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

NCT02212457 | Completed Phase 2 Results

• 3 other identifiers: 205215V102_152013-002451-15
• Study Type: interventional
• Target: 1,063
• Locations: 3 countries
• Sites: 32

Brief Summary

The main purposes for conducting the study are firstly 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, secondly to give the flexibility for the national vaccination program by showing the safety and immunogenicity of MenABCWY administrated according to four different vaccination schedules and additionally to evaluate a potential benefit of the 3-dose vaccination series.

Conditions

Infections, Meningococcal

Outcome Measures

Primary Outcomes (1)

• Human Serum Bactericidal Assay (hSBA) Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup B Test Strains When Administered According to 0_2 Month Schedule.

  The non-inferiority of the Meningococcal (groups A, C, W and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant (MenABCWY) vaccine to Meningococcal (group B) multicomponent recombinant adsorbed (Bexsero) 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, is reported. The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab. This outcome measure was evaluated in the rMenB\_0\_2 and ABCWY\_ 0\_2 Groups.

  At baseline (Month 0) and 1 month after the last meningococcal vaccination (Month 3)

Secondary Outcomes (23)

• 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.

  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.

  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.

  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.

  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.

  At 1 month after last vaccination (Month 7)

Study Arms (6)

rMenB_0_2 Group

EXPERIMENTAL

Subjects received two injections of Bexsero vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.

Biological: Bexsero; Other: Saline Placebo; Biological: Havrix

ABCWY_ 0_2 Group

EXPERIMENTAL

Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.

Other: Saline Placebo; Biological: Havrix; Biological: MenABCWY

ABCWY_0_1 Group

EXPERIMENTAL

Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 1, Havrix vaccine at Visit Month 2 and Visit Month 12 and saline placebo at Visit Month 6.

Other: Saline Placebo; Biological: Havrix; Biological: MenABCWY

ABCWY_0_6 Group

EXPERIMENTAL

Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 6, Havrix vaccine at Visit Month 1 and Visit Month 12 and saline placebo at Visit Month 2.

Other: Saline Placebo; Biological: Havrix; Biological: MenABCWY

ABCWY_0_11 Group

EXPERIMENTAL

Subjects received MenABCWY vaccine at Visit Month 1 and Visit Month 12, Havrix vaccine at Visit Month 0 and Visit Month 6 and saline placebo at Visit Month 2.

Other: Saline Placebo; Biological: Havrix; Biological: MenABCWY

ABCWY_0_2_6 Group

EXPERIMENTAL

Subjects received MenABCWY vaccine at Visit Month 0, Visit Month 2 and Visit Month 6 and Havrix vaccine at Visit Month 1 and Visit Month 12.

Biological: Havrix; Biological: MenABCWY

Interventions

Bexsero BIOLOGICAL

Two doses administered intramuscularly into the deltoid area at Months 0 and 2 in rMenB\_0\_2 Group.

rMenB_0_2 Group

Saline Placebo OTHER

One dose administered intramusculary in the deltoid muscle at Month 1 in ABCWY\_ 0\_2 Group and rMenB\_0\_2 Group, Month 2 in ABCWY\_0\_6 Group and ABCWY\_0\_11 Group and Month 6 in ABCWY\_0\_1 Group.

ABCWY_ 0_2 Group; ABCWY_0_1 Group; ABCWY_0_11 Group; ABCWY_0_6 Group; rMenB_0_2 Group

Havrix BIOLOGICAL

Two doses administered in the deltoid muscle at Month 2 and 12 in ABCWY\_0\_1 Group, Month 1 and 12 in Group ABCWY\_0\_6 Group and ABCWY\_0\_2\_6 Group , Month 0 and 6 in ABCWY\_0\_11 Group and Month 6 and 12 in ABCWY\_ 0\_2 Group and rMenB\_0\_2 Group.

ABCWY_ 0_2 Group; ABCWY_0_1 Group; ABCWY_0_11 Group; ABCWY_0_2_6 Group; ABCWY_0_6 Group; rMenB_0_2 Group

MenABCWY BIOLOGICAL

Two to three doses administered in the deltoid muscle at Month 0 and 1 in ABCWY\_0\_1 Group, Month 0 and 6 in ABCWY\_0\_6 Group, Month 1 and 12 in ABCWY\_0\_11 Group, Month 0, 2 and 6 in ABCWY\_0\_2\_6 Group, Month 0 and 2 in ABCWY\_ 0\_2 Group and rMenB\_0\_2 Group.

ABCWY_ 0_2 Group; ABCWY_0_1 Group; ABCWY_0_11 Group; ABCWY_0_2_6 Group; ABCWY_0_6 Group

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Serious, acute, or chronic illness. Previous or suspected disease caused by N. meningitidis. Previous immunization with any menincococcal or Hepatitis A vaccines.
• Exposure to individuals with clicically proven meningococcal disease or clinical bacterial meningitis without further microbiologic characteriszation.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (32)

GSK Investigational Site

Jonesboro, Arkansas, 72401, United States

Location

GSK Investigational Site

Hialeah, Florida, 33012, United States

Location

GSK Investigational Site

Melbourne, Florida, 32934, United States

Location

GSK Investigational Site

Augusta, Kansas, 67010, United States

Location

GSK Investigational Site

Niles, Michigan, 49120, United States

Location

GSK Investigational Site

Saint Paul, Minnesota, 55108, United States

Location

GSK Investigational Site

Bellevue, Nebraska, 68005, United States

Location

GSK Investigational Site

Omaha, Nebraska, 68114, United States

Location

GSK Investigational Site

Binghamton, New York, 13901, United States

Location

GSK Investigational Site

Cleveland, Ohio, 44122, United States

Location

GSK Investigational Site

Dayton, Ohio, 45406, United States

Location

GSK Investigational Site

Charleston, South Carolina, 29414, United States

Location

GSK Investigational Site

Mt. Pleasant, South Carolina, 29464, United States

Location

GSK Investigational Site

Espoo, 02230, Finland

Location

GSK Investigational Site

Helsinki, 00100, Finland

Location

GSK Investigational Site

Helsinki, 00930, Finland

Location

GSK Investigational Site

Jarvenpaa, 04400, Finland

Location

GSK Investigational Site

Kokkola, 67100, Finland

Location

GSK Investigational Site

Oulu, 90200, Finland

Location

GSK Investigational Site

Pori, 28100, Finland

Location

GSK Investigational Site

Seinäjoki, 60100, Finland

Location

GSK Investigational Site

Tampere, 33100, Finland

Location

GSK Investigational Site

Turku, 20520, Finland

Location

GSK Investigational Site

Vantaa, 01300, Finland

Location

GSK Investigational Site

Dębica, 39200, Poland

Location

GSK Investigational Site

Gdansk, 80 542, Poland

Location

GSK Investigational Site

Gdansk, 80-546, Poland

Location

GSK Investigational Site

Lodz, 91347, Poland

Location

GSK Investigational Site

Osielsko, 86031, Poland

Location

GSK Investigational Site

Siemianowice Śląskie, 41 103, Poland

Location

GSK Investigational Site

Warsaw, 01809, Poland

Location

GSK Investigational Site

Wroclaw, 50368, Poland

Location

MeSH Terms

Conditions

Meningococcal Infections

Interventions

4CMenB vaccine; Hepatitis A Vaccines

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Viral Hepatitis Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2014
• First Posted: August 8, 2014
• Study Start: August 21, 2014
• Primary Completion: May 22, 2015
• Study Completion: March 3, 2016
• Last Updated: June 27, 2019
• Results First Posted: July 21, 2017

Record last verified: 2019-06

Locations

US (13); FI (11); PL (8)