Comparison of GlaxoSmithKline (GSK)134612 in Subjects With Increased Risk for Meningococcal Disease Versus Healthy Subjects

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01641042
First received: July 12, 2012
Last updated: July 10, 2014
Last verified: July 2014
  Purpose

The purpose of this study is to investigate the immunogenicity, reactogenicity and safety of the new meningococcal vaccine 134612 in subjects with increased risk of meningococcal disease and compare it to its activity in healthy subjects.


Condition Intervention Phase
Infections, Meningococcal
Biological: Meningococcal vaccine GSK134612
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety Study of GSK Biologicals' Meningococcal Vaccine GSK 134612 Administered to at Risk Subjects From 1 to Less Than 18 Years

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Immunogenicity with respect to components of the investigational vaccine in terms of vaccine response [ Time Frame: One month after the first vaccine dose (at Month 1). ] [ Designated as safety issue: No ]
  • Immunogenicity with respect to components of the investigational vaccine in terms of vaccine response [ Time Frame: One month after the second vaccine dose (at Month 3). ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Immunogenicity with respect to components of the investigational vaccine in terms of antibody titres [ Time Frame: Just before and after the first vaccine dose and after the second vaccine dose (At Month 0, Month 1 and Month 3). ] [ Designated as safety issue: No ]
  • Immunogenicity with respect to components of the investigational vaccine in terms of antibody concentrations [ Time Frame: Just before and after the first vaccine dose and after the second vaccine dose (At Month 0, Month 1 and Month 3). ] [ Designated as safety issue: No ]
  • Occurrence of solicited local and general symptoms [ Time Frame: Within 4 days (Day 0 to Day 3) after each vaccine dose. ] [ Designated as safety issue: No ]
  • Occurrence of unsolicited adverse events [ Time Frame: Within 31 days (Day 0 to Day 30) after each vaccine dose. ] [ Designated as safety issue: No ]
  • Occurrence of serious adverse events [ Time Frame: From the first dose until the end of the extended safety follow-up period (From Month 0 up to Month 8). ] [ Designated as safety issue: No ]
  • Occurrence of new onset of chronic illnesses [ Time Frame: From the first dose until the end of the extended safety follow-up period (From Month 0 up to Month 8). ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: September 2012
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Healthy Group
The subjects in the Healthy group will be age-matched to the subjects in the At-risk group. Subjects will receive 2 doses of the investigational vaccine.
Biological: Meningococcal vaccine GSK134612
2 doses of the vaccine administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
Experimental: At-risk Group
This group includes subjects with medical conditions placing them at an increased risk for meningococcal disease. Subjects will receive 2 doses of the investigational vaccine.
Biological: Meningococcal vaccine GSK134612
2 doses of the vaccine administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.

Detailed Description:

For each at risk subject enrolled, an age-matched healthy subject will be enrolled. Age matching will be performed according to the following age strata: 1-5 years, 6-10 years, 11-17 years.

  Eligibility

Ages Eligible for Study:   1 Year to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol.
  • A male or female 1 to 17 years of age at the time of the first vaccination.
  • Written informed consent obtained from the parent(s)/LAR(s) of the subject and informed assent obtained from the subject, if appropriate, prior to enrolment.
  • Female subjects of non-childbearing potential may be enrolled in the study.
  • Female subjects of childbearing potential may be enrolled in the study, if

    • the subject has practiced adequate contraception for one month (30 days) prior to the first vaccine dose, and
    • has a negative pregnancy test on the day of vaccination, and
    • has agreed to continue adequate contraception from administration of the first vaccine dose until 2 months after administration of the second vaccine dose.

Additional inclusion criterion for At-risk group • Subjects with an increased risk for meningococcal disease, such as anatomic asplenia or some degree of functional asplenia or complement deficiencies.

Additional inclusion criteria for Healthy group

  • Healthy subject as established by medical history and clinical examination before entering into the study.
  • Age-matched to a subject from the At-risk group according to age strata 1-5 years, 6-10 years and 11 to 17 years.

Exclusion Criteria:

  • Child in care.
  • Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period (until the phone contact at Month 8).
  • Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting 30 days before administration of each study vaccine dose until 30 days after administration of each study vaccine dose. Administration of licensed inactivated influenza vaccines is allowed as per local recommendations.
  • Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
  • History of meningococcal disease.
  • Any confirmed or suspected Human Immunodeficiency Virus (HIV) infection, based on medical history and physical examination.
  • Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine until one month after the second dose of study vaccine.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine including latex.
  • Major congenital defects.
  • History of any neurological disorders or seizures, including Guillain-Barré syndrome (GBS). History of a simple, single febrile seizure is permitted.
  • Acute disease and/or fever at the time of enrolment.
  • Pregnant or lactating female.
  • History of chronic alcohol consumption and/or drug abuse.
  • Female planning to become pregnant or planning to discontinue contraceptive precautions.

Additional exclusion criteria for the At-risk group

• Vaccination against meningococcal disease of any serogroup

  • within the last 3 years for subjects younger than 7 years.
  • within the last 5 years for subjects 7 years and older.

Additional exclusion criteria for the Healthy group

  • Vaccination against meningococcal disease of any serogroup with polysaccharide or conjugate vaccine within the last 5 years.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months prior to the first vaccine dose.
  • Family history of congenital or hereditary immunodeficiency.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition.
  • Serious chronic illness.
  • History of asplenia or hyposplenia or complement deficiencies.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01641042

Locations
United States, California
GSK Investigational Site
Antioch, California, United States, 94509
GSK Investigational Site
Daly City, California, United States, 94015
GSK Investigational Site
Fremont, California, United States, 94538
GSK Investigational Site
Hayward, California, United States, 94545
GSK Investigational Site
Oakland, California, United States, 94611
GSK Investigational Site
Redwood City, California, United States, 94063
GSK Investigational Site
Roseville, California, United States, 95661
GSK Investigational Site
Sacramento, California, United States, 95823
GSK Investigational Site
Sacramento, California, United States, 95815
GSK Investigational Site
Santa Clara, California, United States, 95051
GSK Investigational Site
Santa Rosa, California, United States, 95403
GSK Investigational Site
Vallejo, California, United States, 94589
United States, North Carolina
GSK Investigational Site
Durham, North Carolina, United States, 27705
GSK Investigational Site
Durham, North Carolina, United States, 27704
Czech Republic
GSK Investigational Site
Brno, Czech Republic, 613 00
GSK Investigational Site
Hradec Kralove, Czech Republic, 500 02
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01641042     History of Changes
Other Study ID Numbers: 115524, 2011-002410-36
Study First Received: July 12, 2012
Last Updated: July 10, 2014
Health Authority: United States: Food and Drug Administration
Czech Republic: State Institute for Drug Control

Keywords provided by GlaxoSmithKline:
Meningococcal vaccines
Vaccines, conjugate
Neisseria meningitidis
Immunocompromised patient

Additional relevant MeSH terms:
Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on July 23, 2014