Comparison · NCT00449670-sae
H5N1 Adjuvanted Group vs H5N1 Un-adjuvanted 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. H5N1 Adjuvanted Group vs H5N1 Un-adjuvanted Group: serious adverse events. Trial comparisons, record NCT00449670-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00449670-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 | 0.026 | 0.0177 | 0.0381 | wilson | |
| Risk in group 2 | 0.0204 | 0.00875 | 0.0469 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00561 | -0.0221 | 0.0224 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.27 | 0.493 | 3.3 | log | |
| Odds ratio, group 1 over group 2 | 1.28 | 0.486 | 3.38 | log | |
| Number needed to harm, for one more participant with a serious adverse event on H5N1 Adjuvanted Group than on H5N1 Un-adjuvanted Group | 178 | 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 | H5N1 Adjuvanted Group | Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1, 2, 3 or 4) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743). | 25 | 961 | EG000 |
| Group 2 | H5N1 Un-adjuvanted Group | Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine(lot 1 or 2) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days. | 5 | 245 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs up to 21 days (Day 0-20) after the first vaccination and 30 days (Day 0-29) after the second vaccination, SAEs during the entire study period (Day 0 - Month 12).
Source ClinicalTrials.gov
Trial
- Title
- Assess Consistency of Immunogenicity of GlaxoSmithKline Biologicals' Pandemic Influenza Vaccine (GSK1562902A) in Adults
- NCT number
- NCT00449670
- Phases
- PHASE3
- Conditions
- Influenza, Influenza Vaccines
- Interventions
- H5N1 adjuvanted split virus vaccine (A/Vietnam/1194/2004 strain), H5N1 non-adjuvanted split virus vaccine (A/Vietnam/1194/2004 strain), H5N1 adjuvanted split virus vaccine (A/Indonesia/05/2005 strain)
- Lead sponsor
- GlaxoSmithKline
- Results first posted
- 2020-04-09
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00449670?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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