The purpose of VAN00010 study is to assess the safety and immunogenicity of the investigational pentavalent meningococcal ABCYW vaccine in adults and adolescents. The study duration will be up to 12 months for all participants.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Number of participants with immediate adverse events (AEs)
Timeframe: Within 30 minutes after each vaccination
Number of participants with solicited injection site reactions or systemic reactions
Timeframe: Within 7 days after each vaccination
Number of participants with unsolicited AEs
Timeframe: Within 30 days after each vaccination
Number of participants with serious adverse events (SAEs)
Timeframe: From baseline up to 12 months
Number of participants with medically attended adverse events (MAAEs)
Timeframe: From baseline up to 12 months
Number of participants with out-of-range biological test results
Timeframe: Before each vaccination up to 7 days after primary vaccination visits in the sentinel cohorts (the first 5 participants enrolled in each vaccine group) of each age group
hSBA meningococcal serogroups A, C, W, and Y vaccine seroresponse pre-dose and 1 month after the second dose in adolescent participants
Timeframe: Day 01 (pre-dose) and Day 211 (for Group 1 to 7)
hSBA meningococcal serogroups A, C, W, and Y antibody titers pre-dose and 1 month after the second dose in adolescent participants
Timeframe: Day 211 (for Group 1 to 7)
Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroups A, C, W and Y pre-dose and 1 month after the second dose in adolescent participants
Timeframe: Day 01 (pre-dose) and Day 31 Day 211 (for Group 1 to 7)
Percentage of participants with hSBA titers more or equal to lower limit of quantification (LLOQ) against each of serogroups A, C, W, and Y in adolescent participants
Timeframe: Day 01 (pre-dose) Day 211 (for Group 1 to 7)
hSBA meningococcal serogroup B seroresponse pre-dose and 1 month after second dose in adolescent participants
Timeframe: Day 01 (pre-dose) and Day 211 (for Group 1 to 7)
Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference MenB strains) ≥ 1:4 pre-dose 1 and 1 month post-second dose in adolescent participants
Timeframe: Day 01 (pre-dose) and Day 211 (for Group 1 to 7)
Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference MenB strains) ≥ 1:8 pre-dose 1 and 1 month post-second dose in adolescent participants
Timeframe: Day 01 (pre-dose) and Day 211 (for Group 1 to 7)
Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroup B (reference MenB strains) pre-dose 1 and 1 month post-second dose in adolescent participants
Timeframe: Day 01 (pre-dose) and Day 211 (for Group 1 to 7)
Percentage of participants with hSBA titers more or equal to lower limit of quantification (LLOQ) against each and all serogroups B (reference MenB strains) in adolescent participants
Timeframe: Day 01 (pre-dose) and Day 211 (for Group 1 to 7)