Comparison of GSK134612 in Subjects Previously Vaccinated Against Meningococcal Disease Versus Non-vaccinated Subjects

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00661557
First received: April 14, 2008
Last updated: September 3, 2009
Last verified: September 2009
  Purpose

In this study, subjects who were vaccinated with a meningococcal polysaccharide vaccine in a previous study (whose objectives & outcome measures are presented in a separate protocol posting with NCT number = 00227422) will be vaccinated with a new vaccine using conjugation technology.

These subjects will be compared to subjects vaccinated with the new vaccine, but who were not previously vaccinated with a meningococcal polysaccharide vaccine.


Condition Intervention Phase
Meningococcal Disease
Biological: Meningococcal vaccine GSK134612
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Immunogenicity & Safety Study of GSK Biologicals' Meningococcal Vaccine GSK134612 Administered in Healthy Subjects Either Previously Primed With Mencevax™ ACWY or naïve to Meningococcal Vaccination.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Meningococcal rSBA titres [ Time Frame: One month post-vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Meningococcal rSBA titres [ Time Frame: Prior to vaccination ] [ Designated as safety issue: No ]
  • Anti-meningococcal polysaccharide concentrations [ Time Frame: Prior to and one month post-vaccination ] [ Designated as safety issue: No ]
  • Anti-tetanus toxoid antibody concentrations [ Time Frame: Prior to and one month post-vaccination ] [ Designated as safety issue: No ]
  • Vaccine response to meningococcal antigens [ Time Frame: Prior to and one month post-vaccination ] [ Designated as safety issue: No ]
  • Occurrence of solicited local and general symptoms [ Time Frame: Day 0 to Day 3 post-vaccination ] [ Designated as safety issue: Yes ]
  • Occurrence of unsolicited symptoms [ Time Frame: Up to one month post-vaccination ] [ Designated as safety issue: Yes ]
  • Occurrence of Serious Adverse Events [ Time Frame: Day 0 to study month 6 ] [ Designated as safety issue: Yes ]
  • Occurrence of specific adverse events of rash, new onset of chronic illness(es), conditions prompting ER visits and/or any event related to lack of vaccine efficacy (i.e. documented meningococcal disease [ Time Frame: Day 0 to study month 6 ] [ Designated as safety issue: Yes ]

Enrollment: 272
Study Start Date: May 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MPS
Subjects who were vaccinated with Mencevax™ ACWY in a previous study
Biological: Meningococcal vaccine GSK134612
one dose, as intramuscular injection
Experimental: noMPS
Subjects who were never vaccinated with a meningococcal vaccine (or not in the previous 10 years)
Biological: Meningococcal vaccine GSK134612
one dose, as intramuscular injection

Detailed Description:

GSK Biologicals has developed a meningococcal conjugate vaccine (GSK134612). This candidate vaccine has been shown to be well tolerated and immunogenic in toddlers, children aged 3-5 years, and adolescents/young adults. Repeated vaccinations with unconjugated meningococcal polysaccharide vaccine has shown to induce hyporesponsiveness to re-vaccination, this for serogroup C, and a recent publication suggest the same may be true for other serogroups.

This study will evaluate GSK Biologicals' candidate vaccine's ability to induce satisfactory immune response for the serogroups it contains across subjects 4.5 through 34 years of age who previously received a tetravalent meningococcal polysaccharide vaccine when aged 2-30 years. A non-randomised age-strata matched group of subjects, who have not previously received (or not received within the preceding 10 years) any meningococcal vaccine, will also be administered the GSK134612 vaccine for comparison.

  Eligibility

Ages Eligible for Study:   4 Years to 34 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Only subjects who the investigator believes that they and/or their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
  • For the MPS group, a male or female between, and including, 4.5 and 34 years of age at the time of the study vaccination, who has been vaccinated in GSK Biologicals' study 102394.
  • For the noMPS group, a male or female between, and including, 4.5 and 34 years of age at the time of the study vaccination.
  • Written informed consent obtained from the subject/ from the parent or guardian of the subject.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • Previously completed routine childhood vaccinations to the best of his/her knowledge.
  • If the subject is female, she must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.

Exclusion Criteria:

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding administration of the study vaccine, or planned use during the complete study period (active phase and extended safety follow-up).
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the study vaccine dose.
  • Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of administration of the study vaccine and up to 30 days after the study vaccine.
  • Concurrently participating in another clinical study, at any time during the study period (active phase and extended safety follow-up), in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
  • For the MPS Group, vaccination against meningococcal disease after completion of study 102394
  • For the noMPS group, previous vaccination, or vaccination within the last 10 years, against meningococcal disease (of any serogroup).
  • Previous vaccination against tetanus within 30 days.
  • History of meningococcal disease.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection, based on medical history and physical.
  • A family history of congenital or hereditary immunodeficiency, unless the child has previously been documented, through laboratory testing, to have normal immune function.
  • History of reactions or allergic disease likely to be exacerbated by any component of the vaccine.
  • Know hypersensitivity to any component of the vaccine.
  • Major congenital defects or serious chronic illness.
  • History of seizures (this criterion does not apply to subjects who have had a single, uncomplicated febrile convulsion in the past) or progressive neurological disease.
  • Acute disease at the time of enrolment
  • Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the active stage of the study period.
  • Pregnant or lactating female.
  • Female planning to become pregnant or planning to discontinue contraceptive precautions.
  • History of chronic alcohol consumption and/or drug abuse.
  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: NCT00661557

Locations
Lebanon
GSK Investigational Site
Beirut, Lebanon, 1107-2020
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00661557     History of Changes
Other Study ID Numbers: 107408
Study First Received: April 14, 2008
Last Updated: September 3, 2009
Health Authority: Lebanon: Institutional Review Board

Keywords provided by GlaxoSmithKline:
Meningococcal vaccine
Meningococcal disease
immunogenicity
Safety
Booster vaccination

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

ClinicalTrials.gov processed this record on October 23, 2014