Trial record 19 of 25 for:    Guillain-Barré Syndrome

Study to Evaluate the Long-term Antibody Persistence of GlaxoSmithKline (GSK) Biologicals' MenACWY-TT Vaccine (GSK134612) Versus Mencevax ACWY in Healthy Adolescents and Adults and Booster Response to MenACWY-TT Vaccine Administered at 10 Years Post-primary Vaccination

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by GlaxoSmithKline
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01934140
First received: August 22, 2013
Last updated: July 3, 2014
Last verified: July 2014
  Purpose

The purpose of this study is to evaluate the long-term antibody persistence from 6, 7, 8, 9 to 10 years post-administration of MenACWY-TT conjugate vaccine as compared to Mencevax ACWY when given to healthy subjects 11 to 55 years of age. In addition, the safety and immunogenicity of a booster dose of MenACWY-TT vaccine administered to all eligible subjects 10 years after the primary vaccination will be evaluated.

All Filipino subjects who received the primary vaccination in the primary vaccination study 107386 (NCT00356369) will be invited to enrol in the long-term follow up and booster phase. No new subjects will be enrolled.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Long-term Antibody Persistence of GSK Biologicals' MenACWY-TT Vaccine (GSK134612) Versus Mencevax ACWY in Healthy Adolescents and Adults and Booster Response to MenACWY-TT Vaccine Administered at 10 Years Post-primary Vaccination

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Immunogenicity with respect to the components of the investigational vaccine in terms of antibody titres [ Time Frame: During the long-term follow-up phase (6, 7, 8, 9 and 10 years after primary vaccination in Study MENACWY-TT-015) ] [ Designated as safety issue: No ]
    rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titres ≥ 1:8, ≥ 1:128 and geometric mean titres (GMTs)


Secondary Outcome Measures:
  • Immunogenicity with respect to the components of the investigational vaccine in terms of antibody titres and antibody concentration [ Time Frame: One month post booster vaccination at ten years after primary vaccination ] [ Designated as safety issue: No ]
  • Occurrence of solicited local and general symptoms [ Time Frame: Days 0-3 following the booster vaccination ] [ Designated as safety issue: No ]
  • Occurrence of unsolicited symptoms [ Time Frame: Up to 31 days following booster vaccination ] [ Designated as safety issue: No ]
  • Occurrence of serious AEs, and new onset chronic illness(es) (e.g. autoimmune disorders, asthma, type 1 diabetes and allergies), GBS (Guillain-Barre Syndrome) and meningococcal disease [ Time Frame: From administration of the vaccine dose until study end (Month 126) ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: April 2014
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ACWY-TT group
All subjects vaccinated with MenACWY-TT in study MENACWY-TT-015 will be assigned to this group. At Month 120 after primary vaccination, these subjects will be vaccinated with a booster dose of MenACWY-TT in this study.
Biological: Meningococcal vaccine GSK134612
1 dose administered intramuscularly in the non-dominant deltoid region.
Active Comparator: MenPS group
All subjects vaccinated with Mencevax ACWY in study MENACWY-TT-015 will be assigned to this group. At Month 120 after primary vaccination, these subjects will be vaccinated with a dose of MenACWY-TT in this study.
Biological: Meningococcal vaccine GSK134612
1 dose administered intramuscularly in the non-dominant deltoid region.

  Eligibility

Ages Eligible for Study:   17 Years to 66 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

All subjects must satisfy the following criteria at study entry to the persistence phase:

  • Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol. Or /and subjects' parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
  • A male or female between and including 17 and 66 years of age at the time of entry into the present study.
  • Has completed the vaccination phase of the vaccination study MENACWY-TT-015.
  • In alignment with local laws and regulations, written informed consent obtained from parents/LAR(s) of the subject and written informed assent obtained from the subject if the subject is less than 18 years of age, or written informed consent obtained from the subject if the subject has achieved the 18th birthday. The subjects ≥18 years of age at the time of enrollment will sign the informed consent form, even if the parent/ LAR previously signed the ICF before the subject reached the legal age of consent.
  • Healthy subjects as established by medical history and history-directed physical examination before entering into the study.

All subjects must satisfy the following additional criteria prior to entry of the booster phase:

  • Female subjects of non-childbearing potential may be enrolled in the study.

    • Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause.
  • Female subjects of childbearing potential may be enrolled in the study, if the subject:

    • has practiced adequate contraception for 30 days prior to vaccination, and
    • has a negative pregnancy test on the day of vaccination, and
    • has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.

Exclusion Criteria:

  • Child in care.
  • Previous vaccination with meningococcal polysaccharide or conjugate vaccine outside of study MENACWY-TT-015.
  • History of meningococcal disease due to serogroup A, C, W-135 or Y.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, including Human Immunodeficiency Virus (HIV) infection, based on medical history and physical examination.
  • Major congenital defects or serious chronic illness.
  • Family history of congenital or hereditary immunodeficiency.
  • History of chronic alcohol consumption and/or drug abuse.

Additional exclusion criteria for booster phase at Month 120 study entry (to be checked at Month 120) for all subjects

  • Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the booster dose of study vaccine, or planned use during the follow-up period.
  • Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the booster vaccine dose. Inhaled and topical steroids are allowed.
  • Administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the booster dose of study vaccine or planned administration within 30 days after vaccination (with the day of vaccination considered Day 0), with the exception of a licensed inactivated influenza vaccine.
  • Administration of immunoglobulins and/or any blood products within the three months preceding the booster vaccination or planned administration during the follow-up period.
  • 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 vaccine/product.
  • Previous vaccination with tetanus toxoids within the last month.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
  • 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 enrollment.

    • Fever is defined as temperature ≥ 37.5°C for oral, axillary or tympanic route, or ≥ 38.0°C for rectal route. The preferred route for recording temperature in this study will be oral.
    • Subjects with a minor illness without fever may, be enrolled at the discretion of the investigator.
  • Pregnant or lactating female.
  • Female planning to become pregnant or planning to discontinue contraceptive precautions.
  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: NCT01934140

Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com

Locations
Philippines
GSK Investigational Site Recruiting
Manila, Philippines, 1000
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Muntinlupa, Philippines, 1781
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01934140     History of Changes
Other Study ID Numbers: 116725
Study First Received: August 22, 2013
Last Updated: July 3, 2014
Health Authority: Philippines: Philippines Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Healthy
Adults
Safety
Neisseria meningitidis
Booster response
Immunogenicity
Adolescents
Serogroups A, C, W-135, and Y
long-term antibody persistence

Additional relevant MeSH terms:
Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Antibodies
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 31, 2014