Comparison · NCT00988884-sae
Concomitant Vaccination vs Non-concomitant Vaccination: 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. Concomitant Vaccination vs Non-concomitant Vaccination: serious adverse events. Trial comparisons, record NCT00988884-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00988884-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 | 0.00816 | 0.00349 | 0.019 | wilson | |
| Risk in group 2 | 0.00818 | 0.0035 | 0.019 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0000267 | -0.0118 | 0.0117 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.997 | 0.29 | 3.43 | log | |
| Odds ratio, group 1 over group 2 | 0.997 | 0.287 | 3.46 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Concomitant Vaccination than on Non-concomitant Vaccination | 37,500 | 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 | Concomitant Vaccination | V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1 | 5 | 613 | EG000 |
| Group 2 | Non-concomitant Vaccination | V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm at Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1 | 5 | 611 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Serious adverse events: up to Month 7; Other adverse events: up to Day 15 following any vaccination
Source ClinicalTrials.gov
Trial
- Title
- A Study of V503 Given Concomitantly With Menactra™ and Adacel™ in 11 to 15 Year Olds (V503-005)
- NCT number
- NCT00988884
- Phases
- PHASE3
- Conditions
- Human Papillomavirus Infection
- Interventions
- V503, Comparator: Menactra™ (Concomitant), Comparator: Adacel™ (Concomitant), Comparator: Menactra™ (Non-Concomitant), Comparator: Adacel™ (Non-concomitant)
- Lead sponsor
- Merck Sharp & Dohme LLC
- Results first posted
- 2015-01-13
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00988884?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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