Last updated: 04/11/2025 06:31:02

Safety and Immunogenicity of Different Meningitis Vaccine Formulations in Adolescents and Young Adults

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GSK study ID
205281
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Clinicaltrials.gov ID
NCT01272180
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Phase 2, Observer Blinded, Controlled, Randomized Multi-Center Study in Adolescents and Young Adults to Evaluate Safety and Immunogenicity of Two Different rMenB With OMV + MenACWY Combination Vaccination Formulations
Trial description: This study will evaluate the safety and immunogenicity of combination vaccines as compared to the reference vaccines.
Primary purpose:
Not applicable
Trial design:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:

Percentages of Subjects With a Seroresponse Against N.Meningitidis Serogroups A,C,W-135,Y, After Receiving Different Formulations of MenABCWY Combination Vaccine.

Timeframe: One month after the second vaccination (Day 91)

Desirability Index for Each Vaccine Group, Based on Immunogenicity and Reactogenicity Parameters.

Timeframe: One month after the second vaccination (Day 91)

Secondary outcomes:

Percentages of Subjects With hSBA Titers ≥ 1:8 Against N.Meningitidis Serogroups A,C,W-135 and Y, After Vaccination With Different Formulations of MenABCWY Combination Vaccine.

Timeframe: Day 1 and one month after second vaccination (Day 91)

The hSBA GMTs Against N.Meningitidis Serogroups A,C,W-135 and Y, After Vaccination With Different Formulations of MenABCWY Combination Vaccine.

Timeframe: Day 1 and one month after the second vaccination (Day 91)

Percentages of Subjects With hSBA Titers ≥ 1:5 and ≥ 1:8 Against N.Meningitidis Serogroup B, After Vaccination With Different Formulations of MenABCWY Combination Vaccine.

Timeframe: Day 1 and one month after the second vaccination (Day 91)

Percentages of Subjects With at Least 4-fold Increase in hSBA Titers Against N.Meningitidis Serogroup B, After Vaccination With Different Formulations of MenABCWY Combination Vaccine.

Timeframe: One month after the second vaccination (Day 91)

The hSBA GMTs Against N.Meningitidis serogroupB, After Vaccination With Different Formulations of MenABCWY Combination Vaccine.

Timeframe: Day 1 and one month after the second vaccination (Day 91)

The Geometric Mean Ratio of Post vs Pre Vaccination GMTs Against N.Meningitidis Serogroup B, After Vaccination With Different Formulations of MenABCWY Combination Vaccine.

Timeframe: One month after the second vaccination/prevaccination (Day 91/day 1)

The Number of Subjects Reporting Solicited Adverse Events After Receiving Any Vaccination in This Study.

Timeframe: Day 1 through day 7 after any vaccination

The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Any Vaccination in This Study.

Timeframe: Throughout the study (Day 1 to Day 241)

Interventions:
Biological/vaccine: Meningococcal (groups A, C, W, Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine + OMV.
Biological/vaccine: Meningococcal (groups A, C, W, Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine + qOMV.
Biological/vaccine: Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus OMV.
Biological/vaccine: Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine.
Enrollment:
484
Observational study model:
Not applicable
Primary completion date:
2012-03-04
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Infections, Meningococcal
Product
Not applicable
Collaborators
Not applicable
Study date(s)
August 2011 to April 2012
Type
Interventional
Phase
2

Participation criteria

Sex
Female & Male
Age
10 - 25 Years
Accepts healthy volunteers
Yes
  • Healthy adolescents aged 10 through 25 years of
  • age inclusive at the time of enrollment.
  • History of any meningococcal vaccine
  • administration;
Inclusion and exclusion criteria
Inclusion criteria:

    Healthy adolescents aged 10 through 25 years of age inclusive at the time of enrollment.

Exclusion criteria:

    History of any meningococcal vaccine administration;

    • Current or previous, confirmed or suspected disease caused by N. meningitidis;
    • Pregnant or nursing (breastfeeding) mothers;
    • Females of childbearing age who have not used or do not plan to use acceptable birth control measures, for the duration of the study;
    • Any serious, chronic, or progressive disease;
    • Known or suspected impairment/alteration of the immune system;
    • Receipt of blood, blood products and/or plasma derivatives, or a parenteral immunoglobulin preparation within the previous 90 days;
    • History of severe allergic reactions after previous vaccinations or hypersensitivity to any vaccine component.

Trial location(s)

Location
Status
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Location
GSK Investigational Site
Bardstown, Kentucky, United States, 40004
Status
Study Complete
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Location
GSK Investigational Site
Birmingham, Alabama, United States, 35205
Status
Study Complete
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Location
GSK Investigational Site
Huber Heights, Ohio, United States, 45424
Status
Study Complete
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Location
GSK Investigational Site
Izabelin, Poland, 05080
Status
Study Complete
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Location
GSK Investigational Site
Kettering, Ohio, United States, 45420
Status
Study Complete
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Location
GSK Investigational Site
Krakow, Poland, 31223
Status
Study Complete
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Location
GSK Investigational Site
Krakow, Poland, 31422
Status
Study Complete
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Location
GSK Investigational Site
Lebanon, Tennessee, United States, 37087
Status
Study Complete
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Location
GSK Investigational Site
Louisville, Kentucky, United States, 40291
Status
Study Complete
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Location
GSK Investigational Site
Madera, California, United States, 93637
Status
Study Complete
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Location
GSK Investigational Site
Paramount, California, United States, 90723
Status
Study Complete
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Location
GSK Investigational Site
Warszawa, Poland, 01809
Status
Study Complete
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Location
GSK Investigational Site
Wroclaw, Poland, 50-077
Status
Study Complete
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Study documents

Study report synopsis
Available language(s): English
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If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Completed
Actual primary completion date
2012-03-04
Actual study completion date
2012-03-04

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.

Additional information about the trial

Additional information
Not applicable
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