The Long-term Antibody Persistence of GSK Biologicals' Meningococcal Vaccine GSK134612 in Healthy Adolescents/Adults

NCT ID: NCT00715910

Last Updated: 2014-11-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 818 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2013-10-31

Brief Summary

In this study, the concentration of antibody to the vaccine one year, three and five years after vaccination in subjects who were vaccinated with GSK Biologicals' meningococcal vaccine GSK134612 and Menactra® in a previous study (whose objectives & outcome measures are presented in a separate protocol posting with NCT number =00454909) will be evaluated. The safety and immune response to a booster dose of vaccine GSK134612 administered at 5 years post-primary vaccination and a primary vaccination of a newly enrolled group with GSK 134612 vaccine will also be evaluated.

Detailed Description

GSK Biologicals has developed a meningococcal conjugate vaccine (GSK134612). This candidate vaccine has been shown to be well tolerated and immunogenic in subjects as of 12 months of age.

The purpose of this study is to evaluate the antibody persistence at approximately 1 year, 3 years and 5 years post-administration of one dose of GlaxoSmithKline (GSK) Biologicals' meningococcal vaccine GSK134612 as compared to Menactra® (meningococcal serogroups A, C, W-135 and Y-diphtheria toxoid conjugate vaccine, sanofi pasteur) when given to healthy adolescents/ adults 11 to 25 years of age In addition, the safety and immunogenicity of a booster dose of GSK134612 administered to all eligible subjects at 5 years after the primary vaccination will be evaluated.

Another cohort of subjects (naïve control group) 15 to <31 years of age will be offered a dose of MenACWY-TT vaccine at the same time to allow for evaluation of a primary (naïve control group) and booster dose within the same study.

This Protocol Posting has been updated following Protocol Amendment 1, May 2010 and Protocol Amendment 2, May 2011.

Conditions

Infections, Meningococcal

Keywords

Meningococcal vaccine; Booster vaccination; Immunogenicity; Meningococcal disease; Safety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Nimenrix 1 Group

Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination

Group Type: EXPERIMENTAL

Nimenrix

Intervention Type: BIOLOGICAL

One dose, as intramuscular injection

Blood sampling

Intervention Type: PROCEDURE

Blood samples will be collected from subjects 10-25 years of age as per enrollment in primary study and from subjects in the Nimerix Naive Group at Month 60 (Year 5) and 1 month post booster vaccination (Month 61).

Menactra Group

Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination

Group Type: ACTIVE_COMPARATOR

Nimenrix

Intervention Type: BIOLOGICAL

One dose, as intramuscular injection

Blood sampling

Intervention Type: PROCEDURE

Blood samples will be collected from subjects 10-25 years of age as per enrollment in primary study and from subjects in the Nimerix Naive Group at Month 60 (Year 5) and 1 month post booster vaccination (Month 61).

Nimenrix 2 Group

Subjects 10\<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination

Group Type: EXPERIMENTAL

Nimenrix

Intervention Type: BIOLOGICAL

One dose, as intramuscular injection

Blood sampling

Intervention Type: PROCEDURE

Blood samples will be collected from subjects 10-25 years of age as per enrollment in primary study and from subjects in the Nimerix Naive Group at Month 60 (Year 5) and 1 month post booster vaccination (Month 61).

Nimenrix Naive Group

Subjects 15 to \<31 years of age at the time of primary vaccination with 1 dose of Nimenrix vaccine at year 5 of the current study

Group Type: EXPERIMENTAL

Nimenrix

Intervention Type: BIOLOGICAL

One dose, as intramuscular injection

Blood sampling

Intervention Type: PROCEDURE

Blood samples will be collected from subjects 10-25 years of age as per enrollment in primary study and from subjects in the Nimerix Naive Group at Month 60 (Year 5) and 1 month post booster vaccination (Month 61).

Nimenrix Pooled Group

Pooled group of subjects 10-25 years of age from Nimenrix 1 and Nimenrix 2 groups in the primary study (NCT00454909) who had received 1 dose of Nimenrix vaccine in that study and will receive a booster dose in this current study.

Group Type: EXPERIMENTAL

Nimenrix

Intervention Type: BIOLOGICAL

One dose, as intramuscular injection

Menactra Booster Group

Subjects 11-25 years of age who had received 1 dose of Menactra vaccine in primary study (NCT00454909) and will receive 1 dose of Nimenrix vaccine in this current study.

Group Type: ACTIVE_COMPARATOR

Nimenrix

Intervention Type: BIOLOGICAL

One dose, as intramuscular injection

Interventions

Nimenrix

One dose, as intramuscular injection

Intervention Type: BIOLOGICAL

Blood sampling

Blood samples will be collected from subjects 10-25 years of age as per enrollment in primary study and from subjects in the Nimerix Naive Group at Month 60 (Year 5) and 1 month post booster vaccination (Month 61).

Intervention Type: PROCEDURE

Other Intervention Names

Meningococcal vaccine GSK134612 (MenACWY-TT)

Eligibility Criteria

Inclusion Criteria

Persistence phase:

• A male or female who was between and including 10 and 25 years of age at the time of primary vaccination in the study with NCT number = 00454909.
• Written informed consent obtained from parents/guardian 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.
• Healthy subjects as established by medical history.
• Having completed the active phase of the vaccination study with NCT number = 00454909.

Booster phase:

• Written informed consent obtained from parents/guardian 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.
• Subjects who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study.
• Healthy subjects as established by medical history and history-directed physical examination before entering into the study.
• If the subject is female, she must be of non-childbearing potential, i.e., pre-menarche, have a current tubal ligation, hysterectomy, oophorectomy or be post-menopausal, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test on the day of vaccination and continue adequate contraception for 2 months after vaccination.

Additional inclusion criterion for the naïve control group:

• A male or female between, and including, 15 and 30 years of age at the time of the vaccination.

Exclusion Criteria

Persistence phase:

• Use of any investigational or non-registered product within 30 days of each persistence time point.
• Vaccination with meningococcal polysaccharide or conjugate vaccine of serogroup A, C, W-135, and/or Y outside of study with NCT number = 00454909.
• History of any meningococcal disease due to serogroup A, B, C, W-135, or Y.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history.
• Administration of immunoglobulins and/or any blood products within the three months preceding each persistence time point.
• Concurrently participating in another clinical study within 30 days of each persistence time point, in which the subject has been or will be exposed to an investigational or a non-investigational product.
• Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy.
• Chronic alcohol or drug abuse.
• Subjects withdrew consent to be contacted for follow-up studies.

Booster phase (to be checked at Year 5 for all subject, including naïve control group):

• Child in care
• Not enrolled in the Kaiser Healthcare system.
• Use of any investigational or non-registered product within 30 days preceding administration of the study vaccine, or planned use throughout the extended safety follow-up period.
• Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior administration of the booster dose.
• Previous vaccination with meningococcal polysaccharide or conjugate vaccine of serogroup A, C, W-135, and/or Y outside of study with NCT number = 00454909.
• History of any meningococcal disease.
• Any confirmed or suspected immunosuppressive or immunodeficient condition,including human immunodeficiency virus infection based on medical history and physical examination.
• Administration of immunoglobulins and/or any blood products within the three months preceding the booster vaccination or planned administration through Day 30 after vaccination.
• 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.
• Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy.
• History of chronic alcohol consumption and/or drug abuse.
• Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting 30 days before until 30 days after the day of administration of the dose of vaccine(s) with the exception of any licensed inactivated influenza vaccine.
• Previous vaccination with tetanus and diphtheria toxoids within the last month.
• A family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated.
• History of allergic disease or any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine, including latex.
• Major congenital defects or serious chronic illness.
• History of any neurological disorders or seizures.
• Previous history of Guillain-Barré syndrome
• Acute disease at the time of vaccination.
• Pregnant or lactating female.
• Female planning to become pregnant or planning to discontinue contraceptive precautions within 2 months after vaccination.
• For groups A, B and C only: Subjects withdrew consent to be contacted for follow-up studies.

Note: if the subject is female, prior to vaccination she must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test on the day of vaccination and continue adequate contraception for 2 months after vaccination.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Daly City, California, United States

GSK Investigational Site

Fairfield, California, United States

GSK Investigational Site

Redwood City, California, United States

GSK Investigational Site

Sacramento, California, United States

GSK Investigational Site

Vallejo, California, United States

GSK Investigational Site

Walnut Creek, California, United States

GSK Investigational Site

Honolulu, Hawaii, United States

GSK Investigational Site

Honolulu, Hawaii, United States

GSK Investigational Site

Waianae, Hawaii, United States

GSK Investigational Site

Waipio, Hawaii, United States

Countries

United States

References

Baxter R et al. Immunogenicity and safety of an investigational quadrivalent meningococcal ACWY tetanus toxoid conjugate vaccine in healthy adolescents and young adults: 1-year follow-up. Abstract presented at the 51st Annual Interscience Conference on Antimicrobial Agents & Chemotherapy. Chicago, US, 17-20 September 2011.

Reference Type: BACKGROUND

Baxter R et al. Antibody persistence and safety 3 years after a single dose of MenACWY-TT vaccine in healthy individuals aged 10-25 years. Abstract presented at the 31st Annual Meeting of European Society for Paediatric Infectious Diseases (ESPID), Milan, Italy, 28 May-1 June 2013.

Reference Type: BACKGROUND

Baxter R, Baine Y, Kolhe D, Baccarini CI, Miller JM, Van der Wielen M. Five-year Antibody Persistence and Booster Response to a Single Dose of Meningococcal A, C, W and Y Tetanus Toxoid Conjugate Vaccine in Adolescents and Young Adults: An Open, Randomized Trial. Pediatr Infect Dis J. 2015 Nov;34(11):1236-43. doi: 10.1097/INF.0000000000000866.

Reference Type: DERIVED

PMID: 26237742 (View on PubMed)

Other Identifiers

111670

Identifier Type: -

Identifier Source: org_study_id