The Long-term Antibody Persistence of GSK Biologicals' Meningococcal Vaccine GSK134612 in Healthy Toddlers

NCT00718666 | Completed Phase 2 Results

• 2 other identifiers: 1120212012-002719-24
• Study Type: interventional
• Target: 387
• Locations: 1 country
• Sites: 14

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 in a previous study (whose objectives \& outcome measures are presented in a separate protocol posting with NCT number =00471081) will be evaluated. The safety and immune response of a booster dose of vaccine GSK134612 administered at 5 years post-primary vaccination will also be evaluated. In addition, the immune response to a dose of vaccine GSK134612 administered to age-matched controls not previously given a meningococcal vaccine will be evaluated. This protocol posting has been updated further to protocol amendment 2, dated 28 october 2010. The sections impacted are summary, study design, outcome measures, intervention, and eligibility criteria.

Conditions

Infections, Meningococcal

Keywords

Safety; Vaccines, conjugate; Immunogenicity; Meningococcal vaccine; Booster vaccination; Primary vaccination; Neisseria meningitides; Toddlers; Humans; Meningococcal disease

Outcome Measures

Primary Outcomes (3)

• Number of Subjects With Serum Bactericidal Assay (Using Human Complement) (hSBA) Titers ≥ the Cut-off

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

  At Year 1 (12 months post primary vaccination)

• Number of Subjects With Serum Bactericidal Assay (Using Human Complement) (hSBA) Titers ≥ the Cut-off

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

  At Year 3 (36 months post primnary vaccination)

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

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

  At Year 5 (60 months post primary vaccination)

Secondary Outcomes (33)

• Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Titers ≥ the Cut-off Values

  At Year 1 (12 months post vaccination)

• Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Titers ≥ the Cut-off Values

  At Year 3 (36 months post primary vaccination)

• Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Titers ≥ the Cut-off Values

  At Year 5 (60 months post primary vaccination)

• hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Antibody Titers

  At Year 1 (12 months post primary vaccination)

• hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Antibody Titers

  At Year 3 (36 months post primary vaccination)

Study Arms (3)

Group A

EXPERIMENTAL

Subjects who were previously vaccinated with one dose of GSK134612 at 12 months of age.

Biological: Meningococcal vaccine GSK134612

Group B

EXPERIMENTAL

Subjects who were previously vaccinated with two doses of GSK134612, one each at 9 and 12 months of age.

Biological: Meningococcal vaccine GSK134612

Group C

EXPERIMENTAL

Subjects aged 5-6 years not previously administered meningococcal vaccine.

Biological: Meningococcal vaccine GSK134612

Interventions

Meningococcal vaccine GSK134612 BIOLOGICAL

One dose, as intramuscular injection

Group A; Group B; Group C

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• All subjects must satisfy the following criteria for the persistence phase of the study entry:
• A male or female toddler who was vaccinated 1, 3 or 5 years ago with the last dose of MenACWY-TT in study with NCT number=00471081.
• Written informed consent obtained from parents/guardian of the subject.
• Healthy subjects as established by medical history before entering into the study.
• Having completed the active phase of the vaccination study with NCT number=00471081 (i.e., not withdrawn, had received all planned doses of study vaccines, provided a post-vaccination blood sample after the final dose).
• All subjects must meet the following criteria prior to receiving the booster vaccination:
• Written informed consent obtained from parents/guardian of the subject.
• Subjects who can and will comply with the requirements of the protocol.
• Subjects who provide a blood sample 5 years after last vaccination in study with NCT number=00471081.
• All subjects must satisfy the following criteria prior to enrollment in the naïve control group:
• Subjects who the investigator believes can and will comply with the requirements of the protocol.
• A male or female between, and including, 5-6 years of age at the time of the vaccination.
• Written informed consent obtained from parents/guardian of the subject.
• Healthy subjects as established by medical history and history-directed physical examination before entering into the study.

You may not qualify if:

• Use of any investigational or non-registered product (drug or vaccine) within 30 days of each persistence timepoint.
• Vaccination with meningococcal polysaccharide or conjugate vaccine of serogroup A, B, C, W-135, and/or Y outside of study with NCT number=00471081.
• History of any meningococcal disease due to serogroup A, B, C, W-135, or Y.
• Any confirmed or suspected immunosuppressive or immunodeficiency condition based on medical history and physical examination (no laboratory testing is required).
• Administration of immunoglobulins and/or any blood products within the three months preceding each persistence timepoint.
• Concurrently participating in another clinical study within 30 days of each persistence timepoint, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
• Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy.
• Subjects withdrew consent to be contacted for follow-up studies.
• Child in care.
• Subjects who were enrolled in the Kaiser Healthcare system in study with NCT number=00471081, but are no longer enrolled.
• Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the primary (naive control)/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 primary (naive control)/booster vaccination. (For corticosteroids, this will mean prednisone, or equivalent, \>= 0.5 mg/kg/day. Inhaled and topical steroids are allowed).
• Vaccination with meningococcal polysaccharide or conjugate vaccine outside of study with NCT number=00471081.
• History of any meningococcal disease.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history (no laboratory testing is required).

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (14)

GSK Investigational Site

Benton, Arkansas, 72019, United States

Location

GSK Investigational Site

Little Rock, Arkansas, 72205, United States

Location

GSK Investigational Site

Antioch, California, 94509, United States

Location

GSK Investigational Site

Fremont, California, 94538, United States

Location

GSK Investigational Site

Hayward, California, 94545, United States

Location

GSK Investigational Site

Santa Rosa, California, 95403, United States

Location

GSK Investigational Site

Vacaville, California, 95688, United States

Location

GSK Investigational Site

Lakewood, Colorado, 30226, United States

Location

GSK Investigational Site

Littleton, Colorado, 80122, United States

Location

GSK Investigational Site

Littleton, Colorado, 80123, United States

Location

GSK Investigational Site

Westminster, Colorado, 80234, United States

Location

GSK Investigational Site

Wheat Ridge, Colorado, 80033, United States

Location

GSK Investigational Site

Canton, Ohio, 44708, United States

Location

GSK Investigational Site

Amarillo, Texas, 79124, United States

Location

Related Publications (2)

• Klein NP, Baine Y, Bianco V, Lestrate PR, Naz A, Blatter M, Friedland LR, Miller JM. One or two doses of quadrivalent meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccine is immunogenic in 9- to 12-month-old children. Pediatr Infect Dis J. 2013 Jul;32(7):760-7. doi: 10.1097/INF.0b013e31828693c5.

  PMID: 23348814 BACKGROUND

• Klein NP, Baine Y, Kolhe D, Baccarini CI, Miller JM, Van der Wielen M. Five-year Antibody Persistence and Booster Response After 1 or 2 Doses of Meningococcal A, C, W and Y Tetanus Toxoid Conjugate Vaccine in Healthy Children. Pediatr Infect Dis J. 2016 Jun;35(6):662-72. doi: 10.1097/INF.0000000000001123.

  PMID: 26928521 BACKGROUND

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Meningococcal Infections; Meningitis, Meningococcal

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Meningitis, Bacterial; Central Nervous System Bacterial Infections; Central Nervous System Infections; Central Nervous System Diseases; Nervous System Diseases; Meningitis; Neuroinflammatory Diseases

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 17, 2008
• First Posted: July 21, 2008
• Study Start: October 20, 2008
• Primary Completion: November 13, 2013
• Study Completion: March 28, 2014
• Last Updated: June 26, 2019
• Results First Posted: August 23, 2018

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Locations

US (14)