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 Evaluating the Infectivity, Safety, and Immunogenicity of a Respiratory Syncytial Virus Vaccine (RSV 6120/∆NS2/1030s) in RSV-Seropositive Children and RSV-Seronegative Infants and Children (NCT03387137), a randomized phase 1 study. The primary outcome is Number of Participants With Solicited Adverse Events (AEs) by Grade - (RSV-seropositive Participants).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03387137 |
| Phase | Phase 1 |
| Condition | RSV Infection |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 45 |
| Arms in the primary outcome | n/a |
| Lead sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
| Results posted | Yes |
2. Clinical Question
Population
The study included RSV-seropositive children 12 to 59 months of age and RSV-seronegative infants and children 6 to 24 months of age. The registry reports enrollment of 45 participants. The primary endpoint population is described as participants who received inoculation and were followed on study past Day 0.
Intervention
Participants assigned to vaccine received a single dose of recombinant live-attenuated RSV 6120/∆NS2/1030s as nose drops at study entry, Day 0. The listed dose was 10^5.7 plaque-forming units for RSV-seropositive children and 10^5.0 PFUs for RSV-seronegative infants and children.
Comparator
The comparator was placebo, also given as a single dose at study entry. The record describes vaccine and placebo groups within both the RSV-seropositive and RSV-seronegative populations.
Primary question
The primary endpoint asks how many RSV-seropositive participants experienced solicited adverse events, classified by grade, through Day 10. The listed event categories are fever, otitis media, upper respiratory illness, lower respiratory illness, and cough without lower respiratory illness. The endpoint is descriptive: it counts affected participants rather than directly estimating a comparative treatment effect.
In statistical terms, the registry describes a safety and immunogenicity study, but the stated primary endpoint is a safety count. The clinical question is therefore whether the registry presents the frequency and grade of specified events after vaccination in the RSV-seropositive group, alongside placebo experience. The seronegative group is described separately, with its own vaccine and placebo assignments and a different stated vaccine dose.
The record also lists secondary outcomes concerning natural infection with wild-type RSV, illness among participants with natural infection, antibody measures, and antibody rises in the seronegative group. Those outcomes broaden the study’s questions beyond the primary safety endpoint. However, the registry record does not present corresponding analysis results in the information available for this account. The evidence that can be interpreted is consequently limited to the reported group counts and the endpoint definitions, rather than a full assessment of all stated study questions.
3. Trial Design
This was a Phase I, randomized, quadruple-masked, parallel-group, placebo-controlled study. The registry lists enrollment of 45 and status as completed. Its title describes a single dose of RSV 6120/∆NS2/1030s delivered as nose drops to RSV-seropositive children 12 to 59 months of age and RSV-seronegative infants and children 6 to 24 months of age.
The design separates participants according to RSV serostatus. RSV-seropositive children were assigned to vaccine or placebo; the vaccine dose listed for this group was 10^5.7 plaque-forming units. RSV-seronegative infants and children were also assigned to vaccine or placebo, with a listed vaccine dose of 10^5.0 PFUs. Both groups received their assigned single dose at study entry, Day 0. These population-specific assignments matter when reading the counts: vaccine and placebo groups should be understood within their serostatus group, not treated as though all participants belonged to one interchangeable population.
Random allocation supports a planned comparison between assigned groups, while masking is intended to limit the influence of knowledge of assignment on trial conduct and assessment. Those design features do not, by themselves, supply an estimate of an effect or show that the groups were balanced in the posted data. The registry does not report the allocation procedure in greater detail, how masking was implemented, or whether masking was assessed.
The primary endpoint describes solicited adverse events among RSV-seropositive participants, measured through Day 10. Its population definition includes participants who received inoculation and were followed on study past Day 0. The record does not state how many participants met that definition within each group for the primary endpoint. It also does not report a sample-size justification or a detailed statistical analysis plan. The listed enrollment should therefore be read as the study’s total enrollment, not as a substitute for endpoint-specific denominators or evidence about the planned precision of a comparison.
The registry lists 23 outcome measures and no analysis records. It gives additional secondary-outcome descriptions, but those descriptions do not establish that results for those outcomes are available. The study dates and additional operational details are part of the registry record, but they do not resolve the absence of endpoint-specific effect estimates or analysis methods.
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: Of the 73 participants that were screened, 45 met eligibility criteria, parent agreed to enroll and were inoculated with study product.
Overall Study
| Stage | Group 1: RSV 6120/∆NS2/1030s Vaccine | Group 1: Placebo | Group 2: RSV 6120/∆NS2/1030s Vaccine | Group 2: Placebo |
|---|---|---|---|---|
| STARTED | 10 | 5 | 20 | 10 |
| COMPLETED | 10 | 5 | 20 | 10 |
| NOT COMPLETED | 0 | 0 | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: Study participants who received inoculation and were followed on study past Day 0 were included.
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 | Group 1: RSV 6120/∆NS2/1030s Vaccine | Group 1: Placebo | Group 2: RSV 6120/∆NS2/1030s Vaccine | Group 2: Placebo | Total |
|---|---|---|---|---|---|---|
| Participants analysed | 10 | 5 | 20 | 10 | 45 | |
| Age, Customized: < 1 year of age | Participants | 0 | 0 | 7 | 5 | 12 |
| Age, Customized: 1 year of age | Participants | 6 | 1 | 12 | 5 | 24 |
| Age, Customized: 2 years of age | Participants | 1 | 2 | 1 | 0 | 4 |
| Age, Customized: 3 years of age | Participants | 2 | 0 | 0 | 0 | 2 |
| Age, Customized: 4 years of age | Participants | 1 | 2 | 0 | 0 | 3 |
| Age, Customized: > 4 years of age | Participants | 0 | 0 | 0 | 0 | 0 |
| Sex: Female, Male: Female | Participants | 6 | 4 | 11 | 3 | 24 |
| Sex: Female, Male: Male | Participants | 4 | 1 | 9 | 7 | 21 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 | 0 | 2 | 0 | 2 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 10 | 5 | 18 | 10 | 43 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 2 | 1 | 1 | 0 | 4 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 1 | 0 | 1 | 0 | 2 |
| Race (NIH/OMB): White | Participants | 6 | 1 | 16 | 9 | 32 |
| Race (NIH/OMB): More than one race | Participants | 1 | 3 | 2 | 1 | 7 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment: United States | participants | 10 | 5 | 20 | 10 | 45 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Participants With Solicited Adverse Events (AEs) by Grade - (RSV-seropositive Participants), measured over Measured through Day 10.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint counts RSV-seropositive participants who experienced solicited adverse events, classified by grade, through Day 10. The listed categories are fever, otitis media, upper respiratory illness, lower respiratory illness, and cough without lower respiratory illness. The record says a participant is counted once within each category, at the highest grade experienced in that category. Grades are described as ranging from Grade 1, mild, to Grade 4, life-threatening, under the protocol-defined grading system.
A participant count is a direct way to describe how many people experienced an event in a defined group and observation period. Grade classification adds information about severity rather than treating every reported event as equivalent. Counting a participant once per category at the highest grade also avoids counting repeated episodes as multiple affected participants within that category. These features can make a safety summary easier to interpret than a list of every event episode.
Such a count does not, by itself, describe the timing, duration, recurrence, or relationship of events to vaccination. Nor does a count alone quantify the uncertainty around a difference between vaccine and placebo groups. The registry identifies the endpoint and its rules, but the solicited-event counts by category and grade are not reported in the registry record available for this analysis. The separate adverse-event counts therefore should not be mistaken for results on this defined primary endpoint.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry’s primary safety question concerns solicited adverse events by grade among RSV-seropositive participants through Day 10. Although the endpoint is defined in detail, its category- and grade-specific results are not reported in the registry record. As a result, the primary endpoint cannot be used to describe which solicited events occurred, how often each grade was observed, or how vaccine and placebo groups compared on that endpoint.
The posted adverse-event figures separately show zero participants with reported serious adverse events in each of the four groups and zero deaths in each group. For the other adverse-event category, the reported affected-participant counts are 6 of 10 in the RSV-seropositive vaccine group, 2 of 5 in the RSV-seropositive placebo group, 20 of 20 in the RSV-seronegative vaccine group, and 9 of 10 in the RSV-seronegative placebo group. These are counts in the registry’s adverse-event fields, not results for the primary solicited-event endpoint unless the record explicitly identifies them as such; it does not.
The group counts are descriptive. They show the number of affected participants and the reported at-risk denominators, but the registry does not provide a comparative effect estimate, confidence interval, or statistical test for these figures. Without those results, the precision of a difference between groups cannot be assessed from the registry record. The small group denominators also mean that each participant’s outcome has substantial influence on the displayed count, though the exact uncertainty is not quantified in the posted data.
The two serostatus populations have different eligibility descriptions and different vaccine doses. Their counts should not be combined or interpreted as though they were observations from a single homogeneous comparison. In particular, comparing a vaccine group in one serostatus population with a placebo group in the other would mix differences in population and dose with the assigned intervention. The sensible descriptive comparisons are within the populations as described in the record, while recognizing that formal estimates are not reported.
The absence of recorded serious adverse events and deaths is a statement about the reported observations, not proof that such events cannot occur. Likewise, the other adverse-event counts alone do not establish causation. The registry does not provide the event-level detail, adjudication information, or inferential analysis needed for stronger claims. Overall, the posted figures support a limited account of recorded counts, while leaving the primary solicited-event results and their comparative precision unresolved.
9. Statistical Methods Explained
Counts and denominators describe how many participants had an event out of how many participants were considered at risk. For example, the adverse-event record reports affected participants alongside group-specific at-risk counts. This is useful for understanding the scale of the observations, but it is not the same as a model-based comparison or a causal conclusion. The registry does not report a comparative estimate for these adverse-event counts.
What does a participant count capture?
A count of participants with an event focuses on people rather than episodes. If a participant experiences repeated events in a category, the endpoint description says the participant is counted once in that category, at the highest grade experienced. That convention makes the unit of analysis the participant-category combination. It means the count does not reveal how many total episodes occurred, when they occurred, or whether events recurred. The event-counting rule is important because different rules could produce different summaries from the same underlying observations.
The primary endpoint also classifies events by grade. A grade communicates the protocol-defined severity level, and the endpoint description identifies Grade 1 as mild and Grade 4 as life-threatening. This grading can retain clinically relevant distinctions that would be lost in a single total count. At the same time, interpreting grade categories depends on consistent application of the protocol definitions. The registry refers to protocol-defined grading, but does not provide the detailed grading criteria in the record.
What can group comparisons establish?
In a randomized study, comparing assigned groups is intended to assess how outcomes differ under the trial’s assignment scheme. A raw count can be a starting point, but groups with different denominators should not be compared using counts alone. Proportions or other effect measures can account for group size, and confidence intervals can express the uncertainty in an estimated contrast. General statistical interpretation: a confidence interval represents a range of values compatible with the data and the method used, rather than a guarantee that the true value lies within a particular interval. The registry does not report confidence intervals or a formal comparison for the adverse-event counts.
Small group sizes make estimates imprecise because a change in the outcome status of a participant can have a sizable influence on a group summary. This is a general property of estimates based on limited observations. It does not establish that a particular observed difference is meaningful or unimportant. Precision should be evaluated with uncertainty estimates, which are not reported for these counts.
Why does the primary endpoint need to be kept distinct?
The primary endpoint has a specified population, event list, grading scheme, counting rule, and observation period. The adverse-event fields also report group counts, but the registry does not identify those counts as the primary solicited events by grade. Treating the two kinds of information as interchangeable would ignore the endpoint definition. The posted adverse-event figures therefore give safety context, but they cannot fill in missing results for the primary endpoint.
The endpoint definition focuses on solicited events, while the registry’s secondary outcomes address other questions, including natural wild-type RSV infection, illness, and antibody responses. These measure different outcomes and may require different analysis methods. The registry record does not report results or analysis details for those secondary measures in the information.
What statistical analysis is documented?
The registry lists no analysis records. It does not report a model, statistical test, confidence interval, adjustment strategy, or method for handling missing endpoint data. The record also does not report whether analyses were planned by treatment assignment, by treatment received, or under another analysis population. These omissions prevent a reader from reproducing or evaluating an inferential analysis from the registry record alone.
General statistical explanation: randomization can support unbiased comparisons when assignment is preserved in analysis and outcomes are observed and handled appropriately. Missing observations, exclusions after randomization, or deviations from assigned treatment can affect interpretation. The registry’s primary population description says participants received inoculation and were followed on study past Day 0, but does not give group-specific counts meeting this definition or explain how other participants were handled.
Over-dispersion is a general issue for count data when the observed variability exceeds what a particular count model assumes. In such cases, a model that assumes too little variability can give uncertainty estimates that are too narrow. This concept does not imply that over-dispersion occurred in this trial: the registry does not report a count model or the data needed to assess that property. The primary endpoint is a participant count by event category and grade, not a reported model-based event-rate analysis.
The record includes sample-size planning illustrations based on the observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. Such illustrations are planning comparisons under stated assumptions; they are not the trial’s documented design justification, and they are not observed power. The sample-size justification for this trial is not reported in the registry record. Without the underlying effect estimates and endpoint-specific analysis, the illustrations cannot supply missing evidence about the primary endpoint’s precision.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 23 outcome measures, including a primary safety endpoint with multiple event categories and grades, as well as secondary outcomes concerning infection, illness, and antibody measures. When many outcomes or categories are examined, the chance of finding an apparently notable result by chance can increase. General statistical practice may address this through prespecified testing hierarchies, multiplicity adjustments, or an explicitly exploratory interpretation. The registry record does not report a multiplicity strategy, so it is not possible to determine how any collection of outcome tests would have been interpreted.
The registry lists no analysis records. It does not describe statistical tests, confidence intervals, model choices, or whether any analyses were adjusted for baseline variables. The sample-size justification and a full statistical analysis plan are not reported in the registry record. Consequently, the intended confirmatory status of the secondary outcomes and the handling of multiple comparisons are unclear.
Missing-data handling is also not reported. The primary population description includes participants who received inoculation and were followed on study past Day 0, but group-specific numbers meeting that definition are not given for the primary outcome. The record does not explain whether participants with incomplete follow-up were excluded, how missing event assessments were treated, or whether sensitivity analyses were conducted.
These gaps matter because analysis populations and missing-outcome assumptions can change the meaning of a safety count. A count among participants with observed follow-up is not automatically equivalent to a count among everyone randomized. The registry record does not provide enough information to determine whether these populations differed or how any differences were addressed.
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 |
|---|---|---|---|
| Group 1: RSV 6120/∆NS2/1030s Vaccine | 0 | 10 | 0.0% |
| Group 1: Placebo | 0 | 5 | 0.0% |
| Group 2: RSV 6120/∆NS2/1030s Vaccine | 0 | 20 | 0.0% |
| Group 2: Placebo | 0 | 10 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Group 1: RSV 6120/∆NS2/1030s Vaccine | 0 of 10 |
| Group 1: Placebo | 0 of 5 |
| Group 2: RSV 6120/∆NS2/1030s Vaccine | 0 of 20 |
| Group 2: Placebo | 0 of 10 |
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 |
|---|---|
| Group 1: RSV 6120/∆NS2/1030s Vaccine | 6 of 10 |
| Group 1: Placebo | 2 of 5 |
| Group 2: RSV 6120/∆NS2/1030s Vaccine | 20 of 20 |
| Group 2: Placebo | 9 of 10 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Group 1: RSV 6120/∆NS2/1030s Vaccine | Group 1: Placebo | Group 2: RSV 6120/∆NS2/1030s Vaccine | Group 2: Placebo |
|---|---|---|---|---|---|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | 4 of 10 | 1 of 5 | 19 of 20 | 8 of 10 |
| Cough | Respiratory, thoracic and mediastinal disorders | 1 of 10 | 0 of 5 | 9 of 20 | 9 of 10 |
| Pyrexia | General disorders | 2 of 10 | 0 of 5 | 9 of 20 | 6 of 10 |
| Otitis Media | Infections and infestations | 0 of 10 | 0 of 5 | 5 of 20 | 3 of 10 |
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | 1 of 10 | 0 of 5 | 3 of 20 | 1 of 10 |
| Rash | Skin and subcutaneous tissue disorders | 0 of 10 | 0 of 5 | 3 of 20 | 2 of 10 |
| Pain | General disorders | 1 of 10 | 0 of 5 | 3 of 20 | 0 of 10 |
| Wheezing | Respiratory, thoracic and mediastinal disorders | 0 of 10 | 0 of 5 | 2 of 20 | 1 of 10 |
| Stomatitis | Gastrointestinal disorders | 0 of 10 | 0 of 5 | 2 of 20 | 0 of 10 |
| Croup | Infections and infestations | 0 of 10 | 0 of 5 | 2 of 20 | 0 of 10 |
The serious adverse-event fields report zero affected participants in each group, and the death fields report zero deaths in each group. The other adverse-event fields report 6 of 10 affected in the RSV-seropositive vaccine group, 2 of 5 in the RSV-seropositive placebo group, 20 of 20 in the RSV-seronegative vaccine group, and 9 of 10 in the RSV-seronegative placebo group. These are registry-reported counts with the corresponding at-risk group sizes.
A zero count means that no event was recorded in that category among the listed participants; it does not establish that the underlying risk is zero. With limited group sizes, the data cannot exclude uncommon events or precisely characterize the frequency of events beyond the observed follow-up. No confidence intervals or comparative tests for these figures are reported in the registry record.
The other-event counts should not be relabeled as the primary solicited adverse-event results. The primary endpoint specifies particular event categories, grades, an RSV-seropositive population, and follow-up through Day 10. The adverse-event fields do not provide those category-by-grade details. They also do not establish that an event was caused by the assigned intervention. The counts are best read as recorded safety observations, not as proof of a treatment effect or a complete safety profile.
12. What the Result Does, and Does Not, Mean
The registry record establishes that the study was randomized, quadruple-masked, placebo-controlled, and designed to assess infectivity, safety, and immunogenicity after a single dose of RSV 6120/∆NS2/1030s. It specifies distinct RSV-seropositive and RSV-seronegative populations, different vaccine doses for those groups, and a primary solicited-event endpoint through Day 10 in RSV-seropositive participants. It also reports adverse-event counts by group.
The posted data show zero reported serious adverse events and zero deaths in every group, alongside the reported counts for the other adverse-event category. Those observations describe what was recorded among the participants at risk in the registry fields. They do not, by themselves, show that the vaccine caused or prevented an event. A randomized design supports comparisons in principle, but the registry does not provide estimates, uncertainty intervals, or tests for these counts.
The record does not report the primary endpoint counts by solicited-event category and grade. Therefore, it cannot answer how frequently fever, otitis media, upper respiratory illness, lower respiratory illness, or cough without lower respiratory illness occurred at each grade in the primary population. The stated secondary outcomes also cannot be evaluated from the outcome descriptions alone; their results are not reported in the registry record available for this analysis.
The study’s enrollment and group counts do not justify broad conclusions about event frequency outside the observed participants and follow-up. The registry does not give a sample-size justification, missing-data methods, or a detailed analysis plan. Thus, the evidence supports a descriptive reading of the reported safety counts, but not a precise comparative conclusion or a complete account of the study’s stated objectives.
These limitations concern what can be concluded from the registry record, not what may have been analyzed in other materials. No clinical advice or conclusion about treatment benefit follows from the posted counts alone.
13. Why This Trial Matters Statistically
This trial is statistically informative as an example of why endpoint definitions and posted results must be read together. The registry defines a primary safety outcome carefully: a specified population, named event categories, a grading scheme, a rule for counting participants, and a follow-up period. Those details determine what a result would mean. Without the corresponding category- and grade-specific counts, however, the endpoint definition cannot be converted into an estimate of observed safety experience.
The study also has separate serostatus populations and vaccine doses. That structure makes clear why combining all participants into one vaccine-versus-placebo summary could conceal important design distinctions. A valid interpretation must preserve the population and assignment structure described in the record, rather than treating every group as a direct counterpart.
The posted adverse-event counts illustrate the difference between descriptive reporting and inferential analysis. Counts and denominators identify observed events, but they do not quantify uncertainty or establish that differences are attributable to assignment. A confidence interval or a prespecified comparison could help answer those questions, yet the registry does not report such results for the safety counts.
The trial also illustrates that a completed registry record can contain detailed outcome definitions without posting the results needed to assess every outcome. The record lists 23 outcome measures and no analysis records. That distinction is important for readers: study objectives, outcome descriptions, observed counts, and statistical conclusions are separate kinds of information. Keeping them separate prevents the design from being mistaken for evidence about results that are not reported.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The primary endpoint is described but its results by solicited-event category and grade are not reported in the registry record. The available adverse-event counts do not provide enough detail to reconstruct that endpoint. They should not be substituted for the prespecified category-by-grade summary.
The reported safety figures are counts with at-risk denominators, but no comparative effect estimates, confidence intervals, or statistical tests are listed. Their precision therefore cannot be assessed from the registry record. The registry does not report group-specific numbers meeting the primary endpoint population definition, beyond the separate at-risk counts in the adverse-event fields.
The study includes two distinct serostatus populations, with different ages and different listed vaccine doses. This limits interpretation of pooled summaries and means that cross-population comparisons could mix population differences with treatment assignment. The registry does not supply enough analysis detail to determine whether any such comparisons were planned or performed.
The record does not report how missing observations were handled, how many participants completed endpoint follow-up, or how deviations from assigned treatment were treated. It also does not report detailed statistical methods, multiplicity handling, or the sample-size justification. These omissions limit assessment of bias, uncertainty, and the confirmatory status of the listed outcomes.
Finally, the serious adverse-event and death counts are observed registry counts, not proof that no such events could occur. The registry’s other adverse-event category is not described in enough detail to map it to the solicited primary endpoint, and the counts alone do not establish causation. The conclusions must remain bounded by the reported categories, populations, and follow-up descriptions.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Evaluating the Infectivity, Safety, and Immunogenicity of a Respiratory Syncytial Virus Vaccine (RSV 6120/∆NS2/1030s) in RSV-Seropositive Children and RSV-Seronegative Infants and Children — NCT03387137.
- Registry record last updated 2024-12-11; status last verified 2024-11.
- Results first posted 2023-08-03.
- 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
NCT03387137 is a completed randomized, quadruple-masked, parallel-group, placebo-controlled Phase I study with enrollment of 45. It evaluated a single dose of RSV 6120/∆NS2/1030s in RSV-seropositive children 12 to 59 months of age and RSV-seronegative infants and children 6 to 24 months of age. The primary endpoint counted solicited adverse events by grade among RSV-seropositive participants through Day 10.
The registry reports zero affected participants in the serious adverse-event fields and zero deaths in all four groups. It also reports other adverse-event counts of 6 of 10, 2 of 5, 20 of 20, and 9 of 10 for the RSV-seropositive vaccine, RSV-seropositive placebo, RSV-seronegative vaccine, and RSV-seronegative placebo groups, respectively. The solicited primary-endpoint results by event category and grade are not reported in the registry record. The record lists 23 outcome measures and no analysis records, leaving comparative precision, missing-data handling, and multiplicity methods unreported.