustment, a hierarchy among secondary outcomes, or whether the primary strain-specific comparisons were handled as a single family or separately. It also does not describe an interim-analysis plan. Those details are not reported in the registry record, so no claim about error-rate control or testing order can be made.
For missing data, the primary analysis is identified as Per Protocol, with exclusions for incorrect vaccination, major protocol deviations and other reasons described in the population definition. The record does not report how missing HI measurements were handled, how many participants were excluded from the primary analysis, or whether sensitivity analyses assessed the effect of missingness or exclusions. The specific missing-data assumptions and procedures are not reported in the registry record.
In general, missing measurements can affect precision and may also bias estimates if the chance of having an observed measurement is related to the outcome. The direction or size of such effects cannot be inferred without information on missingness and analysis procedures. The Per Protocol definition clarifies eligibility for the stated analysis, but does not by itself explain how missing endpoint data were treated.
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 |
|---|---|---|---|
| QIVc (≥18 Years) | 52 | 1324 | 3.9% |
| TIV1c (≥ 18 Years) | 22 | 673 | 3.3% |
| TIV2c (≥18 Years) | 21 | 665 | 3.2% |
| Total | 95 | 2662 | 3.6% |
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 |
|---|---|
| QIVc (≥18 Years) | 681 of 1324 |
| TIV1c (≥ 18 Years) | 332 of 673 |
| TIV2c (≥18 Years) | 335 of 665 |
| Total | 1348 of 2662 |
Most frequent serious adverse event terms
| Event term | Organ system | QIVc (≥18 Years) | TIV1c (≥ 18 Years) | TIV2c (≥18 Years) | Total |
|---|---|---|---|---|---|
| CARDIAC FAILURE CONGESTIVE | Cardiac disorders | 5 of 1324 | 0 of 673 | 2 of 665 | 7 of 2662 |
| ATRIAL FIBRILLATION | Cardiac disorders | 3 of 1324 | 1 of 673 | 1 of 665 | 5 of 2662 |
| CORONARY ARTERY DISEASE | Cardiac disorders | 2 of 1324 | 2 of 673 | 1 of 665 | 5 of 2662 |
| MYOCARDIAL INFARCTION | Cardiac disorders | 4 of 1324 | 0 of 673 | 1 of 665 | 5 of 2662 |
| PNEUMONIA | Infections and infestations | 2 of 1324 | 0 of 673 | 3 of 665 | 5 of 2662 |
| CELLULITIS | Infections and infestations | 3 of 1324 | 1 of 673 | 0 of 665 | 4 of 2662 |
| CARDIAC ARREST | Cardiac disorders | 0 of 1324 | 2 of 673 | 1 of 665 | 3 of 2662 |
| OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | 3 of 1324 | 0 of 673 | 0 of 665 | 3 of 2662 |
| HYPERTENSION | Vascular disorders | 2 of 1324 | 0 of 673 | 1 of 665 | 3 of 2662 |
| MYOCARDIAL ISCHAEMIA | Cardiac disorders | 1 of 1324 | 1 of 673 | 0 of 665 | 2 of 2662 |
Most frequent non-serious adverse event terms
| Event term | Organ system | QIVc (≥18 Years) | TIV1c (≥ 18 Years) | TIV2c (≥18 Years) | Total |
|---|---|---|---|---|---|
| INJECTION SITE PAIN | General disorders | 444 of 1324 | 187 of 673 | 195 of 665 | 826 of 2662 |
| FATIGUE | General disorders | 183 of 1324 | 113 of 673 | 81 of 665 | 377 of 2662 |
| HEADACHE | Nervous system disorders | 191 of 1324 | 93 of 673 | 93 of 665 | 377 of 2662 |
| MYALGIA | Musculoskeletal and connective tissue disorders | 160 of 1324 | 83 of 673 | 79 of 665 | 322 of 2662 |
| INJECTION SITE ERYTHEMA | General disorders | 167 of 1324 | 80 of 673 | 68 of 665 | 315 of 2662 |
| INJECTION SITE INDURATION | General disorders | 134 of 1324 | 55 of 673 | 60 of 665 | 249 of 2662 |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | 98 of 1324 | 56 of 673 | 58 of 665 | 212 of 2662 |
| DIARRHOEA | Gastrointestinal disorders | 91 of 1324 | 49 of 673 | 48 of 665 | 188 of 2662 |
| NAUSEA | Gastrointestinal disorders | 96 of 1324 | 39 of 673 | 46 of 665 | 181 of 2662 |
| DECREASED APPETITE | Metabolism and nutrition disorders | 82 of 1324 | 45 of 673 | 40 of 665 | 167 of 2662 |
Serious events with the highest arm-level rate: pneumonia (0.5%), cardiac failure congestive (0.4%), myocardial infarction (0.3%), small intestinal obstruction (0.3%), cardiac arrest (0.3%).
The registry lists serious adverse events and other adverse events by vaccine group. For serious adverse events, the affected counts are 52 in QIVc (≥18 Years), 22 in TIV1c (≥ 18 Years) and 21 in TIV2c (≥18 Years); the corresponding at-risk counts are 1324, 673 and 665. The record’s total row lists 95 affected and 2662 at risk. For other adverse events, the affected counts are 681, 332 and 335, respectively, with at-risk counts of 1324, 673 and 665; the total row lists 1348 affected and 2662 at risk.
These are registry counts, not an estimate of a causal effect. The record does not establish from these figures whether an event was caused by vaccination. It also does not report deaths in these group entries. The listed serious-event terms include pneumonia (0.5%), cardiac failure congestive (0.4%), myocardial infarction (0.3%), small intestinal obstruction (0.3%), cardiac arrest (0.3%) and coronary artery disease (0.3%). The record does not provide further detail about the denominator or overlap for these term percentages.
Safety counts should be interpreted with the recorded group denominators and event definitions in mind. They are distinct from the immunogenicity analysis and do not determine whether the primary GMT non-inferiority criterion was met.
12. What the Result Does, and Does Not, Mean
The study was designed to compare antibody responses after one dose of QIVc with those after the appropriate trivalent vaccine comparator. Its primary endpoint is a strain-specific GMT measured by HI assay three weeks after vaccination. The registry defines a non-inferiority criterion using the upper bound of a two-sided 95% confidence interval for the comparator-to-QIVc ratio.
Those details establish what the study intended to evaluate and how the primary comparison was to be judged. They do not establish the outcome. The primary GMT estimates, ratios, confidence intervals and non-inferiority conclusions are not reported in the registry record. It is therefore not possible from these registry entries to state whether the criterion was met, quantify the relative antibody responses, or assess their precision.
Even if a non-inferiority conclusion were available, its meaning would be specific to the defined endpoint, strains, comparators, population and assessment time. In general, an antibody titre endpoint is a measure of immunogenicity; it is not itself a direct measure of clinical influenza cases or other clinical outcomes. The registry’s listed secondary measures address additional antibody response summaries but do not replace the primary endpoint.
The adverse-event counts provide descriptive safety information recorded for the groups. They do not, on their own, establish causation or a comparative safety effect. The registry does not report death counts for the listed groups. The serious-event term percentages are reported, but further denominator and overlap details are not given in the record.
The most defensible reading is therefore limited: the record describes a randomized, masked Phase III non-inferiority study, its strain-specific immunogenicity question and its decision rule, alongside adverse-event counts. The key numerical primary outcome evidence needed to judge the trial’s non-inferiority result is not reported in the registry record.
13. Why This Trial Matters Statistically
This trial illustrates why the definition of a non-inferiority endpoint matters as much as the label attached to a study. The relevant quantity is a comparator-to-QIVc GMT ratio, and the decision rule is based on the upper bound of a two-sided 95% confidence interval relative to a margin of 1.5. Interpretation depends on the ratio’s direction, the specified margin and the uncertainty around the estimate.
It also illustrates that a vaccine comparison may be organized by strain rather than as one undifferentiated contrast. QIVc is compared with TIV1c for H1N1, H3N2 and B1, and with TIV2c for B2. Each pairing addresses a defined part of the immunogenicity question. A single overall label would not reveal whether every specified comparison was assessed or what each estimate showed.
The record also makes the analysis population explicit. The primary endpoint is assigned to the Per Protocol population, defined by correct vaccination and exclusions for specified protocol deviations or other reasons. Population definitions shape the evidence being summarized and should be read alongside the endpoint and estimand.
Finally, the record demonstrates an important limitation of registry interpretation: a detailed design and decision rule cannot substitute for reported outcome estimates. Without the GMTs, ratios and confidence intervals, the non-inferiority result cannot be independently interpreted. The posted safety counts answer a different descriptive question and should not be mistaken for the missing immunogenicity results.
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 for statistical interpretation is that the registry record does not report numerical primary outcome results. There are no strain-specific GMT estimates, comparator-to-QIVc ratios, confidence intervals or reported conclusions against the non-inferiority margin. Consequently, the precision of the estimates and whether the stated criterion was met cannot be assessed from the record.
The primary endpoint includes several categories or time points and is not reduced to one comparison. The record identifies the strain-comparator pairings, but does not provide the corresponding result details. Although 13 outcome measures and 12 analyses are listed, the relationship between all analyses and the primary decision is not described in enough detail to assess a testing hierarchy or multiplicity handling.
The primary analysis population is defined as Per Protocol, but the number analyzed in that population is not reported in the registry record. The record also does not report missing endpoint counts, missing-data procedures, sensitivity analyses or the detailed statistical model used for GMT ratio estimation. The full statistical analysis plan is not reported in the registry record.
The safety entries report affected counts and at-risk counts, but do not establish causal attribution. The record does not report death counts for the listed groups, and does not provide further details about the denominator or overlap underlying the serious-event term percentages. These limitations restrict interpretation of both the primary immunogenicity question and the safety summaries.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Safety and Immunogenicity of Three Influenza Vaccines Adults Ages 18 and Older — NCT01992094.
- Registry record last updated 2015-12-10; status last verified 2015-11.
- Results first posted 2015-12-10.
- 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 describes a completed Phase III, stratified, randomized, quadruple-masked, parallel-group, multicenter non-inferiority study in adults aged 18 years and older. It compares QIVc with TIV1c and TIV2c, with the comparator assigned by influenza strain for the primary HI antibody GMT assessment at Day 22.
The stated non-inferiority rule uses the upper bound of a two-sided 95% confidence interval for the comparator-to-QIVc GMT ratio and a margin of 1.5. The primary analysis population is Per Protocol. Numerical primary endpoint results and the non-inferiority conclusion are not reported in the registry record.
The record lists 13 outcome measures, 12 analyses and descriptive adverse-event counts by group. It does not report the full multiplicity or missing-data procedures, nor does it report death counts in the listed safety groups.