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, Safety of GSKs Tdap Vaccine Boostrix When Coadministered With GSKs Influenza Vaccine Fluarix in Adults (NCT00385255), a randomized phase 3 study. The primary outcome is Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Toxoid Antigens.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00385255 |
| Phase | Phase 3 |
| Condition | Acellular Pertussis, Diphtheria, Tetanus |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 1726 |
| Arms in the primary outcome | n/a |
| Lead sponsor | GlaxoSmithKline |
| Results posted | Yes |
2. Clinical Question
Population
The study enrolled healthy male and female adults aged 19 to 64 years inclusive, and adults aged 65 years or older. The stated purpose included immunogenicity and safety information in both age ranges. The primary immunogenicity analysis used the According-to-Protocol cohort, defined in the registry record as evaluable subjects with available immunogenicity data. That analysis population should not be assumed to include every randomized or enrolled participant.
Intervention
In the coadministration group, participants received Boostrix and Fluarix at Day 0. The vaccines were injected intramuscularly in the left and right upper deltoid regions, respectively. The study therefore assessed a schedule in which both vaccines were administered at the same visit, using the sites described in the record.
Comparator
The comparison group received Fluarix at Day 0 and Boostrix at Month 1. Both injections were administered intramuscularly in the upper left deltoid region. This is a sequential schedule rather than coadministration. The registry does not report additional details about how participants were assigned to the groups beyond describing the allocation as randomized.
Primary question
The primary outcome counted subjects whose anti-diphtheria and anti-tetanus antibody concentrations met the stated seroprotection threshold at Month 1 post-Boostrix vaccination. The clinical question is whether the posted endpoint data describe seroprotection under the coadministration schedule in relation to the sequential schedule. The registry record does not report the numerical primary-outcome results or a numerical between-group comparison, so the size and precision of any difference cannot be assessed from these registry entries.
3. Trial Design
This was a randomized, parallel-group Phase 3 study, with no masking reported. Its title and stated purpose concern the immunogenicity and safety of Boostrix when coadministered with Fluarix in adults. The record lists an enrollment of 1726 and identifies the study as completed. It does not report the randomization method, allocation concealment, or other procedural details about assignment.
The study contrasted coadministration with a sequential schedule. Participants in the Boostrix+Fluarix group received both vaccines at Day 0, in the left and right upper deltoid regions, respectively. Participants in the Fluarix Boostrix group received Fluarix at Day 0 and Boostrix at Month 1; both injections were given in the upper left deltoid region. The primary endpoint timeframe is Month 1 post-Boostrix vaccination. The record does not explain the calendar-time alignment of endpoint assessments between the schedules, so no further inference about assessment timing should be made.
The population description includes healthy adults aged 19 to 64 years inclusive and adults aged 65 years or older. The primary immunogenicity analysis was performed in the According-to-Protocol cohort, which included evaluable subjects with available immunogenicity data. The record does not provide group-specific counts for that analysis population or describe exclusions from it.
The record lists 15 outcome measures and 12 analyses. Secondary outcomes cover antibody measures for diphtheria, tetanus, and pertussis antigens; influenza antibody titers; booster responses; and solicited symptoms. The primary outcome is a participant count, not a continuous measurement. Numerical results for the primary comparison, its uncertainty, and the statistical method used for that comparison are not reported in the registry record. Consequently, the design can be described, but the comparative immunogenicity result cannot be reconstructed from the stated details.
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: Out of the 1726 subjects originally enrolled in this study, 8 subjects (7 subjects from the 19-64 years of age cohort and 1 subject from the 65 years of age cohort) did not receive the study vaccine and hence were not included in the Total Vaccinated Cohort.
Overall Study
| Stage | Boostrix+Fluarix Group | Fluarix Boostrix Group |
|---|---|---|
| STARTED | 860 | 858 |
| ≥ 65 Years of Age (YOA) Cohort | 112 | 109 |
| 19-64 Years of Age (YOA) Cohort | 748 | 749 |
| COMPLETED | 839 | 785 |
| NOT COMPLETED | 21 | 73 |
Reasons for not completing this period:
| Reason | Boostrix+Fluarix Group | Fluarix Boostrix Group |
|---|---|---|
| Serious Adverse Event | 1 | 2 |
| Protocol Violation | 0 | 4 |
| Withdrawal by Subject | 0 | 8 |
| Migrated/moved from study area | 0 | 1 |
| Lost to Follow-up | 20 | 58 |
Analysis population for the primary outcome, as defined in the registry: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures 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 | Boostrix+Fluarix Group | Fluarix Boostrix Group | Total |
|---|---|---|---|---|
| Participants analysed | 860 | 858 | 1718 | |
| Age, Continuous | Years | 48.95 (SD 14.74) | 49.29 (SD 14.58) | 49.12 (SD 14.66) |
| Sex: Female, Male: Female | Participants | 527 | 481 | 1008 |
| Sex: Female, Male: Male | Participants | 333 | 377 | 710 |
| Race/Ethnicity, Customized: Geographic ancestry – African heritage/African American | Participants | 69 | 82 | 151 |
| Race/Ethnicity, Customized: Geographic ancestry – American Indian or Alaskan native | Participants | 2 | 0 | 2 |
| Race/Ethnicity, Customized: Geographic ancestry – Asian-Central/South Asian heritage | Participants | 0 | 1 | 1 |
| Race/Ethnicity, Customized: Geographic ancestry – Asian-East Asian heritage | Participants | 1 | 2 | 3 |
| Race/Ethnicity, Customized: Geographic ancestry – Asian-Japanese heritage | Participants | 1 | 2 | 3 |
| Race/Ethnicity, Customized: Geographic ancestry – Asian-South East Asian heritage | Participants | 3 | 4 | 7 |
| Race/Ethnicity, Customized: Geographic ancestry – Native Hawaiian or other Pacific Islander | Participants | 1 | 0 | 1 |
| Race/Ethnicity, Customized: Geographic ancestry – White-Arabic/North African heritage | Participants | 7 | 4 | 11 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Toxoid Antigens, measured over At Month 1 post-Boostrix® vaccination.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint counts participants who met the registry’s definition of seroprotection against diphtheria and tetanus toxoid antigens. A subject qualified when the anti-D and anti-T antibody concentrations were each at least 0.1 International Units per milliliter. The assessment timeframe was Month 1 post-Boostrix vaccination.
This kind of endpoint reduces laboratory antibody measurements to a clinically interpretable threshold classification: each evaluated participant is counted according to whether the specified antibody criteria are met. It is therefore a binary outcome at the participant level, summarized as a count of participants rather than as an average antibody concentration. The underlying antibody concentrations are also listed among the secondary outcomes, but the registry’s primary endpoint is the number of seroprotected subjects.
In general, a threshold endpoint can make it easier to describe how many participants cross a prespecified antibody level. It does not show how far above or below the threshold individual measurements fall, and a participant count alone cannot convey the full distribution of antibody concentrations. The registry record does not report the numerical endpoint counts or group comparison. It also does not provide a numerical confidence interval or p-value for the primary endpoint. Thus, the endpoint definition is available, but the magnitude and precision of the observed primary result are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The central interpretive point is that the registry record defines the primary outcome but does not report its numerical results. It specifies a count of subjects meeting the anti-D and anti-T seroprotection criteria at Month 1 post-Boostrix vaccination. Without the group counts or a reported comparison, it is not possible to describe the observed contrast between coadministration and sequential administration, quantify its precision, or assess whether the posted data support a particular statistical conclusion.
The intervention schedules differ in timing. One group received Boostrix and Fluarix together at Day 0; the comparison group received Fluarix at Day 0 and Boostrix at Month 1. The primary outcome is defined relative to Boostrix vaccination. The record does not provide assessment dates or further details that would establish how measurements were aligned across schedules. That matters when interpreting an endpoint tied to time since vaccination, but the registry entries do not support assumptions about the schedule-specific assessment procedure.
In general, a point estimate describes the observed magnitude of a comparison, while a confidence interval describes the range of values compatible with the data under the method used. A p-value, when reported, addresses compatibility with a specified null hypothesis under its analysis assumptions; it is not a measure of clinical importance. None of these numerical comparison statistics is reported for the primary endpoint in the registry record. The outcome definition alone cannot substitute for them.
The record identifies the According-to-Protocol cohort for the primary immunogenicity analysis. This means the stated analysis population was restricted to evaluable subjects with available immunogenicity data. The record does not give the group counts in that cohort, explain how evaluability was determined, or report how exclusions and missing measurements were handled. The enrolled population and the analyzed population therefore should not be treated as interchangeable.
Safety information is also described in the record, including serious adverse event counts and listed serious-event terms. Those observations are descriptive. They do not resolve the unreported primary immunogenicity comparison, and they should not be taken as a complete characterization of benefit or harm. Overall, the record supports a clear description of the design, outcome definition, and analysis population, but not a numerical conclusion about the primary comparison.
9. Statistical Methods Explained
The primary endpoint is a binary participant-level outcome: a subject either met the specified seroprotection definition or did not. The record defines seroprotection using anti-D and anti-T concentrations of at least 0.1 International Units per milliliter, respectively, at Month 1 post-Boostrix vaccination. The endpoint is expressed as a count of subjects. Although this outcome structure is clear, the registry record does not report the observed counts by group, the statistical test or model, or an estimate of the between-group contrast.
What does a confidence interval add?
General statistical explanation: A confidence interval communicates the uncertainty around an estimated quantity, such as a group proportion or a difference between groups. Its width depends on factors including the amount of information and the variability of the observations, as well as the method used. A narrow interval indicates greater precision than a wide interval, but an interval does not by itself determine whether an effect is important in practice. For this trial’s primary endpoint, a numerical interval is not reported in the registry record, so its precision cannot be assessed.
What does a p-value answer?
General statistical explanation: A p-value is calculated under a statistical model and a null hypothesis. It describes how compatible the observed data are with that hypothesis, conditional on the model and its assumptions. It is not the probability that the null hypothesis is true, and it does not measure the size or practical relevance of an effect. The registry record does not report a p-value for the primary endpoint or identify the test from which one might have been obtained.
Why does the analysis population matter?
The record says the primary immunogenicity analysis used the According-to-Protocol cohort, consisting of evaluable subjects with available immunogenicity data. In general, an analysis population determines which participants contribute information to an estimate. A restricted population can differ from the randomized population if participants are excluded or lack evaluable measurements. The registry record does not report the number of analyzed subjects in each group, the criteria for evaluability, reasons for exclusions, or a complementary analysis population. Accordingly, readers cannot determine from these registry entries how the analysis population relates numerically to the enrolled groups.
How should the schedule be considered?
The two schedules place Boostrix at different study visits: coadministration occurs at Day 0, while the sequential group receives Boostrix at Month 1. Since the primary timeframe is Month 1 post-Boostrix vaccination, the endpoint is framed relative to the Boostrix dose. In general, relative timing is important when outcomes may change over time after vaccination. The record does not report more detailed assessment dates or explain the timing alignment, so interpretation should remain limited to the stated endpoint timeframe and schedules.
What does randomization contribute?
General statistical explanation: Random assignment is intended to reduce systematic differences between groups at baseline, on average, when the process is implemented as planned. It does not guarantee that the groups are identical, and it does not remove uncertainty from sampling. The record describes allocation as randomized but does not report the sequence-generation method, concealment procedures, or stratification factors. Those details cannot be inferred from the allocation label alone.
What can planning calculations say?
General statistical explanation: Sample-size calculations are prospective planning exercises based on assumptions about the effect to detect, variability, allocation, and a chosen significance level. They are not observed power, and they do not establish what effect the trial actually found. The record’s planning assumptions specify a two-sided significance level of 0.05, equal allocation, and a normal approximation, with the effect to detect expressed as a fraction of the observed effect. It states that calculations for time-to-event outcomes would use total events, while other calculations would use participants per arm. Specific planning values are not reported in the registry record, and the primary comparison’s numerical observed effect is also not reported. Therefore, no planning estimate can be interpreted as a result of the trial.
The endpoint definition, design, and analysis population are all relevant to interpretation, but they do not replace outcome estimates. The registry record does not report the primary counts, effect estimate, confidence interval, p-value, or detailed analysis procedure. Statistical conclusions about the comparative primary result must therefore remain open.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 15 outcome measures and 12 analyses. In addition to the primary seroprotection endpoint for diphtheria and tetanus, the secondary outcomes include antibody concentrations for diphtheria, tetanus, and pertussis antigens; booster responses; influenza antibody titers; and solicited local and general symptoms. Considering multiple outcomes or analyses can raise a multiplicity issue: in general, when many statistical tests are conducted, the chance of at least one apparently notable result can increase unless the analysis plan addresses that possibility.
The registry record does not report a multiplicity adjustment, a hierarchy for testing outcomes, or a prespecified strategy for interpreting the different analyses. It also does not report the statistical analysis plan or identify which outcomes were confirmatory versus descriptive. No assumption should be made about how multiplicity was handled.
For the primary immunogenicity outcome, the stated population was the According-to-Protocol cohort, including evaluable subjects with available immunogenicity data. The record does not report the number of participants with missing antibody measurements, the reasons for missingness, or any imputation or other missing-data method. It does not specify how participants who were not evaluable were treated in other analyses.
In general, missingness can affect an estimate when availability of measurements is related to participant characteristics or outcomes. The direction and extent of such an effect depend on the missing-data pattern and analysis choices. Since those details are not reported in the registry record, the impact of missing data cannot be evaluated. The distinction between enrollment and the According-to-Protocol analysis population should be kept in view when reading any reported immunogenicity result.
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 |
|---|---|---|---|
| Boostrix+Fluarix Group | 3 | 860 | 0.3% |
| Fluarix Boostrix Group | 7 | 858 | 0.8% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Boostrix+Fluarix Group | 0 of 860 |
| Fluarix Boostrix Group | 0 of 858 |
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 |
|---|---|
| Boostrix+Fluarix Group | 640 of 860 |
| Fluarix Boostrix Group | 619 of 858 |
Most frequent serious adverse event terms
| Event term | Organ system | Boostrix+Fluarix Group | Fluarix Boostrix Group |
|---|---|---|---|
| Chest pain | General disorders | 0 of 860 | 2 of 858 |
| Headache | Nervous system disorders | 0 of 860 | 2 of 858 |
| Anaemia | Blood and lymphatic system disorders | 0 of 860 | 1 of 858 |
| Gastric ulcer | Gastrointestinal disorders | 0 of 860 | 1 of 858 |
| Vomiting | Gastrointestinal disorders | 0 of 860 | 1 of 858 |
| Pneumonia | Infections and infestations | 0 of 860 | 1 of 858 |
| Urosepsis | Infections and infestations | 1 of 860 | 0 of 858 |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | 0 of 860 | 1 of 858 |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | 0 of 860 | 1 of 858 |
| Leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1 of 860 | 0 of 858 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Boostrix+Fluarix Group | Fluarix Boostrix Group |
|---|---|---|---|
| Pain | General disorders | 509 of 860 | 473 of 858 |
| Myalgia | Musculoskeletal and connective tissue disorders | 294 of 860 | 313 of 858 |
| Headache | Nervous system disorders | 244 of 860 | 276 of 858 |
| Fatigue | General disorders | 240 of 860 | 240 of 858 |
| Erythema | Skin and subcutaneous tissue disorders | 203 of 860 | 227 of 858 |
| Swelling | General disorders | 198 of 860 | 177 of 858 |
| Arthralgia | Musculoskeletal and connective tissue disorders | 151 of 860 | 156 of 858 |
| Gastrointestinal disorder | Gastrointestinal disorders | 139 of 860 | 145 of 858 |
| Chills | General disorders | 76 of 860 | 86 of 858 |
| Pyrexia | General disorders | 59 of 860 | 88 of 858 |
Serious events with the highest arm-level rate: chest pain (0.2%), headache (0.2%), anaemia (0.1%), gastric ulcer (0.1%), vomiting (0.1%).
The registry reports serious adverse events for the two study groups. In the Boostrix+Fluarix group, 3 participants were affected among 860 at risk; in the Fluarix Boostrix group, 7 were affected among 858 at risk. The listed serious-event terms include chest pain and headache at 0.2% each, and anaemia, gastric ulcer, vomiting, and pneumonia at 0.1% each. These percentages are quoted as recorded and are not recalculated.
The record reports 0 deaths in each group. It also lists other adverse events, with 640 affected among 860 at risk in the Boostrix+Fluarix group and 619 among 858 at risk in the Fluarix Boostrix group. These are separate registry categories; the registry entries do not describe further details about their definitions, severity, duration, or relationship to vaccination.
In general, adverse-event counts describe observations within the recorded follow-up and population. They do not establish that an event was caused by a vaccine, and small counts do not by themselves establish that risks are equivalent. Interpretation would also depend on event definitions, ascertainment, follow-up, and analysis methods. Those additional details are not reported in the registry record. The serious-event figures should therefore be read descriptively, not as a complete account of safety or as a causal comparison.
12. What the Result Does, and Does Not, Mean
The record establishes what the trial set out to compare: coadministration of Boostrix with Fluarix versus giving Fluarix first and Boostrix at Month 1. It also defines the primary endpoint as a participant count meeting the stated anti-D and anti-T antibody threshold at Month 1 post-Boostrix vaccination. These details make the research question and its measurement approach understandable.
However, the numerical primary endpoint results and group comparison are not reported in the registry record. No effect estimate, confidence interval, or p-value for that endpoint is available in the stated details. As a result, the magnitude of any observed difference and the precision of that estimate cannot be assessed. The endpoint definition alone does not show whether the groups had similar or different seroprotection counts.
The record describes a randomized, unmasked, parallel-group design, but it does not include details of the randomization procedure or a complete statistical analysis plan. The stated primary analysis used an According-to-Protocol immunogenicity cohort, not an explicitly described all-enrolled analysis. Group-specific analysis-population counts and missing-data handling are not reported. These limitations restrict what can be concluded about the analyzed sample and potential sources of uncertainty.
The safety entries provide counts of serious adverse events, deaths, other adverse events, and selected serious-event terms. They are descriptive and do not establish causation or equivalence between schedules. They should not be used to fill the gap in the unreported primary immunogenicity results.
In general, a trial’s design and endpoint definition describe how a question was studied, while the results and their uncertainty are needed to characterize the observed comparison. Here, the design and endpoint are described, but the numerical primary outcome is not. The registry record therefore does not support a quantitative conclusion about comparative seroprotection, and it should not be interpreted as establishing a treatment effect or lack of effect.
13. Why This Trial Matters Statistically
This study is statistically relevant because it compares schedules that differ in whether Boostrix and Fluarix are administered together or sequentially. The registry’s primary outcome is a threshold-based participant count for anti-diphtheria and anti-tetanus antibodies, measured at Month 1 post-Boostrix vaccination. That combination of a defined threshold, a specified assessment timeframe, and contrasting schedules illustrates how trial questions depend on both the outcome definition and the timing of measurement.
The design is described as randomized and parallel, with no masking. Those features help readers frame the comparison, while the absence of reported randomization details and masking means that further design assessment is limited. The use of an According-to-Protocol cohort for the primary immunogenicity analysis also illustrates why the analysis population matters: the eligible analysis set can differ from the enrolled population, and the registry does not report the group-specific analyzed counts.
The record also lists multiple immunogenicity, influenza antibody, and symptom outcomes. In general, multiple endpoints require careful interpretation of which findings are primary, how analyses relate to each other, and whether multiplicity was addressed. The registry record does not report that strategy. This is an important distinction between having a broad set of measurements and having a transparent plan for drawing confirmatory conclusions from them.
Finally, the record demonstrates the boundary between a stated endpoint and an interpretable result. The endpoint definition is detailed, but the numerical primary comparison and its uncertainty are not reported. Statistical interpretation depends on both: knowing what was measured is not enough to judge the observed contrast. The study can be described methodologically, but its primary comparative finding cannot be quantified from the registry record.
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 largest limitation for interpreting the primary question is that the registry record does not report the primary endpoint counts or a numerical between-group comparison. It therefore provides no estimate of the observed difference and no reported confidence interval or p-value. The endpoint’s threshold and timeframe are stated, but the result itself cannot be assessed quantitatively.
The study included healthy adults aged 19 to 64 years inclusive and adults aged 65 years or older, but the record does not give age-specific enrollment or outcome results. It does not report how many participants in each group contributed to the According-to-Protocol immunogenicity analysis, nor does it provide detailed criteria for evaluability. The extent and handling of missing immunogenicity data are not reported in the registry record.
The schedules place Boostrix at different visits. The primary timeframe is defined relative to Boostrix vaccination, but detailed dates for endpoint assessment and any procedures for aligning assessment times are not reported. The record also describes the trial as unmasked but does not state how outcomes were ascertained or whether laboratory assessors were masked.
Other details relevant to appraisal are not reported in the registry record, including the randomization procedure, allocation concealment, a full statistical analysis plan, and a multiplicity strategy for the listed outcomes and analyses. The adverse-event entries are descriptive, and definitions, follow-up detail, and causal assessments are not included in the stated details. These gaps limit assessment of both the primary comparison and the broader safety and immunogenicity profile.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Immunogenicity, Safety of GSKs Tdap Vaccine Boostrix When Coadministered With GSKs Influenza Vaccine Fluarix in Adults — NCT00385255.
- Registry record last updated 2019-06-10; status last verified 2019-06.
- Results first posted 2018-09-17.
- 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
NCT00385255 is a completed randomized Phase 3 parallel-group study of Boostrix and Fluarix in healthy adults aged 19 years and older. The record describes no masking and an enrollment of 1726. It compares coadministration at Day 0 with Fluarix at Day 0 followed by Boostrix at Month 1.
The primary endpoint counts subjects meeting the anti-D and anti-T seroprotection definition at Month 1 post-Boostrix vaccination. The primary immunogenicity analysis used the According-to-Protocol cohort of evaluable subjects with available data. Secondary outcomes include antibody measurements, booster responses, influenza antibody titers, and solicited symptoms.
The registry record does not report numerical results for the primary endpoint or its comparative statistical analysis. Serious adverse event counts, other adverse-event counts, and selected serious-event terms are listed descriptively. Additional details about missing data, multiplicity, randomization procedures, and the full statistical analysis are not reported in the registry record.