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 Novartis H1N1 Vaccine in Pregnant Women (NCT00992719), a randomized phase 2 study. The primary outcome is Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00992719 |
| Phase | Phase 2 |
| Condition | Influenza |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 84 |
| Arms in the primary outcome | n/a |
| Lead sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
| Results posted | Yes |
2. Clinical Question
Population
Pregnant women were studied alongside a non-pregnant comparison group. The brief summary describes participants ages 18-39 and states that the study includes 200 pregnant women and 100 non-pregnant women. The enrollment field lists 84; these registry figures do not agree, and the actual analyzed population for the primary outcome is not reported in the registry record.
Intervention
The intervention was an unadjuvanted inactivated H1N1 vaccine. The pregnant groups were assigned to 15 mcg or 30 mcg, and the non-pregnant comparison group was assigned to 15 mcg.
Comparator
The record describes comparisons between pregnant groups receiving different dose levels and a non-pregnant group receiving 15 mcg. It does not report a placebo or untreated group. Details of the allocation process and the planned statistical comparisons are not reported in the registry record.
Primary question
The registered primary outcome counts participants reporting maternal complications of pregnancy, labor and delivery at the time of delivery. The record also describes safety and immune response as study aims. It does not report the primary-outcome group counts, an effect estimate, a confidence interval, or a statistical test.
The registry identifies the study as randomized, with a parallel design and no masking. The listed intervention and groups frame questions about safety across dose levels in pregnant participants, as well as differences between pregnant and non-pregnant participants receiving 15 mcg. Those comparisons are not interchangeable: pregnancy status differs between the latter groups, while dose differs between the pregnant groups.
Secondary outcomes include counts of participants with a serum HAI antibody titer greater than or equal to 40 against the novel influenza H1N1 2009 virus, measured in maternal blood at delivery and in cord blood. The posted results do not give those outcome counts or analyses. Consequently, the record describes the questions the study was designed to address, but does not provide enough outcome results to quantify answers.
3. Trial Design
The record describes a phase II, randomized, parallel study with no masking. Its registered intervention is an inactivated H1N1 vaccine. Pregnant participants are described in two groups, receiving 15 mcg or 30 mcg, and a non-pregnant comparison group is described as receiving 15 mcg. The official title characterizes the vaccine as unadjuvanted.
The enrollment field lists 84. Separately, the brief summary describes 200 pregnant women and 100 non-pregnant women, and the arm descriptions specify 100 participants in each of the three groups. These enrollment descriptions are inconsistent. The registry record does not explain the discrepancy, and the listed safety denominators are 28 for each group. Those denominators should not be treated as a reconciliation of the conflicting enrollment figures.
The study start is listed as 2009-11, primary completion as 2011-02, and status as completed. The brief summary describes physical examinations, blood samples, and a daily memory aid for temperature and side effects for 8 days after vaccination, with study-related procedures lasting about 6 months. These are descriptions of planned procedures, not outcome results.
The primary outcome is the number of participants reporting maternal complications of pregnancy, labor and delivery, with collection at the time of delivery. The registry says participants were contacted after delivery and medical records reviewed, using a prospectively defined list of complications. It identifies the relevant population as participants from whom outcome data were collected in the ITT safety population. The number in that population and the group-specific primary-outcome results are not reported in the registry record.
Details such as the randomization method, allocation concealment, protocol deviations, and planned statistical model are not reported in the registry record. The record also does not explain how the planned group sizes relate to the enrollment field or the safety denominators.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine | Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine | Group 3: Non-pregnant Women: 15 Mcg H1N1 Vaccine |
|---|---|---|---|
| STARTED | 28 | 28 | 28 |
| COMPLETED | 27 | 27 | 28 |
| NOT COMPLETED | 1 | 1 | 0 |
Analysis population for the primary outcome, as defined in the registry: All participants from whom outcome data were collected are included in the ITT safety population for this outcome measure.
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: Pregnant Women: 15 Mcg H1N1 Vaccine | Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine | Group 3: Non-pregnant Women: 15 Mcg H1N1 Vaccine | Total |
|---|---|---|---|---|---|
| Participants analysed | 28 | 28 | 28 | 84 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 28 | 28 | 28 | 84 |
| Age, Categorical: >=65 years | Participants | 0 | 0 | 0 | 0 |
| Age Continuous | years | 30 (SD 6.0) | 28.8 (SD 4.9) | 30.8 (SD 5.6) | 29.9 (SD 5.5) |
| Sex: Female, Male: Female | Participants | 28 | 28 | 28 | 84 |
| Sex: Female, Male: Male | Participants | 0 | 0 | 0 | 0 |
| Region of Enrollment: United States | participants | 28 | 28 | 28 | 84 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery, measured over At time of delivery.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the number of participants reporting maternal complications of pregnancy, labor and delivery at the time of delivery. The registry description says information was collected after delivery through participant contact and medical-record review. Collection followed a prospectively defined list of complications. The record notes that some complications may also have been reported as serious adverse events when they met the applicable requirements.
A count of participants with an event is a binary-outcome summary at the participant level: each participant either has at least one qualifying event or does not, according to the endpoint definition. This differs from a count of all event occurrences, because a participant may experience more than one complication. The registry names the measure as a number of participants, but does not report the group-specific counts or clarify how multiple complications in a participant contribute to any separate event totals.
General statistical context: an endpoint of this kind can summarize clinically relevant events over a defined period and can be compared across groups. Interpretation depends on a clear event definition, consistent ascertainment, and complete follow-up. Medical-record review and participant contact are the described collection methods, but the record does not report completeness of ascertainment or how missing outcome information was handled.
The primary endpoint is useful for organizing the safety question around pregnancy, labor and delivery complications. It does not, by itself, provide evidence about immune response; the registered HAI antibody outcomes address that separate question. No primary endpoint result or statistical analysis is reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted record identifies a completed randomized phase II study and gives the primary outcome definition, but it does not provide primary-outcome results. There are no group-specific complication counts, comparative estimates, confidence intervals, or p-values in the record. The field indicating the number of analyses is 0. Therefore, the registry record does not support a quantitative interpretation of differences in maternal complications between the groups.
The safety figures available concern serious and other adverse events, not the registered primary endpoint as described. For the pregnant 15 mcg group, the record lists 8 serious events among 28 at risk and 19 other events among 28 at risk. For the pregnant 30 mcg group, it lists 6 serious events among 28 at risk and 24 other events among 28 at risk. For the non-pregnant 15 mcg group, it lists 1 serious event among 28 at risk and 19 other events among 28 at risk. These are registry event summaries and should not be substituted for the unavailable primary-outcome counts. The record does not explain the relationship between these safety denominators and the conflicting enrollment descriptions.
General statistical context: an estimate describes the observed contrast between groups, while a confidence interval indicates the range of values reasonably compatible with the data under the analysis assumptions. Without an estimate and interval, readers cannot assess either the direction or precision of a comparative result. A lack of a reported test is not evidence that groups were equivalent; equivalence requires a suitable design and analysis, which are not reported in the registry record.
The study has three groups that differ in dose and pregnancy status. Comparisons between the two pregnant groups address a dose contrast within the described pregnant population. A comparison of pregnant and non-pregnant participants at 15 mcg also reflects a difference in pregnancy status, not only a treatment contrast. The record does not report adjusted comparisons or a plan for interpreting these contrasts.
For immune response, the record lists maternal and cord-blood HAI outcomes, defined using a titer threshold of greater than or equal to 40. It does not provide results for either outcome. The posted information therefore allows readers to identify the registered safety and immunogenicity questions, but not to estimate the magnitude or precision of answers to them.
9. Statistical Methods Explained
Statistical methods can help distinguish what an observed result says from what remains uncertain. In this record, however, the analysis methods and primary-outcome results are not reported in the registry record. General explanations below describe how common methods would be interpreted; they do not claim that those methods were used in this study.
What does a participant count represent?
The primary outcome is a number of participants reporting complications. For a binary participant-level endpoint, each participant is classified according to whether the defined event occurred. A group count can be made more interpretable by reporting the number with the event alongside the number assessed. Comparative analysis can then estimate a difference or another contrast between groups. No such primary-outcome counts or estimates are reported in the registry record.
Participant counts and event counts are not necessarily the same. A participant may have multiple complications, while a participant-level endpoint may count that person only once. The record defines the primary measure as a number of participants and describes a list of complications, but does not report separate counts of events or further operational detail about handling multiple complications.
What would a confidence interval add?
General statistical context: a confidence interval communicates uncertainty around an estimated effect. A narrow interval indicates greater precision under the model and assumptions used; a wide interval indicates less precision. It does not guarantee that the estimate is unbiased or that the study design and measurement were free of problems. Because the record has no primary-outcome estimate or interval, the precision of any group comparison cannot be assessed from the posted results.
How should a p-value be read?
General statistical context: a p-value describes how unusual data at least as incompatible with a specified null model would be, assuming that model and the analysis assumptions. It is not the probability that the null hypothesis is true, and it does not measure the size or importance of an effect. The registry record reports no primary-outcome p-value or analysis, so no significance conclusion can be drawn from it.
Why do group definitions matter?
The groups differ in ways that shape the meaning of any contrast. The two pregnant groups receive different dose levels. The non-pregnant group receives the same listed dose as the pregnant 15 mcg group, but differs in pregnancy status. General statistical context: a randomized allocation can support causal comparisons of assigned interventions when implementation, follow-up, and analysis are appropriate. The record says allocation was randomized, but the method, allocation concealment, and analysis details are not reported. The comparison involving pregnancy status should not be described as if pregnancy status itself had been randomized.
General statistical context: adjustment can account for measured covariates, but it cannot automatically remove bias from unmeasured differences or flawed measurement. The record does not report adjusted estimates, covariates, or a statistical model. It is therefore not possible to determine whether the posted safety summaries are adjusted or whether any group comparisons account for other factors.
What does over-dispersion mean?
General statistical context: over-dispersion occurs when the variability in count data exceeds what a chosen model expects. If ignored, uncertainty estimates can be too small. It is relevant when analyzing counts of events, particularly when participants can experience multiple events. The primary measure is described as participants reporting complications, not a total event count, and no count model or dispersion information is reported. It would be inappropriate to assert that over-dispersion was present or that a particular model was used.
What can planning calculations show?
The registry record describes a sample-size illustration based on a fraction of an observed effect, a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It specifies that such illustrations are planning calculations, not observed power. No calculated sample-size values are reported in the registry record for this explanation. The registry record does not report that this illustration was the trial's original design justification or that the trial was planned around the observed effect. Its own design justification is not reported in the registry record.
General statistical context: sample-size calculations depend on assumptions about the target effect, variability or event frequency, analysis, and allocation. A planning illustration can show how required enrollment changes under different assumed effects, but it does not establish whether a completed study was adequately powered. Observed power is not a substitute for interpreting an effect estimate and its confidence interval. Here, primary-outcome estimates and intervals are not reported, so the illustration cannot fill that gap.
What is available for safety interpretation?
The registry lists event counts and denominators for serious and other adverse events, along with selected serious-event terms and percentages. These summaries can describe what the registry recorded, but the record does not provide a comparative statistical analysis, definitions for every listed category, or a complete account of event ascertainment. General statistical context: safety interpretation benefits from clear definitions, exposure time, participant-level and event-level summaries, and uncertainty estimates. Those details are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The trial has multiple registered outcomes, including the primary maternal-complication outcome and secondary maternal-blood and cord-blood HAI antibody outcomes. The registry lists 11 outcome measures, but no analyses. It does not report a multiplicity strategy, such as whether outcomes or comparisons were ordered in advance, whether the primary outcome had a single planned contrast, or whether any adjustment for multiple testing was used. Without those details, the risk of selectively emphasizing results across outcomes cannot be assessed from the registry record.
The primary outcome description says that participants from whom outcome data were collected are included in the ITT safety population for this measure. This identifies the stated population definition, but does not give the number assessed in each group or explain how participants without outcome data were handled. Missing-data counts, reasons for missingness, and sensitivity analyses are not reported in the registry record.
The record also does not describe protocol deviations, withdrawals, exclusions after allocation, or whether all randomized participants were included in each analysis. The brief summary describes follow-up procedures, but does not establish how complete follow-up was or how incomplete records affected the outcome results.
General statistical context: missing data can affect both the precision and validity of an estimate, particularly if the chance of missingness is related to outcome status or group assignment. Different handling methods rely on different assumptions. A clear analysis population and sensitivity checks help readers understand how dependent conclusions are on those assumptions. No missing-data method or sensitivity analysis is reported.
Because the record provides no outcome analyses, it is not possible to evaluate whether the reported safety figures use the ITT safety population or another population, or whether multiplicity affected any inferential claims.
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: Pregnant Women: 15 Mcg H1N1 Vaccine | 8 | 28 | 28.6% |
| Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine | 6 | 28 | 21.4% |
| Group 3: Non-pregnant Women: 15 Mcg H1N1 Vaccine | 1 | 28 | 3.6% |
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 |
|---|---|
| Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine | 19 of 28 |
| Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine | 24 of 28 |
| Group 3: Non-pregnant Women: 15 Mcg H1N1 Vaccine | 19 of 28 |
Most frequent serious adverse event terms
| Event term | Organ system | Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine | Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine | Group 3: Non-pregnant Women: 15 Mcg H1N1 Vaccine |
|---|---|---|---|---|
| Pre-eclampsia | Pregnancy, puerperium and perinatal conditions | 1 of 28 | 3 of 28 | 0 of 28 |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | 2 of 28 | 1 of 28 | 0 of 28 |
| Premature baby | Pregnancy, puerperium and perinatal conditions | 0 of 28 | 2 of 28 | 0 of 28 |
| Premature labour | Pregnancy, puerperium and perinatal conditions | 1 of 28 | 0 of 28 | 0 of 28 |
| Amniorrhoea | Pregnancy, puerperium and perinatal conditions | 1 of 28 | 0 of 28 | 0 of 28 |
| Vaginal haemorrhage | Reproductive system and breast disorders | 1 of 28 | 0 of 28 | 0 of 28 |
| Postpartum haemorrhage | Pregnancy, puerperium and perinatal conditions | 1 of 28 | 0 of 28 | 0 of 28 |
| Premature separation of placenta | Pregnancy, puerperium and perinatal conditions | 0 of 28 | 1 of 28 | 0 of 28 |
| Renal colic | Renal and urinary disorders | 0 of 28 | 1 of 28 | 0 of 28 |
| Thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 0 of 28 | 0 of 28 | 1 of 28 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine | Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine | Group 3: Non-pregnant Women: 15 Mcg H1N1 Vaccine |
|---|---|---|---|---|
| Tenderness | General disorders | 13 of 28 | 15 of 28 | 14 of 28 |
| Malaise | General disorders | 7 of 28 | 14 of 28 | 4 of 28 |
| Headache | Nervous system disorders | 8 of 28 | 9 of 28 | 7 of 28 |
| Injection site pain | General disorders | 4 of 28 | 8 of 28 | 6 of 28 |
| Nausea | Gastrointestinal disorders | 3 of 28 | 8 of 28 | 3 of 28 |
| Myalgia | Musculoskeletal and connective tissue disorders | 1 of 28 | 6 of 28 | 4 of 28 |
| Upper respiratory tract infection | Infections and infestations | 4 of 28 | 0 of 28 | 6 of 28 |
| Injection site erythema | General disorders | 2 of 28 | 2 of 28 | 2 of 28 |
| Feeling hot | General disorders | 0 of 28 | 2 of 28 | 3 of 28 |
| Injection site swelling (functional grading) | General disorders | 1 of 28 | 2 of 28 | 2 of 28 |
Serious events with the highest arm-level rate: pre-eclampsia (10.7%), respiratory distress (7.1%), premature baby (7.1%), premature labour (3.6%), amniorrhoea (3.6%).
The registry lists serious and other adverse-event figures for each group. In the pregnant 15 mcg group, the serious-event summary is 8 among 28 at risk, and the other-event summary is 19 among 28 at risk. In the pregnant 30 mcg group, the corresponding summaries are 6 among 28 at risk and 24 among 28 at risk. In the non-pregnant 15 mcg group, they are 1 among 28 at risk and 19 among 28 at risk. The record does not report deaths.
Selected serious-event terms are listed with percentages: Pre-eclampsia, 10.7%; Respiratory distress, 7.1%; Premature baby, 7.1%; Premature labour, 3.6%; Amniorrhoea, 3.6%; and Vaginal haemorrhage, 3.6%. The registry record does not explain in this summary whether these percentages refer to participants, events, or another denominator, so they should be read as the recorded term-and-percentage entries rather than converted into counts.
These safety summaries do not provide a complete comparative analysis. The record does not report confidence intervals, hypothesis tests, exposure-adjusted rates, or details sufficient to determine how multiple events in one participant are represented. The safety denominators also differ from the planned group sizes described in the arm descriptions, and the registry does not explain that discrepancy. The figures should not be treated as results for the primary maternal-complications endpoint.
12. What the Result Does, and Does Not, Mean
The registry record documents a randomized phase II study of an inactivated H1N1 vaccine with two dose levels in pregnant women and a non-pregnant comparison group. It describes a primary safety outcome based on maternal complications at delivery and secondary HAI antibody outcomes in maternal and cord blood. These details establish the questions and group structure recorded for the study.
The posted results do not include primary-outcome counts, immune-response results, comparative estimates, confidence intervals, or p-values. As a result, they do not show the magnitude or precision of any difference between groups on the registered primary endpoint or the secondary antibody outcomes. The adverse-event summaries provide some recorded safety counts, but cannot replace the missing endpoint results or establish a comparative effect.
General statistical context: a result that is not reported is not equivalent to a finding of no effect, no difference, or no risk. Likewise, the absence of a statistical test does not establish that groups are equivalent. Equivalence or non-inferiority claims require appropriate prespecified criteria and analysis, which are not reported in the registry record.
The study's randomized designation is relevant to how assigned-dose comparisons might be interpreted, but the registry does not give enough detail to assess implementation or analysis. The pregnant and non-pregnant groups also differ by pregnancy status, so their comparison cannot isolate dose as the only difference. The record does not provide an analysis that addresses this distinction.
The enrollment field lists 84, while the brief summary and arm descriptions state larger planned group sizes. The registry does not explain the discrepancy. The safety denominators are 28 per group, but those figures do not resolve the conflicting enrollment descriptions or reveal the number included in the primary-outcome analysis.
13. Why This Trial Matters Statistically
This study is statistically notable for the way its groups separate two questions. Within pregnant participants, the listed dose levels are 15 mcg and 30 mcg. The comparison group is non-pregnant and receives 15 mcg. A dose comparison among pregnant participants is conceptually distinct from a comparison by pregnancy status at the same listed dose. Keeping those contrasts separate is essential for interpreting any reported effect.
The registered primary endpoint is a count of participants reporting maternal complications through pregnancy, labor and delivery. The endpoint description includes participant contact and medical-record review and notes that a prospectively defined list was used. This makes the outcome definition and ascertainment process central to interpretation. Yet the registry record does not provide the actual primary counts or comparative analysis, leaving the central statistical question unanswered in the posted results.
The record also illustrates why consistency across registration fields matters. The enrollment field lists 84, whereas the brief summary and arm descriptions state 200 pregnant women and 100 non-pregnant women, with 100 in each group. Safety denominators are 28 for each group. Because the record does not explain these differing figures, readers cannot use one description to infer the analyzed population or explain the others.
General statistical context: transparent reporting of analysis populations, missingness, effect estimates, uncertainty, and multiplicity helps readers judge how much confidence to place in findings. These details are not reported for the primary endpoint. The record therefore supports an understanding of the design and registered questions, while demonstrating the limits of interpreting an outcome record without its analysis results.
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 record contains an internal discrepancy in participant numbers. The enrollment field lists 84, while the brief summary describes 200 pregnant women and 100 non-pregnant women, and each arm description states 100 participants. The safety summaries list 28 at risk per group. The record does not explain how these figures relate to one another, so they should not be combined or treated as interchangeable descriptions of the analyzed population.
The primary endpoint is defined, but its results are absent. No group-specific primary counts, effect estimates, confidence intervals, or tests are reported. The record also reports no analyses, despite listing 11 outcome measures. Secondary HAI outcomes are named but their results are not reported.
Important design and analysis details are not reported in the registry record, including the randomization method, allocation concealment, analysis model, missing-data handling, protocol deviations, and multiplicity strategy. The ITT safety population is mentioned for the primary outcome, but its group sizes and the treatment of participants without collected outcome data are not described.
The safety summary is limited by missing detail about event definitions and the meaning of the percentages attached to selected serious-event terms. The record does not report deaths. It also does not provide uncertainty estimates or a comparative analysis for the adverse-event figures.
Finally, the groups differ by dose and pregnancy status. The non-pregnant comparison group cannot by itself isolate the effect of pregnancy status from other group differences, and the record does not report an adjusted analysis. These limitations restrict quantitative interpretation of the posted record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Novartis H1N1 Vaccine in Pregnant Women — NCT00992719.
- Registry record last updated 2013-08-07; status last verified 2010-07.
- Results first posted 2012-03-05.
- 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
The registry describes NCT00992719, a completed phase II randomized, parallel study with no masking, evaluating an unadjuvanted inactivated H1N1 vaccine. Pregnant participants are described as receiving 15 mcg or 30 mcg, with a non-pregnant comparison group receiving 15 mcg. The primary outcome is the number of participants reporting maternal complications of pregnancy, labor and delivery at the time of delivery.
The record lists maternal and cord-blood HAI antibody outcomes as secondary measures. It reports selected serious and other adverse-event summaries, but no primary-outcome or antibody-outcome results, and no analyses. The enrollment field, arm descriptions, and safety denominators are inconsistent; the registry does not explain the discrepancy. The record does not report the statistical analysis plan, missing-data methods, or multiplicity handling. Consequently, the posted information describes the trial design and questions but does not permit a quantitative conclusion about the primary endpoint.