Study conducted in healthy adolescents to evaluate safety and antibody response after the administration of different schedules of a vaccine produced by GSK Vaccines and Diagnostics compared to GSK Meningococcal group B vaccineand and directed against Meningococcal serogroup A, B, C, Y and W strains.

A Phase 2b, Randomized, Controlled, Observer-Blind, Multi-Center Study Assessing the Immunogenicity and Safety of GSK Meningococcal ABCWY Vaccine Administered at Different Schedules Compared to GSK Meningococcal group B vaccine, in Healthy Adolescents

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-002451-15-FI

Enrollment

1050

Registered

2014-05-27

Start date

2014-09-19

Completion date

Unknown

Last updated

2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The current study is designed to assess immunological non-inferiority of the MenABCWY vaccine, administered according to 0, 2 month schedule to healthy adolescents 10 to 18 years of age, to those of the licensed rMenB+OMV vaccine (Bexsero™) in terms of hSBA GMTs at one month after the second vaccination. MedDRA version: 19.0 Level: PT Classification code 10027202 Term: Meningitis bacterial System Organ Class: 10021881 - Infections and infestations

Interventions

Product Name: MenACYW conjugate combined with rMenB + OMV Product Code: MenABCWY Pharmaceutical Form: Powder and suspension for suspension for injection INN or Proposed INN: Recombinant Neisseria men

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adolescents from 10-18 years of age, generally in good health, and available for all study visits, who/whose legally acceptable representative has given written informed consent at the time of enrollment. Female subjects of childbearing potential must have a negative urine pregnancy test. Are the trial subjects under 18? yes Number of subjects for this age range: 1050 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Serious, acute, or chronic illnesses. Previous or suspected disease caused by N. meningitidis. Previous immunization with any meningococcal vaccine or Hepatitis A vaccine. Exposure to individuals with clinically proven meningococcal disease or clinical bacterial meningitis without further microbiologic characterization

Design outcomes

Primary

Measure	Time frame
Main Objective: 1. To demonstrate the non-inferiority of the MenABCWY vaccine to that of the rMenB+OMV vaccine, administered according to 0, 2 month schedule, as measured by hSBA GMTs against N. meningitidis serogroup B test strains at 1 month after the last meningococcal vaccination.;Secondary Objective: Secondary Safety Objective: 1. To assess reactogenicity and safety of the study vaccines. Secondary Immunogenicity Objectives: 1. To demonstrate a sufficient immune response following rMenB+OMV vaccine, administered according to 0, 2 month schedule, as measured by the percentage of subjects with hSBA titers = Lower Limit of Quantitation (LLQ) against N. meningitidis serogroup B test strains1 at 1 month after the last meningococcal vaccination. 2. To assess the immunogenicity of MenABCWY vaccine, administered according to 0, 2, 6 months schedule, and according to 0, 2 month schedule, as measured by percentages of subjects with hSBA titers = LLQ and hSBA GMTs against N. meningitidis serogroups A, C, W and Y and serogroup B test strains1 at 1 month after the last meningococcal vaccination ;Primary end point(s): Primary Immunogenicity Endpoints: The following measures will be summarized for subjects in the B_0_2 and ABCWY_0_2 groups at 1 month after the last meningococcal vaccination: • hSBA GMTs against each of N. meningitidis serogroup B test strains . ;Timepoint(s) of evaluation of this end point: 1 month after the last meningococcal vaccination.	—

Measure

Time frame

Main Objective: 1. To demonstrate the non-inferiority of the MenABCWY vaccine to that of the rMenB+OMV vaccine, administered according to 0, 2 month schedule, as measured by hSBA GMTs against N. meningitidis serogroup B test strains at 1 month after the last meningococcal vaccination.;Secondary Objective: Secondary Safety Objective: 1. To assess reactogenicity and safety of the study vaccines. Secondary Immunogenicity Objectives: 1. To demonstrate a sufficient immune response following rMenB+OMV vaccine, administered according to 0, 2 month schedule, as measured by the percentage of subjects with hSBA titers = Lower Limit of Quantitation (LLQ) against N. meningitidis serogroup B test strains1 at 1 month after the last meningococcal vaccination. 2. To assess the immunogenicity of MenABCWY vaccine, administered according to 0, 2, 6 months schedule, and according to 0, 2 month schedule, as measured by percentages of subjects with hSBA titers = LLQ and hSBA GMTs against N. meningitidis serogroups A, C, W and Y and serogroup B test strains1 at 1 month after the last meningococcal vaccination ;Primary end point(s): Primary Immunogenicity Endpoints: The following measures will be summarized for subjects in the B_0_2 and ABCWY_0_2 groups at 1 month after the last meningococcal vaccination: • hSBA GMTs against each of N. meningitidis serogroup B test strains . ;Timepoint(s) of evaluation of this end point: 1 month after the last meningococcal vaccination.

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Secondary

Measure	Time frame
Secondary end point(s): Secondary Safety Endpoints: • Any solicited and unsolicited AEs reported within 30 minutes after each vaccination; • Solicited local and systemic AEs reported from Day 1 (6 hours) to Day 7 after each and any vaccination; • Other indicators of reactogenicity (e.g. use of analgesics / antipyretics, body temperature) within 7 days after each and any vaccination; • Unsolicited AEs reported from Day 1 to Day 30 after each and any vaccination; • Medically-attended AEs reported during the entire study period; • AEs leading to premature withdrawal from the study during the entire study period; • SAEs reported during the entire study period. Secondary Immunogenicity Endpoints: The following measures will be summarized for all subjects at 1 month after the last meningococcal vaccination: • hSBA GMTs against each of N. meningitidis serogroups A, C, W and Y and serogroup B test strains1. The following measures will be summarized for all subjects at Month 0 (baseline), Month 2, Month 3, Month 7, and Month 13: • Percentage of subjects with hSBA titers = LLQ, = 5, = 8, = 16, = 32, = 64, = 128 against N. meningitidis serogroups A, C, W and Y and serogroup B test strains . • Percentage of subjects with hSBA titers =LLQ against each of four N. meningitidis serogroups (A, C, W and Y) and against each of four serogroup B test strains1. Percentage of subjects with hSBA titers =LLQ against N. meningitidis serogroups C and Y, and against each of the three serogroup B test strains (M14459 (fHbp), 96217 (NadA) and M07-0241084 (NHBA)).The following measures will be summarized for all subjects at Month 2, Month 3, Month 7, and Month 13 with respect to baseline (Month 0): • Percentages of subjects with two-, three-, and four-fold rise in hSBA titers against the N. meningitidis serogroups A, C, W and Y and serogroup B test strains. The following measures will be summarized for all subjects, overall (from Month 0 to Month 13) and by period (from Month 0	—

Measure

Time frame

Secondary end point(s): Secondary Safety Endpoints: • Any solicited and unsolicited AEs reported within 30 minutes after each vaccination; • Solicited local and systemic AEs reported from Day 1 (6 hours) to Day 7 after each and any vaccination; • Other indicators of reactogenicity (e.g. use of analgesics / antipyretics, body temperature) within 7 days after each and any vaccination; • Unsolicited AEs reported from Day 1 to Day 30 after each and any vaccination; • Medically-attended AEs reported during the entire study period; • AEs leading to premature withdrawal from the study during the entire study period; • SAEs reported during the entire study period. Secondary Immunogenicity Endpoints: The following measures will be summarized for all subjects at 1 month after the last meningococcal vaccination: • hSBA GMTs against each of N. meningitidis serogroups A, C, W and Y and serogroup B test strains1. The following measures will be summarized for all subjects at Month 0 (baseline), Month 2, Month 3, Month 7, and Month 13: • Percentage of subjects with hSBA titers = LLQ, = 5, = 8, = 16, = 32, = 64, = 128 against N. meningitidis serogroups A, C, W and Y and serogroup B test strains . • Percentage of subjects with hSBA titers =LLQ against each of four N. meningitidis serogroups (A, C, W and Y) and against each of four serogroup B test strains1. Percentage of subjects with hSBA titers =LLQ against N. meningitidis serogroups C and Y, and against each of the three serogroup B test strains (M14459 (fHbp), 96217 (NadA) and M07-0241084 (NHBA)).The following measures will be summarized for all subjects at Month 2, Month 3, Month 7, and Month 13 with respect to baseline (Month 0): • Percentages of subjects with two-, three-, and four-fold rise in hSBA titers against the N. meningitidis serogroups A, C, W and Y and serogroup B test strains. The following measures will be summarized for all subjects, overall (from Month 0 to Month 13) and by period (from Month 0

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Countries

Finland, Poland, United States

Contacts

Public ContactClinical Disclosure Advisor

GSK Vaccines

GSKClinicalSupportHD@gsk.com+4420899 4466

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026