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 20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 4-Dose Series in Healthy Infants (NCT04382326), a randomized phase 3 study. The primary outcome is Percentage of Participants With Local Reactions Within 7 Days After Dose 1.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04382326 |
| Phase | Phase 3 |
| Condition | Pneumococcal Disease |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 1997 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Pfizer |
| Results posted | Yes |
2. Clinical Question
Population
Healthy infants enrolled in a phase 3 trial. The registry record lists an enrollment of 1997 and identifies pneumococcal disease as the condition of interest. For the primary safety outcome, the analysis population included participants who received at least one dose of the investigational product and had safety follow-up after any dose; the number analyzed was based on participants with electronic diary data reported after Dose 1.
Intervention
The 20-valent pneumococcal conjugate vaccine, identified in the record as 20vPnC. The study title describes evaluation of a 4-dose series. The registry record does not provide the detailed timing of each dose in the registry record for this analysis.
Comparator
The 13-valent pneumococcal conjugate vaccine, identified as 13vPnC. Both study arms are described as receiving a pneumococcal conjugate vaccine. The registry record identifies the trial as randomized, double-blind, quadruple-masked, and parallel-group.
Primary question
What percentage of participants had a local reaction within 7 days after Dose 1? Local reactions were redness, swelling, or pain at the injection site, recorded using an electronic diary. The registry record does not report arm-specific numerical estimates for this primary outcome, so the size and precision of any between-group difference cannot be described from these registry entries.
The clinical question is principally about short-term injection-site reactions after the first dose, alongside broader safety and immunogenicity assessment across a vaccine series. The named secondary outcomes include serotype-specific immunoglobulin G (IgG) concentrations and geometric mean concentrations, geometric mean ratios, predefined antibody concentrations after Dose 4, and opsonophagocytic activity (OPA) titers. They also include antibody fold rises across specified time points and an outcome concerning a predefined Hib antibody level.
Those outcomes address different aspects of the study. Local reactions describe reported injection-site events over a defined observation period. Antibody concentrations and functional titers are laboratory measures of immune response. Neither type of measure, on its own, is a direct measure of prevention of pneumococcal disease. The registry record names the outcomes but the registry entries do not include their numerical results.
3. Trial Design
The registry record identifies a randomized, double-blind, quadruple-masked, parallel-group phase 3 trial. Participants were assigned to receive either the 20-valent pneumococcal conjugate vaccine or the 13-valent pneumococcal conjugate vaccine. The enrollment recorded for the study is 1997. The sponsor is Pfizer, and the study status is completed.
The study title describes a 4-dose series in healthy infants. Its primary outcome concerns local reactions within 7 days after Dose 1, while the named secondary outcomes cover antibody measures after Dose 3 and Dose 4, as well as changes between specified assessment times. This combination reflects assessment of both safety and immunogenicity. The record lists 27 outcome measures and 74 analyses, indicating that multiple outcomes and analyses were registered. Those counts do not, by themselves, describe how results were prioritized or how statistical testing was handled.
The study start date is 2020-05-20, and the primary completion date is 2022-09-02. The registry record reports the design features, arms, and outcome descriptions but does not report additional details such as the randomization procedure, allocation ratio, or the methods used to maintain masking. The record also does not report a sample-size justification in the registry record for this analysis.
Randomization is generally used to make treatment groups comparable, on average, with respect to measured and unmeasured participant characteristics. Masking is generally intended to reduce the influence of knowledge about assignment on participant reports, clinical assessments, or other study procedures. These are general purposes of the design features; the registry record does not provide enough detail to assess how they were implemented in this trial.
The parallel-group structure means that the listed arms represent separate groups rather than a crossover in which participants receive both vaccines in sequence. The registry entries do not specify the complete visit schedule, the exact administration schedule, or whether participants received other vaccines during the study. Those details 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: A total of 1997 participants were enrolled and assigned to receive 4 doses of 20-valent pneumococcal conjugate vaccine (20vPnC) or 13vPnC of which 6 participants were not vaccinated and 1991 were vaccinated with either 20vPnC or 13vPnC.
Overall Study
| Stage | 20vPnC | 13vPnC |
|---|---|---|
| STARTED | 1001 | 987 |
| COMPLETED | 821 | 799 |
| NOT COMPLETED | 180 | 188 |
Reasons for not completing this period:
| Reason | 20vPnC | 13vPnC |
|---|---|---|
| Adverse Event, not serious | 1 | 2 |
| Other | 1 | 0 |
| Withdrawal By Parent/Guardian | 50 | 54 |
| No Longer Meets Eligibility Criteria | 50 | 44 |
| Protocol Violation | 29 | 23 |
| Physician Decision | 0 | 1 |
| Lost to Follow-up | 48 | 63 |
| Adverse Event, non-fatal | 1 | 1 |
Analysis population for the primary outcome, as defined in the registry: Safety population included all the participants who received at least 1 dose of the investigational product (IP) with safety follow up after any dose. 'Number of Participants Analyzed' = number of participants with any electronic diary (e-diary) data reported after Dose 1.
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.
Population: Safety population included all participants who received at least 1 dose of 20vPnC or 13vPnC and had safety data assessed after any dose.
| Characteristic | Unit | 20vPnC | 13vPnC | Total |
|---|---|---|---|---|
| Participants analysed | 1001 | 987 | 1988 | |
| Age, Continuous | Days | 65.9 (SD 7.98) | 65.6 (SD 7.12) | 65.8 (SD 7.56) |
| Sex: Female, Male: Female | Participants | 483 | 482 | 965 |
| Sex: Female, Male: Male | Participants | 518 | 505 | 1023 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 312 | 293 | 605 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 661 | 659 | 1320 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 28 | 35 | 63 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 4 | 3 | 7 |
| Race (NIH/OMB): Asian | Participants | 16 | 16 | 32 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 2 | 2 | 4 |
| Race (NIH/OMB): Black or African American | Participants | 110 | 108 | 218 |
| Race (NIH/OMB): White | Participants | 754 | 742 | 1496 |
| Race (NIH/OMB): More than one race | Participants | 68 | 73 | 141 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 47 | 43 | 90 |
6. Primary Endpoint
The registry lists the primary outcome as Percentage of Participants With Local Reactions Within 7 Days After Dose 1, measured over Within 7 days after Dose 1.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | 95% Confidence Interval |
| Unit | Percentage of participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the percentage of participants with local reactions within 7 days after Dose 1. Local reactions were defined as redness, swelling, or pain at the injection site and were recorded using an electronic diary. Redness and swelling were graded by size, while pain was graded according to the participant’s observable response and whether it limited limb movement. The endpoint therefore combines several kinds of injection-site response rather than representing a single symptom.
A percentage is a way to describe how common an event was among participants who could be assessed. The registry record defines the primary safety population as participants who received at least one dose of the investigational product and had safety follow-up after any dose. For this outcome, the number analyzed was the number with any electronic diary data reported after Dose 1. This distinction matters: the analysis denominator is tied to diary availability, not simply to total trial enrollment.
Short-term local reactions are used in vaccine safety assessment because they capture events occurring near the injection site during a defined period after administration. The seven-day window makes the observation period explicit, but the endpoint does not by itself describe events outside that window, other safety outcomes, or long-term effects. The registry record specifies a 95% confidence interval as the measure of precision for the percentage, but arm-specific percentages and intervals are not reported in the registry record in the registry record.
Because the endpoint includes multiple reaction types and grades, a single percentage would need a defined rule for which reactions count as an event. The outcome description identifies the reaction categories and grading system, but the registry entries do not include the detailed numerical results or the category-level estimates.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record establishes the study question and the endpoint definition, but the registry entries do not include numerical results for the primary local-reaction outcome. There is therefore no basis to describe which arm had a higher reported percentage, the size of a difference, or the precision of a between-arm comparison. The primary outcome has several categories or time points and is not reduced to one comparison in the registry entries. Any numerical comparison would require result estimates that are not reported in the registry record.
The record identifies a 95% confidence interval as the dispersion measure for the primary percentage. In general, a confidence interval describes the uncertainty around an estimated quantity under the analysis method used. A narrower interval indicates greater precision than a wider interval, but interpretation also depends on the estimate, the interval’s endpoints, and the analysis design. Those values are not available for this primary outcome here, so no conclusion about its precision can be drawn.
The registry does report safety counts for serious and other adverse events by arm. For 20vPnC, the serious-event entry lists 45 affected participants among 1001 at risk, and the other-adverse-event entry lists 966 among 1001. For 13vPnC, the corresponding entries are 31 among 987 and 939 among 987. The death count is 0 in each group. These figures describe registry entries; without definitions and further detail, they should not be treated as a complete account of event severity, timing, causality, or clinical importance. The top serious-event terms and their percentages are also listed, but their group attribution is not specified in the registry record.
The named immunogenicity outcomes cover several serotypes and assessment times. These include IgG geometric mean concentrations and ratios, OPA geometric mean titers, predefined antibody thresholds, and geometric mean fold rises. Such measures describe antibody response according to the stated laboratory outcomes. They are not interchangeable with clinical disease outcomes, and the registry record’s outcome names alone do not establish the magnitude or comparative pattern of any response.
Overall, the record supports a description of the design, planned outcome domains, and selected safety counts. It does not support a numerical interpretation of the primary endpoint or the named immunogenicity outcomes. The absence of those estimates in the registry record should not be mistaken for evidence that no events or responses occurred; it means the relevant numerical results are not reported in the registry record.
9. Statistical Methods Explained
Statistical methods determine how observations are converted into estimates and how uncertainty is described. The registry record specifies some features of the outcomes and their precision measures, but it does not report a complete statistical analysis plan in the registry record for this analysis. The explanations below describe general statistical concepts and distinguish them from trial-specific details.
What does a percentage measure?
For a binary event outcome, a percentage describes the proportion of participants meeting an event definition among the participants counted in the analysis. Here, the event definition concerns local reactions within 7 days after Dose 1. The record says reactions were collected in an electronic diary and identifies the safety population and the diary-based denominator rule. In general, a percentage is interpretable only alongside its event definition, observation period, and analysis denominator. A percentage based on participants with diary data may differ from one based on all enrolled participants if diary availability differs. The extent of missing diary information is not reported in the registry record.
What does a confidence interval add?
The primary outcome lists a 95% confidence interval. In general, a confidence interval expresses uncertainty about an estimated quantity using a method with stated assumptions. It is not a guarantee that the true value lies within a particular interval, and it does not replace examination of the point estimate or the analysis population. For a comparison between groups, estimates and intervals for each group may not be sufficient to establish the uncertainty of the difference; a direct comparison and its method are needed. The registry entries contain no primary arm-specific estimates, interval limits, or direct comparison result.
Why do outcome definitions matter?
The primary outcome combines redness, swelling, and pain, with different grading rules for physical size and observed pain response. In general, choices about whether an event means any reaction, a particular severity, or a specific reaction type can change what the resulting percentage represents. The record supplies reaction definitions and a seven-day window, but the registry entries do not give category-level estimates. A reader should therefore avoid assuming that every reaction category occurred at the same frequency or had the same severity.
What is the role of randomization and masking?
In general, random assignment is intended to reduce systematic differences between groups at the start of a study. Masking is intended to limit the influence of treatment knowledge on behavior, reporting, and assessment. The registry describes this trial as randomized, double-blind, quadruple-masked, and parallel-group. Those labels identify design features, not proof that all potential biases were eliminated. The randomization method, allocation ratio, masking procedures, and any assessment of masking are not reported in the registry record.
How should multiple outcomes be understood?
The record lists 27 outcome measures and 74 analyses, including multiple antibody measures and assessment times. In general, testing many outcomes can increase the chance of obtaining at least one apparently notable result by chance if each is treated as a separate test. Statistical approaches can address this issue by defining a testing hierarchy, adjusting significance thresholds, or emphasizing estimation and confidence intervals. The registry record does not report whether any multiplicity adjustment or prespecified testing hierarchy was used. The counts of outcomes and analyses alone do not reveal whether a particular result was confirmatory or exploratory.
What does over-dispersion mean in general?
For count outcomes, over-dispersion means that observed variability exceeds what a simple statistical model assumes. A model that does not account for that extra variability can make uncertainty appear too small. This general issue is not a stated feature of the primary endpoint, which is a participant percentage, and the registry entries do not report an over-dispersion assessment or model for the listed outcomes. It should not be assumed that a particular model was used.
What can planning calculations say?
In general, sample-size planning asks how many participants would be needed to detect a specified effect under stated assumptions. A planning illustration is not an observed result and is not observed power. The registry record does not report the trial’s own sample-size justification in the registry record for this analysis. Nor do the available primary outcome details provide an observed effect estimate from which to interpret a planning scenario. Any sample-size illustration should therefore be read as conditional on its assumptions, rather than as evidence about the trial’s achieved result or design rationale.
The distinction between a statistical estimate and its interpretation remains important throughout. A reported percentage describes an observed frequency in a defined analysis population; an interval describes uncertainty under a method; and a test addresses a specified statistical comparison. None can be evaluated for the primary outcome without the numerical results and the details of the comparison method, which are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists 27 outcome measures and 74 analyses. The secondary outcomes span multiple serotypes, laboratory measures, dose-related assessment times, and changes between assessment times. In general, the more comparisons that are examined, the more important it is to understand which analyses were planned as primary, how tests were organized, and whether any adjustment for multiple testing was used. The registry entries do not report a multiplicity strategy, a testing hierarchy, or which analyses were designated confirmatory beyond identifying the primary outcome.
Missing data can also affect interpretation. The primary safety population is defined as participants who received at least one dose and had safety follow-up after any dose. For the primary outcome, the number analyzed is defined by having any electronic diary data reported after Dose 1. This makes clear that the primary analysis denominator depends on diary data availability. The registry entries do not state how many participants lacked diary data, how missing entries were handled, or whether any imputation or sensitivity analysis was performed. Those methods are not reported in the registry record.
The registry entries also do not describe the analysis populations for the immunogenicity outcomes, how missing laboratory measurements were handled, or whether analysis populations differed by outcome. These details matter because conclusions depend on which participants contributed data and on the assumptions used when observations are absent. The named outcome measures and the safety population definition are not enough to infer those procedures.
Consequently, the outcome and analysis counts should be read as evidence that the record includes many registered measures, not as a statement about statistical significance or the handling of multiplicity. The available information does not allow assessment of whether missingness was balanced between arms or whether it could have influenced the reported analyses.
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 |
|---|---|---|---|
| 20vPnC | 45 | 1001 | 4.5% |
| 13vPnC | 31 | 987 | 3.1% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| 20vPnC | 0 of 1001 |
| 13vPnC | 0 of 987 |
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 |
|---|---|
| 20vPnC | 966 of 1001 |
| 13vPnC | 939 of 987 |
Most frequent serious adverse event terms
| Event term | Organ system | 20vPnC | 13vPnC |
|---|---|---|---|
| Respiratory syncytial virus bronchiolitis | Infections and infestations | 7 of 1001 | 3 of 987 |
| Bronchiolitis | Infections and infestations | 4 of 1001 | 4 of 987 |
| Respiratory syncytial virus infection | Infections and infestations | 5 of 1001 | 2 of 987 |
| Gastroenteritis | Infections and infestations | 0 of 1001 | 5 of 987 |
| Febrile convulsion | Nervous system disorders | 2 of 1001 | 2 of 987 |
| Pneumonia | Infections and infestations | 2 of 1001 | 1 of 987 |
| Dehydration | Metabolism and nutrition disorders | 2 of 1001 | 1 of 987 |
| Failure to thrive | Metabolism and nutrition disorders | 2 of 1001 | 1 of 987 |
| Escherichia urinary tract infection | Infections and infestations | 0 of 1001 | 2 of 987 |
| Hand-foot-and-mouth disease | Infections and infestations | 1 of 1001 | 1 of 987 |
Most frequent non-serious adverse event terms
| Event term | Organ system | 20vPnC | 13vPnC |
|---|---|---|---|
| Irritability (IRRITABILITY) | Psychiatric disorders | 894 of 1001 | 863 of 987 |
| Hypersomnia (INCREASED SLEEP) | Nervous system disorders | 823 of 1001 | 798 of 987 |
| Injection site pain (PAIN) | General disorders | 689 of 1001 | 663 of 987 |
| Decreased appetite (DECREASED APPETITE) | Metabolism and nutrition disorders | 521 of 1001 | 492 of 987 |
| Injection site erythema (REDNESS) | General disorders | 498 of 1001 | 492 of 987 |
| Injection site swelling (SWELLING) | General disorders | 353 of 1001 | 359 of 987 |
| Pyrexia (FEVER) | General disorders | 322 of 1001 | 314 of 987 |
| Upper respiratory tract infection | Infections and infestations | 114 of 1001 | 112 of 987 |
| Otitis media | Infections and infestations | 56 of 1001 | 50 of 987 |
Serious events with the highest arm-level rate: respiratory syncytial virus bronchiolitis (0.7%), gastroenteritis (0.5%), respiratory syncytial virus infection (0.5%), bronchiolitis (0.4%), escherichia urinary tract infection (0.2%).
The serious adverse-event entries list 45 affected participants among 1001 at risk in the 20vPnC group and 31 among 987 at risk in the 13vPnC group. The entries for other adverse events list 966 among 1001 and 939 among 987, respectively. The death count is 0 in each group. These are registry counts and denominators; they should be read as reported rather than as a complete clinical interpretation of every event.
The record also lists the following serious-event terms and percentages: respiratory syncytial virus bronchiolitis, 0.7%; gastroenteritis, 0.5%; respiratory syncytial virus infection, 0.5%; bronchiolitis, 0.4%; Escherichia urinary tract infection, 0.2%; and febrile convulsion, 0.2%. The registry entries do not specify which arm each term belongs to, the event counts behind these percentages, or whether participants could contribute more than one event. The percentages should not be assigned to a group or summed.
In general, an adverse event is a recorded event, and its presence does not alone establish that a study intervention caused it. Interpretation also depends on definitions, timing, severity, follow-up, and the comparison method. Those details are not reported in the registry record. The figures therefore describe the recorded safety entries but do not, on their own, establish comparative risk or causation.
12. What the Result Does, and Does Not, Mean
The registry record describes a randomized comparison of two pneumococcal conjugate vaccines in healthy infants, with safety and immunogenicity as the study focus. Its primary endpoint is the percentage of participants with local reactions within 7 days after Dose 1. The record also names a range of antibody outcomes and supplies selected adverse-event counts. These registry entries define what the study was intended to assess, but they do not include the numerical results needed to characterize the primary local-reaction comparison.
Accordingly, the available record details do not establish whether local reactions were more frequent in one arm, how large any difference was, or how precisely it was estimated. They also do not establish the comparative pattern of the listed immunogenicity outcomes. The 95% confidence interval is named for the primary percentage, but its endpoints and the percentage estimates are not reported in the registry record.
The safety counts can be described as counts among the recorded at-risk participants, but they do not establish that an event was caused by a vaccine. The serious-event term percentages are not assigned to a particular arm in the registry entries. General statistical principles require attention to definitions, denominators, follow-up, and uncertainty before making comparisons.
Immunogenicity measures such as antibody concentrations, ratios, titers, and fold rises are laboratory outcomes. They can describe measured immune responses, but they are not the same as observed disease outcomes. The record identifies pneumococcal disease as the condition of interest, yet the registry entries do not include a disease-prevention result.
These limits are not evidence that a particular result was absent or that an intervention had no effect. They mean that the numerical estimates and analysis details required for those conclusions are not reported in the registry record. The interpretation should stay within what is documented: design, outcome definitions, selected safety counts, and the absence of primary and immunogenicity estimates in the available record.
13. Why This Trial Matters Statistically
This trial is statistically informative as an example of a randomized, masked, parallel-group study with both safety and immunogenicity outcomes. It illustrates why the endpoint definition and analysis population must be read together: the local-reaction outcome has a fixed observation window, several reaction types, and a denominator tied to electronic diary data after Dose 1. Without that context, a percentage could be misread as applying to all enrolled participants or to a different period.
The registry record also shows how a single study can include many related outcomes. Serotype-specific antibody concentrations, ratios, titers, thresholds, and fold rises answer distinct measurement questions and may be assessed at different times. The presence of 27 outcome measures and 74 analyses makes multiplicity and outcome prioritization relevant statistical considerations. The record details do not report how these issues were handled, so they cannot be resolved from outcome counts alone.
Safety reporting also demonstrates the importance of separating counts from interpretation. The serious and other adverse-event entries have stated denominators, and the death count is 0 in each group. Yet event labels and counts alone do not establish causation or comparative risk. Definitions, timing, severity, and a suitable statistical comparison would be needed for a fuller interpretation.
Finally, a registry description and a numerical results report serve different purposes. Design and endpoint information clarify the question a trial set out to study; estimates and uncertainty are needed to evaluate what the data show. Where those estimates are not reported in the registry record, statistical interpretation should remain limited rather than filling gaps with assumptions.
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 registry entries available for this analysis do not include arm-specific numerical results for the primary local-reaction endpoint. The record names a 95% confidence interval but does not include the percentages or interval limits, so the magnitude and precision of the primary comparison cannot be assessed. The primary outcome also has several categories or time points and is not reduced to one comparison in the registry entries.
Detailed statistical methods are not reported in the registry record. In particular, the registry entries do not state the randomization procedure, allocation ratio, analysis method for the primary comparison, multiplicity approach, or handling of missing data. The primary denominator is linked to electronic diary data after Dose 1, but the extent of missing diary information and its treatment are not reported.
The registry record identifies 27 outcome measures and 74 analyses but does not provide the numerical immunogenicity results in the registry record. Nor does it specify the analysis populations or missing-data procedures for those measures. The serious-event term percentages are not attributed to an arm, and their event counts and definitions are not given in the registry record. These limits prevent a detailed comparison of event patterns.
The record reports an enrollment of 1997 and the study as completed, but the registry entries do not provide the number completing follow-up or the number analyzed for every outcome. They also do not provide the trial’s sample-size justification. These omissions limit assessment of precision, completeness, and the relationship between planned and analyzed populations. They should be treated as information not reported in the registry record, not as evidence about what occurred in the study.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: 20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 4-Dose Series in Healthy Infants — NCT04382326.
- Registry record last updated 2023-12-06; status last verified 2023-11.
- Results first posted 2023-12-06.
- 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 record describes NCT04382326, a completed phase 3 randomized, double-blind, quadruple-masked, parallel-group study sponsored by Pfizer. The study title identifies a 4-dose series in healthy infants and compares a 20-valent pneumococcal conjugate vaccine with a 13-valent pneumococcal conjugate vaccine. Enrollment is 1997. The study start date is 2020-05-20, and the primary completion date is 2022-09-02.
The primary outcome is the percentage of participants with local reactions within 7 days after Dose 1. The listed secondary outcomes include serotype-specific IgG and OPA measures and antibody thresholds and fold rises at specified assessment times. The registry lists 27 outcome measures and 74 analyses. Selected adverse-event counts and serious-event terms are recorded, with 0 deaths listed in each group.
Arm-specific primary outcome estimates, confidence interval limits, and numerical immunogenicity results are not reported in the registry record in the registry record for this analysis. The record also does not report the detailed statistical plan, multiplicity approach, or missing-data procedures.