Trial · NCT01352845
Registered outcomes47
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 47
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Greater Than or Equal to(>=)4 Fold Rise in Serum Bactericidal Assay Using Human Complement(hSBA) for 4 Primary Strains and Composite Response (hSBA>=Lower Limit of Quantification for All 4 Primary Strains Combined):Group 1 | One month after third bivalent rLP2086 vaccination | Here, N signifies participants with valid and determinate hSBA titers for given strain at specified time point. This outcome measure was planned to be analyzed for Group 1 only. |
| Primary | Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After First Vaccination | Within 7 days after first vaccination | |
| Primary | Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Second Vaccination | Within 7 days after second vaccination | |
| Primary | Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Third Vaccination | Within 7 days after third vaccination | |
| Primary | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination | Within 7 days after first vaccination | |
| Primary | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination | Within 7 days after second vaccination | |
| Primary | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination | Within 7 days after third vaccination | |
| Primary | Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After First Vaccination | Within 30 days after first vaccination | |
| Primary | Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Second Vaccination | Within 30 days after second vaccination | |
| Primary | Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Third Vaccination | Within 30 days after third vaccination | |
| Primary | Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Any Vaccination | Within 30 days after any vaccination | |
| Primary | Percentage of Participants With at Least 1 Adverse Event (AE) During the Vaccination Phase | From the first vaccination up to 1 month after the third vaccination | |
| Primary | Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After First Vaccination | Within 30 days after first vaccination | |
| Primary | Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Second Vaccination | Within 30 days after second vaccination | |
| Primary | Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Third Vaccination | Within 30 days after third vaccination | |
| Primary | Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Any Vaccination | Within 30 days after any vaccination | |
| Primary | Percentage of Participants With at Least 1 Serious Adverse Event (SAE) During the Follow-up Phase | From 1 month after third vaccination up to 6 months after the third vaccination | |
| Primary | Percentage of Participants With at Least 1 Serious Adverse Event (SAE) During the Vaccination Phase | From the first vaccination up to 1 month after the third vaccination | |
| Primary | Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Throughout the Study Period | From the first vaccination up to 6 month after the third vaccination | |
| Primary | Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After First Vaccination | Within 30 days after first vaccination |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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GET https://conductscience.org/api/trials/v1/NCT01352845/registered