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 Evaluation of the Immune Responses of GSK Biologicals' HPV Vaccine Following Manufacturing Process Adaptation. (NCT00250276), a randomized phase 3 study. The primary outcome is Number of Seroconverted (SCR) Subjects for Anti-Human Papillomavirus Type 16 (Anti-HPV-16) and Anti-Human Papillomavirus Type 18 (Anti-HPV-18).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00250276 |
| Phase | Phase 3 |
| Condition | Infections, Papillomavirus, Papillomavirus Vaccines |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 798 |
| Arms in the primary outcome | n/a |
| Lead sponsor | GlaxoSmithKline |
| Results posted | Yes |
2. Clinical Question
Population
Healthy female subjects aged 18–25 years. The primary endpoint population is the According-to-Protocol cohort for immunogenicity: evaluable subjects with immunogenicity data available, including subjects with assay results for antibodies against at least one study vaccine component at Month 7.
Intervention
Cervarix™ HPV-16/18 L1/AS04 vaccine from three lots manufactured at 600L scale. The regimen was described as intramuscular administration according to a 0, 1, 6-month schedule.
Comparator
A Cervarix group receiving vaccine manufactured at lower 80L scale. The record also describes the three 600L lots separately, making consistency across manufacturing lots a central comparison.
Primary question
At Month 7, how many subjects seroconverted for anti-HPV-16 and anti-HPV-18, and how did the immune responses compare across the vaccine lots and manufacturing scales? The primary endpoint results and a single reduced comparison are not reported in the registry record.
The registry frames the study as an evaluation of immune responses after manufacturing-process adjustments. Its focus is not a clinical disease endpoint: the primary outcome counts subjects who meet the seroconversion definition for the HPV types being assessed. The record lists additional immune response and safety outcomes, but does not give their results in the registry record for this account.
3. Trial Design
This was a Phase 3, randomized, quadruple-masked, parallel-group trial. The registry records enrollment of 798 and lists the study as completed. The sponsor was GlaxoSmithKline. The recorded start date is 2005-10-28, and primary completion is dated 2007-03-01.
The four groups described in the registry comprise three Cervarix™ lots manufactured at 600L scale and a lower-scale 80L vaccine group. The study regimen is described as intramuscular vaccination according to a 0, 1, 6-month schedule. Group descriptions state that subjects were followed for 7 months after the first dose and that telephone contact was planned at Month 12.
Randomization indicates assignment to study groups by a random process, while a parallel design means the groups were followed as separate arms rather than crossing over between regimens. Quadruple masking indicates that the registry classifies the trial as masked at four levels, but the identities of those levels and the practical masking procedures are not reported in the registry record.
The principal design question is whether the vaccine lots produced comparable immune responses after manufacturing adjustments. The three 600L lots allow lot-to-lot comparison, while the lower-scale group provides a manufacturing-scale contrast. The registry record does not report the randomization method, allocation concealment procedures, exact group assignment counts, or the protocol’s rationale for the enrollment target. Those details should not be inferred from the group descriptions or the total enrollment figure.
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.
Overall Study
| Stage | Cervarix Lot1 Group | Cervarix Lot2 Group | Cervarix Lot3 Group | Cervarix Low Group |
|---|---|---|---|---|
| STARTED | 199 | 198 | 201 | 200 |
| COMPLETED | 182 | 177 | 182 | 181 |
| NOT COMPLETED | 17 | 21 | 19 | 19 |
Reasons for not completing this period:
| Reason | Cervarix Lot1 Group | Cervarix Lot2 Group | Cervarix Lot3 Group | Cervarix Low Group |
|---|---|---|---|---|
| Serious Adverse Event | 0 | 0 | 1 | 0 |
| Non-serious Adverse Event | 2 | 0 | 0 | 2 |
| Protocol Violation | 0 | 1 | 0 | 0 |
| Withdrawal by Subject | 1 | 2 | 3 | 2 |
| Migrated/moved from study area | 3 | 0 | 2 | 7 |
| Lost to Follow-up | 11 | 18 | 13 | 8 |
Analysis population for the primary outcome, as defined in the registry: The According-to-Protocol cohort for immunogenicity included all evaluable subjects from whom data concerning immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine component at Month 7.
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 | Cervarix Lot1 Group | Cervarix Lot2 Group | Cervarix Lot3 Group | Cervarix Low Group | Total |
|---|---|---|---|---|---|---|
| Participants analysed | 199 | 198 | 201 | 200 | 798 | |
| Age, Continuous | Years | 21.8 (SD 2.08) | 21.8 (SD 2.08) | 21.9 (SD 2.00) | 22.0 (SD 1.96) | 21.88 (SD 2.03) |
| Sex: Female, Male: Female | Participants | 199 | 198 | 201 | 200 | 798 |
| Sex: Female, Male: Male | Participants | 0 | 0 | 0 | 0 | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Seroconverted (SCR) Subjects for Anti-Human Papillomavirus Type 16 (Anti-HPV-16) and Anti-Human Papillomavirus Type 18 (Anti-HPV-18), measured over At Month 7.
| 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 subjects who seroconverted for anti-HPV-16 and anti-HPV-18 at Month 7. Seroconversion is defined as the appearance of the specified antibodies in serum among subjects who were seronegative before vaccination. The thresholds are anti-HPV-16 concentrations of at least 8 ELISA units per milliliter and anti-HPV-18 concentrations of at least 7 EL.U/mL.
This is a binary participant-level outcome: each subject either meets the stated seroconversion definition for the antibody being assessed or does not. Counting subjects meeting the definition gives a readily interpretable summary of the immune response, while the separate HPV-16 and HPV-18 assessments preserve information about responses to each vaccine target. The endpoint is measured at Month 7, following the schedule described in the record.
General: a prespecified antibody threshold turns a continuous laboratory measurement into a category. That can make an outcome easier to summarize across groups, but it also means the count does not describe the full distribution of antibody concentrations. Concentration summaries and the number seroconverting answer different questions.
The registry record defines the endpoint and its immunogenicity population, but the outcome counts by group are not reported in the registry record. Therefore the magnitude and precision of the observed seroconversion responses cannot be described from this record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The study’s stated aim is to compare immune responses induced by different vaccine lots following manufacturing-process adjustments. Its primary endpoint is a Month 7 count of subjects meeting the seroconversion definition for anti-HPV-16 and anti-HPV-18. However, the primary results are not reported in the registry record available for this account. There are no group-specific seroconversion counts, effect estimates, confidence intervals, or hypothesis-test results in the registry record for this trial. Consequently, the posted information does not establish how similar or different the immune responses were across lots or manufacturing scales.
The registry indicates that the primary outcome has several categories or time points and was not reduced to one comparison. This matters for interpretation: an analysis of HPV-16 and HPV-18 responses may involve more than one result, and a single summary cannot be assumed without knowing the analysis definitions. The record does not specify which comparisons were designated for formal inference, what margin or criterion would define consistency, or how uncertainty was evaluated. These features are not reported in the registry record.
General: an observed difference is not interpreted in isolation. Its uncertainty, the outcome definition, the comparison being made, and the analysis population all affect what can be concluded. A confidence interval, when reported, describes a range of values compatible with the data under the statistical model; its width conveys precision. No confidence interval for the primary endpoint is available in the registry record, so precision cannot be assessed.
The safety information includes serious-event counts for the three 600L groups, a pooled group, and the lower-scale group. The record reports 6 affected subjects among 199 at risk in Cervarix Lot1 Group, 1 among 198 in Cervarix Lot2 Group, 2 among 201 in Cervarix Lot3 Group, 9 among 598 in Pooled Group, and 3 among 200 in Cervarix Low Group. These are descriptive counts, not evidence by themselves of a causal difference between groups. The record does not supply comparative estimates or uncertainty for these safety data.
The registry also lists selected serious-event terms with percentages, but does not provide enough detail in the registry record to connect those terms to particular groups or to interpret them as comparative risks. Death counts are not reported in the registry record. The available information therefore supports description of selected recorded safety figures, but not a comprehensive comparative safety assessment.
9. Statistical Methods Explained
General: the study’s randomized, parallel-group design is intended to compare outcomes across assigned groups. Randomization can reduce systematic differences between groups at baseline, on average, but does not guarantee identical groups or remove the need to examine the analysis population and missing data. The registry identifies the study as randomized and parallel; it does not report the sequence-generation procedure or allocation concealment method.
What does a binary count represent?
The primary outcome is a participant count based on whether a subject meets a seroconversion definition. For a binary outcome, a group count is often interpreted alongside the number assessed in that group. The registry definition establishes the antibody thresholds and the Month 7 assessment, but the outcome counts and group denominators for the primary analysis are not reported in the registry record. Without those results, no event proportion, between-group difference, or uncertainty estimate can be stated.
General: a confidence interval expresses uncertainty around an estimate under the assumptions of the analysis. Wider intervals generally indicate less precision, while narrower intervals indicate greater precision. A confidence interval is not a guarantee that the true value lies within its bounds, and it does not itself establish clinical importance. No primary endpoint confidence intervals are reported in the registry record for this trial.
How should lot consistency be assessed?
General: consistency questions usually require a clearly defined comparison and a criterion for how much variation between lots would be acceptable. A failure to detect a difference is not, on its own, proof that responses are sufficiently similar; the study needs an appropriate analysis and a prespecified interpretation framework. The registry record describes lot-to-lot consistency as the study aim, but the statistical criterion, margin, comparison structure, and formal decision rule are not reported in the registry record.
The three 600L groups and the lower-scale group indicate the broad contrasts of interest. The record does not state whether each 600L lot was compared separately with the others, whether a pooled estimate was primary, or how the 80L group entered the formal primary analysis. The pooled group appears in the safety details, but its role in the primary immunogenicity analysis is not specified. These analytic choices should not be inferred from the group names.
What is known about sample-size planning?
The registry entries include a planning illustration based on the observed effect, with a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The illustration considers detecting a stated fraction of the observed effect. Such sample-size figures are planning illustrations, not observed power and not evidence that the trial was designed using those assumptions. The registry’s own sample-size justification is not reported in the registry record.
General: a sample-size calculation depends on the target effect, outcome variability, significance level, power target, allocation, and analysis method. Changing an assumption can change the resulting planning requirement. A calculation using an effect estimated from trial results is retrospective in its choice of effect size and should not be presented as the trial’s original design rationale. No new sample-size value or power estimate can be derived in the registry record.
Why can multiple outcomes matter?
The registry lists primary seroconversion outcomes for two HPV types and several secondary outcome categories, including seropositivity, solicited local and general symptoms, and new onset chronic diseases. When many outcomes or comparisons are assessed, the chance of at least one apparently unusual result can increase if each is tested separately without adjustment. General statistical approaches may control a family-wise error rate or emphasize estimation rather than a sequence of significance tests. Which approach was used in this trial is not reported in the registry record.
The number of outcome measures and analyses recorded does not identify the exact statistical models, tests, adjustment procedures, or analysis hierarchy. The registry does not report whether there were interim analyses, how missing values were handled, or whether any sensitivity analyses were planned. Those methods cannot be reconstructed from the endpoint descriptions alone.
What analysis population is defined?
The primary endpoint description identifies an According-to-Protocol cohort for immunogenicity. It includes evaluable subjects with immunogenicity data available, including subjects with assay results for antibodies against at least one study vaccine component at Month 7. This definition describes who could contribute to that cohort, but the number analyzed and the detailed eligibility or exclusion rules are not reported in the registry record.
General: an according-to-protocol analysis can differ from an analysis that includes all randomized subjects, because it may exclude subjects who do not meet protocol or evaluability criteria. Such exclusions can affect comparability if they are related to treatment assignment or outcome. The registry entries do not identify a separate intention-to-treat analysis or explain how the primary analysis population was chosen.
10. Multiplicity, Missing Data and Analysis Populations
The primary endpoint covers seroconversion for anti-HPV-16 and anti-HPV-18, while the secondary outcomes include seropositivity, solicited local symptoms, solicited general symptoms, and new onset chronic diseases. The record lists 16 outcome measures and 10 analyses. These counts do not disclose which results were formally tested together, the testing hierarchy, or any adjustment for multiple comparisons. The multiplicity strategy is not reported in the registry record.
General: when several outcomes or group contrasts are examined, separate tests can increase the likelihood of at least one result appearing notable by chance. An adjustment or prespecified testing hierarchy can address that issue, while descriptive estimates and intervals can help readers assess the magnitude and precision of each result. The appropriate interpretation depends on the planned inferential framework, which is not reported for this trial.
The defined immunogenicity population is the According-to-Protocol cohort for immunogenicity, consisting of evaluable subjects with immunogenicity data available and assay results at Month 7 for at least one study vaccine component. The registry entries do not provide the analyzed counts by group, the reasons for exclusions, or a missing-data method. They also do not report a separate intention-to-treat result for the primary endpoint.
General: missing outcome data can reduce precision, and its impact depends partly on why measurements are absent. Analyses based only on observed or evaluable cases can be affected if missingness is related to group assignment or immune response. The registry record does not describe assumptions about missingness, imputation, or sensitivity analyses, so the effect of missing data on the primary comparison cannot be assessed.
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 |
|---|---|---|---|
| Cervarix Lot1 Group | 6 | 199 | 3.0% |
| Cervarix Lot2 Group | 1 | 198 | 0.5% |
| Cervarix Lot3 Group | 2 | 201 | 1.0% |
| Pooled Group | 9 | 598 | 1.5% |
| Cervarix Low Group | 3 | 200 | 1.5% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 4.9% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Cervarix Lot1 Group | 196 of 199 |
| Cervarix Lot2 Group | 194 of 198 |
| Cervarix Lot3 Group | 191 of 201 |
| Pooled Group | 581 of 598 |
| Cervarix Low Group | 194 of 200 |
Most frequent serious adverse event terms
| Event term | Organ system | Cervarix Lot1 Group | Cervarix Lot2 Group | Cervarix Lot3 Group | Pooled Group | Cervarix Low Group |
|---|---|---|---|---|---|---|
| Basedow's disease | Endocrine disorders | 1 of 199 | 0 of 198 | 0 of 201 | 1 of 598 | 0 of 200 |
| Appendicitis | Infections and infestations | 0 of 199 | 0 of 198 | 0 of 201 | 0 of 598 | 2 of 200 |
| Cerebral malaria | Infections and infestations | 1 of 199 | 0 of 198 | 0 of 201 | 1 of 598 | 0 of 200 |
| Pelvic inflammatory disease | Infections and infestations | 1 of 199 | 0 of 198 | 0 of 201 | 1 of 598 | 0 of 200 |
| Tuberculosis | Infections and infestations | 1 of 199 | 0 of 198 | 0 of 201 | 1 of 598 | 0 of 200 |
| Femur fracture | Injury, poisoning and procedural complications | 1 of 199 | 0 of 198 | 0 of 201 | 1 of 598 | 0 of 200 |
| Road traffic accident | Injury, poisoning and procedural complications | 0 of 199 | 0 of 198 | 1 of 201 | 1 of 598 | 0 of 200 |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | 0 of 199 | 0 of 198 | 1 of 201 | 1 of 598 | 0 of 200 |
| Abortion missed | Pregnancy, puerperium and perinatal conditions | 0 of 199 | 1 of 198 | 0 of 201 | 1 of 598 | 0 of 200 |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | 1 of 199 | 0 of 198 | 0 of 201 | 1 of 598 | 0 of 200 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Cervarix Lot1 Group | Cervarix Lot2 Group | Cervarix Lot3 Group | Pooled Group | Cervarix Low Group |
|---|---|---|---|---|---|---|
| Pain | General disorders | 194 of 198 | 192 of 197 | 190 of 199 | 576 of 594 | 192 of 197 |
| Redness | General disorders | 118 of 198 | 128 of 197 | 127 of 199 | 373 of 594 | 126 of 197 |
| Swelling | General disorders | 116 of 198 | 112 of 197 | 113 of 199 | 341 of 594 | 107 of 197 |
| Fatigue | General disorders | 117 of 198 | 117 of 197 | 106 of 199 | 340 of 594 | 105 of 197 |
| Headache | General disorders | 99 of 198 | 103 of 197 | 95 of 199 | 297 of 594 | 93 of 197 |
| Myalgia | General disorders | 75 of 198 | 82 of 197 | 73 of 199 | 230 of 594 | 66 of 197 |
| Gastrointestinal | General disorders | 55 of 198 | 61 of 197 | 57 of 199 | 173 of 594 | 49 of 197 |
| Arthralgia | General disorders | 38 of 198 | 40 of 197 | 32 of 199 | 110 of 594 | 35 of 197 |
| Fever/(Axillary) (°C) | General disorders | 16 of 198 | 18 of 197 | 14 of 199 | 48 of 594 | 15 of 197 |
| Rash | General disorders | 11 of 198 | 10 of 197 | 19 of 199 | 40 of 594 | 15 of 197 |
Serious events with the highest arm-level rate: appendicitis (1.0%), abortion missed (0.5%), basedow's disease (0.5%), cerebral malaria (0.5%), pelvic inflammatory disease (0.5%).
The registry reports serious adverse event figures as affected subjects and subjects at risk. Cervarix Lot1 Group has 6 affected among 199 at risk; Cervarix Lot2 Group has 1 among 198; Cervarix Lot3 Group has 2 among 201; Pooled Group has 9 among 598; and Cervarix Low Group has 3 among 200. These are group-level descriptive counts. The pooled group is listed separately, and its figures should not be added to the lot-specific groups.
The registry also lists Appendicitis at 1.0%, and Abortion missed, Basedow's disease, Cerebral malaria, Pelvic inflammatory disease, and Tuberculosis at 0.5% each, as selected serious-event terms. The registry entries do not specify the group attribution or further context for each term. Death counts are not reported in the registry record; that does not establish that there were no deaths.
General: an adverse event recorded during a trial does not, by itself, establish that the intervention caused it. Counts also need context, including follow-up, definitions, group allocation, and uncertainty, before comparative interpretation. The registry entries do not provide adjusted comparisons or confidence intervals for the serious-event figures. These data should therefore be read as descriptive reporting, not as a definitive test of differences in safety between groups.
12. What the Result Does, and Does Not, Mean
The record establishes the trial’s objective, design, endpoint definition, analysis population description, and selected safety counts. It describes a randomized comparison of three 600L vaccine lots and a lower 80L manufacturing-scale group, with immune response assessed at Month 7. It also identifies seroconversion thresholds for HPV-16 and HPV-18.
What the registry entries do not establish is the primary endpoint result. No seroconversion counts by group, comparative effect estimates, confidence intervals, or primary hypothesis-test results are reported in the registry record. The direction, size, and precision of any differences in immune response therefore cannot be described. Nor can the record establish whether the lots met a prespecified criterion for consistency, because the criterion and corresponding analysis results are not reported.
The serious adverse event counts and selected event terms provide descriptive safety information, but they do not show whether any group differed meaningfully from another. The registry entries do not include comparative safety estimates or uncertainty measures. The listed serious-event terms also should not be treated as evidence that the vaccine caused those events.
General: a trial’s design and endpoint definitions explain what investigators intended to evaluate; they are not substitutes for outcome results. Likewise, an absence of reported statistical evidence in the registry entries is not evidence of no difference. The responsible interpretation is limited to the information recorded: the study was designed to compare immune responses across manufacturing lots and scales, but the results needed to answer that comparison are not reported in the registry record.
No conclusion about clinical protection against HPV infection or cervical cancer follows from the endpoint definition alone. The primary outcome measures antibody seroconversion, not a reported clinical disease outcome. Interpretation should stay within the outcomes and results actually recorded.
13. Why This Trial Matters Statistically
This trial is statistically notable for separating manufacturing-lot consistency from the broader question of whether an intervention changes a clinical outcome. Its stated focus is the immune response associated with different HPV-16/18 L1/AS04 vaccine lots after manufacturing adjustments. The endpoint uses antibody thresholds to classify seroconversion at Month 7, while the design includes three lots produced at 600L scale and a lower 80L group.
General: manufacturing comparisons can involve two related but distinct statistical questions: whether different lots produce sufficiently similar responses, and whether a manufacturing-scale change is associated with a different response. Clear comparison definitions and criteria are important because similarity is not established merely by failing to find a statistically significant difference. The registry record states the consistency objective but does not report its formal criterion or analysis results.
The trial also illustrates why endpoint detail and analysis-population detail matter. The seroconversion definition is explicit, and the immunogenicity cohort is described as according-to-protocol and evaluable. Yet without group-specific results, denominators, uncertainty estimates, and missing-data information, readers cannot determine the strength or precision of the evidence.
Finally, the registry’s safety figures show why descriptive counts should be distinguished from comparative inference. Serious-event counts are recorded by group, but the registry entries do not provide adjusted comparisons or uncertainty. The statistical value of the record is therefore in its design and endpoint documentation; the outcome information is insufficient to resolve the stated immune-response comparison.
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 primary immunogenicity results are not reported in the registry record. In particular, group-specific seroconversion counts, analysis denominators, effect estimates, confidence intervals, and hypothesis-test results are unavailable in the registry record for this account. This prevents assessment of the magnitude and precision of the primary comparison.
The registry describes lot-to-lot consistency as an objective but does not report the prespecified consistency criterion, margin, formal comparison structure, or decision rule. It also does not clarify how the lower-scale group was incorporated into the primary analysis. The endpoint is described for two HPV types, but the way results across those types were handled statistically is not reported.
The primary analysis population is defined as an according-to-protocol immunogenicity cohort, but the group-specific analyzed counts, detailed exclusion rules, and reasons for missing measurements are not reported. The registry record does not describe a missing-data method, sensitivity analyses, or an intention-to-treat analysis for the primary endpoint.
The randomization and masking categories are recorded, but the randomization procedure, allocation concealment, and practical masking details are not reported in the registry record. The original sample-size justification and statistical analysis plan are also not reported. Finally, safety information is limited to selected serious-event counts and terms in the registry record; comparative estimates and uncertainty are not reported, and death counts are not reported in the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Evaluation of the Immune Responses of GSK Biologicals' HPV Vaccine Following Manufacturing Process Adaptation. — NCT00250276.
- Registry record last updated 2020-01-02; status last verified 2019-12.
- Results first posted 2017-03-17.
- 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
NCT00250276 is a completed Phase 3 randomized, quadruple-masked, parallel-group trial sponsored by GlaxoSmithKline. It enrolled 798 and studied Cervarix™ HPV-16/18 L1/AS04 vaccine lots made at 600L scale alongside a lower 80L group. The described schedule was 0, 1, 6 months.
The primary endpoint was the number of subjects seroconverting for anti-HPV-16 and anti-HPV-18 at Month 7, using stated antibody thresholds and an according-to-protocol immunogenicity population. The primary outcome results and the formal statistical criterion for lot consistency are not reported in the registry record. Selected serious adverse event counts are recorded by group, but comparative safety analyses and death counts are not reported in the registry record.