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 Consistency Lots Vaccine Study (V260-009) (NCT00092456), a randomized phase 3 study. The primary outcome is Serum Neutralizing Antibodies (SNA) Response Against Rotavirus Serotypes G1, G2, G3, G4 and P1A[8].
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00092456 |
| Phase | Phase 3 |
| Condition | Rotavirus Infections |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 793 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Merck Sharp & Dohme LLC |
| Results posted | Yes |
2. Clinical Question
Population
Healthy infants enrolled in a phase 3 study of a rotavirus vaccine. The primary analysis used the Per Protocol Population, excluding protocol violators and subjects with invalid data based on laboratory determinations.
Intervention
Rotavirus vaccine, live, oral, pentavalent, given as RotaTeq Lot 1, Lot 2, or Lot 3. The listed descriptions are approximately 8.81 X 10^7, 8.01 X 10^7, and 6.91 X 10^7 IU/Dose, respectively.
Comparator
Placebo was included as a comparator group. The registry record does not describe the placebo formulation.
Primary question
How did serum neutralizing antibody geometric mean titers against rotavirus serotypes G1, G2, G3, G4, and P1A[8] compare across the three vaccine lots and placebo 42 days following the 3rd vaccination?
The stated aim was to evaluate consistency in antibody response across three manufactured lots of an investigational rotavirus vaccine. This is a question about immunogenicity: whether the measured antibody responses were comparable across lots. The registry record also includes a placebo group, but the primary outcome description focuses on the geometric mean titers for each group rather than stating a single lot-to-lot contrast.
The record does not give a prespecified margin for acceptable lot consistency or identify a single pairwise comparison as the primary contrast. It therefore does not establish from the information available whether the study was framed as an equivalence or non-inferiority analysis. Numerical geometric mean titers and confidence intervals are not reported in the registry record, so the observed size and precision of the antibody responses cannot be described.
3. Trial Design
NCT00092456, titled “Consistency Lots Vaccine Study (V260-009),” is listed as a phase 3, randomized, double-masked, parallel-group study. The official title describes a comparison of immunogenicity and safety of three consistency lots of V260 in healthy infants. Enrollment was 793. The study is listed as completed, with a start date of 2003-05 and primary completion in 2004-08.
Four groups are described: RotaTeq Lot 1, RotaTeq Lot 2, RotaTeq Lot 3, and placebo. The vaccine lot descriptions give approximately 8.81 X 10^7 IU/Dose, 8.01 X 10^7 IU/Dose, and 6.91 X 10^7 IU/Dose, respectively. The registry identifies the intervention as a live, oral, pentavalent rotavirus vaccine. It does not describe the randomization sequence, allocation concealment, masking procedures, or whether participants, caregivers, investigators, and outcome assessors were all masked.
The primary outcome is an immunogenicity measure based on serum neutralizing antibodies. Its stated assessment time is 42 days following the 3rd vaccination. The primary analysis population is the Per Protocol Population, excluding protocol violators and subjects with invalid data based on laboratory determinations. The registry record does not report how many participants were included in that population or how participants were assigned to the four groups.
The study also collected safety outcomes. The posted results include group counts for serious adverse events and other adverse events. Further information about follow-up schedules, vaccine administration procedures, protocol deviations, and safety-analysis populations is not reported in the registry record. The record lists 10 outcome measures and 3 analyses, but those counts do not by themselves specify the full analysis plan.
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: Subjects with prior rotavirus disease, chronic diarrhea, and fever at time of immunization were excluded from the trial.
Overall Study
| Stage | RotaTeq™ Lot 1 | RotaTeq™ Lot 2 | RotaTeq™ Lot 3 | Placebo |
|---|---|---|---|---|
| STARTED | 226 | 225 | 229 | 113 |
| Vaccinated at Visit 1 | 226 | 225 | 229 | 113 |
| Vaccinated at Visit 2 | 208 | 217 | 210 | 104 |
| Vaccinated at Visit 3 | 202 | 210 | 200 | 98 |
| COMPLETED | 201 | 208 | 200 | 97 |
| NOT COMPLETED | 25 | 17 | 29 | 16 |
Reasons for not completing this period:
| Reason | RotaTeq™ Lot 1 | RotaTeq™ Lot 2 | RotaTeq™ Lot 3 | Placebo |
|---|---|---|---|---|
| Adverse Event | 0 | 0 | 1 | 1 |
| Lost to Follow-up | 2 | 2 | 1 | 2 |
| Protocol Violation | 5 | 7 | 8 | 6 |
| Withdrawal by Subject | 13 | 5 | 16 | 6 |
| Moved | 1 | 1 | 0 | 1 |
| Other | 4 | 2 | 3 | 0 |
Analysis population for the primary outcome, as defined in the registry: Per Protocol Population; excluding protocol violators and subjects with invalid data based on laboratory determinations.
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 | RotaTeq™ Lot 1 | RotaTeq™ Lot 2 | RotaTeq™ Lot 3 | Placebo | Total |
|---|---|---|---|---|---|---|
| Participants analysed | 226 | 225 | 229 | 113 | 793 | |
| Age, Customized: 6 to 12 Weeks | participants | 225 | 224 | 228 | 113 | 790 |
| Age, Customized: Over 12 Weeks | participants | 1 | 1 | 1 | 0 | 3 |
| Sex: Female, Male: Female | Participants | 118 | 98 | 108 | 43 | 367 |
| Sex: Female, Male: Male | Participants | 108 | 127 | 121 | 70 | 426 |
| Race/Ethnicity, Customized: White | participants | 139 | 144 | 147 | 68 | 498 |
| Race/Ethnicity, Customized: Hispanic American | participants | 57 | 49 | 52 | 28 | 186 |
| Race/Ethnicity, Customized: Black | participants | 13 | 11 | 6 | 5 | 35 |
| Race/Ethnicity, Customized: Multi-Racial | participants | 10 | 10 | 16 | 6 | 42 |
| Race/Ethnicity, Customized: Other | participants | 7 | 11 | 8 | 6 | 32 |
6. Primary Endpoint
The registry lists the primary outcome as Serum Neutralizing Antibodies (SNA) Response Against Rotavirus Serotypes G1, G2, G3, G4 and P1A[8], measured over 42 days following the 3rd vaccination.
| Element | Registry entry |
|---|---|
| Result type | Geometric Mean |
| Measure of spread | 95% Confidence Interval |
| Unit | dilution units |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint measures serum neutralizing antibody response against rotavirus serotypes G1, G2, G3, G4, and P1A[8]. Results are expressed as geometric mean titers in dilution units, assessed 42 days following the 3rd vaccination. A neutralizing antibody assay measures the extent to which serum can inhibit a virus-related process under laboratory conditions; in general, such measurements are used to characterize an immune response rather than to count clinical infections.
A geometric mean is appropriate for measurements that are positive and may vary multiplicatively across participants. In general, it is calculated after taking logarithms of the measurements, averaging on that scale, and converting back to the original scale. This can make a group summary less dominated by unusually high values than an arithmetic mean. The registry record identifies the geometric mean titer as the summary measure but does not report the assay protocol or the calculation details.
The record states that the endpoint is accompanied by a 95% confidence interval. In general, a confidence interval conveys uncertainty around an estimated group value: narrower intervals indicate greater precision under the method used. It is not a guarantee that an individual participant’s antibody response lies within the interval. Numerical titers and intervals are not reported in the registry record, so the magnitude and precision of the measured responses cannot be assessed from the listed endpoint description alone.
Antibody response is used as an immunogenicity outcome. The registry record does not state that this endpoint directly measures clinical protection, disease incidence, or duration of protection. It should therefore be interpreted as a laboratory measure of antibody response, not as a clinical disease outcome.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes a randomized, double-masked comparison of three RotaTeq lots and placebo, with antibody response as the primary outcome. The stated aim was to evaluate consistency in response across manufactured lots. However, numerical primary-outcome results are not reported in the registry record. Without the group geometric mean titers and confidence intervals, it is not possible to describe how similar or different the observed antibody responses were, or how precisely they were estimated.
The outcome description lists results against G1, G2, G3, G4, and P1A[8]. This is a collection of serotype-specific measurements rather than a single summary contrast. The registry record does not identify a particular primary lot-to-lot comparison, provide a decision rule for consistency, or state an acceptable difference between lots. A conclusion about consistency would require interpreting the relevant estimates in relation to a prespecified criterion; that criterion is not reported in the registry record.
The primary population was per protocol and excluded protocol violators and subjects with invalid laboratory data. This means the named primary analysis was not described as an analysis of every enrolled participant. The number included in the per-protocol analysis, the numbers excluded, and the reasons for exclusion are not reported in the registry record. Those omissions limit assessment of how closely the analysis population reflects the randomized groups.
The posted safety figures include serious adverse events in each group: 4 among 226 for Lot 1, 4 among 224 for Lot 2, 2 among 229 for Lot 3, and 3 among 111 for placebo. Other adverse events were recorded for 206 among 226, 212 among 224, 211 among 229, and 101 among 111, respectively. These are descriptive counts. The registry record does not provide a statistical comparison, establish causality, or report deaths for these groups. The listed serious-event terms and percentages also do not establish whether events were considered related to study intervention.
Overall, the posted information identifies the design, intended immunogenicity question, analysis population, and selected safety counts, but it does not include the numerical primary endpoint results needed to assess the antibody findings. The trial’s listed completion status is not itself evidence about the direction, size, or clinical meaning of the outcome.
9. Statistical Methods Explained
What does a geometric mean titer summarize?
The registry identifies the primary measure as a geometric mean titer in dilution units. In general, a geometric mean summarizes measurements on a multiplicative scale. An analyst commonly works with logarithms of the individual measurements, calculates a mean on that transformed scale, and converts the result back. This approach is useful when values are positive and differences are more naturally understood as proportional changes than as fixed additive changes. That general explanation does not specify the exact procedure used in this study; the calculation details are not reported in the registry record.
Each listed serotype represents a distinct antibody measurement. A group’s result for one serotype does not automatically describe its result for another. The endpoint description names G1, G2, G3, G4, and P1A[8], and the registry record does not provide a combined score that would replace those separate measurements. The numerical estimates for the serotypes are not reported in the registry record.
How should a confidence interval be read?
The primary measure is described with a 95% confidence interval. In general, a confidence interval gives a range of values compatible with the observed estimate under the statistical method and assumptions used. It communicates precision, not the spread of individual participants’ measurements. A narrow interval indicates a more precise estimate than a wide interval, although precision alone does not show whether a result is clinically important or whether two groups meet a formal criterion for consistency.
The registry record does not report the confidence-interval construction method, the transformed-scale estimates, or the numerical intervals. It is therefore not possible to assess their width or evaluate overlap between groups. Even when intervals are available, visual overlap is not by itself a formal test of equality or equivalence. A formal conclusion depends on the planned contrast and decision rule, which are not reported in the registry record.
What does randomization contribute?
In general, random allocation is intended to reduce systematic differences between groups at the start of a study, while masking can reduce the influence of expectations on care and assessment. This study is identified as randomized and double masked, but the details of the allocation procedure and masking arrangements are not reported in the registry record. The design labels alone do not show whether allocation was concealed or how masking was maintained.
The study is also described as parallel group. In general, this means participants are assigned to a group and assessed in that group rather than crossing between interventions. The registry lists three vaccine-lot groups and placebo. It does not state the precise allocation ratio or provide group enrollment counts for the primary analysis. Enrollment was 793, but this overall enrollment figure should not be substituted for the number analyzed for the primary endpoint.
What is the role of the per-protocol population?
The stated primary analysis population excludes protocol violators and subjects with invalid data based on laboratory determinations. In general, a per-protocol analysis focuses on participants who meet specified study requirements and have usable outcome data. Such an analysis can address response among participants with evaluable measurements, but excluding participants after randomization can affect comparability if exclusions differ between groups or are related to outcomes.
The criteria and counts for exclusions, the handling of missing antibody measurements, and results from any broader analysis population are not reported in the registry record. The phrase “Per Protocol Population” therefore identifies the analysis set described for the endpoint, but it does not provide enough detail to evaluate the consequences of exclusions.
What can be inferred about the statistical plan?
The record reports 10 outcome measures and 3 analyses. It does not give the statistical test used for the primary comparison, the model or adjustment variables, the specific contrasts among lots, or any threshold for concluding that lots were consistent. It also does not report whether the confidence intervals were adjusted for multiple outcomes or comparisons. No interim analyses or sample-size justification are reported in the registry record.
General statistical context: when several outcomes or comparisons are examined, the chance of at least one apparently unusual result can increase if each is assessed independently. Methods for controlling multiplicity can address that issue, but the appropriate approach depends on the prespecified questions and analysis plan. The registry record does not report a multiplicity strategy, so none should be assumed.
The record’s planning illustration is described as using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect to detect expressed as a fraction of the observed effect. It is explicitly a planning illustration computed from the observed effect, not the trial’s own design. These assumptions do not establish the study’s original sample-size rationale or its actual analysis method. Any sample-size illustrations are planning quantities, not observed power.
General context on over-dispersion: if variation in observed data is greater than a statistical model expects, standard errors can be underestimated and confidence intervals can be too narrow. Appropriate models may account for extra variation. The registry record does not report a model for over-dispersion, nor does the endpoint description identify a count outcome for which such a model would necessarily apply. This concept should not be mistaken for a method used in this study.
10. Multiplicity, Missing Data and Analysis Populations
The primary endpoint includes antibody measurements against G1, G2, G3, G4, and P1A[8], and the record lists 10 outcome measures and 3 analyses. Multiple outcomes and comparisons create a multiplicity question: when many hypotheses are assessed, chance findings can become more likely if each result is treated as an independent confirmatory test. In general, a prespecified hierarchy, adjusted significance level, or other multiplicity strategy can help define how such results should be interpreted.
The registry record does not report which outcomes were designated confirmatory beyond the primary endpoint description, which pairwise or overall comparisons were prespecified, or whether any adjustment was planned. It also does not state how the five named serotype results were combined, prioritized, or interpreted for the consistency question. No adjustment method or decision threshold should be inferred from the outcome list alone.
Missing-data handling is also not reported in the registry record. The stated primary analysis excludes subjects with invalid laboratory data and protocol violators, but the record does not give the number or reasons for those exclusions, describe other missing observations, or explain whether any values were imputed. The size of the per-protocol population is not reported. This prevents assessment of the extent or possible influence of missing endpoint data.
The primary analysis population is identified as per protocol. The registry record does not report results from an intention-to-treat or other analysis population, nor does it explain whether additional analyses were used to test robustness. The specific primary statistical model, covariate adjustments, treatment of assay values outside measurable limits, and any interim-analysis plan are not reported in the registry record. These gaps make it difficult to evaluate the full analysis strategy or determine how the posted outcome descriptions map to the analyses conducted.
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 |
|---|---|---|---|
| RotaTeq™ Lot 1 | 4 | 226 | 1.8% |
| RotaTeq™ Lot 2 | 4 | 224 | 1.8% |
| RotaTeq™ Lot 3 | 2 | 229 | 0.9% |
| Placebo | 3 | 111 | 2.7% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 1% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| RotaTeq™ Lot 1 | 206 of 226 |
| RotaTeq™ Lot 2 | 212 of 224 |
| RotaTeq™ Lot 3 | 211 of 229 |
| Placebo | 101 of 111 |
Most frequent serious adverse event terms
| Event term | Organ system | RotaTeq™ Lot 1 | RotaTeq™ Lot 2 | RotaTeq™ Lot 3 | Placebo |
|---|---|---|---|---|---|
| Bronchiolitis | Infections and infestations | 1 of 226 | 2 of 224 | 1 of 229 | 1 of 111 |
| Congenital ventricular septal defect | Congenital, familial and genetic disorders | 0 of 226 | 0 of 224 | 1 of 229 | 0 of 111 |
| Constipation | Gastrointestinal disorders | 0 of 226 | 0 of 224 | 0 of 229 | 1 of 111 |
| Gastroenteritis | Infections and infestations | 1 of 226 | 0 of 224 | 0 of 229 | 0 of 111 |
| Influenza | Infections and infestations | 1 of 226 | 0 of 224 | 0 of 229 | 0 of 111 |
| Otitis media | Infections and infestations | 1 of 226 | 0 of 224 | 0 of 229 | 0 of 111 |
| Pneumonia viral | Infections and infestations | 0 of 226 | 1 of 224 | 0 of 229 | 0 of 111 |
| Sepsis | Infections and infestations | 0 of 226 | 0 of 224 | 1 of 229 | 0 of 111 |
| Skin infection | Infections and infestations | 1 of 226 | 0 of 224 | 0 of 229 | 0 of 111 |
| Upper respiratory tract infection | Infections and infestations | 0 of 226 | 1 of 224 | 0 of 229 | 0 of 111 |
Most frequent non-serious adverse event terms
| Event term | Organ system | RotaTeq™ Lot 1 | RotaTeq™ Lot 2 | RotaTeq™ Lot 3 | Placebo |
|---|---|---|---|---|---|
| Pyrexia | General disorders | 119 of 226 | 122 of 224 | 115 of 229 | 52 of 111 |
| Diarrhoea | Gastrointestinal disorders | 110 of 226 | 122 of 224 | 103 of 229 | 50 of 111 |
| Vomiting | Gastrointestinal disorders | 74 of 226 | 85 of 224 | 77 of 229 | 34 of 111 |
| Upper respiratory tract infection | Infections and infestations | 73 of 226 | 71 of 224 | 69 of 229 | 36 of 111 |
| Otitis media | Infections and infestations | 46 of 226 | 53 of 224 | 51 of 229 | 20 of 111 |
| Irritability | Psychiatric disorders | 31 of 226 | 49 of 224 | 49 of 229 | 18 of 111 |
| Nasopharyngitis | Infections and infestations | 40 of 226 | 50 of 224 | 34 of 229 | 22 of 111 |
| Cough | Respiratory, thoracic and mediastinal disorders | 28 of 226 | 23 of 224 | 29 of 229 | 13 of 111 |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | 27 of 226 | 20 of 224 | 22 of 229 | 11 of 111 |
| Injection site pain | General disorders | 14 of 226 | 27 of 224 | 20 of 229 | 7 of 111 |
Serious events with the highest arm-level rate: constipation (0.9%), bronchiolitis (0.9%), urinary tract infection (0.9%), urosepsis (0.9%), febrile convulsion (0.9%).
The registry lists serious adverse events by group. The counts are 4 among 226 participants for RotaTeq Lot 1, 4 among 224 for Lot 2, 2 among 229 for Lot 3, and 3 among 111 for placebo. These figures describe participants recorded as having a serious adverse event in the listed group; they do not, by themselves, establish that an event was caused by the intervention. The record does not provide a comparison estimate, confidence interval, or statistical test for these counts.
The registry also lists other adverse events for 206 among 226 participants in Lot 1, 212 among 224 in Lot 2, 211 among 229 in Lot 3, and 101 among 111 in placebo. These are separate descriptive counts, and the record does not explain the detailed event-coding rules or whether participants could contribute more than one event to other summaries.
The listed serious-event terms and percentages are constipation, 0.9%; bronchiolitis, 0.9%; urinary tract infection, 0.9%; urosepsis, 0.9%; febrile convulsion, 0.9%; and pneumonia viral, 0.4%. The registry record does not specify group attribution for these terms in the information. Deaths are not reported in the registry record. Differences in these descriptive counts should not be treated as evidence of a causal safety difference without the relevant analysis and context.
12. What the Result Does, and Does Not, Mean
The registry record establishes that this was a randomized, double-masked, phase 3 study designed to evaluate antibody-response consistency across three manufactured vaccine lots, with placebo included. It identifies the primary outcome as geometric mean neutralizing antibody titers against specified rotavirus serotypes 42 days following the 3rd vaccination. It also identifies a per-protocol analysis population and posts selected adverse-event counts.
The record does not include numerical geometric mean titers or their 95% confidence intervals. Consequently, it is not possible to state whether responses were similar across the lots, how large any observed differences were, or how precisely the group estimates were measured. The registry record also does not give a formal consistency margin, a primary lot-to-lot contrast, or a stated statistical decision rule. The study’s aim should not be confused with a reported statistical conclusion.
Antibody titers are laboratory measures of immunogenicity. The endpoint description does not establish that those measurements directly represent clinical protection, disease incidence, or durability of protection. No conclusion about those clinical outcomes can be drawn from the endpoint definition alone.
The posted safety counts are descriptive and do not establish causation. The record does not provide adjusted comparisons or enough detail to determine whether any event was related to the vaccine. It also does not report deaths in the listed safety groups. The figures should therefore be read as a record of reported event counts, not as proof that one group had greater or lesser risk.
In general, a completed study may still have incomplete public reporting of results. The completion status and enrollment figure do not replace endpoint estimates, analysis details, or uncertainty intervals. The information in the registry record supports understanding the study question and broad design, but not a quantitative conclusion about its primary antibody results.
13. Why This Trial Matters Statistically
Lot-consistency studies address a distinct statistical question from a comparison aimed only at detecting whether an intervention differs from placebo. Manufacturing consistency asks whether separate production lots produce sufficiently similar responses under the study’s planned criteria. That requires a defined comparison and a clear standard for what counts as acceptably consistent. The registry record describes the consistency aim, but the margin and decision rule are not reported.
This distinction matters because a failure to detect a difference is not, by itself, proof that groups are equivalent. In general, equivalence or non-inferiority conclusions require prespecified margins and confidence-interval interpretation that are aligned with the study question. Without the numerical estimates and planned criterion, the record does not support a statistical conclusion about lot consistency.
The study also illustrates why an endpoint definition is not a result. The record names the geometric mean titer, serotypes, assessment timing, and per-protocol population, but provides no numerical titers or confidence intervals in the information. Those missing quantities are necessary to judge both the estimated response and its precision.
Finally, the presence of placebo and safety counts does not resolve the primary lot-to-lot question. Immunogenicity, safety, and clinical disease outcomes are different domains, and each requires its own appropriate analysis. The record makes the design and intended measurements identifiable, while leaving central statistical details and primary outcome results unreported.
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 important limitation for interpreting this trial from the registry record is the absence of numerical primary endpoint results. The group geometric mean titers and 95% confidence intervals are not reported, so the magnitude, precision, and pattern of antibody responses cannot be described. The specific statistical contrast used to assess lot consistency is also not reported.
The registry does not state an acceptable consistency margin or give a formal decision rule. Without these, even numerical group estimates would not fully establish how the study defined a successful consistency assessment. The statistical method used to construct confidence intervals, any transformations or adjustments, and any covariates included in the primary analysis are not reported in the registry record.
The primary population is described as per protocol, but its size is not reported. The number excluded for protocol violations or invalid laboratory determinations, the reasons for other missing measurements, and the handling of missing data are also not reported. Without this information, the influence of exclusions on the analysis cannot be evaluated.
The record lists 10 outcome measures and 3 analyses but does not describe how outcomes or comparisons were prioritized, or whether multiplicity was addressed. The details of randomization and masking are not reported beyond the design labels. Group enrollment numbers for the primary endpoint are not given. The posted adverse-event counts are descriptive, and the record does not establish causal attribution or provide inferential comparisons. Together, these gaps constrain interpretation of both the immunogenicity and safety information.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Consistency Lots Vaccine Study (V260-009) — NCT00092456.
- Registry record last updated 2015-10-05; status last verified 2015-09.
- Results first posted 2011-04-12.
- 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
NCT00092456 is a completed phase 3 randomized, double-masked, parallel-group study titled “Consistency Lots Vaccine Study (V260-009).” It enrolled 793 healthy infants and compared three RotaTeq manufacturing lots with placebo. The listed study start was 2003-05 and primary completion was 2004-08.
The primary outcome was serum neutralizing antibody geometric mean titers in dilution units against G1, G2, G3, G4, and P1A[8], measured 42 days following the 3rd vaccination. The named primary population was per protocol, excluding protocol violators and subjects with invalid laboratory data. Numerical primary outcome results and confidence intervals are not reported in the registry record.
The posted safety information gives serious and other adverse-event counts by group, along with a list of serious-event terms and percentages. Statistical comparison methods, multiplicity handling, missing-data methods, the consistency criterion, and the detailed analysis plan are not reported in the registry record.