Trial to Assess Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Meningococcal ABCWY Vaccine as Compared to Meningococcal B Vaccine in Adolescents

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02212457
• Date of registration: 06/08/2014
• Prospective Registration: Yes
• Primary sponsor: GlaxoSmithKline
• Public title: Trial to Assess Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Meningococcal ABCWY Vaccine as Compared to Meningococcal B Vaccine in Adolescents
• Scientific title: 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
• Date of first enrolment: August 21, 2014
• Target sample size: 1063
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02212457
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Finland, Poland, United States

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

Key inclusion & exclusion criteria

Inclusion 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).

3. Female subjects of childbearing potential must have a negative urine preganancy test.

Exclusion Criteria:

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.



Age minimum: 10 Years
Age maximum: 18 Years
Gender: All

Health Condition(s) or Problem(s) studied

Infections, Meningococcal

Intervention(s)

Biological: Bexsero

Biological: Havrix

Other: Saline Placebo

Biological: MenABCWY

Primary Outcome(s)

Human Serum Bactericidal Assay (hSBA) Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup B Test Strains When Administered According to 0_2 Month Schedule. [Time Frame: At baseline (Month 0) and 1 month after the last meningococcal vaccination (Month 3)]

Secondary Outcome(s)

Number of Participants Reporting Any Unsolicited AEs Within 30 Minutes After Vaccination. [Time Frame: Within 30 minutes after vaccination]

Percentages of Subjects With hSBA Titers =LLQ, =5, =8, =16, =32, =64, =128 Against M14459 B Strain for All Schedules. [Time Frame: At Month 0, Month 2, Month 3, Month 7 and Month 13.]

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. [Time Frame: At 1 month after last vaccination (Month 7)]

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. [Time Frame: At Month 2, Month 3, Month 7 and Month 13]

hSBA GMTs Against Serogroups A, C, W and Y and Serogroup B Test Strains at All the Relevant Time Points for All Schedules. [Time Frame: At Month 0, Month 2, Month 3, Month 7 and Month 13]

Number of Participants Reporting Unsolicited AEs From Day 1 to Day 30 After Any Vaccination. [Time Frame: Day 1 through Day 30 after any vaccination]

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. [Time Frame: At baseline (Month 0) and 1 month after the last meningococcal vaccination (Month 3)]

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. [Time Frame: 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, =5, =8, =16, =32, =64, =128 Against A Human Serogroup for All Schedules. [Time Frame: 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. [Time Frame: 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. [Time Frame: At Month 0, Month 2, Month 3, Month 7 and Month 13.]

Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. [Time Frame: At Day 1 (6 hours) to Day 7 after vaccination]

Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. [Time Frame: Within 30 minutes after vaccination]

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. [Time Frame: At baseline (Month 0) and 1 month after the last meningococcal vaccination (Month 7)]

Number of Participants Reporting Any Serious AE (SAE), Medically Attended AEs (MAAEs), AEs Leading to Premature Withdrawal [Time Frame: During the entire study period (Month 0 to Month 13)]

Percentages of Subjects With hSBA Titers =LLQ, =5, =8, =16, =32, =64, =128 Against M07-0241084 B Strain for All Schedules. [Time Frame: At Month 0, Month 2, Month 3, Month 7 and Month 13.]

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. [Time Frame: 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)]

Percentages of Subjects With hSBA Titers =LLQ, =5, =8, =16, =32, =64, =128 Against NZ98/254 B Strain for All Schedules. [Time Frame: 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. [Time Frame: At Month 0, 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. [Time Frame: From Month 0 to Month 13]

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. [Time Frame: 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)]

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. [Time Frame: 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, =5, =8, =16, =32, =64, =128 Against W Human Serogroup for All Schedules. [Time Frame: At Month 0, Month 2, Month 3, Month 7 and Month 13.]

Secondary ID(s)

205215

2013-002451-15

V102_15

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 21/07/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02212457