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 Immunogenicity and Safety of GlaxoSmithKline Biologicals' Infanrix™-IPV+Hib Vaccine (NCT01309646), a randomized phase 3 study. The primary outcome is Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies..
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01309646 |
| Phase | Phase 3 |
| Condition | Poliomyelitis, Tetanus, Acellular Pertussis |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 454 |
| Arms in the primary outcome | n/a |
| Lead sponsor | GlaxoSmithKline |
| Results posted | Yes |
2. Clinical Question
Population
Healthy Korean infants aged between, and including, 42 and 69 days at the time of first vaccination were eligible for the described regimens. The registry record gives total enrollment as 454. The primary immunogenicity analysis was described for an According-To-Protocol cohort, but the complete cohort criteria are not reported in the registry record.
Intervention
One group received Infanrix™-IPV+Hib at 2, 4 and 6 months of age. The description also lists Synflorix™ at 6 weeks, 3.5 months and 5.5 months, and Rotarix™ at 6 weeks and 3.5 months.
Comparator
The other group received Infanrix™ IPV and Hiberix™ together at separate injection sites at 2, 4 and 6 months of age. Its description also lists Synflorix™ at 6 weeks, 3.5 months and 5.5 months, and Rotarix™ at 6 weeks and 3.5 months.
Primary question
At Month 5, how many participants met the registry definition of seroprotection for both anti-diphtheria and anti-tetanus antibodies? The record defines the threshold, but a numerical result for this primary measure is not reported in the registry record.
The question concerns measured antibody responses after the primary vaccination course, alongside safety. The two regimens differ in the study vaccines used for the diphtheria, tetanus, pertussis, polio and Haemophilus influenzae type b components: one arm received the combined Infanrix™-IPV+Hib vaccine, while the comparator arm received Infanrix™ IPV and Hiberix™ at separate injection sites. Both arm descriptions list the same Synflorix™ and Rotarix™ schedules.
This is a randomized, parallel-group comparison without masking. Randomization is intended, in general, to make treatment groups comparable at assignment, while a parallel design means participants are assigned to one regimen rather than crossing between regimens. The record does not report a numerical primary-outcome comparison, so the clinical question can be described but its answer cannot be quantified from the registry information recorded.
3. Trial Design
The registry identifies this as a randomized, unmasked, parallel-group phase 3 study sponsored by GlaxoSmithKline. It lists enrollment as 454 and status as completed. The recorded study start was 2011-03-04, and primary completion was 2012-02-24. Its stated purpose was to evaluate the safety and immunogenicity of Infanrix™-IPV+Hib when given as a primary vaccination course to healthy Korean infants at 2, 4 and 6 months of age.
Participants were assigned to one of two described vaccine regimens. In the Infanrix-IPV+Hib group, the study vaccine was scheduled at 2, 4 and 6 months of age. The arm description also lists three doses of Synflorix™ at 6 weeks, 3.5 months and 5.5 months, and two doses of Rotarix™ at 6 weeks and 3.5 months. In the Infanrix IPV group, Infanrix™ IPV and Hiberix™ were co-administered at separate injection sites at 2, 4 and 6 months of age; the description lists the same Synflorix™ and Rotarix™ schedules.
Random allocation can reduce systematic differences between groups at the point of assignment, but it does not by itself establish that all later comparisons are unbiased. The absence of masking is relevant because participants and study personnel were not blinded according to the registry. For laboratory antibody measurements, general statistical interpretation also depends on how specimens and assays were handled; those details are not reported in the registry record.
The registry lists 17 outcome measures, including antibody seropositivity, seroprotection, antibody concentrations and polio antibody titres. The primary measure was assessed at Month 5. A detailed account of allocation procedures, the planned sample-size justification, and the full analysis schedule is 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: Initially, a total of 454 subjects were enrolled in the study but 3 subjects had withdrawn from the study. Therefore, a total of 451 subjects were enrolled in the study.
Overall Study
| Stage | Infanrix-IPV+Hib Group | Infanrix IPV Group |
|---|---|---|
| STARTED | 224 | 227 |
| COMPLETED | 224 | 227 |
| NOT COMPLETED | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine according to their random assignment, for whom administration site of study vaccine was known and for whom immunogenicity data were available.
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 | Infanrix-IPV+Hib Group | Infanrix IPV Group | Total |
|---|---|---|---|---|
| Participants analysed | 224 | 227 | 451 | |
| Age, Continuous | weeks | 8.8 (SD 1.10) | 8.8 (SD 1.09) | 8.8 (SD 1.09) |
| Sex: Female, Male: Female | Participants | 97 | 115 | 212 |
| Sex: Female, Male: Male | Participants | 127 | 112 | 239 |
| Race/Ethnicity, Customized: Asian - East Asian Heritage | Participants | 224 | 226 | 450 |
| Race/Ethnicity, Customized: Not specified | Participants | 0 | 1 | 1 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies., measured over At Month 5.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the number of participants meeting the registry definition of seroprotection for both anti-diphtheria (anti-D) and anti-tetanus (anti-T) antibodies at Month 5. A participant counted as seroprotected if the recorded concentration for each antibody was equal to or above 0.1 international units per milliliter (IU/mL). The outcome is a count of participants, rather than a direct measure of the average antibody concentration.
A threshold-based endpoint is used to express whether measured antibody concentrations meet a stated criterion. This can make the endpoint easier to interpret as a proportion or count meeting that criterion, but it also discards information about how far a measurement lies above or below the threshold. Two groups could therefore have similar counts meeting the threshold while differing in the distribution of antibody concentrations, or the reverse. The registry includes separate secondary measures of antibody concentrations, which address a different aspect of the response.
The threshold is the endpoint definition recorded for this study; it should not be treated as a complete description of all immunogenicity evidence. Interpretation also depends on the population analyzed, the timing and completeness of measurements, and the between-group results. Those numerical primary results and the complete analysis-population criteria are not reported in the registry record. The endpoint definition alone therefore explains what was intended to be counted, but cannot establish how many participants met the criterion in either group or how the groups compared.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry describes a randomized comparison of two vaccine regimens and specifies an immunogenicity endpoint at Month 5. It does not report the numerical result for the primary measure in the information recorded for this trial. Consequently, no conclusion about the size, direction, or precision of a between-group difference in seroprotection can be drawn from this record summary. The endpoint definition is available, but a definition is not an outcome result.
The primary measure counts participants whose anti-D and anti-T antibody concentrations both meet the specified threshold. A count should be interpreted in relation to the number of participants assessed in each arm and to the analysis population used. Although the record describes the intended According-To-Protocol cohort, its full eligibility and measurement criteria are not reported in the registry record. The full set of denominators used for primary immunogenicity results is also not reported in the registry record.
In general, a between-group estimate is more informative when accompanied by an uncertainty interval. A confidence interval describes a range of values reasonably compatible with the data under the statistical model and method used. A narrow interval indicates greater precision than a wide interval, while neither width nor statistical significance alone determines clinical importance. No primary effect estimate, confidence interval, or primary-outcome p-value is reported in the registry record, so those features cannot be assessed for this outcome.
The record notes that the primary outcome has several categories or time points and was not reduced to one comparison. This makes it especially important not to select a single result without knowing the prespecified comparison and analysis plan. Multiple outcomes or comparisons can raise multiplicity concerns: when many hypotheses are tested, the chance of at least one chance finding can increase. Whether and how that issue was addressed is not reported in the registry record.
The safety counts are reported separately from the primary immunogenicity result. The record lists serious adverse event counts of 25 in the Infanrix-IPV+Hib group and 21 in the Infanrix IPV group, with 224 and 227 participants at risk, respectively. It also lists other adverse-event counts of 218 and 220, and zero deaths in each group. These are descriptive registry counts; they do not replace a prespecified comparative safety analysis. The record does not report comparative estimates or uncertainty intervals for these counts.
Overall, the registry supports a description of the study question, design, endpoint definition and recorded safety counts. It does not supply enough primary-outcome results to assess the observed immunogenicity contrast or its precision. The available information should therefore be read as a record of study structure and selected outcomes, not as a complete statistical report of efficacy or safety comparisons.
9. Statistical Methods Explained
The statistical methods that can be discussed are limited by what the registry record reports. It identifies randomized allocation, no masking and a parallel-group model, and defines a binary primary outcome as the number of participants meeting an antibody threshold. It does not report the test or model used for the primary comparison, adjustment variables, confidence intervals, missing-data procedures, or a complete analysis plan. These omissions mean that the numerical result cannot be reconstructed or interpreted as if a particular method had been documented.
What does randomization contribute?
In general, randomization assigns participants to study groups using a chance-based process. Its purpose is to reduce systematic differences in measured and unmeasured baseline characteristics, supporting a fair comparison of assigned regimens. Randomization does not guarantee that groups will be identical, nor does it prevent bias from missing measurements, departures from assigned treatment, or differences in outcome assessment. The registry confirms randomized allocation but does not report the sequence-generation or concealment procedures.
A parallel-group design assigns each participant to one group for the comparison. This avoids the need to interpret within-participant crossover effects, but it makes the between-group comparison dependent on the groups' composition and follow-up. The registry says masking was none. In general, lack of masking can influence behavior, reporting or decisions about outcome assessment; the risk depends on the outcome and study procedures. Details of those procedures are not reported in the registry record.
What does a threshold-based count represent?
The primary outcome counts participants meeting the stated anti-D and anti-T seroprotection definition at Month 5. This is a binary classification at the participant level: each assessed participant either meets the criterion or does not. General methods for comparing binary outcomes may report group-specific counts and denominators, a difference or ratio between groups, and an uncertainty interval. The choice of measure and statistical method should be prespecified and suited to the study question. The registry does not report which method was used or a numerical primary comparison.
Thresholding has an interpretive trade-off. It focuses on whether the criterion was reached, which can be straightforward to communicate, but it does not preserve the full range of antibody concentrations. Continuous concentration outcomes can provide complementary information about the magnitude and distribution of measured responses. The listed secondary outcomes include antibody concentrations and, for polio, titres. Numerical results for those measures are not reported in the registry information addressed.
Why do denominators and analysis populations matter?
A count is not interpretable as a group rate without its denominator. Denominators can differ across outcomes if measurements are unavailable or participants are excluded under analysis rules. The primary population is described as an According-To-Protocol cohort for immunogenicity, including evaluable participants who received one dose of either study vaccine according to random assignment, had a known administration site, and had immunogenicity data meeting further criteria. The remaining criteria are not reported in the registry record. The full primary-outcome denominators and the handling of missing measurements are also not reported.
In general, an analysis based on participants who followed the protocol can answer a different question from an analysis that retains all randomized participants in their assigned groups. Exclusions after randomization may affect comparability if reasons for exclusion relate to treatment or outcome. The record does not provide enough information to assess the extent or consequences of exclusions, or to determine whether additional analysis populations were used.
How should uncertainty and multiplicity be considered?
A confidence interval represents uncertainty around an estimate under the assumptions of the statistical method. It helps distinguish a precise estimate from one that is compatible with a broad range of effects. A p-value, when reported, describes how unusual the data would be under a specified null model; it does not measure the probability that the null hypothesis is true, nor the size or importance of an effect. No primary confidence interval or p-value is reported in the registry record.
Multiplicity arises when several outcomes, time points, or comparisons are examined. In general, testing many hypotheses without accounting for the number or structure of tests can increase the chance of false-positive findings. The record lists 17 outcome measures and indicates that the primary outcome has several categories or time points and was not reduced to one comparison. Any hierarchy of endpoints, correction procedure, or interpretation rule is not reported in the registry record. It would therefore be inappropriate to infer that a particular multiplicity method was applied.
What do the planning assumptions mean?
The record describes a planning illustration based on the observed effect, using a two-sided significance level of 0.05, equal allocation between arms and a normal approximation. Such an illustration asks how many participants per arm might be required to detect a chosen fraction of an observed effect under stated assumptions. It is not the trial's original design justification, and it is not observed power. The registry does not report the original sample-size justification. No planning estimate should be interpreted as evidence that the study was adequately powered for the primary endpoint, especially when the primary result and its uncertainty are not available.
General statistical interpretation also depends on whether the chosen model fits the data and whether its assumptions are reasonable. For binary outcomes, one consideration is how the comparison handles the event probability and any stratification or covariates. For continuous antibody measurements, distributions may be skewed, and transformations or other methods may be considered. These are general methodological considerations, not descriptions of methods confirmed for this trial. The particular modeling choices are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 17 outcome measures, spanning seropositivity, seroprotection, antibody concentrations and polio titres. It also notes that the primary outcome has several categories or time points and was not reduced to one comparison. When studies assess multiple outcomes or time points, multiplicity is a concern in general because repeated testing can increase the chance of a false-positive result. The registry record does not report an endpoint hierarchy, adjustment for multiple comparisons, or another strategy for interpreting several tests.
Missing-data rules are not reported in the registry record. This matters because antibody outcomes require measurements at the relevant time point. If measurements are absent, the number assessed may differ from the number assigned, and the analysis can depend on whether missingness is related to treatment or outcome. The record does not describe imputation, exclusion rules beyond the partial analysis-population description, or sensitivity analyses for missing results.
The primary outcome population is described as an According-To-Protocol cohort for immunogenicity. It includes evaluable participants who received one dose of either study vaccine according to their random assignment, had a known administration site, and met additional immunogenicity-data criteria. Those remaining criteria are not reported in the registry record. No full intention-to-treat analysis definition or comparison is reported, and the extent of exclusions from the primary analysis cannot be assessed from the available description.
These limitations prevent a full appraisal of selection after randomization, missing outcome data, and the implications of testing multiple outcomes. They do not establish that the analysis was improperly conducted; rather, the registry does not report enough detail to determine the methods used.
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 |
|---|---|---|---|
| Infanrix-IPV+Hib Group | 25 | 224 | 11.2% |
| Infanrix IPV Group | 21 | 227 | 9.3% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Infanrix-IPV+Hib Group | 0 of 224 |
| Infanrix IPV Group | 0 of 227 |
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 |
|---|---|
| Infanrix-IPV+Hib Group | 218 of 224 |
| Infanrix IPV Group | 220 of 227 |
Most frequent serious adverse event terms
| Event term | Organ system | Infanrix-IPV+Hib Group | Infanrix IPV Group |
|---|---|---|---|
| Bronchiolitis | Infections and infestations | 7 of 224 | 5 of 227 |
| Urinary tract infection | Infections and infestations | 1 of 224 | 6 of 227 |
| Pneumonia | Infections and infestations | 5 of 224 | 1 of 227 |
| Gastroenteritis | Infections and infestations | 4 of 224 | 1 of 227 |
| Viral infection | Infections and infestations | 1 of 224 | 3 of 227 |
| Bronchitis | Infections and infestations | 2 of 224 | 0 of 227 |
| Inguinal hernia | Gastrointestinal disorders | 1 of 224 | 1 of 227 |
| Pharyngitis | Infections and infestations | 2 of 224 | 0 of 227 |
| Skull fracture | Injury, poisoning and procedural complications | 1 of 224 | 1 of 227 |
| Asthma | Respiratory, thoracic and mediastinal disorders | 0 of 224 | 1 of 227 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Infanrix-IPV+Hib Group | Infanrix IPV Group |
|---|---|---|---|
| Irritability/Fussiness | General disorders | 181 of 224 | 182 of 227 |
| Redness | General disorders | 177 of 224 | 167 of 227 |
| Drowsiness | General disorders | 153 of 224 | 147 of 227 |
| Pain | General disorders | 143 of 224 | 146 of 227 |
| Swelling | General disorders | 130 of 224 | 121 of 227 |
| Loss of appetite | General disorders | 120 of 224 | 103 of 227 |
| Temperature (Tympanic) | General disorders | 83 of 224 | 81 of 227 |
| Nasopharyngitis | Infections and infestations | 37 of 224 | 29 of 227 |
| Upper respiratory tract infection | Infections and infestations | 34 of 224 | 29 of 227 |
| Diarrhoea | Gastrointestinal disorders | 29 of 224 | 10 of 227 |
Serious events with the highest arm-level rate: bronchiolitis (3.1%), urinary tract infection (2.6%), pneumonia (2.2%), gastroenteritis (1.8%), viral infection (1.3%).
The registry records serious adverse events in two groups. It lists 25 participants with a serious adverse event among 224 at risk in the Infanrix-IPV+Hib group, and 21 among 227 at risk in the Infanrix IPV group. Other adverse-event counts are listed as 218 among 224 at risk and 220 among 227 at risk, respectively. Deaths are recorded as zero in each group. These are descriptive counts, not adjusted comparisons.
The registry also lists serious-event terms with percentages: bronchiolitis, 3.1%; urinary tract infection, 2.6%; pneumonia, 2.2%; gastroenteritis, 1.8%; viral infection, 1.3%; and bronchitis, 0.9%. The record does not specify in this information the denominators or whether a participant could contribute to more than one listed term. These percentages should therefore be read as registry-reported figures, not converted into counts or treated as mutually exclusive categories.
In general, safety comparisons depend on definitions, duration of observation, exposure, event ascertainment and uncertainty. Those details and comparative estimates are not reported in the registry record. The counts alone cannot establish whether any difference is attributable to a regimen.
12. What the Result Does, and Does Not, Mean
The registry establishes that this was a randomized, unmasked, parallel-group phase 3 study of two vaccine regimens in healthy Korean infants. It describes the primary immunogenicity endpoint as the number meeting an anti-D and anti-T antibody threshold at Month 5, and it records selected safety counts. These registry entries clarify what the trial was designed to examine and how its primary threshold was defined.
The registry record does not report a numerical primary-outcome comparison. It therefore does not show the number meeting the threshold in each group, the size or direction of a difference, or the precision of such a comparison. Without those results, the record cannot establish whether the observed antibody responses were similar or different. Nor can it support a conclusion about the magnitude of any difference.
More generally, a threshold-based immunogenicity result is not the same as a complete account of immune response. It classifies participants according to a specified concentration criterion, while separate concentration or titre outcomes can describe other features of the measured response. Those additional measures are listed in the registry, but their numerical results are not included in the record details.
The safety information has a similar boundary. Serious adverse event counts, other adverse-event counts, selected serious-event terms and deaths are recorded. Without complete methods, denominators for each listed term, follow-up details and comparative uncertainty estimates, the figures do not establish that a regimen caused or prevented an event, or that the safety profiles were equivalent.
Accordingly, this record supports a description of trial design, intended endpoint and selected safety observations. It does not, on its own, provide a complete statistical basis for judging comparative immunogenicity or safety. The absence of a reported comparison should not be mistaken for a finding of no difference; it means the registry information does not quantify the result.
13. Why This Trial Matters Statistically
This trial is statistically relevant because it compares a combined vaccine regimen with a regimen in which Infanrix™ IPV and Hiberix™ were given at separate injection sites, while both arm descriptions include the same listed Synflorix™ and Rotarix™ schedules. Randomization provides the framework for comparing assigned regimens, and the parallel design makes the group-level contrast central to interpretation.
The primary endpoint illustrates a common measurement choice in immunogenicity studies: converting antibody concentrations into a threshold-based count of participants meeting a defined criterion. Such endpoints are straightforward to state, but they depend on the threshold and do not retain all information in the underlying measurements. The presence of separate concentration and titre outcomes in the registry highlights why multiple complementary outcome measures may be relevant.
The record also illustrates why a study's design and endpoint definitions are not enough to interpret its result. Readers need numerical outcomes, denominators, analysis populations and uncertainty measures to evaluate the comparison. The primary result and its precision are not reported in the registry record, and the full methods for missing data and multiplicity are not reported either. Thus, the intended statistical question is clear, but the recorded information is insufficient to quantify its answer.
Finally, descriptive adverse-event counts are not substitutes for a comparative analysis. Safety interpretation depends on how events were defined, collected and analyzed, as well as on the period of observation. The registry provides selected counts and terms, but not all the information needed to judge comparative uncertainty. These distinctions are useful when reading trial records that contain design descriptions and endpoint definitions but incomplete numerical 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 most direct limitation is that the numerical primary immunogenicity result is not reported in the registry record. The record defines seroprotection at Month 5, but does not provide group-specific primary counts, denominators, an effect estimate, or an uncertainty interval. The primary outcome was not reduced to one comparison because it has several categories or time points, so a single comparison cannot be selected from the available information.
The primary analysis population is described only in part. It was an According-To-Protocol cohort for immunogenicity, with stated criteria involving evaluability, receipt of a study-vaccine dose according to random assignment, known administration site and immunogenicity data. The complete criteria are not reported in the registry record. Missing-data handling, exclusions, sensitivity analyses and the use of any other analysis populations are also not reported.
The registry identifies randomized allocation and no masking, but details of randomization procedures and outcome assessment are not reported. It also does not report the statistical method for the primary comparison, a multiplicity strategy, or the study's original sample-size justification. The planning illustration is based on the observed effect and should not be confused with the original design calculation or observed power.
Safety information is limited to recorded counts and selected serious-event terms. Comparative estimates, uncertainty intervals, event-specific denominators, and fuller details of event collection and observation are not reported in the registry record. These gaps limit the strength of conclusions that can be drawn from the record; they do not determine what the complete study report may contain.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Immunogenicity and Safety of GlaxoSmithKline Biologicals' Infanrix™-IPV+Hib Vaccine — NCT01309646.
- Registry record last updated 2019-11-27; status last verified 2019-11.
- Results first posted 2013-04-02.
- 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 NCT01309646, a completed randomized, unmasked, parallel-group phase 3 study sponsored by GlaxoSmithKline. It lists enrollment as 454, a start date of 2011-03-04 and primary completion on 2012-02-24. The study evaluated safety and immunogenicity for two vaccine regimens in healthy Korean infants.
The primary outcome was the number of participants with anti-D and anti-T antibody concentrations at or above 0.1 IU/mL at Month 5. The primary analysis was described for an According-To-Protocol immunogenicity cohort, although its full criteria are not reported in the registry record. A numerical primary-outcome comparison and its uncertainty are also not reported.
The record lists serious adverse event counts of 25 and 21 across the two groups, other adverse-event counts of 218 and 220, and zero deaths in each group. These are descriptive figures; the recorded information does not include a complete comparative statistical analysis.