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 Study Evaluating Pneumococcal Vaccine in Healthy Infants (NCT00205803), a randomized phase 1, phase 2 study. The primary outcome is Percentage of Participants Reporting Pre-Specified Local Reactions.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00205803 |
| Phase | Phase 1, Phase 2 |
| Condition | Healthy Subjects, Pneumococcal Infections |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 249 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Wyeth is now a wholly owned subsidiary of Pfizer |
| Results posted | Yes |
2. Clinical Question
Population
Healthy infants were the intended population. The registry describes the safety population as participants who received at least one dose of vaccine; the number with known values could differ by outcome. Registry enrollment was 249, while the arm-specific safety denominators varied across the reported periods.
Intervention
The intervention was the 13-valent pneumococcal conjugate vaccine, identified as 13vPnC. The registry describes this as the first study of this vaccine in infants and lists safety and immunogenicity as study aims.
Comparator
The comparator was the 7-valent pneumococcal conjugate vaccine, identified as 7vPnC. The trial was randomized, double-blind, and parallel-group. Further details about who was masked, the allocation ratio, and the exact procedures for assigning participants are not reported in the registry record.
Primary question
The primary endpoint asked what percentage of participants reported pre-specified local reactions within 15 days after each dose. It covered tenderness, induration, and erythema, with categories describing presence or severity. The registry record does not report the primary endpoint results, so the observed reaction percentages and the comparison between vaccine groups are not available in the record.
The study also assessed antibody responses and responses to other childhood vaccine antigens. Those secondary questions included antibody levels after the infant series and toddler dose, as well as geometric mean antibody concentrations. The registry lists 15 outcome measures and 59 analyses. Their presence indicates a broad set of questions, but does not by itself establish which outcomes were designated as confirmatory or how comparisons across them were handled.
3. Trial Design
The registry identifies this as a phase I/II, two-stage, randomized, double-blind trial with a parallel-group model. The official title describes the study as an evaluation of safety, tolerability, and immunogenicity of 13vPnC in healthy infants. A 7vPnC vaccine served as the comparator. The registry does not describe the operational meaning of the two stages, so details such as whether they corresponded to distinct enrollment or analysis stages are not reported in the registry record.
Enrollment was 249. The registry lists the study as completed and gives a start date of 2004-09. Arm descriptions are not reported in the registry record. The stated sponsor is Wyeth, described in the record as now a wholly owned subsidiary of Pfizer.
The primary endpoint concerned local reactions reported within 15 days after each dose. Local reaction events were collected using a paper worksheet. Tenderness was categorized as any tenderness or significant tenderness, with significant tenderness defined as present and interfering with limb movement. Induration and erythema were categorized as any presence, mild, moderate, or severe. Participants could be represented in more than one category, so the severity categories should not be assumed to be mutually exclusive.
The registry also lists secondary outcomes on antibody responses to pneumococcal serotypes and other vaccine antigens. These include the percentage reaching a stated antibody level after the toddler dose, geometric mean antibody concentrations after the infant series, and responses before and after the toddler dose. Specific timing and definitions are given for some outcomes, but a complete statistical analysis plan, allocation ratio, and detailed dose schedule are 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: Participants were enrolled into the study according to the inclusion/exclusion criteria without a screening period.
Infant Series
| Stage | 13vPnC | 7vPnC |
|---|---|---|
| STARTED | 122 | 127 |
| Vaccinated Dose 1 | 121 | 126 |
| Vaccinated Dose 2 | 115 | 122 |
| Vaccinated Dose 3 | 110 | 118 |
| COMPLETED | 104 | 116 |
| NOT COMPLETED | 18 | 11 |
Reasons for not completing this period:
| Reason | 13vPnC | 7vPnC |
|---|---|---|
| Lost to Follow-up | 10 | 4 |
| Withdrawal by Subject | 2 | 5 |
| Physician Decision | 3 | 1 |
| Protocol Violation | 1 | 0 |
| Lost Kaiser coverage | 0 | 1 |
| Non-compliant | 1 | 0 |
| Sponsor request | 1 | 0 |
After Infant Series
| Stage | 13vPnC | 7vPnC |
|---|---|---|
| STARTED | 104 | 116 |
| COMPLETED | 86 | 103 |
| NOT COMPLETED | 18 | 13 |
Reasons for not completing this period:
| Reason | 13vPnC | 7vPnC |
|---|---|---|
| Adverse Event | 1 | 1 |
| Protocol Violation | 1 | 1 |
| Lost to Follow-up | 2 | 1 |
| Physician Decision | 3 | 2 |
| Withdrawal by Subject | 1 | 4 |
| Other | 10 | 4 |
Toddler Dose
| Stage | 13vPnC | 7vPnC |
|---|---|---|
| STARTED | 86 | 103 |
| COMPLETED | 84 | 100 |
| NOT COMPLETED | 2 | 3 |
Reasons for not completing this period:
| Reason | 13vPnC | 7vPnC |
|---|---|---|
| Lost to Follow-up | 2 | 3 |
Analysis population for the primary outcome, as defined in the registry: The safety population included all participants who received at least 1 dose of vaccine;(n)=number of participants with known values.
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 | 13vPnC | 7vPnC | Total |
|---|---|---|---|---|
| Participants analysed | 121 | 126 | 247 | |
| Age Continuous | weeks | 9.2 (SD 1.4) | 9.1 (SD 1.2) | 9.2 (SD 1.3) |
| Sex: Female, Male: Female | Participants | 58 | 59 | 117 |
| Sex: Female, Male: Male | Participants | 63 | 67 | 130 |
6. Primary Endpoint
The registry lists the primary outcome as Percentage of Participants Reporting Pre-Specified Local Reactions, measured over Within 15 days after each dose.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | percentage of participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the percentage of participants reporting pre-specified local reactions within 15 days after each dose. The recorded reaction types were tenderness, induration, and erythema. Tenderness distinguished any tenderness from significant tenderness, defined as tenderness that interfered with limb movement. Induration and erythema were recorded as any presence and by severity: mild was 0.5 centimeters to 2.0 cm, moderate was 2.5 to 7.0 cm, and severe was > 7.0 cm. The registry notes that participants may appear in more than one category.
As a general statistical explanation, a percentage expresses how common a defined event was among a specified group of participants. It can make event frequency easier to interpret than a count alone, but its meaning depends on a clear numerator, denominator, time window, and event definition. The registry states that the safety population included participants who received at least one dose and defines “n” as the number of participants with known values. It does not report the primary endpoint percentages or the comparison estimates in the record.
Local reactions are used as a safety and tolerability measure because they capture events at the injection site over a defined period after dosing. The registry’s endpoint definition identifies what was collected, but does not supply a result for any reaction category. Therefore, the reported endpoint description can clarify what the trial intended to measure, but it cannot establish the frequency or comparative pattern of reactions from the record alone.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a randomized comparison of 13vPnC and 7vPnC in healthy infants and defines local reactions as the primary endpoint. However, it does not report the primary endpoint outcome values. No group-specific reaction percentages, between-group estimates, confidence intervals, or p values for this endpoint are reported in the registry record. Without those results, the direction, size, and precision of the primary comparison cannot be interpreted from the record.
The safety information includes counts of participants affected by serious events and other events for the infant series, toddler dose, and 6-month follow-up. For the infant series, the serious-event counts were 9 among 120 participants in the 13vPnC group and 9 among 126 in the 7vPnC group. For the toddler dose, the counts were 1 among 86 and 0 among 103, respectively. For the 6-month follow-up, the counts were 4 among 86 and 1 among 103, respectively. These are descriptive counts with their reported denominators; they do not establish whether events were caused by vaccination.
The registry also lists other-event counts: 104 among 120 and 110 among 126 for the infant series; 33 among 86 and 51 among 103 for the toddler dose; and 20 among 86 and 33 among 103 for the 6-month follow-up, comparing 13vPnC with 7vPnC within each period. These counts should be read in their stated periods and groups, not combined into a single comparison. The registry record does not provide adjusted estimates or uncertainty intervals for these counts.
As a general statistical point, counts alone do not show how precisely an event frequency has been estimated. Confidence intervals, when reported, describe a range of values compatible with the data under the analysis assumptions; they are not a guarantee that the true value lies within that range. No confidence intervals for the primary endpoint or these event counts are reported in the registry record.
The listed serious-event terms include Bronchiolitis (2.5%), Status asthmaticus (2.3%), Dehydration (1.7%), Asthma exacerbation (1.2%), Complex febrile seizure (1.2%), and Fever of unknown origin (1.2%). The registry does not report enough detail alongside these term percentages to determine their denominators or how repeated events were handled. The figures should therefore be treated as listed descriptive values, not as comparative estimates between vaccine groups.
9. Statistical Methods Explained
For a binary endpoint such as whether a participant reported a reaction, the basic descriptive quantity is the proportion with the event among participants with known values. The primary endpoint expresses that proportion as a percentage. The registry specifies the reaction definitions and the observation window, but does not report the calculated primary endpoint percentages or an inferential comparison. The statistical analysis method for the primary endpoint is not reported in the registry record.
What does a confidence interval add?
As a general statistical explanation, a confidence interval communicates uncertainty around an estimate. A narrow interval indicates greater precision under the model used; a wide interval indicates less precision. For a group comparison, an interval can help readers assess which effect sizes remain compatible with the data. It does not show that an effect is clinically important, and it does not substitute for understanding the endpoint definition and population. No confidence intervals for the primary endpoint are reported in the registry record.
For binary data, precision depends in part on the number of participants with known outcome values and on how frequent the event is. The registry says the safety population included participants who received at least one dose and defines “n” as the number of participants with known values. It does not provide primary endpoint denominators by reaction category. Consequently, the precision of those percentages cannot be assessed from the registry record.
Why do event definitions and categories matter?
The endpoint includes reactions of different kinds and degrees. A definition such as significant tenderness requires both tenderness and interference with limb movement, whereas any tenderness does not. Induration and erythema use size-based categories. These distinctions affect which observations count as events. The record also says a participant may be represented in more than one category. As a general statistical point, categories that overlap cannot be treated as independent or added to obtain a unique participant total unless the analysis explicitly supports that operation.
Repeated observation after doses also matters. An endpoint assessed within 15 days after each dose can produce multiple observations for one participant. As a general explanation, analyses of repeated observations may need to account for the fact that measurements from the same participant are related. The registry does not report whether the primary analysis treated each dose period separately, combined observations, or used a model for within-participant correlation.
What can the planning calculations say?
Any sample-size planning calculations based on an observed effect are planning illustrations, not observed power and not evidence that the original trial was designed around that effect. The stated illustration assumptions are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is a stated fraction of the observed effect. The record does not report the trial’s own sample-size justification or establish that these illustration assumptions were used in the original design.
As a general statistical explanation, a planning calculation asks how much information might be needed to detect a specified effect under chosen assumptions. It is sensitive to the effect size, event frequency, allocation, significance level, and analysis method. It does not tell whether an observed result is reliable, and it is not a post-trial measure of the chance that the study found a true effect. The specific planning values and the observed primary endpoint effect are not reported in the registry record, so those calculations cannot be interpreted as a reconstruction of the trial’s design.
What is not described about the analysis?
The registry lists 15 outcome measures and 59 analyses, but does not report a complete statistical analysis plan. The endpoint-level statistical model, handling of missing values, treatment of repeated measurements, and any adjustments for multiple comparisons are not reported in the registry record. These omissions limit assessment of how the reported analyses were selected and how their uncertainty should be interpreted.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 15 outcome measures and 59 analyses. This is a broad outcome set covering local reactions, antibody responses, and other vaccine-related measures. As a general statistical explanation, examining many outcomes or comparisons creates more opportunities for apparently notable findings to occur by chance. Methods such as prespecifying a primary comparison or adjusting for multiple testing can address some of this concern, but the registry record does not report whether such methods were used.
The record does not provide a complete statistical analysis plan, so it is not possible to determine which analyses were confirmatory, whether additional analyses were exploratory, or how the investigators handled multiplicity. The presence of many listed analyses alone does not show that a multiplicity adjustment was necessary or that one was absent from the full study conduct; the handling is simply not reported in the registry record.
Missing-data procedures are also not reported. For the safety population, the registry includes participants who received at least one dose and defines the reported “n” as the number of participants with known values. This clarifies that available-value counts may depend on the outcome, but does not explain why values might be missing, how missing observations were treated, or whether any sensitivity analyses were conducted.
The primary local-reaction outcome percentages and uncertainty estimates are not reported in the registry record. This prevents assessment of the available denominator by reaction category and the impact that missing values might have had. The analysis populations for the secondary immunogenicity outcomes, and whether they differed from the safety population, are not reported in the registry record.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| 13vPnC Infant Series | 9 | 120 | 7.5% |
| 7vPnC Infant Series | 9 | 126 | 7.1% |
| 13vPnC Toddler Dose | 1 | 86 | 1.2% |
| 7vPnC Toddler Dose | 0 | 103 | 0.0% |
| 13vPnC 6-Month Follow-up | 4 | 86 | 4.7% |
| 7vPnC 6-Month Follow-up | 1 | 103 | 1.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| 13vPnC Infant Series | 104 of 120 |
| 7vPnC Infant Series | 110 of 126 |
| 13vPnC Toddler Dose | 33 of 86 |
| 7vPnC Toddler Dose | 51 of 103 |
| 13vPnC 6-Month Follow-up | 20 of 86 |
| 7vPnC 6-Month Follow-up | 33 of 103 |
Most frequent serious adverse event terms
| Event term | Organ system | 13vPnC Infant Series | 7vPnC Infant Series | 13vPnC Toddler Dose | 7vPnC Toddler Dose | 13vPnC 6-Month Follow-up | 7vPnC 6-Month Follow-up |
|---|---|---|---|---|---|---|---|
| Bronchiolitis | Infections and infestations | 3 of 120 | 3 of 126 | 0 of 86 | 0 of 103 | 1 of 86 | 0 of 103 |
| Dehydration | Metabolism and nutrition disorders | 2 of 120 | 2 of 126 | 0 of 86 | 0 of 103 | 0 of 86 | 0 of 103 |
| Status asthmaticus | Respiratory, thoracic and mediastinal disorders | 0 of 120 | 0 of 126 | 1 of 86 | 0 of 103 | 2 of 86 | 0 of 103 |
| Asthma exacerbation | Respiratory, thoracic and mediastinal disorders | 0 of 120 | 0 of 126 | 0 of 86 | 0 of 103 | 1 of 86 | 1 of 103 |
| Fever of unknown origin | Infections and infestations | 1 of 120 | 0 of 126 | 0 of 86 | 0 of 103 | 1 of 86 | 0 of 103 |
| Gastroenteritis | Gastrointestinal disorders | 1 of 120 | 1 of 126 | 0 of 86 | 0 of 103 | 0 of 86 | 0 of 103 |
| RSV positive bronchiolitis | Respiratory, thoracic and mediastinal disorders | 0 of 120 | 1 of 126 | 0 of 86 | 0 of 103 | 1 of 86 | 0 of 103 |
| Bilateral otitis media | Infections and infestations | 1 of 120 | 0 of 126 | 0 of 86 | 0 of 103 | 0 of 86 | 0 of 103 |
| Bronchiolitis RSV | Infections and infestations | 1 of 120 | 0 of 126 | 0 of 86 | 0 of 103 | 0 of 86 | 0 of 103 |
| Chairi I malformation | Congenital, familial and genetic disorders | 1 of 120 | 0 of 126 | 0 of 86 | 0 of 103 | 0 of 86 | 0 of 103 |
Most frequent non-serious adverse event terms
| Event term | Organ system | 13vPnC Infant Series | 7vPnC Infant Series | 13vPnC Toddler Dose | 7vPnC Toddler Dose | 13vPnC 6-Month Follow-up | 7vPnC 6-Month Follow-up |
|---|---|---|---|---|---|---|---|
| Irritability | General disorders | 79 of 118 | 88 of 124 | 33 of 85 | 48 of 101 | 0 of 0 | 0 of 0 |
| Increased sleep | General disorders | 67 of 119 | 67 of 124 | 24 of 86 | 44 of 101 | 0 of 0 | 0 of 0 |
| Upper respiratory tract infection | Infections and infestations | 57 of 120 | 65 of 126 | 8 of 86 | 10 of 103 | 5 of 86 | 12 of 103 |
| Tenderness (Any) | Skin and subcutaneous tissue disorders | 41 of 119 | 54 of 124 | 19 of 85 | 30 of 101 | 0 of 0 | 0 of 0 |
| Irritability | General disorders | 69 of 110 | 67 of 118 | 0 of 0 | 0 of 0 | 0 of 0 | 0 of 0 |
| Irritability | General disorders | 55 of 107 | 63 of 117 | 0 of 0 | 0 of 0 | 0 of 0 | 0 of 0 |
| Decreased appetite | General disorders | 36 of 118 | 39 of 124 | 19 of 85 | 22 of 101 | 0 of 0 | 0 of 0 |
| Otitis media | Infections and infestations | 40 of 120 | 37 of 126 | 1 of 86 | 10 of 103 | 9 of 86 | 14 of 103 |
| Increased sleep | General disorders | 47 of 111 | 55 of 118 | 0 of 0 | 0 of 0 | 0 of 0 | 0 of 0 |
| Erythema (Any) | Skin and subcutaneous tissue disorders | 25 of 119 | 24 of 124 | 21 of 85 | 19 of 100 | 0 of 0 | 0 of 0 |
Serious events with the highest arm-level rate: bronchiolitis (2.5%), status asthmaticus (2.3%), dehydration (1.7%), asthma exacerbation (1.2%), complex febrile seizure (1.2%).
The registry gives serious-event and other-event counts for each listed period and vaccine group. For the infant series, serious events affected 9 of 120 participants in the 13vPnC group and 9 of 126 in the 7vPnC group. For the toddler dose, the counts were 1 of 86 and 0 of 103. At 6-month follow-up, the counts were 4 of 86 and 1 of 103. These figures describe the recorded groups and periods; they do not identify a cause or establish a treatment effect.
Other-event counts are reported separately: 104 of 120 and 110 of 126 for the infant series, 33 of 86 and 51 of 103 for the toddler dose, and 20 of 86 and 33 of 103 at 6-month follow-up, in 13vPnC and 7vPnC respectively. The registry record does not report definitions or analysis details sufficient to interpret these counts beyond their listed categories and denominators. Death counts are not reported in the registry record.
The listed serious-event terms and percentages are descriptive. The record does not specify their denominators or whether they represent participants, events, or another summary basis. Serious events occurring during a trial are not necessarily caused by the intervention. Establishing causality requires more information than these counts, including clinical context and a suitable comparison. No causal conclusion should be drawn from the listed figures alone.
12. What the Result Does, and Does Not, Mean
The registry record establishes the broad design and questions of the study: a randomized, double-blind, parallel-group phase I/II trial in healthy infants, comparing 13vPnC with 7vPnC and assessing safety and immunogenicity. It also gives a primary endpoint definition focused on local reactions within 15 days after each dose. These details help clarify what the investigators intended to measure.
They do not establish the comparative primary outcome. Reaction percentages, effect estimates, confidence intervals, and p values for the primary endpoint are not reported in the registry record. Without these results, the record cannot show whether one group had more or fewer reported local reactions, how large any difference was, or how precisely it was estimated.
The serious-event counts and listed event terms provide descriptive safety information, but they are not evidence by themselves that a vaccine caused or prevented an event. Counts should be interpreted with their denominators and time periods. The registry does not report causal assessments or uncertainty estimates for these figures. The listed terms also cannot be compared between groups on the basis of the information reported alongside them.
The trial’s secondary outcomes concern antibody levels and responses to other antigens. Such outcomes address immunogenicity, a different question from the frequency of local reactions or serious events. The registry lists the outcomes but does not give their results in the record, so no conclusion about comparative antibody responses can be drawn from those listings alone.
As a general statistical point, absence of a reported result is not evidence that groups were the same, nor is it evidence of a difference. It means the relevant estimate and its uncertainty cannot be evaluated from the registry record. The record also does not report enough about the analysis plan, missing data, or multiplicity to resolve those methodological questions. The appropriate interpretation is therefore limited to the design, endpoint definitions, and descriptive safety counts that are actually recorded.
13. Why This Trial Matters Statistically
This trial is statistically notable for combining a randomized, double-blind comparison with a primary safety endpoint that includes several reaction types, severity categories, and observations after doses. That structure highlights a common challenge in clinical research: a clear outcome definition is essential, but it must be paired with a transparent account of the analysis and the resulting estimates.
The registry specifies how tenderness, induration, and erythema were categorized, including a note that participants could appear in more than one category. This matters because overlapping categories cannot be interpreted as separate, non-overlapping groups. The time window of 15 days after each dose also makes the unit of analysis important: repeated observations from one participant may be related. Whether the analysis addressed that dependence is not reported in the registry record.
The registry lists 15 outcomes and 59 analyses, spanning local reactions and immunogenicity. As a general statistical lesson, a wide outcome set makes prespecification and clear reporting especially useful. Readers need to know which analyses were primary, how comparisons were selected, and whether multiplicity was addressed. Those details are not reported in the registry record.
The record also illustrates why counts and definitions should not be mistaken for complete results. It gives denominators and affected counts for serious and other events across several periods, but does not report the primary endpoint estimates or uncertainty intervals. A transparent trial interpretation depends on both the design and the numerical results, including their precision. The available record permits description of the intended questions and some safety counts, while leaving the primary comparative result unresolved.
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.
A central limitation of the registry record is that it does not report the primary endpoint results. Although local reactions are defined in detail and the assessment window is specified, the record lacks reaction percentages, group contrasts, confidence intervals, and p values. This prevents statistical interpretation of the primary comparison.
The descriptions of the treatment arms are empty, and details of the allocation ratio and masking procedures are not reported in the registry record. The title identifies the trial as two-stage, but the record does not explain how the stages were organized. Dose schedule details beyond the references to the infant series and toddler dose are not reported in the registry record.
The registry lists 15 outcome measures and 59 analyses without reporting a complete statistical analysis plan. The prespecified status of individual analyses, statistical methods, multiplicity handling, and interim analyses are not reported in the registry record. Missing-data procedures and analysis populations for outcomes other than the stated safety population are also not reported.
The serious-event counts are presented for several periods, but the registry record does not provide uncertainty estimates or causal assessments. The serious-event term percentages are listed without enough accompanying detail to identify their denominator or event-counting method. These limitations restrict comparisons and make it important not to interpret the counts as causal evidence.
Finally, the enrollment figure does not itself establish the adequacy of the study for any particular endpoint. The trial’s own sample-size justification is not reported in the registry record. Planning illustrations based on an observed effect should not be treated as the original design rationale or as observed power.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Study Evaluating Pneumococcal Vaccine in Healthy Infants — NCT00205803.
- Registry record last updated 2012-08-15; status last verified 2012-07.
- Results first posted 2012-08-15.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
The registry describes a completed randomized, double-blind, parallel-group phase I/II trial of 13vPnC compared with 7vPnC in healthy infants. Enrollment was 249, and the recorded start date was 2004-09. The study aimed to evaluate safety and immunogenicity.
The primary endpoint was the percentage of participants reporting pre-specified local reactions within 15 days after each dose. The registry defines the reaction categories and states that the safety population included participants who received at least one dose. Primary endpoint outcome values are not reported in the registry record.
Serious-event counts are reported for the infant series, toddler dose, and 6-month follow-up, alongside other-event counts. The record does not report causal assessments, uncertainty estimates, or the primary comparison results. It lists 15 outcome measures and 59 analyses, but does not report a complete statistical analysis plan, missing-data procedures, or multiplicity handling.