Comparison · NCT04526574-sae
(SIIV+20vPnC)/Saline: Coadministration vs (SIIV+Saline)/20vPnC: Separate Administration: 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. (SIIV+20vPnC)/Saline: Coadministration vs (SIIV+Saline)/20vPnC: Separate Administration: serious adverse events. Trial comparisons, record NCT04526574-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04526574-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 | 0.0369 | 0.0264 | 0.0513 | wilson | |
| Risk in group 2 | 0.0368 | 0.0263 | 0.0513 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0000412 | -0.0178 | 0.0179 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1 | 0.623 | 1.61 | log | |
| Odds ratio, group 1 over group 2 | 1 | 0.612 | 1.64 | log | |
| Number needed to harm, for one more participant with a serious adverse event on (SIIV+20vPnC)/Saline: Coadministration than on (SIIV+Saline)/20vPnC: Separate Administration | 24,300 | 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 | (SIIV+20vPnC)/Saline: Coadministration | On Day 1, participants received a single dose of seasonal inactivated influenza vaccine (SIIV) intramuscularly into the right deltoid along with 0.5 milliliter (mL) 20-valent pneumococcal conjugate vaccine (20vPnC) intramuscularly into the left deltoid (Vaccination 1). After one month, participants received 0.5 mL of saline intramuscularly into the left deltoid (Vaccination 2). Participants were followed up for 6 months after Vaccination 2. | 33 | 895 | EG000 |
| Group 2 | (SIIV+Saline)/20vPnC: Separate Administration | On Day 1, participants received a single dose of SIIV intramuscularly into the right deltoid and 0.5 mL of saline intramuscularly into the left deltoid (Vaccination 1). After one month, participants received 0.5 mL of 20vPnC intramuscularly into the left deltoid. (Vaccination 2). Participants were followed up for 6 months after Vaccination 2. | 33 | 896 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Local reactions(systematic assessment): within 10 days after Vaccination 1 for Coadministration group and within 10 days after Vaccination 2 for Separate Administration group, Systemic events(systematic assessment): within 7 days after Vaccination 1 for Coadministration group and within 7 days after Vaccination 2 for Separate Administration group, SAEs: from Day 1 up to 6 months after last vaccination(i.e., up to 7 months) and other AEs: up to 1 month after each vaccination
Source ClinicalTrials.gov
Trial
- Title
- Safety and Immunogenicity of 20vPnC Coadministered With SIIV in Adults ≥65 Years of Age
- NCT number
- NCT04526574
- Phases
- PHASE3
- Conditions
- Pneumococcal Disease
- Interventions
- Experimental 20-valent pneumococcal conjugate vaccine (20vPnC), Saline, Influenza vaccine
- Lead sponsor
- Pfizer
- Results first posted
- 2022-07-08
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04526574?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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