Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Meningococcal Conjugate Vaccine (GSK134612) When Co-administered With Boostrix® in Subjects Between 11 and 25 Years of Age

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01767376
First received: December 21, 2012
Last updated: May 29, 2014
Last verified: February 2014
  Purpose

The purpose of this study is to assess the immunogenicity, safety and reactogenicity of the meningococcal conjugate vaccine (MenACWY-TT) co-administered with Boostrix® versus each of the two vaccines given separately in healthy adolescents and young adults.


Condition Intervention Phase
Acellular Pertussis
Tetanus
Diphtheria
Biological: Meningococcal vaccine GSK134612
Biological: Boostrix®
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Immunogenicity, Safety and Reactogenicity Study of GSK Biologicals' Meningococcal Conjugate Vaccine (GSK134612) When Co-administered With Boostrix® in Healthy Adolescents and Young Adults Between 11 and 25 Years of Age

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: One month after MenACWY-TT vaccination in the Co-ad and ACWYTdap groups ] [ Designated as safety issue: No ]
  • Immunogenicity with respect to the components of the investigational vaccine in terms of antibody concentrations [ Time Frame: One month after Boostrix® vaccination in the Co-ad and TdapACWY groups ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Immunogenicity with respect to the components of the investigational vaccine in terms of antibody titres [ Time Frame: Prior to (i.e. Month 0 for Co-ad and ACWYTdap groups and Month 1 for TdapACWY group) and one month after MenACWY-TT vaccination in all study groups ] [ Designated as safety issue: No ]
  • Immunogenicity with respect to the components of the investigational vaccine in terms of antibody titres [ Time Frame: Prior to (i.e. Month 1) and one month after MenACWY-TT vaccination in the TdapACWY group ] [ Designated as safety issue: No ]
  • Immunogenicity with respect to the components of the investigational vaccine in terms of vaccine response [ Time Frame: One month after MenACWY-TT vaccination in all study groups ] [ Designated as safety issue: No ]
  • Immunogenicity with respect to the components of the investigational vaccine in terms of antibody concentrations [ Time Frame: One month after Boostrix® vaccination in the ACWYTdap group ] [ Designated as safety issue: No ]
  • Immunogenicity with respect to the components of the investigational vaccine in terms of antibody concentration and seroprotection rates [ Time Frame: Prior to (i.e. Month 0 for Co-ad and TdapACWY groups and Month 1 for ACWYTdap group) and one month after Boostrix® vaccination ] [ Designated as safety issue: No ]
  • Immunogenicity with respect to the components of the investigational vaccine in terms of antibody concentration and seroprotection rates [ Time Frame: All time points (i.e. Month 0, Month 1 and Month2) in all study groups ] [ Designated as safety issue: No ]
  • Immunogenicity with respect to the components of the investigational vaccine in terms of antibody concentrations [ Time Frame: Prior to (i.e. Month 0 for Co-ad and TdapACWY groups and Month 1 for ACWYTdap group) and one month after Boostrix® vaccination in all study groups ] [ Designated as safety issue: No ]
  • Immunogenicity with respect to the components of the investigational vaccine in terms of booster responses [ Time Frame: One month after Boostrix® vaccination in all study groups ] [ Designated as safety issue: No ]
  • Occurrence of solicited local and general symptoms [ Time Frame: Days 0-3 following each vaccination ] [ Designated as safety issue: No ]
  • Occurrence of unsolicited symptoms [ Time Frame: Days 0-30 following each vaccination ] [ Designated as safety issue: No ]
  • Occurrence of SAEs [ Time Frame: Throughout the study (Month 0 - Month 2) ] [ Designated as safety issue: No ]
  • Occurrence of NOCIs [ Time Frame: Throughout the study (Month 0 - Month 2) ] [ Designated as safety issue: No ]

Enrollment: 692
Study Start Date: January 2013
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Co-ad Group
Subjects will receive MenACWY-TT co-administered with Boostrix® at Month 0.
Biological: Meningococcal vaccine GSK134612
One dose administered intramuscularly (IM) in the deltoid muscle of the arm.
Other Names:
  • MenACWY-TT
  • Nimenrix
Biological: Boostrix®
One dose administered intramuscularly (IM) in the deltoid of the right arm (in Co-ad Group) and left arm (in TdapACWY and ACWYTdap Groups).
Other Name: Tdap
Experimental: ACWYTdap Group
Subjects will receive MenACWY-TT at Month 0 and Boostrix® at Month 1.
Biological: Meningococcal vaccine GSK134612
One dose administered intramuscularly (IM) in the deltoid muscle of the arm.
Other Names:
  • MenACWY-TT
  • Nimenrix
Biological: Boostrix®
One dose administered intramuscularly (IM) in the deltoid of the right arm (in Co-ad Group) and left arm (in TdapACWY and ACWYTdap Groups).
Other Name: Tdap
Experimental: TdapACWY Group
Subjects will receive Boostrix® at Month 0 and MenACWY-TT at Month 1.
Biological: Meningococcal vaccine GSK134612
One dose administered intramuscularly (IM) in the deltoid muscle of the arm.
Other Names:
  • MenACWY-TT
  • Nimenrix
Biological: Boostrix®
One dose administered intramuscularly (IM) in the deltoid of the right arm (in Co-ad Group) and left arm (in TdapACWY and ACWYTdap Groups).
Other Name: Tdap

  Eligibility

Ages Eligible for Study:   11 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • Subjects 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, 11 and 25 years of age at the time of the first vaccination.
  • Written informed consent obtained from the subject/from the parent(s)/LAR(s) of the subject.
  • Written informed assent obtained from the subjects when applicable according to local regulations.
  • Female subjects of non-childbearing potential may be enrolled in the study.

    • Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy or ovariectomy.
  • 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 two months after completion of the vaccination series.

Exclusion Criteria:

  • Child in care.
  • Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. For corticosteroids, this will mean prednisone ≥ 10 mg/day, or equivalent. Inhaled and topical steroids are allowed.
  • Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first dose of vaccine and ending 30 days after the last dose of vaccine, with the exception of licensed inactivated influenza vaccine.
  • 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.
  • Previous vaccination with a meningococcal vaccine.
  • History of meningococcal disease.
  • Vaccination with a DTP-containing vaccine within the previous five years.
  • History of serious allergic reaction following any other DTP-containing vaccine or any component of the study vaccines.
  • History of encephalopathy within seven days following administration of a previous dose of pertussis vaccine that is not attributable to another identifiable cause.
  • Temperature of ≥ 40.5°C (105°F) within 48 hours of receipt of a previous dose of DTP vaccine, not due to another identifiable cause.
  • Collapse or shock-like state within 48 hours of receipt of a previous dose of DTP vaccine.
  • Seizures with or without fever within three days of a previous dose of DTP vaccine.
  • Severe Arthus-type hypersensitivity reactions following a prior dose of tetanus toxoid (TT) within the previous ten years.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination during the study period.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
  • Progressive neurologic disorder, uncontrolled epilepsy or progressive encephalopathy.
  • History of any neurologic disorders or seizures, including Guillain-Barré syndrome (GBS). History of a simple, single febrile seizure is permitted.
  • Bleeding disorders, such as haemophilia or thrombocytopenia, or subjects on anticoagulant therapy.
  • Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine, or planned administration during the study period.
  • Pregnant or lactating female.
  • Female planning to become pregnant or planning to discontinue contraceptive precautions.
  • Family history of congenital or hereditary immunodeficiency.
  • Major congenital defects or serious chronic illness.
  • Acute disease and/or fever at the time of enrolment.

    • Fever is defined as temperature ≥ 37.5°C /99.5°F for oral, axillary or tympanic route.
    • Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator.
  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: NCT01767376

Locations
Dominican Republic
GSK Investigational Site
Santo Domingo, Distrito Nacional, Dominican Republic
Germany
GSK Investigational Site
Kehl, Baden-Wuerttemberg, Germany, 77694
GSK Investigational Site
Tuttlingen, Baden-Wuerttemberg, Germany, 78532
GSK Investigational Site
Bindlach, Bayern, Germany, 95463
GSK Investigational Site
Wuerzburg, Bayern, Germany, 97070
GSK Investigational Site
Essen, Nordrhein-Westfalen, Germany, 45359
GSK Investigational Site
Goch, Nordrhein-Westfalen, Germany, 47574
GSK Investigational Site
Frankenthal, Rheinland-Pfalz, Germany, 67227
Korea, Republic of
GSK Investigational Site
Ansan, Korea, Republic of, 425-707
GSK Investigational Site
Incheon, Korea, Republic of, 400-711
GSK Investigational Site
Incheon, Korea, Republic of, 700-711
GSK Investigational Site
Jeonju Jeonbuk, Korea, Republic of, 561-712
GSK Investigational Site
Seoul, Korea, Republic of, 158-710
GSK Investigational Site
Seoul, Korea, Republic of, 150-950
GSK Investigational Site
Seoul, Korea, Republic of, 130-702
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01767376     History of Changes
Other Study ID Numbers: 116705, 2012-002737-11
Study First Received: December 21, 2012
Last Updated: May 29, 2014
Health Authority: Dominican Republic: Consejo Nacional de Bioética en Salud
Germany: Paul-Ehrlich-Institut
Korea: Korea Food & Drug Administration

Keywords provided by GlaxoSmithKline:
Young adults
Adolescents
Reactogenicity
Diphtheria
pertussis
Immunogenicity
Tetanus
Meningococcal vaccines
Safety
Neisseria meningitidis
Healthy

Additional relevant MeSH terms:
Diphtheria
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on September 30, 2014