Full name
A Phase I/II, Randomised, Controlled Study to Assess the Safety, Effectiveness and Immune Response of Meningococcal Combined ABCWY Vaccine When Administered to Healthy Adults (Phase I) and to Healthy Adolescents and Adults (Phase II)
NCT Number
NCT04886154
Geography
US
Non-US
Locations
Australia, Belgium, Brazil, Finland, Poland, Sweden, Turkey, United States
Primary Endpoints
- Percentages of participants with solicited administration site events in study Phase I (Safety Lead-in). During the 7 days (including the day of vaccination) following vaccination at Day 1
- Percentages of participants with solicited administration site events in study Phase I (Safety Lead-in). During the 7 days (including the day of vaccination) following vaccination at Day 31
- Percentages of participants with solicited systemic events in study Phase I (Safety Lead-in). During the 7 days (including the day of vaccination) following vaccination at Day 1
- Percentages of participants with solicited systemic events in study Phase I (Safety Lead-in). During the 7 days (including the day of vaccination) following vaccination at Day 31
- Percentages of participants with any unsolicited adverse events (AEs), including all serious adverse events (SAEs), AEs leading to withdrawal and AEs of special interest (AESIs) in study Phase I (Safety Lead-in). During the 30 days (including the day of vaccination) following vaccination at Day 1
- Percentages of participants with any unsolicited adverse events (AEs), including all serious adverse events (SAEs), AEs leading to withdrawal and AEs of special interest (AESIs) in study Phase I (Safety Lead-in). During the 30 days (including the day of vaccination) following vaccination at Day 31
- Percentages of participants with SAEs, AEs leading to withdrawal and AESIs in study Phase I (Safety Lead-in). Throughout the study period (Day 1 through Day 211)
- Percentages of participants with haematological and biochemical laboratory abnormalities, and changes from the baseline values, in study Phase I (Safety Lead-in). At Day 8 after the first vaccination
- Percentages of samples with bactericidal serum activity against a panel of 110 randomly selected endemic US N. meningitidis serogroup B invasive disease strains in study Phase II (Formulation and Schedule-finding). At Day 211 (1 month after the last vaccination)
- https://clinicaltrials.gov/study/NCT04886154?term=NCT04886154&rank=1#:~:text=the%20last%20vaccination)-,Percentages%20of%20participants%20with%20a%204%2Dfold%20rise%20in%20hSBA%20titers%20against%20serogroups%20A%2C%20C%2C%20W%20and%20Y%20in%20study%20Phase%20II%20(Formulation%20and%20Schedule%2Dfinding),-The%20immune%20response. At 1 month after the vaccination schedule (i.e., Day 211 for the ABCWY groups and at Day 31 the Control group)
- Percentages of participants with solicited administration site events in study Phase II (Formulation and Schedule-finding). During the 7 days (including the day of vaccination) following vaccination at Day 1
- Percentages of participants with solicited administration site events in study Phase II (Formulation and Schedule-finding). During the 7 days (including the day of vaccination) following vaccination at Day 121
- Percentages of participants with solicited administration site events in study Phase II (Formulation and Schedule-finding). During the 7 days (including the day of vaccination) following vaccination at Day 181
- Percentages of participants with any unsolicited AEs (including all SAEs, AEs leading to withdrawal, and AESIs) in study Phase II (Formulation and Schedule-finding). During the 30 days (including the day of vaccination) following vaccination at Day 1
- Percentages of participants with any unsolicited AEs (including all SAEs, AEs leading to withdrawal, and AESIs) in study Phase II (Formulation and Schedule-finding). During the 30 days (including the day of vaccination) following vaccination at Day 121
- Percentages of participants with any unsolicited AEs (including all SAEs, AEs leading to withdrawal, and AESIs) in study Phase II (Formulation and Schedule-finding). During the 30 days (including the day of vaccination) following vaccination at Day 181
- Percentages of participants with SAEs, AEs leading to withdrawal and AESIs in study Phase II (Formulation and Schedule-Finding). Throughout the study period (Day 1 through Day 541)
- Percentages of participants with solicited administration site events in study Phase II (Sourcing). During the 7 days (including the day of vaccination) following vaccination at Day 1
- Percentages of participants with solicited administration site events in study Phase II (Sourcing). During the 7 days (including the day of vaccination) following vaccination at Day 31
- Percentages of participants with solicited administration site events in study Phase II (Sourcing). During the 7 days (including the day of vaccination) following vaccination at Day 61
- Percentages of participants with solicited administration site events in study Phase II (Sourcing). During the 7 days (including the day of vaccination) following vaccination at Day 181
- Percentages of participants with solicited systemic events in study Phase II (Sourcing). During the 7 days (including the day of vaccination) following vaccination at Day 1
- Percentages of participants with solicited systemic events in study Phase II (Sourcing). During the 7 days (including the day of vaccination) following vaccination at Day 31
- Percentages of participants with solicited systemic events in study Phase II (Sourcing). During the 7 days (including the day of vaccination) following vaccination at Day 61
- Percentages of participants with solicited systemic events in study Phase II (Sourcing). During the 7 days (including the day of vaccination) following vaccination at Day 181
- Percentages of participants with any unsolicited AEs (including all SAEs, AEs leading to withdrawal, and AESIs) in study Phase II (Sourcing). During the 30 days (including the day of vaccination) following vaccination at Day 1
- Percentages of participants with any unsolicited AEs (including all SAEs, AEs leading to withdrawal, and AESIs) in study Phase II (Sourcing). During the 30 days (including the day of vaccination) following vaccination at Day 31
- Percentages of participants with any unsolicited AEs (including all SAEs, AEs leading to withdrawal, and AESIs) in study Phase II (Sourcing). During the 30 days (including the day of vaccination) following vaccination at Day 61
- Percentages of participants with any unsolicited AEs (including all SAEs, AEs leading to withdrawal, and AESIs) in study Phase II (Sourcing). During the 30 days (including the day of vaccination) following vaccination at Day 181
- Percentages of participants with SAEs, AEs leading to withdrawal and AESIs in study Phase II (Sourcing). Throughout the study period (Day 1 through Day 211)
- Percentages of participants with SAEs, AEs leading to withdrawal and AESIs in study Phase II (Sourcing). Throughout the study period (Day 1 through Day 241)
- Percentages of participants with SAEs, AEs leading to withdrawal and AESIs in study Phase II (Sourcing). Throughout the study period (Day 1 through Day 361)
External Link
https://clinicaltrials.gov/study/NCT04886154
Order
0
Disease
Version
Phase
1/2