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

Infections, Meningococcal Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01767376
• Other study ID #: 116705
• Secondary ID: 2012-002737-11
• Status: Completed
• Phase: Phase 3
• First received: December 21, 2012
• Last updated: June 1, 2017
• Start date: January 10, 2013
• Est. completion date: January 16, 2014

Study information

• Verified date: June 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 692
• Est. completion date: January 16, 2014
• Est. primary completion date: January 16, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infections, Meningococcal
• Meningococcal Infections

Intervention

Biological:
• Meningococcal vaccine GSK134612
One dose administered intramuscularly (IM) in the deltoid muscle of the arm.
• 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).

Locations

Country	Name	City	State
Dominican Republic	GSK Investigational Site	Santo Domingo, Distrito Nacional
Germany	GSK Investigational Site	Bindlach	Bayern
Germany	GSK Investigational Site	Essen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Frankenthal	Rheinland-Pfalz
Germany	GSK Investigational Site	Goch	Nordrhein-Westfalen
Germany	GSK Investigational Site	Kehl	Baden-Wuerttemberg
Germany	GSK Investigational Site	Tuttlingen	Baden-Wuerttemberg
Germany	GSK Investigational Site	Wuerzburg	Bayern
Korea, Republic of	GSK Investigational Site	Ansan
Korea, Republic of	GSK Investigational Site	Incheon
Korea, Republic of	GSK Investigational Site	Incheon
Korea, Republic of	GSK Investigational Site	Jeonju Jeonbuk
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Dominican Republic,  Germany,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immunogenicity with respect to the components of the investigational vaccine in terms of antibody titres		One month after MenACWY-TT vaccination in the Co-ad and ACWYTdap groups
Primary	Immunogenicity with respect to the components of the investigational vaccine in terms of antibody concentrations		One month after Boostrix® vaccination in the Co-ad and TdapACWY groups
Secondary	Immunogenicity with respect to the components of the investigational vaccine in terms of antibody titres		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
Secondary	Immunogenicity with respect to the components of the investigational vaccine in terms of antibody titres		Prior to (i.e. Month 1) and one month after MenACWY-TT vaccination in the TdapACWY group
Secondary	Immunogenicity with respect to the components of the investigational vaccine in terms of vaccine response		One month after MenACWY-TT vaccination in all study groups
Secondary	Immunogenicity with respect to the components of the investigational vaccine in terms of antibody concentrations		One month after Boostrix® vaccination in the ACWYTdap group
Secondary	Immunogenicity with respect to the components of the investigational vaccine in terms of antibody concentration and seroprotection rates		Prior to (i.e. Month 0 for Co-ad and TdapACWY groups and Month 1 for ACWYTdap group) and one month after Boostrix® vaccination
Secondary	Immunogenicity with respect to the components of the investigational vaccine in terms of antibody concentration and seroprotection rates		All time points (i.e. Month 0, Month 1 and Month2) in all study groups
Secondary	Immunogenicity with respect to the components of the investigational vaccine in terms of antibody concentrations		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
Secondary	Immunogenicity with respect to the components of the investigational vaccine in terms of booster responses		One month after Boostrix® vaccination in all study groups
Secondary	Occurrence of solicited local and general symptoms		Days 0-3 following each vaccination
Secondary	Occurrence of unsolicited symptoms		Days 0-30 following each vaccination
Secondary	Occurrence of SAEs		Throughout the study (Month 0 - Month 2)
Secondary	Occurrence of NOCIs		Throughout the study (Month 0 - Month 2)