Trial · NCT01352845
Outcomes47
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 47
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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 | Evaluable immunogenicity population: all eligible participants randomized, who received correct investigational product, had pre/post vaccination blood drawn at pre-specified time points, had valid and determinate assay results for proposed analysis, received no prohibited treatment or prohibited vaccines, and had no major protocol violations. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After First Vaccination | Within 7 days after first vaccination | Safety population for first vaccination included all participants who received the first dose of investigational product (rLP2086 or saline) and for whom safety information was available from first vaccination until prior to second vaccination. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Second Vaccination | Within 7 days after second vaccination | Safety population for second vaccination included all participants who received the second dose of investigational product (rLP2086 or saline) and for whom safety information was available from second vaccination until prior to third vaccination. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Third Vaccination | Within 7 days after third vaccination | Safety population for third vaccination included all participants who received the third dose of investigational product (rLP2086 or saline) and for whom safety information was available from third vaccination until post third-vaccination blood draw. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination | Within 7 days after first vaccination | Safety population for first vaccination included all participants who received the first dose of investigational product (rLP2086 or saline) and for whom safety information was available from first vaccination until prior to second vaccination. Here, 'N' signifies participants with known values reporting specific characteristic. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination | Within 7 days after second vaccination | Safety population for second vaccination included all participants who received the second dose of investigational product (rLP2086 or saline) and for whom safety information was available from second vaccination until prior to third vaccination. Here, 'N' signifies participants with known values reporting specific characteristic. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination | Within 7 days after third vaccination | Safety population for third vaccination included all participants who received the third dose of investigational product (rLP2086 or saline) and for whom safety information was available from third vaccination until post third-vaccination blood draw. Here, 'N' signifies participants with known values reporting specific characteristic. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After First Vaccination | Within 30 days after first vaccination | Safety population for first vaccination included all participants who received the first dose of investigational product (rLP2086 or saline) and for whom safety information was available from first vaccination until prior to second vaccination. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Second Vaccination | Within 30 days after second vaccination | Safety population for second vaccination included all participants who received the second dose of investigational product (rLP2086 or saline) and for whom safety information was available from second vaccination until prior to third vaccination. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Third Vaccination | Within 30 days after third vaccination | Safety population for third vaccination included all participants who received the third dose of investigational product (rLP2086 or saline) and for whom safety information was available from third vaccination until post third-vaccination blood draw. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Any Vaccination | Within 30 days after any vaccination | Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or saline) and had safety data available. | Percentage of participants | NUMBER |
| 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 | Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or saline) and had safety data available. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After First Vaccination | Within 30 days after first vaccination | Safety population for first vaccination included all participants who received the first dose of investigational product (rLP2086 or saline) and for whom safety information was available from first vaccination until prior to second vaccination. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Second Vaccination | Within 30 days after second vaccination | Safety population for second vaccination included all participants who received the second dose of investigational product (rLP2086 or saline) and for whom safety information was available from second vaccination until prior to third vaccination. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Third Vaccination | Within 30 days after third vaccination | Safety population for third vaccination included all participants who received the third dose of investigational product (rLP2086 or saline) and for whom safety information was available from third vaccination until post third-vaccination blood draw. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Any Vaccination | Within 30 days after any vaccination | Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or saline) and had safety data available. | Percentage of participants | NUMBER |
| 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 | Safety population: all participants who had at least 1 dose of investigational product (rLP2086 or saline) for whom safety information was available from after post-vaccination 3 blood draw to 6 months after last study vaccination. | Percentage of participants | NUMBER |
| 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 | Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or saline) and had safety data available. | Percentage of participants | NUMBER |
| 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 | Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or saline) and had safety data available. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After First Vaccination | Within 30 days after first vaccination | Safety population for first vaccination included all participants who received the first dose of investigational product (rLP2086 or saline) and for whom safety information was available from first vaccination until prior to second vaccination. | Percentage of participants | NUMBER |
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.
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