Clinical trial NCT01767376: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infections, Meningococcal
Keywords: Young adults
Adolescents
Reactogenicity
Diphtheria
pertussis
Immunogenicity
Tetanus
Meningococcal vaccines
Safety
Neisseria meningitidis
Healthy
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2013-01-14
Enrollment: 692
Sex: ALL
Minimum age (years): 11
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Anti-Meningitis Antibody Titers by Serum Bactericidal Assay Using Rabbit Complement (rSBA)
timeFrame: One month after Nimenrix vaccination (i.e. Month 1 for Nimenrix+Boostrix and Nimenrix Groups and Month 2 for Boostrix Group)
measure: Number of Subjects With Anti-D and Anti-T Concentrations Above the Cut-off Value
timeFrame: One month after Boostrix vaccination (i.e. Month 1)
measure: Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations
timeFrame: One month after Boostrix vaccination (i.e. Month 1)
Secondary outcomes:
measure: Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres Above the Cut-off Values
timeFrame: Prior to (i.e. Month 0 for Nimenrix+Boostrix and Nimenrix Groups and Month 1 for Boostrix Group) and one month after Nimenrix vaccination (i.e. Month 1 for Nimenrix+Boostrix and Nimenrix Groups and Month 2 for Boostrix Group)
measure: Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibodies
timeFrame: One month after Nimenrix vaccination (i.e. Month 1 for Nimenrix+Boostrix and Nimenrix Groups and Month 2 for Boostrix Group)
measure: Anti-D Antibody Concentrations
timeFrame: Prior to (PRE i.e. Month 0 for Nimenrix + Boostrix Group and Boostrix Group and Month 1 for Nimenrix Group) and one month after Boostrix vaccination (POST i.e. Month 1 for Nimenrix + Boostrix Group and Boostrix Group and Month 2 for Nimenrix Group)
measure: Anti-T Antibody Concentrations
timeFrame: Prior to (i.e. Month 0 for Nimenrix + Boostrix Group and Boostrix Group and Month 1 for Nimenrix Group), one month after Nimenrix vaccination and one month after Boostrix vaccination
measure: Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Above the Cut-off Value
timeFrame: Prior to (i.e. Month 0 for Nimenrix + Boostrix Group and Boostrix Group and Month 1 for Nimenrix Group) and one month after Boostrix vaccination (i.e. Month 1 for Nimenrix + Boostrix Group and Boostrix Group and Month 2 for Nimenrix Group)
measure: Booster Responses for Anti-PT, Anti-FHA and Anti-PRN Concentrations
timeFrame: One month after Boostrix vaccination (i.e. Month 1 for Nimenrix + Boostrix Group and Boostrix Group and Month 2 for Nimenrix Group)
measure: Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
timeFrame: During the 4-day (Days 0-3) following each vaccination
measure: Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
timeFrame: During the 4-day (Days 0-3) period following each vaccination
measure: Number of Subjects With New Onset of Chronic Diseases (NOCDs)
timeFrame: Throughout the study (Month 0 up to Month 2)
measure: Number of Subjects With Unsolicited Adverse Events AE(s)
timeFrame: During the 31-day (Days 0-30) post-vaccination period
measure: Number of Subjects With Serious Adverse Events SAE(s)
timeFrame: Throughout the study (Month 0 up to Month 2)
Other outcomes:
Locations:
city: Santo Domingo, Distrito Nacional
country: Dominican Republic
facility: GSK Investigational Site
city: Kehl
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Tuttlingen
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Bindlach
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Wuerzburg
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Essen
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Goch
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Frankenthal
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Ansan
country: Korea, Republic of
facility: GSK Investigational Site
city: Incheon
country: Korea, Republic of
facility: GSK Investigational Site
city: Incheon
country: Korea, Republic of
facility: GSK Investigational Site
city: Jeonju Jeonbuk
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Rivera L, Schwarz TF, Kim KH, Kim YK, Behre U, Cha SH, Jo DS, Lee J, Lee JS, Cheuvart B, Jastorff A, Van der Wielen M. Immunogenicity and safety of the quadrivalent meningococcal vaccine MenACWY-TT co-administered with a combined diphtheria-tetanus-acellular pertussis vaccine versus their separate administration in adolescents and young adults: A phase III, randomized study. Vaccine. 2018 Jul 25;36(31):4750-4758. doi: 10.1016/j.vaccine.2018.04.034. Epub 2018 Jun 28.