Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Meningococcal Vaccine With or Without Co-administration of Cervarix and Boostrix in Female Adolescents and Young Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01755689
First received: December 13, 2012
Last updated: May 15, 2014
Last verified: May 2014
  Purpose

The purpose of this study is to evaluate safety and immunogenicity of GSK Biologicals' meningococcal vaccine (MenACWY-TT) co-administered with Cervarix as compared to MenACWY-TT and Cervarix administered alone and the co-administration of MenACWY-TT with Cervarix and Boostrix as compared to MenACWY-TT administered alone and Cervarix co-administered with Boostrix.


Condition Intervention Phase
Infections, Meningococcal
Biological: Meningococcal vaccine GSK134612
Biological: Cervarix®
Biological: Boostrix®
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: Immunogenicity and Safety Study of GSK Biologicals' Meningococcal Vaccine 134612 With or Without Co-administration of Cervarix and Boostrix in Female Adolescents and Young Adults at 9-25 Years of Age

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Immunogenicity with respect to components of the investigational vaccine in terms of antibody titres. [ Time Frame: One month after vaccination with MenACWY-TT (Month 1). ] [ Designated as safety issue: No ]
  • Immunogenicity with respect to the components of Cervarix in terms of antibody titres. [ Time Frame: One month after the 3rd dose of Cervarix (Month 7). ] [ Designated as safety issue: No ]
  • Immunogenicity with respect to the components of Boostrix in terms of antibody concentrations. [ Time Frame: One month after vaccination with Boostrix (Month 1). ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Immunogenicity with respect to the components of the investigational vaccine in terms of antibody titres and vaccine response. [ Time Frame: Prior to (Day 0) and one month after vaccination with MenACWY-TT (Month 1). ] [ Designated as safety issue: No ]
  • Immunogenicity with respect to the components of the investigational vaccine in terms of antibody concentrations. [ Time Frame: Prior to (Day 0) and one month after vaccination with MenACWY-TT (Month 1). ] [ Designated as safety issue: No ]
  • Immunogenicity with respect to the components of Cervarix in terms of antibody titres and seroconversion rate. [ Time Frame: Prior to the first dose of Cervarix (Day 0) and one month after the 3rd dose of Cervarix (Month 7). ] [ Designated as safety issue: No ]
  • Immunogenicity with respect to the components of Boostrix in terms of antibody concentrations. [ Time Frame: Prior to (Day 0) and one month after vaccination with Boostrix (Month 1). ] [ Designated as safety issue: No ]
  • Occurrence of solicited local and general symptoms. [ Time Frame: During Days 0-6 following vaccination with MenACWY-TT, Boostrix or the first dose of Cervarix. ] [ Designated as safety issue: No ]
  • Occurrence of unsolicited adverse events. [ Time Frame: During Days 0-30 following vaccination with MenACWY-TT, Boostrix or the first dose of Cervarix. ] [ Designated as safety issue: No ]
  • Occurrence of serious adverse events. [ Time Frame: Up to 8 months after the first vaccination. ] [ Designated as safety issue: No ]
  • Occurrence of new onset of chronic illness(es) (NOCIs) and Potential immune-mediated diseases (pIMDs). [ Time Frame: Up to 8 months after the first vaccination. ] [ Designated as safety issue: No ]

Enrollment: 1300
Study Start Date: January 2013
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group ACWY-TT
Subjects will receive MenACWY-TT at Month 0 and Cervarix at Month 1, 2 and 7.
Biological: Meningococcal vaccine GSK134612
One dose administered intramuscularly (IM) in the deltoid of the right arm.
Other Name: Nimenrix®
Biological: Cervarix®
Three doses administered intramuscularly (IM) in the deltoid of the left arm.
Experimental: Group ACWYHPV
Subjects will receive MenACWY-TT and Cervarix at Month 0 and Cervarix at Month 1 and 6.
Biological: Meningococcal vaccine GSK134612
One dose administered intramuscularly (IM) in the deltoid of the right arm.
Other Name: Nimenrix®
Biological: Cervarix®
Three doses administered intramuscularly (IM) in the deltoid of the left arm.
Experimental: Group HPV
Subjects will receive Cervarix at Month 0, 1 and 6.
Biological: Cervarix®
Three doses administered intramuscularly (IM) in the deltoid of the left arm.
Experimental: Group Co-ad
Subjects will receive MenACWY-TT, Cervarix and Boostrix at Month 0 and Cervarix at Month 1 and Month 6.
Biological: Meningococcal vaccine GSK134612
One dose administered intramuscularly (IM) in the deltoid of the right arm.
Other Name: Nimenrix®
Biological: Cervarix®
Three doses administered intramuscularly (IM) in the deltoid of the left arm.
Biological: Boostrix®
One dose administered intramuscularly (IM) in the deltoid of the left arm.
Experimental: Group Tdap
Subjects will receive Boostrix and Cervarix at Month 0 and Cervarix at Month 1 and Month 6.
Biological: Cervarix®
Three doses administered intramuscularly (IM) in the deltoid of the left arm.
Biological: Boostrix®
One dose administered intramuscularly (IM) in the deltoid of the left arm.

  Eligibility

Ages Eligible for Study:   9 Years to 25 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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 female between, and including, 9 and 25 years of age at the time of the first vaccination.
  • Written informed consent obtained from parents/guardian of the subject and written informed assent obtained from the subject if the subject is less than legal age, or written informed consent obtained from the subject if the subject has achieved legal age. The legal age will be determined according to local regulations in each participating country.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • 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.
  • Use of any investigational or non-registered product other than the study vaccine(s) 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 be ≥10 mg/day prednisone or equivalent. Inhaled and topical steroids are allowed.
  • Planned administration/administration of a vaccine not foreseen by the study protocol within the period starting 30 days before and ending 30 days after each study dose of vaccine(s), 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 product or a non-investigational vaccine/product.
  • Previous vaccination with a meningococcal polysaccharide or conjugate vaccine within the last 10 years.
  • History of meningococcal disease since birth.
  • History of serious allergic reaction following any other DTP-containing vaccine or any component of the study vaccines.
  • History of encephalopathy within seven days of administration of a previous pertussis antigen-containing vaccine that is not attributable to another identifiable cause.
  • Persons who experienced an Arthus-type hypersensitivity reaction following a prior dose of tetanus-toxoid containing vaccine should not receive Boostrix unless at least 10 years have elapsed since the last dose of tetanus-toxoid containing vaccine.
  • Previous vaccination with a tetanus-toxoid containing vaccine within the previous five years.
  • Temperature of ≥ 40.5°C (105°F) within 48 hours of receipt of a previous dose of DTP vaccine (diphtheria-tetanus-whole cell pertussis [DTPw] and/or diphtheria-tetanus-acellular pertussis [DTaP]), 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.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection, based on medical history and history directed physical examination.
  • A family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated.
  • History of any allergic disease/reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
  • Progressive neurologic disorder, unstable neurologic conditions, uncontrolled epilepsy or progressive encephalopathy.
  • History of any neurologic disorders or seizures. A history of ADHD or depression or a history of a single, simple febrile seizure does not exclude a subject.
  • Major congenital defects or serious chronic illness.
  • Previous history of Guillain-Barré Syndrome.
  • Bleeding disorders, such as hemophilia or thrombocytopenia, or subjects on anti-coagulant therapy.
  • Acute disease and/or fever 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 study period.
  • Previous vaccination against HPV, or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period.
  • Previous administration of MPL or AS04 adjuvant.
  • History of chronic alcohol consumption and/or drug abuse.
  • Pregnant or lactating female.
  • A subject planning to become pregnant, likely to become pregnant or planning to discontinue contraceptive precautions during the study period and up to two months after the last vaccine dose.
  • Subjects must be at least three months post-pregnancy and not breastfeeding to enter the study.
  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: NCT01755689

Locations
Dominican Republic
GSK Investigational Site
Santo Domingo, Dominican Republic
Estonia
GSK Investigational Site
Tartu, Estonia, 50106
Thailand
GSK Investigational Site
Bangkok, Thailand, 10400
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01755689     History of Changes
Other Study ID Numbers: 113823, 2012-001876-13
Study First Received: December 13, 2012
Last Updated: May 15, 2014
Health Authority: Estonia: State Agency of Medicines
Dominican Republic: Ministry of Health
Brazil: ANVISA - Agência Nacional de Vigilância Sanitaria
Thailand: Ministry of Public Health

Keywords provided by GlaxoSmithKline:
pertussis
Meningococcal meningitis
Meningococcal infections
HPV
Neisseria meningitidis
Vaccines, conjugate
tetanus
diphtheria
Meningococcal vaccines
Immunogenicity

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

ClinicalTrials.gov processed this record on September 22, 2014