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 Trivalent Subunit Inactivated Flu Vaccine Administered to Healthy Children and Adolescents 3 to 17 Years of Age (NCT01209780), a randomized phase 3 study. The primary outcome is Comparison of Antibody Responses of Investigational TIV to Control Vaccine in Terms of the Percentage of Subjects Achieving Seroconversion.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01209780 |
| Phase | Phase 3 |
| Condition | Seasonal Influenza |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 3116 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Novartis Vaccines |
| Results posted | Yes |
2. Clinical Question
Population
Healthy children and adolescents aged 3 to 17 years were enrolled. The primary question concerned children aged 3 to 8 years, with antibody responses analyzed in the per-protocol population. The older cohort was included only in safety analyses.
Intervention
Children aged 3 to 8 years received investigational trivalent subunit inactivated influenza vaccine, abbreviated TIV. Non-naive children received one dose; vaccine-naive children received two doses 4 weeks apart.
Comparator
The comparison was with control TIV. In the younger age range, non-naive children received one control dose and vaccine-naive children received two doses 4 weeks apart. The control vaccine differed by age within the 3 to 8 years range.
Primary question
Did the investigational vaccine meet the stated non-inferiority objective for the percentage of children aged 3 to 8 years achieving seroconversion against the three homologous vaccine strains? The registry defines the endpoint and its assessment timing, but numerical results and the non-inferiority margin are not reported in the registry record.
The endpoint was based on haemagglutinin inhibition, or HI, antibody titers measured before and after vaccination. Seroconversion meant either a pre-vaccination HI titer <1:10 followed by a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 followed by at least a four-fold rise. The registry specifies assessment at Day 22 for non-naive children and Day 50 for vaccine-naive children. Those timings reflect the different dose schedules described in the record. The central statistical question is comparative: whether the investigational vaccine’s seroconversion percentage was sufficiently close to the control vaccine’s percentage under the trial’s non-inferiority criterion. The registry does not report the estimates needed to answer that question from the posted record alone.
3. Trial Design
This was a Phase III, randomized, parallel-group study with quadruple masking, described in the official title as observer blind. It evaluated safety, tolerability, and immunogenicity of a trivalent subunit inactivated influenza vaccine in healthy children and adolescents aged 3 to 17 years. The registry lists an enrollment of 3116 and identifies Seasonal Influenza as the condition. The study status is completed.
The age groups had different roles in the analysis. The primary antibody-response comparison was in children aged 3 to 8 years. Children aged 9 to 17 years received one dose of investigational TIV or control vaccine and were included only for safety analysis. In the younger cohort, vaccine-naive children received two doses 4 weeks apart, while non-naive children received one dose. The control TIV used for children aged 3 to <4 years differed from that used for children aged 4 to 8 years. The registry does not further explain how the control formulations were selected or compare those control formulations with each other.
Randomization and masking are design features intended to reduce bias in group assignment and assessment. In general, randomization helps distribute participant characteristics across treatment groups, while masking can limit the influence of treatment knowledge on care, reporting, or assessment. The exact people covered by the registry’s quadruple-masking label are not reported in the registry record, so the roles should not be inferred.
The study began in 2010-09 and had primary completion in 2011-03. Novartis Vaccines is listed as sponsor. The registry describes an investigational vaccine, control vaccines, and age- and vaccination-history-based dose schedules. It does not report a sample-size justification, detailed allocation procedures, or the operational procedures used to maintain masking.
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: Due to GCP non-compliance at the Mexico site, data of 312 subjects (3-8 year olds) enrolled from this site were excluded from the final immunogenicity and safety analysis. The population was analyzed in the enrolled set.
Overall Study
| Stage | TIV (3-8 Years Old) | Control (4-8 Years) | Control (3 to < 4 Years) | TIV (9-17 Years) | Control (9-17 Years) |
|---|---|---|---|---|---|
| STARTED | 1042 | 485 | 48 | 817 | 412 |
| COMPLETED | 1016 | 467 | 44 | 807 | 407 |
| NOT COMPLETED | 26 | 18 | 4 | 10 | 5 |
Reasons for not completing this period:
| Reason | TIV (3-8 Years Old) | Control (4-8 Years) | Control (3 to < 4 Years) | TIV (9-17 Years) | Control (9-17 Years) |
|---|---|---|---|---|---|
| Adverse Event | 0 | 1 | 0 | 0 | 0 |
| Withdrawal by Subject | 9 | 2 | 1 | 1 | 0 |
| Lost to Follow-up | 17 | 12 | 3 | 9 | 4 |
| Protocol Violation | 0 | 1 | 0 | 0 | 0 |
| Inappropriate enrollment | 0 | 2 | 0 | 0 | 1 |
Analysis population for the primary outcome, as defined in the registry: Analysis was done on per protocol population i.e-all subjects who correctly received study vaccinations,provided evaluable serum samples at the relevant time points, and had no major protocol violation as defined prior to unblinding.
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: Demography reported for all enrolled set except for 312 subjects (3-8 year olds) who were enrolled in the Mexico site.
| Characteristic | Unit | TIV (3-8 Years) | Control (3-8 Years) | TIV (9-17 Years) | Control (9-17 Years) | Total |
|---|---|---|---|---|---|---|
| Participants analysed | 1042 | 533 | 817 | 412 | 2804 | |
| Age, Continuous | years | 5.6 (SD 1.6) | 5.6 (SD 1.6) | 12.4 (SD 2.4) | 12.3 (SD 2.3) | 8.6 (SD 3.9) |
| Sex: Female, Male: Female | Participants | 517 | 269 | 398 | 215 | 1399 |
| Sex: Female, Male: Male | Participants | 525 | 264 | 419 | 197 | 1405 |
6. Primary Endpoint
The registry lists the primary outcome as Comparison of Antibody Responses of Investigational TIV to Control Vaccine in Terms of the Percentage of Subjects Achieving Seroconversion, measured over Day 22 for non-naive/Day 50 for naive subjects.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | 95% Confidence Interval |
| Unit | Percentages |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint was the percentage of children aged 3 to 8 years who achieved seroconversion after vaccination, comparing investigational TIV with control TIV for the three homologous vaccine strains. The registry frames the objective as non-inferiority of the antibody response. It defines seroconversion using pre- and post-vaccination HI antibody titers: a baseline titer <1:10 followed by a post-vaccination titer ≥1:40, or a baseline titer ≥1:10 followed by at least a four-fold rise in post-vaccination titer.
The registry lists Day 22 for non-naive children and Day 50 for vaccine-naive children as the assessment times. It also states that the primary analysis used the per-protocol population: participants who correctly received study vaccinations, provided evaluable serum samples at relevant time points, and had no major protocol violation as defined before unblinding.
In general, an antibody-response endpoint provides a laboratory measure of immune response rather than a direct measure of clinical illness. A non-inferiority objective asks whether the investigational group’s response is not unacceptably lower than the comparator’s, according to a prespecified margin. The registry record does not report that margin or the numerical seroconversion estimates, confidence interval, or conclusion. Therefore, the endpoint definition and objective can be described, but the primary result cannot be determined from the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry identifies a comparative non-inferiority question, but does not report the numerical primary endpoint results. It gives the outcome definition, assessment times, and analysis population, but not the seroconversion percentage in either group, the treatment contrast, or a confidence interval. The registry record also does not report the non-inferiority margin or a conclusion about whether the criterion was met. The primary antibody-response finding therefore cannot be interpreted as favoring either vaccine or as demonstrating non-inferiority based on this record.
The endpoint is a percentage defined by HI antibody responses to three homologous vaccine strains. The age range for the primary assessment is 3 to 8 years, not the full enrolled age range. Although adolescents aged 9 to 17 years were enrolled, the arm descriptions state that this cohort was included only for safety analysis. It would therefore be inaccurate to treat the older cohort as contributing to the primary immunogenicity comparison.
The registry also lists secondary outcomes concerning HI titers ≥40, seroconversion, vaccine-naive children after two doses, and adverse events. The presence of these outcome descriptions does not supply their numerical findings. Their results, estimates, and uncertainty are not reported in the registry record in the registry record for this explanation. In particular, secondary outcome labels cannot substitute for the missing primary comparison.
For a non-inferiority assessment, the estimated difference between groups must be interpreted in relation to a clinically justified margin and its uncertainty. In general, the confidence interval is important because it shows a range of effect estimates compatible with the data under the analysis assumptions. Without the contrast, confidence interval, and margin, it is not possible to assess whether the data exclude an unacceptable reduction in response. Nor can the direction or precision of the comparison be described.
The record does give safety event counts by arm. These can be read as reported counts within the listed groups, not as proof that vaccination caused an event. The record does not establish whether event rates differed statistically between groups, and no deaths are reported in the registry record. Serious adverse events are uncommon in the listed group counts, but the record alone does not establish comparative risk or explain the clinical circumstances of individual events.
Overall, the posted information establishes the trial’s design, target population, endpoint definition, and some safety counts. It does not provide the main numerical evidence required to evaluate the stated antibody-response objective. Any conclusion about the primary non-inferiority result would go beyond what is reported in the registry record.
9. Statistical Methods Explained
The statistical details reported in the registry are limited. The record identifies the primary endpoint as a percentage, specifies a 95% confidence interval as the dispersion measure, describes a non-inferiority objective, and names the per-protocol population. It does not report the numerical primary estimates, the analysis procedure used to calculate them, or the non-inferiority margin. The following explains the relevant statistical ideas in general and distinguishes them from the details actually reported for this trial.
What does a percentage endpoint represent?
The endpoint is the percentage of children meeting the stated seroconversion definition. In general, a percentage expresses the share of an analyzed group that meets an outcome definition. Here, the outcome is based on paired pre- and post-vaccination HI titers. A child meets the definition if the baseline and follow-up titers satisfy either of the two criteria in the registry: baseline HI titer <1:10 with a post-vaccination titer ≥1:40, or baseline titer ≥1:10 with at least a four-fold rise afterward.
The endpoint is strain-specific in the sense that the primary objective concerns the three homologous vaccine strains. The registry does not provide the strain-specific estimates or explain how results across strains were combined for the stated comparison. It would not be appropriate to assume a particular aggregation rule.
What does non-inferiority mean?
In general, a non-inferiority trial asks whether an intervention’s result is not worse than a comparator by more than a prespecified acceptable amount. That amount is called the non-inferiority margin. The estimated group contrast and its confidence interval are interpreted in relation to the margin and the direction in which the contrast is defined. The registry calls the primary objective non-inferiority, but the margin, contrast definition, and decision rule are not reported in the registry record. Without those details and the numerical result, the non-inferiority conclusion cannot be independently assessed.
Non-inferiority is not established merely because a conventional test fails to detect a difference. In general, an absence of evidence for a difference and evidence that a result lies within an acceptable margin are distinct statistical claims. The confidence interval and the prespecified margin are central to distinguishing them. Neither the interval nor the margin for this primary comparison is reported in the record.
How should the confidence interval be read?
In general, a confidence interval describes the uncertainty around an estimated effect under the assumptions of the analysis. A narrower interval indicates greater precision than a wider interval, while the interval’s location indicates which effects remain compatible with the data and method. The registry names a 95% confidence interval as the dispersion measure for the primary endpoint but does not give the interval itself. Consequently, neither precision nor compatibility with a non-inferiority margin can be evaluated from the registry record.
A confidence interval is not a guarantee that the true effect lies within its endpoints. Its interpretation depends on the sampling and analysis framework. The registry does not give enough detail to describe the exact calculation or assumptions for this interval.
Why does the analysis population matter?
The primary analysis was described as per protocol. The registry defines this population as participants who correctly received the study vaccinations, provided evaluable serum samples at relevant time points, and had no major protocol violation as defined before unblinding. In general, a per-protocol analysis focuses on participants who followed the specified study procedures. It can be relevant in a non-inferiority setting because protocol deviations may affect the comparison, but restricting an analysis to participants who meet criteria can also change the population being compared. Interpretation therefore depends on the criteria and the number and pattern of exclusions, which are not reported in the registry record.
The record does not report an intention-to-treat analysis, how missing serum measurements were handled, or whether other analysis populations were used for the primary comparison. No conclusion about those procedures should be inferred from the per-protocol description alone.
How do dose schedules and assessment times fit the analysis?
The primary outcome timeframe is Day 22 for non-naive children and Day 50 for vaccine-naive children. The arm descriptions state that non-naive children received one dose, while vaccine-naive children received two doses 4 weeks apart. Thus, the listed assessment time differs according to vaccination history and schedule. The registry does not provide separate numerical endpoint results for those subgroups, nor does it describe whether or how those data were combined in the primary comparison.
In general, outcomes measured at different times should be interpreted with their timing in view, because the response being measured may depend on when it is assessed. The timing information alone does not reveal the magnitude or persistence of an antibody response.
What other statistical details are unavailable?
The registry record does not report the statistical test or model used for the primary endpoint, handling of the three vaccine strains, adjustment for multiple comparisons, interim analyses, or a sample-size justification. It also does not give a p-value or the primary effect estimate. These omissions limit reproduction and evaluation of the analysis. The randomized design and the endpoint description are useful context, but they do not replace the missing analysis details or result.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists multiple secondary outcomes, including percentages reaching HI titers ≥40, seroconversion percentages, outcomes among vaccine-naive children after two doses, and counts of solicited and unsolicited adverse events. It also identifies three homologous vaccine strains for the primary objective. Considering multiple outcomes or strain-specific comparisons can raise multiplicity concerns: in general, the more statistical claims examined, the greater the chance that some apparent findings arise by chance. The registry record does not report whether multiplicity was addressed, which outcomes were treated as confirmatory, or how any adjustments were made.
The primary population is described as per protocol, with requirements for correct vaccination, evaluable serum samples at relevant times, and no major protocol violation defined before unblinding. The record does not report the number excluded from this population, reasons for exclusion, or the resulting analysis denominators. It also does not report how missing serum measurements were handled or whether sensitivity analyses assessed their impact. These details matter because exclusions and missing outcomes can affect the estimated response and the comparability of randomized groups.
The registry record does not report whether an intention-to-treat or other analysis population was used for the primary endpoint. It also does not give an account of protocol deviations, withdrawals, or missingness by group. No assumptions about imputation or other missing-data procedures can be made from the available description.
The record’s description of the per-protocol population as defined before unblinding is a reported feature, but it does not resolve the missing information about implementation. A complete assessment would require the analysis populations, participant flow, missing-data handling, and multiplicity strategy. Those details are not reported in the registry record.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| TIV (3-8 Years) | 14 | 1039 | 1.3% |
| Control (3-8 Years) | 3 | 531 | 0.6% |
| TIV (9-17 Years) | 4 | 817 | 0.5% |
| Control (9-17 Years) | 3 | 412 | 0.7% |
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 |
|---|---|
| TIV (3-8 Years) | 657 of 1039 |
| Control (3-8 Years) | 342 of 531 |
| TIV (9-17 Years) | 385 of 817 |
| Control (9-17 Years) | 196 of 412 |
Most frequent serious adverse event terms
| Event term | Organ system | TIV (3-8 Years) | Control (3-8 Years) | TIV (9-17 Years) | Control (9-17 Years) |
|---|---|---|---|---|---|
| Dengue fever | Infections and infestations | 1 of 1039 | 0 of 531 | 1 of 817 | 1 of 412 |
| Urinary tract infection | Infections and infestations | 2 of 1039 | 0 of 531 | 1 of 817 | 0 of 412 |
| Gastroenteritis bacterial | Infections and infestations | 2 of 1039 | 0 of 531 | 0 of 817 | 0 of 412 |
| Asthma | Respiratory, thoracic and mediastinal disorders | 1 of 1039 | 0 of 531 | 1 of 817 | 0 of 412 |
| Abscess | Infections and infestations | 1 of 1039 | 0 of 531 | 0 of 817 | 0 of 412 |
| Amoebiasis | Infections and infestations | 1 of 1039 | 0 of 531 | 0 of 817 | 0 of 412 |
| Appendicitis | Infections and infestations | 0 of 1039 | 0 of 531 | 0 of 817 | 1 of 412 |
| Ascariasis | Infections and infestations | 1 of 1039 | 0 of 531 | 0 of 817 | 0 of 412 |
| Bronchopneumonia | Infections and infestations | 1 of 1039 | 0 of 531 | 0 of 817 | 0 of 412 |
| Cellulitis | Infections and infestations | 1 of 1039 | 0 of 531 | 0 of 817 | 0 of 412 |
Most frequent non-serious adverse event terms
| Event term | Organ system | TIV (3-8 Years) | Control (3-8 Years) | TIV (9-17 Years) | Control (9-17 Years) |
|---|---|---|---|---|---|
| injection site pain | General disorders | 363 of 1039 | 215 of 531 | 268 of 817 | 146 of 412 |
| pyrexia | General disorders | 164 of 1039 | 91 of 531 | 43 of 817 | 15 of 412 |
| headache | Nervous system disorders | 106 of 1039 | 54 of 531 | 94 of 817 | 41 of 412 |
| malaise | General disorders | 77 of 1039 | 52 of 531 | 68 of 817 | 27 of 412 |
| myalgia | Musculoskeletal and connective tissue disorders | 79 of 1039 | 51 of 531 | 54 of 817 | 34 of 412 |
| upper respiratory tract infection | Infections and infestations | 102 of 1039 | 41 of 531 | 0 of 817 | 0 of 412 |
| hyperhidrosis | Skin and subcutaneous tissue disorders | 37 of 1039 | 29 of 531 | 43 of 817 | 22 of 412 |
| nasopharingitis | Infections and infestations | 85 of 1039 | 37 of 531 | 0 of 817 | 0 of 412 |
| fatigue | General disorders | 0 of 1039 | 0 of 531 | 52 of 817 | 21 of 412 |
Serious events with the highest arm-level rate: appendicitis (0.2%), dengue fever (0.2%), suicide attempt (0.2%), gastroenteritis bacterial (0.2%), urinary tract infection (0.2%).
The registry lists serious adverse events and other adverse events by study group. For serious adverse events, the reported counts are 14 among 1039 at risk in TIV (3-8 Years), 3 among 531 at risk in Control (3-8 Years), 4 among 817 at risk in TIV (9-17 Years), and 3 among 412 at risk in Control (9-17 Years). The record lists no deaths; death information is not reported in the registry record.
These are group-level counts as entered in the registry. They should not be treated as evidence that vaccination caused an event, and they do not by themselves establish a difference in risk between groups. The record does not provide a comparative statistical analysis of these serious adverse event counts or details about event timing, severity beyond the serious-event classification, or causal assessment.
The listed most frequent serious-event terms each have a reported rate of 0.2%: Appendicitis, Dengue fever, Suicide attempt, Gastroenteritis bacterial, Urinary tract infection, and Gastroenteritis viral. The registry record does not provide enough detail to assign these terms to particular groups or to interpret them as treatment-related. The separate other-adverse-event counts are 657 among 1039, 342 among 531, 385 among 817, and 196 among 412 in the respective groups. Those counts also require context about definitions and ascertainment, which is not reported in the registry record.
12. What the Result Does, and Does Not, Mean
The trial’s primary question concerns comparative antibody response after vaccination in children aged 3 to 8 years. The registry specifies a seroconversion definition, assessment times, and a per-protocol analysis population. It also states that the objective was to evaluate non-inferiority of investigational TIV relative to control TIV against the three homologous vaccine strains. These details describe what the primary analysis was intended to assess.
They do not establish the result. The registry record does not report the group percentages, treatment contrast, 95% confidence interval, or non-inferiority margin. Without those elements, the evidence cannot be judged against the stated objective. The record therefore does not support a conclusion that the investigational vaccine met or failed the non-inferiority criterion.
In general, an antibody endpoint measures a laboratory response, not a direct clinical outcome such as influenza illness. A difference in seroconversion percentages would describe the measured immune response under the study’s definitions; by itself, it would not quantify clinical protection. The record does not report clinical influenza outcomes as the primary question.
The safety information offers counts of serious and other adverse events by group, but the counts alone do not establish causation or comparative safety. A clinical interpretation would require information about event definitions, timing, clinical context, follow-up, and comparative analyses. Those details are not reported in the registry record. The listed adverse-event data should therefore be understood as descriptive registry entries rather than as a definitive estimate of treatment-related risk.
The enrolled age range was 3 to 17 years, but the registry describes the older cohort as safety-only. The primary immunogenicity question is consequently narrower than the full study population. The dosing schedules also differed by vaccination history in the younger cohort, and the registry lists different assessment days for non-naive and vaccine-naive children. These features are essential context when interpreting any eventual primary estimate.
In short, the registry record documents a randomized, masked study and defines its main antibody-response question, but does not include the numerical primary result required to answer it. It supports description of the trial’s intent and reported safety counts, not a conclusion about comparative immunogenicity or clinical benefit.
13. Why This Trial Matters Statistically
This trial illustrates why a clear endpoint definition is only part of a statistical result. The registry states how seroconversion was defined and identifies the comparison as non-inferiority, but a reader also needs the estimated response in each group, the contrast, its uncertainty, and the non-inferiority margin. Without those components, the objective is understandable but the evidence for or against it cannot be assessed.
It also shows why population and timing deserve attention. The primary antibody-response analysis concerns children aged 3 to 8 years, whereas participants aged 9 to 17 years were included only for safety analysis. Within the younger age range, dose schedules and assessment days depend on vaccination history. Those distinctions shape which participants and measurements can answer the primary question.
The per-protocol population is another important design detail. In general, analysis populations can affect interpretation, especially when the question is whether an intervention is not unacceptably worse than a comparator. Knowing the eligibility criteria is useful, but evaluating the analysis also requires participant flow, exclusions, missing-data handling, and the actual estimates. Those details are not reported in the registry record.
Finally, the safety listings illustrate the difference between descriptive counts and comparative inference. Counts can convey what the registry records in each group, but do not establish whether an event was caused by a vaccine or whether group risks differ. Statistical interpretation depends on definitions, follow-up, denominators, and analysis methods.
The trial is therefore statistically informative as a study design and endpoint example, while the registry record remains insufficient for judging its principal comparative result. That distinction matters: a trial’s stated objective and its observed evidence are not interchangeable.
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 interpreting the primary objective is that the registry record does not report the numerical endpoint results. The group seroconversion percentages, contrast, 95% confidence interval, and non-inferiority margin are absent. Without them, neither the magnitude nor precision of the comparison can be assessed, and the non-inferiority claim cannot be evaluated.
The registry describes a per-protocol primary analysis but does not report the number of participants included in that analysis, participant flow, or reasons for exclusion. Missing serum data and their handling are also not reported in the registry record. These gaps limit assessment of how the analyzed population relates to the randomized population.
The primary question applies to children aged 3 to 8 years. The 9 to 17 years cohort was included only for safety analysis, so the primary antibody-response result cannot be generalized to the full enrolled age range using the endpoint description alone. Within the younger cohort, vaccination history determined whether participants received one or two doses, and the registry lists different assessment days. Subgroup results or details of any combined analysis are not reported.
The record does not report the statistical test or model, the handling of results across the three homologous strains, a multiplicity strategy, or a sample-size justification. It also does not report numerical results for the secondary immunogenicity outcomes. Those omissions prevent a fuller assessment of the analysis plan and the consistency of findings across outcomes.
For safety, the registry gives event counts but does not provide the clinical context, causal assessments, or comparative analyses needed to interpret them fully. These are limitations of the information reported in the registry record, rather than evidence that the procedures were not performed.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Safety and Immunogenicity of Trivalent Subunit Inactivated Flu Vaccine Administered to Healthy Children and Adolescents 3 to 17 Years of Age — NCT01209780.
- Registry record last updated 2014-03-11; status last verified 2014-02.
- Results first posted 2014-03-11.
- 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
NCT01209780 is a completed, randomized, parallel-group, Phase III study of trivalent subunit inactivated influenza vaccine in healthy children and adolescents aged 3 to 17 years. It is listed as quadruple masked and observer blind, with Novartis Vaccines as sponsor and an enrollment of 3116. The study began in 2010-09 and had primary completion in 2011-03.
The primary objective compared investigational TIV with control TIV for seroconversion in children aged 3 to 8 years, using HI antibody titers and a per-protocol population. Non-naive children received one dose; vaccine-naive children received two doses 4 weeks apart. The older cohort received one dose and was included only for safety analysis.
The registry record defines the primary endpoint and assessment timing but does not report the numerical primary result, confidence interval, or non-inferiority margin. Safety event counts are listed by group; no deaths are reported in the registry record.