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

NCT00715910 | Completed Phase 2 Results

• 1 other identifier: 111670
• Study Type: interventional
• Target: 818
• Locations: 1 country
• Sites: 10

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.

Conditions

Infections, Meningococcal

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Number of Subjects With Serum Bactericidal Assay (Using Human Complement) (hSBA) Titers Equal to or Above the Cut-off Values

  hSBA antibody titers were assessed for the hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY serogroups respectively. The antibody cut-off value assessed was equal to or above 1:8.

  At year 1 persistence

• Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values

  hSBA antibody titers were assessed for the hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY serogroups respectively. The antibody cut-off value assessed was equal to or above 1:8.

  At year 3 persistence

• Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values

  hSBA antibody titers were assessed for the hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY serogroups respectively. The antibody cut-off value assessed was equal to or above 1:8.

  At year 5 persistence

Secondary Outcomes (19)

• Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values

  At year 1 persistence

• Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values

  At year 3 persistence

• Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values

  At year 5 persistence

• hSBA Antibody Titers

  At year 1 persistence

• hSBA Antibody Titers

  At year 3 persistence

Study Arms (6)

Nimenrix 1 Group

EXPERIMENTAL

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

Biological: Nimenrix; Procedure: Blood sampling

Menactra Group

ACTIVE COMPARATOR

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

Biological: Nimenrix; Procedure: Blood sampling

Nimenrix 2 Group

EXPERIMENTAL

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

Biological: Nimenrix; Procedure: Blood sampling

Nimenrix Naive Group

EXPERIMENTAL

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

Biological: Nimenrix; Procedure: Blood sampling

Nimenrix Pooled Group

EXPERIMENTAL

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.

Biological: Nimenrix

Menactra Booster Group

ACTIVE COMPARATOR

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.

Biological: Nimenrix

Interventions

Nimenrix BIOLOGICAL

One dose, as intramuscular injection

Also known as: Meningococcal vaccine GSK134612 (MenACWY-TT)

Menactra Booster Group; Menactra Group; Nimenrix 1 Group; Nimenrix 2 Group; Nimenrix Naive Group; Nimenrix Pooled Group

Blood sampling 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; Nimenrix 1 Group; Nimenrix 2 Group; Nimenrix Naive Group

Eligibility Criteria

• Age: 15 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (10)

GSK Investigational Site

Daly City, California, 94015, United States

Location

GSK Investigational Site

Fairfield, California, 94533, United States

Location

GSK Investigational Site

Redwood City, California, 94063, United States

Location

GSK Investigational Site

Sacramento, California, 95815, United States

Location

GSK Investigational Site

Vallejo, California, 94589, United States

Location

GSK Investigational Site

Walnut Creek, California, 94596, United States

Location

GSK Investigational Site

Honolulu, Hawaii, 96814, United States

Location

GSK Investigational Site

Honolulu, Hawaii, 96819, United States

Location

GSK Investigational Site

Waianae, Hawaii, 96792, United States

Location

GSK Investigational Site

Waipio, Hawaii, 96797, United States

Location

Related Publications (3)

• 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.

  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.

  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.

  PMID: 26237742 DERIVED

MeSH Terms

Conditions

Meningococcal Infections

Interventions

tetravalent meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccine; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2008
• First Posted: July 15, 2008
• Study Start: July 1, 2008
• Primary Completion: April 1, 2013
• Study Completion: October 1, 2013
• Last Updated: November 27, 2014
• Results First Posted: May 29, 2014

Record last verified: 2014-09

Locations

US (10)