A Phase 3, Randomized, Placebo-controlled, Observer-blinded, Trial To Assess The Safety, Tolerability, And Immunogenicity Of Bivalent Rlp2086 Vaccine When Administered As A 3-dose Regimen In Healthy Young Adults Aged >=18 To <26 Years
Abstract
This study is looking at a new vaccine that might prevent meningococcal disease, and will study the immune response elicited by this vaccine when given to healthy young adults. The study will also look at the safety of the new vaccine as well as how it is tolerated.
Conditions: Healthy.
Primary outcome: 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; Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After First Vaccination; Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Second Vaccination; Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Third Vaccination; Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination; Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination; Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination; Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After First Vaccination; Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Second Vaccination; Percentage of Participants With at Least…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 3,301 participants or records.
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