Trial to Assess Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Meningococcal ABCWY Vaccine as Compared to Meningococcal B Vaccine in Adolescents
Trial overview
Human Serum Bactericidal Assay (hSBA) Geometric Mean Titers (GMTs) against N. meningitidis serogroup B test strains when administered according to 0_2 month schedule.
Timeframe: At baseline (Month 0) and 1 month after the last meningococcal vaccination (Month 3)
hSBA GMTs against N. meningitidis serogroups A, C, W and Y and serogroup B test strains when administered according to 0_2_6 month and 0_2 month schedule.
Timeframe: At baseline (Month 0) and 1 month after the last meningococcal vaccination (Month 3 for ABCWY_ 0_2 Group and Month 7 for ABCWY_0_2_6 Group)
Percentages of subjects with hSBA titers ≥LLQ against N. meningitidis serogroups A, C, W and y and serogroup B test strains when administered according to 0_2_6 month and 0_2 month schedule.
Timeframe: At baseline (Month 0) and 1 month after the last meningococcal vaccination (Month 3 for ABCWY_ 0_2 Group and Month 7 for ABCWY_0_2_6 Group)
hSBA GMTs against each of N. meningitidis serogroups A, C, W and Y and serogroup B test strains when administered according to 0_1 month, 0_2 month, 0_6 month and 0, 11 month schedule.
Timeframe: At 1 Month after the last vaccination (Month 2 for ABCWY_0_1 Group, Month 3 for ABCWY_0_2 Group, Month 7 for ABCWY_0_6 Group and Month 13 for ABCWY_0_11 Group)
Percentages of subjects with hSBA titers ≥ Lower Limit of Quantitation (LLQ) against N. meningitidis serogroup B test strains when administered according to 0_2 month schedule.
Timeframe: At baseline (Month 0) and 1 month after the last meningococcal vaccination (Month 3)
hSBA GMTs against N. meningitidis serogroups A, C, W and Y and serogroup B test strains when administered according to 0_2_6 month and 0_6 month schedule.
Timeframe: At 1 month after last vaccination (Month 7)
Percentages of subjects with hSBA titers ≥ Lower Limit of Quantitation (LLQ) against serogroups A, C, W and Y and serogroup B test strains when administered according to 0_2_6 month and 0_6 month schedule.
Timeframe: At baseline (Month 0) and 1 month after the last meningococcal vaccination (Month 7)
Percentages of subjects with hSBA titers ≥ LLQ against N. meningitidis serogroups A, C, W and Y and serogroup B test strains when administered according to 0_1 month, 0_2 month, 0_6 month and 0_11 month schedule.
Timeframe: At 1 month after second vaccination (Month 2 for ABCWY_0_1 Group, Month 3 for ABCWY_0_2 Group , Month 7 for ABCWY_0_6 Group and Month 13 for ABCWY_0_11 Group)
hSBA GMTs against serogroups A, C, W and Y and serogroup B test strains at all the relevant time points for all schedules.
Timeframe: At Month 0, Month 2, Month 3, Month 7 and Month 13
Percentages of subjects with hSBA titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 against NZ98/254 B strain for all schedules.
Timeframe: At Month 0, Month 2, Month 3, Month 7 and Month 13.
Percentages of subjects with hSBA titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 against M14459 B strain for all schedules.
Timeframe: At Month 0, Month 2, Month 3, Month 7 and Month 13.
Percentages of subjects with hSBA titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 against M07-0241084 B strain for all schedules.
Timeframe: At Month 0, Month 2, Month 3, Month 7 and Month 13.
Percentages of subjects with hSBA titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 against 96217 B strain for all schedules.
Timeframe: At Month 0, Month 2, Month 3, Month 7 and Month 13.
Percentages of subjects with hSBA titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 against A human serogroup for all schedules.
Timeframe: At Month 0, Month 2, Month 3, Month 7 and Month 13.
Percentages of subjects with hSBA titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 against C human serogroup for all schedules.
Timeframe: At Month 0, Month 2, Month 3, Month 7 and Month 13.
Percentages of subjects with hSBA titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 against W human serogroup for all schedules.
Timeframe: At Month 0, Month 2, Month 3, Month 7 and Month 13.
Percentages of subjects with hSBA titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 against Y human serogroup for all schedules.
Timeframe: At Month 0, Month 2, Month 3, Month 7 and Month 13.
Percentages of subjects with two-, three- and four-fold titer rise against serogroups A, C, W and Y and serogroup B test Strains for all schedules.
Timeframe: At Month 2, Month 3, Month 7 and Month 13
The area under the curve (AUC) for percentage of subjects with hSBA titers ≥LLQ for all serogroups and strains.
Timeframe: From Month 0 to Month 13
Number of participants reporting any solicited local or systemic AEs and other indicators of reactogenicity within 30 minutes after vaccination.
Timeframe: Within 30 minutes after vaccination
Number of participants reporting any unsolicited AEs within 30 minutes after vaccination.
Timeframe: Within 30 minutes after vaccination
Number of participants reporting unsolicited AEs from Day 1 to Day 30 after any vaccination.
Timeframe: Day 1 through Day 30 after any vaccination
Number of participants reporting any solicited local or systemic adverse events (AEs) and other indicators of reactogenicity from Day 1 to Day 7.
Timeframe: At Day 1 (6 hours) to Day 7 after vaccination
Number of participants reporting any serious AE (SAE), medically attended AEs (MAAEs), AEs leading to premature withdrawal
Timeframe: During the entire study period (Month 0 to Month 13)
Participation criteria
- 1.) Adolecents from 10-18 yearsof age, generally in good health, and available for all study visits, and who/whose legally acceptable representative has given written informed consent at the time of enrollment.
- 2.)Individuals of who the investigator believes can and will comply with the requirements of the protocol (e.g. use of an eDiary, return for follow-up visits, available for phone contacts).
- 1.) Serious, acute, or chronic illness. Previous or suspected disease caused by N. meningitidis. Previous immunization with any menincococcal or Hepatitis A vaccines.
- 2.) Exposure to individuals with clicically proven meningococcal disease or clinical bacterial meningitis without further microbiologic characteriszation.
- 1.) Adolecents from 10-18 yearsof age, generally in good health, and available for all study visits, and who/whose legally acceptable representative has given written informed consent at the time of enrollment. 2.)Individuals of who the investigator believes can and will comply with the requirements of the protocol (e.g. use of an eDiary, return for follow-up visits, available for phone contacts). 3.)Female subjects of childbearing potential must have a negative urine preganancy test.
- 1.) Serious, acute, or chronic illness. Previous or suspected disease caused by N. meningitidis. Previous immunization with any menincococcal or Hepatitis A vaccines. 2.) Exposure to individuals with clicically proven meningococcal disease or clinical bacterial meningitis without further microbiologic characteriszation.
Trial location(s)
Study documents
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.