This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for A Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Candidate Vaccine (GSK2321138A) Manufactured Using a New Process in Adults and Children (NCT02207413), a randomized phase 3 study. The primary outcome is Number of Subjects Aged 18-49 Years Reporting Solicited Local Adverse Events (AEs)..
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02207413 |
| Phase | Phase 3 |
| Condition | Influenza |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 1886 |
| Arms in the primary outcome | n/a |
| Lead sponsor | GlaxoSmithKline |
| Results posted | Yes |
2. Clinical Question
Population
The trial included adults and children, with groups described as adults aged 18 to 49 years, children aged 3 to 17 years, and children aged 6 to 35 months. The primary endpoint was defined for adults aged 18 to 49 years in the Adult-Total Vaccinated cohort: participants with at least one vaccine administration documented.
Intervention
The intervention was Influsplit Tetra™ vaccine manufactured using the investigational process (IP). The registry describes the trial’s purpose as evaluating the safety profile and immunological non-inferiority of this production process.
Comparator
The comparator was Influsplit Tetra™ vaccine manufactured using the currently licensed process (LP). This comparison concerns the manufacturing process used for the vaccine, rather than a comparison between vaccination and no vaccination.
Primary question
For adults aged 18 to 49 years, how many participants reported solicited local adverse events during the 7-day (Days 0-6) post-vaccination period? The registry also describes an immunological non-inferiority objective, but the primary endpoint listed in the record is the number of adults reporting local events. Results for that endpoint and for immunogenicity are not reported in the registry record.
3. Trial Design
NCT02207413 is listed as a Phase 3, randomized, quadruple-masked, parallel-group trial. Its status is completed, and the registry lists enrollment as 1886. The sponsor is GlaxoSmithKline. The registry gives a start date of 2014-08-18 and a primary completion date of 2015-04-18. Those dates describe the registered study timeline; they do not by themselves show when particular outcomes were assessed or analyzed.
The two vaccine groups received Influsplit Tetra™ produced with either the investigational process or the licensed process. For adults aged 18 to 49 years, the listed regimen was one dose on Day 0. For children aged 3 to <9 years, the descriptions distinguish primed participants, who received one dose, from unprimed participants, who received doses on Days 0 and 28. Children aged 9-17 years are described as receiving one dose. The descriptions for children aged 6 to 35 months also distinguish primed participants receiving one dose from unprimed participants receiving doses on Days 0 and 28. The registry record does not report further regimen details beyond the descriptions available for each group.
Randomization indicates that assignment was not described as a non-random choice by participants or investigators. Quadruple masking indicates that the registry classified the study as masked at four levels, but which roles those levels represent is not reported in the registry record. Allocation ratio, sequence-generation details, concealment procedures, and reasons for the selected design are not reported in the registry record.
The registry’s broad purpose was to evaluate safety and immunological non-inferiority of vaccine made with the investigational process relative to vaccine made with the licensed process. The adult local-event measure is the listed primary outcome. The record lists 43 outcome measures and 8 analyses, but the statistical plan and detailed analysis methods are not reported in the registry record.
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: For 5 subjects, study vaccine dose not administered at all but subject number was allocated. Some data has been analysed in sub-groups by age: 3-4 years, 5-17 years, 6 months to \<5 years.
Overall Study
| Stage | Influsplit Tetra_IP Adult Group | Influsplit Tetra_LP Adult Group | Influsplit Tetra_IP 3-17y Group | Influsplit Tetra_LP 3-17y Group | Influsplit Tetra_IP 6-35m Group | Influsplit Tetra_LP 6-35m Group |
|---|---|---|---|---|---|---|
| STARTED | 60 | 60 | 410 | 411 | 466 | 474 |
| COMPLETED | 59 | 60 | 410 | 410 | 459 | 461 |
| NOT COMPLETED | 1 | 0 | 0 | 1 | 7 | 13 |
Reasons for not completing this period:
| Reason | Influsplit Tetra_IP Adult Group | Influsplit Tetra_LP Adult Group | Influsplit Tetra_IP 3-17y Group | Influsplit Tetra_LP 3-17y Group | Influsplit Tetra_IP 6-35m Group | Influsplit Tetra_LP 6-35m Group |
|---|---|---|---|---|---|---|
| Withdrawal by Subject | 1 | 0 | 0 | 0 | 3 | 7 |
| Lost to Follow-up | 0 | 0 | 0 | 1 | 1 | 5 |
| Adverse Event | 0 | 0 | 0 | 0 | 2 | 1 |
| Migrated/moved from study area | 0 | 0 | 0 | 0 | 1 | 0 |
Analysis population for the primary outcome, as defined in the registry: The analysis was performed on the Adult-Total Vaccinated cohort which included all subjects aged 18 to 49 years with at least one vaccine administration documented.
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 | Influsplit Tetra_IP Adult Group | Influsplit Tetra_LP Adult Group | Influsplit Tetra_IP 3-17y Group | Influsplit Tetra_LP 3-17y Group | Influsplit Tetra_IP 6-35m Group | Influsplit Tetra_LP 6-35m Group |
|---|---|---|---|---|---|---|---|
| Participants analysed | 60 | 60 | 410 | 411 | 466 | 474 | |
| Age, Continuous | Years | 29.8 (SD 8.7) | 31.2 (SD 9.3) | 9.4 (SD 4.2) | 9.4 (SD 4.2) | NA (SD NA) | NA (SD NA) |
| Age, Continuous | Months | NA (SD NA) | NA (SD NA) | NA (SD NA) | NA (SD NA) | 19.7 (SD 8.0) | 19.9 (SD 8.3) |
| Sex: Female, Male: Female | Participants | 41 | 35 | 196 | 187 | 223 | 209 |
| Sex: Female, Male: Male | Participants | 19 | 25 | 214 | 224 | 243 | 265 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Subjects Aged 18-49 Years Reporting Solicited Local Adverse Events (AEs)., measured over During the 7-day (Days 0-6) post-vaccination period.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | Subjects |
| Endpoint classification | Binary Endpoint |
The primary endpoint counts subjects aged 18-49 years reporting solicited local adverse events during the 7-day (Days 0-6) post-vaccination period. The assessed symptoms were pain, redness, and swelling. The registry defines “Any” as occurrence of the specified symptom regardless of intensity. It defines Grade 3 pain as significant pain at rest and pain that prevented normal everyday activities; Grade 3 redness and swelling are defined as greater than 100 millimeters.
This endpoint describes the frequency of reported local symptoms over a specified period after vaccination. Counting participants who report an event is a way to summarize how commonly the listed events occurred in the defined analysis cohort. The “Any” definition combines occurrences regardless of intensity, while the separate Grade 3 definitions identify more severe symptom categories. Those categories should not be treated as interchangeable: a count for any event answers a different question from a count for Grade 3 events.
The endpoint is specified for the Adult-Total Vaccinated cohort, which includes adults aged 18 to 49 years with at least one vaccine administration documented. The registry record does not report the observed primary endpoint counts, an effect estimate comparing groups, or an uncertainty interval. It also does not report a statistical test or a conclusion for this endpoint. Consequently, the endpoint definition clarifies what was intended to be counted, but the record does not establish the comparative result.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The central comparative question is whether adults receiving vaccine made with the investigational process differed from adults receiving vaccine made with the licensed process in the number reporting solicited local symptoms during the defined 7-day period. The registry specifies the symptoms, severity definitions, and analysis cohort. It does not report the observed counts or an estimate of the difference between groups. No direction or size of an adult local-event contrast can therefore be described from the registry record.
The trial’s stated broader purpose included immunological non-inferiority. A non-inferiority analysis asks whether evidence is compatible with the new approach being no worse than the comparator by more than a prespecified margin. The margin, analysis method, immunogenicity estimates, and non-inferiority conclusion are not reported in the registry record. The stated purpose is not itself evidence that non-inferiority was demonstrated.
The posted safety summary includes affected-participant counts for serious events and other events by listed group. For serious events, the adult IP group reports 1 affected participant among 60 at risk, and the adult LP group reports 1 among 60. The 3-17-year IP group reports 1 among 410, while the corresponding LP group reports 0 among 411. The 6-35-month IP group reports 7 among 466, and the corresponding LP group reports 11 among 474. Deaths are reported as 0 in each listed group. These are descriptive counts; the registry record does not report comparative uncertainty intervals or a statistical test for these safety counts.
For other adverse events, the listed affected counts are 51 among 60 in the adult IP group and 42 among 60 in the adult LP group; 327 among 410 in the 3-17-year IP group and 324 among 411 in the corresponding LP group; and 315 among 466 in the 6-35-month IP group and 319 among 474 in the corresponding LP group. These figures should be read as the registry’s separate “other” event summary, not as the primary endpoint counts: the primary endpoint is specifically adult solicited local symptoms during the 7-day period. The definitions and analysis details for the separate other-event counts are not reported in the registry record.
The numerical safety summaries are not enough to establish equivalence, non-inferiority, or a causal explanation for any difference in counts. A statistical comparison would require a stated estimand and analysis, and interpretation of precision would require uncertainty estimates. Those details, along with the primary outcome and immunogenicity results, are not reported in the registry record.
9. Statistical Methods Explained
Randomization assigns participants to study groups using a chance-based process. In general, random assignment is intended to make groups comparable on average with respect to factors known and unknown at the time of assignment. It does not guarantee identical groups in a particular trial, and it does not remove the need to report the analysis population, outcome data, and statistical methods. The registry identifies this trial as randomized but does not report the sequence-generation or allocation-concealment procedures.
What does masking contribute?
Masking can reduce the influence of expectations on participant reports, clinical assessments, or other decisions. This is especially relevant for symptom outcomes that depend on participants reporting pain, redness, or swelling. The registry labels the trial quadruple-masked, but does not identify the four masked roles or describe how masking was maintained. The label alone cannot show whether masking remained intact throughout the study.
What kind of outcome is the primary measure?
The primary measure is a count of participants reporting an event, rather than a continuous measurement such as a laboratory value. The event is defined over a specified observation window and in a specified cohort. In general, a group’s event count can be interpreted only alongside its denominator, the event definition, the observation period, and how missing observations were handled. The registry supplies the endpoint definition and cohort description, but does not report the primary counts or the missing-data approach.
When comparing binary outcomes, analysts may use measures such as a difference in event proportions, a risk ratio, or an odds ratio. These measures answer related but distinct questions. In general, an estimate should be accompanied by an uncertainty interval, such as a confidence interval, which describes a range of values compatible with the data under the model and assumptions used. A confidence interval is not a guarantee that the true value lies in that range. No comparative estimate, uncertainty interval, or test result for the primary endpoint is reported in the registry record.
How should non-inferiority be understood?
In general, a non-inferiority design evaluates whether a new intervention is not worse than a comparator by more than a clinically or scientifically chosen margin. The margin must be specified before results are interpreted, and the analysis must be designed to address that particular question. A conventional test for a difference is not automatically a non-inferiority test. The registry describes immunological non-inferiority as an objective, but the margin, hypotheses, analysis population, and immunogenicity results are not reported in the registry record. The objective therefore cannot be translated into a statistical conclusion from the information recorded.
What do the planning assumptions mean?
The planning illustration is described as a calculation based on the observed effect, using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It considers an effect to detect expressed as a stated fraction of the observed effect. For time-to-event tables, the stated convention is a total number of events; for other calculations, it is participants per arm. These are planning assumptions, not observed results and not evidence of achieved power. The trial’s own sample-size justification and design assumptions are not reported in the registry record. An illustration based on an observed effect also depends on that effect estimate and should not be mistaken for a prospective design rationale.
In general, a p-value measures how incompatible the observed data are with a specified null model, under the assumptions of the test. It does not measure the probability that the null hypothesis is true, nor does it describe the size or practical importance of an effect. The registry record does not report a primary-endpoint p-value or statistical test. No conclusion about statistical significance can be made from the event totals alone.
In general, over-dispersion occurs when outcome variability is greater than assumed by a statistical model. A model that ignores extra variability can produce uncertainty estimates that are too narrow. Whether over-dispersion is relevant depends on the outcome and model. The registry record does not report a model for the primary outcome, so there is no basis to say that over-dispersion was assessed or that a particular model was used.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 43 outcome measures and 8 analyses, alongside several immune-response outcomes and safety outcomes across age groups. Testing or estimating many outcomes can create a multiplicity issue: in general, the chance of at least one apparently notable result can increase when many statistical tests are conducted. A prespecified hierarchy, adjustment procedure, or clear distinction between primary and exploratory outcomes can help readers understand how multiple results are interpreted. The multiplicity strategy, any hierarchy among outcomes, and any adjustment are not reported in the registry record.
The record identifies the adult solicited-local-event measure as primary and describes immunological non-inferiority as part of the study purpose. It does not report the detailed analysis plan, the exact population used for the immunogenicity analyses, or whether analyses were adjusted for other factors. A listed outcome or study objective does not reveal whether it was a confirmatory hypothesis or how it was handled among the other outcomes.
Missing data can affect estimates if participants lack outcome observations or are excluded from an analysis. In general, interpretation depends on how much data are missing, why they are missing, and the assumptions used to handle them. The registry identifies the Adult-Total Vaccinated cohort as including adults with at least one documented vaccine administration, but does not report missingness, exclusions, imputation, or sensitivity analyses for the primary endpoint. The record also does not report a full participant flow or the numbers analyzed for the listed outcomes. It is therefore not possible to assess the effect of missing data or determine whether analysis populations differed across outcomes.
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 |
|---|---|---|---|
| Influsplit Tetra_IP Adult Group | 1 | 60 | 1.7% |
| Influsplit Tetra_LP Adult Group | 1 | 60 | 1.7% |
| Influsplit Tetra_IP 3-17 y | 1 | 410 | 0.2% |
| Influsplit Tetra_LP 3-17 y | 0 | 411 | 0.0% |
| Influsplit Tetra_IP 6-35 m | 7 | 466 | 1.5% |
| Influsplit Tetra_LP 6-35 m | 11 | 474 | 2.3% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Influsplit Tetra_IP Adult Group | 0 of 60 |
| Influsplit Tetra_LP Adult Group | 0 of 60 |
| Influsplit Tetra_IP 3-17 y | 0 of 410 |
| Influsplit Tetra_LP 3-17 y | 0 of 411 |
| Influsplit Tetra_IP 6-35 m | 0 of 466 |
| Influsplit Tetra_LP 6-35 m | 0 of 474 |
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 |
|---|---|
| Influsplit Tetra_IP Adult Group | 51 of 60 |
| Influsplit Tetra_LP Adult Group | 42 of 60 |
| Influsplit Tetra_IP 3-17 y | 327 of 410 |
| Influsplit Tetra_LP 3-17 y | 324 of 411 |
| Influsplit Tetra_IP 6-35 m | 315 of 466 |
| Influsplit Tetra_LP 6-35 m | 319 of 474 |
Most frequent serious adverse event terms
| Event term | Organ system | Influsplit Tetra_IP Adult Group | Influsplit Tetra_LP Adult Group | Influsplit Tetra_IP 3-17 y | Influsplit Tetra_LP 3-17 y | Influsplit Tetra_IP 6-35 m | Influsplit Tetra_LP 6-35 m |
|---|---|---|---|---|---|---|---|
| Gastroenteritis | Infections and infestations | 0 of 60 | 0 of 60 | 0 of 410 | 0 of 411 | 3 of 466 | 2 of 474 |
| Bronchitis | Infections and infestations | 0 of 60 | 0 of 60 | 0 of 410 | 0 of 411 | 2 of 466 | 2 of 474 |
| Bronchiolitis | Infections and infestations | 0 of 60 | 0 of 60 | 0 of 410 | 0 of 411 | 0 of 466 | 2 of 474 |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | 0 of 60 | 0 of 60 | 0 of 410 | 0 of 411 | 1 of 466 | 1 of 474 |
| Post procedural inflammation | Injury, poisoning and procedural complications | 0 of 60 | 1 of 60 | 0 of 410 | 0 of 411 | 0 of 466 | 0 of 474 |
| Back pain | Musculoskeletal and connective tissue disorders | 1 of 60 | 0 of 60 | 0 of 410 | 0 of 411 | 0 of 466 | 0 of 474 |
| Meningitis viral | Infections and infestations | 0 of 60 | 0 of 60 | 1 of 410 | 0 of 411 | 0 of 466 | 0 of 474 |
| Adenovirus infection | Infections and infestations | 0 of 60 | 0 of 60 | 0 of 410 | 0 of 411 | 0 of 466 | 1 of 474 |
| Asthma | Respiratory, thoracic and mediastinal disorders | 0 of 60 | 0 of 60 | 0 of 410 | 0 of 411 | 1 of 466 | 0 of 474 |
| Bronchopneumonia | Infections and infestations | 0 of 60 | 0 of 60 | 0 of 410 | 0 of 411 | 1 of 466 | 0 of 474 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Influsplit Tetra_IP Adult Group | Influsplit Tetra_LP Adult Group | Influsplit Tetra_IP 3-17 y | Influsplit Tetra_LP 3-17 y | Influsplit Tetra_IP 6-35 m | Influsplit Tetra_LP 6-35 m |
|---|---|---|---|---|---|---|---|
| Pain | General disorders | 41 of 60 | 32 of 60 | 252 of 410 | 264 of 411 | 89 of 466 | 98 of 474 |
| Erythema | Skin and subcutaneous tissue disorders | 0 of 60 | 0 of 60 | 131 of 410 | 128 of 411 | 106 of 466 | 107 of 474 |
| Swelling | General disorders | 2 of 60 | 4 of 60 | 109 of 410 | 110 of 411 | 50 of 466 | 51 of 474 |
| Irritability | Psychiatric disorders | 0 of 60 | 0 of 60 | 10 of 410 | 16 of 411 | 155 of 466 | 141 of 474 |
| Cough | Respiratory, thoracic and mediastinal disorders | 3 of 60 | 2 of 60 | 43 of 410 | 44 of 411 | 86 of 466 | 100 of 474 |
| Decreased appetite | Metabolism and nutrition disorders | 0 of 60 | 0 of 60 | 13 of 410 | 16 of 411 | 127 of 466 | 116 of 474 |
| Fatigue | General disorders | 32 of 60 | 20 of 60 | 97 of 410 | 101 of 411 | 0 of 466 | 0 of 474 |
| Somnolence | Nervous system disorders | 0 of 60 | 0 of 60 | 16 of 410 | 11 of 411 | 115 of 466 | 103 of 474 |
| Pyrexia | General disorders | 0 of 60 | 0 of 60 | 21 of 410 | 24 of 411 | 95 of 466 | 92 of 474 |
| Headache | Nervous system disorders | 31 of 60 | 16 of 60 | 85 of 410 | 84 of 411 | 0 of 466 | 1 of 474 |
Serious events with the highest arm-level rate: post procedural inflammation (1.7%), back pain (1.7%), gastroenteritis (0.6%), bronchitis (0.4%), bronchiolitis (0.4%).
The serious-event summary gives, for each listed group, the number at risk and the number affected. Read as counts, the adult IP and LP groups each report 1 serious-event-affected participant among 60 at risk. In ages 3-17 years, the IP group reports 1 among 410 and the LP group reports 0 among 411. In ages 6-35 months, the IP group reports 7 among 466 and the LP group reports 11 among 474. Deaths are reported as 0 for every listed group.
The record also lists other-event counts separately: 51 among 60 and 42 among 60 in the adult IP and LP groups; 327 among 410 and 324 among 411 in the 3-17-year groups; and 315 among 466 and 319 among 474 in the 6-35-month groups. These are descriptive summaries, not adjusted comparisons. The registry record does not report confidence intervals, a statistical test, event timing, or further definitions for these safety summaries. The listed serious terms and percentages are separate summaries and should not be used to infer an overall comparative safety result.
Serious adverse events and solicited local symptoms are different outcome categories. The serious-event counts do not supply the missing result for the primary adult local-event endpoint.
12. What the Result Does, and Does Not, Mean
The registry record establishes the trial’s broad comparison: Influsplit Tetra™ produced with an investigational process versus the same named vaccine produced with a licensed process. It also identifies the age groups, randomized quadruple-masked parallel design, and the adult primary measure of solicited local symptoms during the 7-day (Days 0-6) post-vaccination period. These details clarify what was intended to be studied, but they do not provide the primary endpoint result.
The available safety counts describe the number of affected participants in each listed group. They can be read as descriptive observations within those groups. Without comparative effect estimates and uncertainty intervals, they do not show how precisely the groups differ or whether observed count differences are compatible with chance variation. The registry record does not report an inferential safety analysis. The counts also do not establish whether event patterns were caused by the manufacturing process.
The record’s stated immunological objective is non-inferiority, but the result cannot be judged without the relevant immune-response estimates, a prespecified margin, and the analysis approach. Those items are not reported in the registry record. The absence of a posted result in the record should not be recast as evidence for or against non-inferiority.
In general, a completed trial status indicates that the study is registered as completed; it does not ensure that every outcome result or analysis is available in the registry. Here, primary outcome findings, immunogenicity findings, detailed statistical methods, and missing-data handling are not reported in the registry record. The evidence described is therefore limited to the design, endpoint definitions, and posted safety summaries. It cannot support a conclusion about the comparative primary endpoint or the broader immunological objective.
13. Why This Trial Matters Statistically
This trial poses a focused statistical comparison: whether a vaccine made using an investigational production process can be evaluated against a vaccine made using the licensed process. The randomized parallel design provides a framework for comparing groups, while the adult solicited-local-event endpoint gives a defined safety measure over a specified period. The registry’s broader objective also highlights that immunological non-inferiority requires a different interpretation from simply looking for a statistically significant difference.
The age-stratified groups matter because the registry describes different age ranges and dosing schedules. A pooled safety count across those groups could obscure variation in populations and regimens, so group-specific summaries should be read in their stated context. The posted serious-event counts retain those group distinctions, but they do not provide the uncertainty estimates needed to judge comparative precision.
The record also illustrates why registered objectives and posted results must be distinguished. A stated objective explains what the trial sought to evaluate; it does not demonstrate what the data showed. Without the primary endpoint counts, comparative estimates, immune-response results, non-inferiority margin, and analysis plan, the core statistical conclusions remain unavailable in the registry record.
For biostatistical interpretation, the key lesson is to separate design information, outcome definitions, descriptive counts, and inferential results. Each answers a different question. Design and endpoint definitions establish how a comparison was intended to work; descriptive counts show recorded event totals; estimates and uncertainty quantify the comparative evidence. The available registry entries support the first two kinds of description, but not a full assessment of comparative efficacy or safety.
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 main limitation for interpretation is that the registry record does not report the primary endpoint result. Although it defines the adult cohort, symptoms, severity categories, and observation window, it does not provide the adult local-event counts or a comparison between the vaccine-process groups. The record also does not report the immunogenicity findings needed to assess the stated non-inferiority objective.
The non-inferiority margin, statistical analysis plan, exact hypotheses, model specifications, multiplicity handling, and confidence intervals are not reported in the registry record. The record also does not report missing-data handling, the number analyzed for each outcome, or sensitivity analyses. These omissions limit assessment of both the validity and precision of any comparative conclusion.
The safety summaries are counts by listed group, but the registry record does not report inferential comparisons for them. Definitions and observation windows for the serious and other-event summaries are not reported in the registry record. The trial’s design is described as randomized and quadruple-masked, but details about allocation, who was masked, and maintenance of masking are not reported in the registry record.
Finally, the registry lists a broad set of 43 outcome measures and 8 analyses, while the detailed statistical plan is not reported. This limits assessment of which analyses were prespecified, how multiple outcomes were prioritized, and how selective reporting might be evaluated. These limits concern what can be concluded from the registry record; they do not establish what may be available elsewhere.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Candidate Vaccine (GSK2321138A) Manufactured Using a New Process in Adults and Children — NCT02207413.
- Registry record last updated 2018-06-06; status last verified 2018-05.
- Results first posted 2016-06-20.
- 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
NCT02207413 is a completed Phase 3 randomized, quadruple-masked, parallel-group trial sponsored by GlaxoSmithKline. It enrolled 1886 participants and compared Influsplit Tetra™ vaccine made with an investigational process against vaccine made with the licensed process. The registry describes adults aged 18 to 49 years and pediatric groups aged 3 to 17 years and 6 to 35 months.
The primary endpoint is the number of adults reporting solicited local adverse events during the 7-day (Days 0-6) post-vaccination period. The record defines the symptoms and analysis cohort, but does not report the primary outcome results. It also states an immunological non-inferiority objective without reporting the margin or immune-response findings. Descriptive serious-event counts and deaths are listed by group; comparative uncertainty and detailed statistical methods are not reported in the registry record.