Comparison · NCT03207750-sae
HRV Porcine Circovirus (PCV)-Free Liquid Group vs HRV Lyophilized Group: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. HRV Porcine Circovirus (PCV)-Free Liquid Group vs HRV Lyophilized Group: serious adverse events. Trial comparisons, record NCT03207750-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03207750-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.0316 | 0.0206 | 0.0484 | wilson | |
| Risk in group 2 | 0.0297 | 0.0191 | 0.0459 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00196 | -0.0177 | 0.0218 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.07 | 0.574 | 1.98 | log | |
| Odds ratio, group 1 over group 2 | 1.07 | 0.564 | 2.02 | log | |
| Number needed to harm, for one more participant with a serious adverse event on HRV Porcine Circovirus (PCV)-Free Liquid Group than on HRV Lyophilized Group | 511 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | HRV Porcine Circovirus (PCV)-Free Liquid Group | Healthy female or male subjects, between and including 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in PCV-free liquid formulation, according to a 0, 2-month schedule, co-administered with one dose of each Pediarix, Hiberix and Prevnar-13 at three timepoints (day 1, month 2 and month 4). PCV-free implies no detection of PCV-1 and PCV-2 according to the limit of detection of the tests used. | 20 | 632 | EG000 |
| Group 2 | HRV Lyophilized Group | Healthy female or male subjects, between and including 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in lyophilized formulation, according to a 0, 2-month schedule, co-administered with one dose of each Pediarix, Hiberix and Prevnar-13 at three timepoints (day 1, month 2 and month 4). | 19 | 640 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after each HRV vaccination. SAEs: Throughout the study period (Day 1 to Month 10).
Source ClinicalTrials.gov
Trial
- Title
This Study Will Evaluate the Immunogenicity, Reactogenicity and Safety of the Routine Infant Vaccines Pediarix®, Hiberix® and Prevenar 13® When Co-administered With GlaxoSmithKline (GSK) Biologicals' Liquid Human Rotavirus Vaccine (HRV) as Compared to GSK's Licensed Lyophilized Vaccine
- NCT number
- NCT03207750
- Phases
- PHASE3
- Conditions
- Rotavirus Infection, Rotavirus Vaccines
- Interventions
- Rotarix, Pediarix, Hiberix, Prevenar 13
- Lead sponsor
- GlaxoSmithKline
- Results first posted
- 2019-10-31
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03207750?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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