Persistence and Booster Study of GSK Biologicals' Meningococcal Vaccine (GSK134612) in Healthy Children

NCT01266993 | Completed Phase 3 Results

• 2 other identifiers: 1139772010-018730-51
• Study Type: interventional
• Target: 271
• Locations: 2 countries
• Sites: 24

Brief Summary

The purpose of the study is to evaluate the persistence of the immune response of GSK134612 vaccine up to 68 months after vaccination in the primary vaccination study (NCT number = NCT00674583) of 2 to 10 year old subjects. This study will also evaluate the safety and immunogenicity of a booster dose of GSK134612 vaccine subjects who were primed in the primary vaccination study with either GSK134612 vaccine or Menjugate®. This protocol posting deals with objectives \& outcome measures of the persistence and booster epochs. The objectives \& outcome measures of the primary epoch are presented in a separate protocol posting (NCT number = NCT00674583)

Conditions

Infections, Meningococcal; Meningococcal Vaccines

Keywords

Immunogenicity; Persistence; Safety; Conjugate vaccine; Meningococcal vaccine

Outcome Measures

Primary Outcomes (4)

• Number of Subjects With Serum Bactericidal Assay, Using Baby Rabbit Complement, Against Neisseria Meningitides Serogroup A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers Was Greater Than or Equal to (≥) 1:8, at Month 32.

  The pre-defined cut-off value of the assay for the rSBA titers was greater than or equal to (≥) 1:8. These analyses have been performed by the Health Protection Agency (HPA) laboratory.

  At Month 32, post-primary vaccination

• Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:8, at Month 44.

  The pre-defined cut-off value of the assay for the rSBA titers was greater than or equal to (≥) 1:8. These analyses have been performed by the Health Protection Agency (HPA) laboratory.

  At Month 44, post-primary vaccination

• Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:8, at Month 56.

  The pre-defined cut-off value of the assay for the rSBA titers was greater than or equal to (≥) 1:8. These analyses have been performed by the Health Protection Agency (HPA) laboratory.

  At Month 56, post-primary vaccination

• Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:8, at Month 68.

  The pre-defined cut-off value of the assay for the rSBA titers was greater than or equal to (≥) 1:8. These analyses have been performed by the Health Protection Agency (HPA) laboratory.

  At Month 68, post-primary vaccination

Secondary Outcomes (28)

• Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128, at Month 32.

  At Month 32, post-primary vaccination

• Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128, at Month 44.

  At Month 44, post-primary vaccination

• Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128, at Month 56.

  At Month 56, post-primary vaccination

• Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128, at Month 68.

  At Month 68, post-primary vaccination

• Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY, at Month 32.

  At Month 32, post-primary vaccination

Study Arms (2)

Nimenrix Group

EXPERIMENTAL

Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Nimenrix vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.

Biological: Nimenrix (GSK134612 vaccine)

Menjugate Group

EXPERIMENTAL

Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Menjugate vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Menjugate vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.

Biological: Menjugate

Interventions

Nimenrix (GSK134612 vaccine) BIOLOGICAL

Intramuscular, 1 dose

Nimenrix Group

Menjugate BIOLOGICAL

Intramuscular, 1 dose

Menjugate Group

Eligibility Criteria

• Age: 4 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol should be enrolled in the study.
• A male or female who was primed with MenACWY-TT or Menjugate in the primary vaccination study (NCT number = NCT00674583).
• Written informed consent obtained from the parent(s)/Legally Acceptable Representatives(s) of the subject and written informed assent obtained from the subject (at investigator discretion).
• Healthy subjects as established by medical history and clinical examination before entering into the study.
• All subjects must meet the additional following criteria prior to receiving the booster vaccination:
• Subjects who had a blood sample taken at Visit 4 during the persistence epoch of the current study.
• Female subjects of non-childbearing potential may be enrolled in the study.
• 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.

You may not qualify if:

• Child in care.
• Use of any investigational or non-registered product within 30 days preceding the first persistence blood sample or planned use within 30 days preceding a blood sample during the study period.
• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs during the study period. (For corticosteroids, prednisone \<10 mg/day, or equivalent, inhaled and topical steroids are allowed).
• Concurrently participating in another clinical study or planned participation in another clinical study, in which the subject has been or will be exposed to an investigational or a non-investigational product within 30 days of a blood sample.
• History of meningococcal disease.
• Administration of a meningococcal polysaccharide or a meningococcal polysaccharide conjugate vaccine since the previous vaccination in the primary vaccination study (NCT number = NCT00674583).
• Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection, based on medical history and physical examination.
• Serious chronic illness.
• Administration of immunoglobulins and/or blood products within the 3 months preceding the subject's first visit.
• Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy.
• Subjects in contact with somebody suffering from an invasive infection with meningococcal serogroups A, C, Y or W-135.
• Subjects living in a geographic area where local outbreak with meningococcal serogroup C has occurred.
• Child in care.
• Use of any investigational or non-registered product within 30 days preceding the booster vaccination or planned use during the study period.
• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the booster vaccination. (For corticosteroids, prednisone \<10 mg/day, or equivalent, inhaled and topical steroids are allowed).

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (24)

GSK Investigational Site

Draguignan, 83300, France

Location

GSK Investigational Site

Le Havre, 76600, France

Location

GSK Investigational Site

Lingolsheim, 67380, France

Location

GSK Investigational Site

Miribel, 01700, France

Location

GSK Investigational Site

Nice, 06300, France

Location

GSK Investigational Site

Paris, 75015, France

Location

GSK Investigational Site

Saint-Laurent-du-Var, 06700, France

Location

GSK Investigational Site

Tours, 37000, France

Location

GSK Investigational Site

Munich, Bavaria, 81241, Germany

Location

GSK Investigational Site

Munich, Bavaria, 81735, Germany

Location

GSK Investigational Site

Olching, Bavaria, 82140, Germany

Location

GSK Investigational Site

Detmold, North Rhine-Westphalia, 32756, Germany

Location

GSK Investigational Site

Goch, North Rhine-Westphalia, 47574, Germany

Location

GSK Investigational Site

Heiligenhaus, North Rhine-Westphalia, 42579, Germany

Location

GSK Investigational Site

Hille, North Rhine-Westphalia, 32479, Germany

Location

GSK Investigational Site

Solingen, North Rhine-Westphalia, 42719, Germany

Location

GSK Investigational Site

Velbert, North Rhine-Westphalia, 42551, Germany

Location

GSK Investigational Site

Frankenthal, Rhineland-Palatinate, 67227, Germany

Location

GSK Investigational Site

Mainz, Rhineland-Palatinate, 55131, Germany

Location

GSK Investigational Site

Trier, Rhineland-Palatinate, 54290, Germany

Location

GSK Investigational Site

Berlin, 10315, Germany

Location

GSK Investigational Site

Berlin, 10627, Germany

Location

GSK Investigational Site

Berlin, 13055, Germany

Location

GSK Investigational Site

Berlin, 14197, Germany

Location

MeSH Terms

Conditions

Meningococcal Infections

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

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 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2010
• First Posted: December 24, 2010
• Study Start: January 3, 2011
• Primary Completion: March 31, 2014
• Study Completion: May 17, 2014
• Last Updated: November 23, 2020
• Results First Posted: January 31, 2019

Record last verified: 2020-11

Locations

FR (8); DE (16)