Immunogenicity and Safety of Meningococcal Vaccine GSK134612 Given as 1 or 2 Doses to Healthy 9-12 Months Old Toddlers.

NCT00471081 | Completed Phase 2 Results

• 1 other identifier: 109375
• Study Type: interventional
• Target: 385
• Locations: 1 country
• Sites: 19

Brief Summary

The purpose of the study is to characterize the safety and immunogenicity of 1 dose of GSK134612 vaccine at 12 months of age and of GSK134612 vaccine administered as 2 doses at 9 and 12 months of age.

Conditions

Infections, Meningococcal

Keywords

Neisseria meningitidis;; Humans;; Meningococcal vaccines;; Safety; Vaccines, conjugate;; Toddlers;; Immunogenicity;

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y) Antibody Titers Greater Than or Equal to the Cut-off Value

  The cut-off value for the hSBA titers was greater than or equal to (≥) 1:8.

  One month after the last dose (at Month 4)

Secondary Outcomes (16)

• Number of Subjects With Serum Bactericidal Assay Using hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value

  One month after the first dose (at Month 1)

• Number of Subjects With Serum Bactericidal Assay Using hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value

  At Month 1 (for GSK 134612 2 doses Group only) and Month 4

• hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers

  At Month 1 (for GSK 134612 2 doses Group only) and Month 4

• Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers Greater Than or Equal to the Cut-off Value

  At Month 1 (for GSK 134612 2 doses Group only) and Month 4

• Number of Subjects With Serum Bactericidal Assay Using rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Greater Than or Equal to the Cut-off Value

  At Month 1 (GSK 134612 2 doses Group only) and Month 4

Study Arms (2)

Group A

EXPERIMENTAL

Single dose GSK134612.

Biological: Meningococcal vaccine GSK134612

Group B

EXPERIMENTAL

Two doses of GSK134612.

Biological: Meningococcal vaccine GSK134612

Interventions

Meningococcal vaccine GSK134612 BIOLOGICAL

One or 2 intramuscular injections.

Group A; Group B

Eligibility Criteria

• Age: 9 Months - 9 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Subjects whose parents/guardians the investigator believes can and will comply with the requirements of the protocol
• A male or female of 9 months of age (has not attained 10 months of age) at the time of enrollment.
• Up to date on vaccinations based on ACIP recommendations and the standard practice at the investigational site.
• Written informed consent obtained from parents/guardian of the subject.
• Healthy subjects as established by medical history and clinical examination before entering into the study.

You may not qualify if:

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding enrollment, 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 vaccine dose.
• Planned administration/ administration of a vaccine not foreseen by the study protocol within 1 month of a dose of study vaccine(s), with the exception of influenza vaccine.
• Planned administration of a tetanus toxoid (TT) containing vaccine throughout the active phase of the study (through one month after the last vaccination).
• Previous vaccination with meningococcal polysaccharide or conjugate vaccine of serogroup A, C W and/or Y.
• History of meningococcal diseases.
• Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including human immunodeficiency virus (HIV) infection, based on medical history and physical examination (no laboratory testing is required).
• A family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated.
• History of reactions or allergic disease likely to be exacerbated by any component of the vaccine.
• Major congenital defects or serious chronic illness.
• History of any neurologic disorders or seizures.
• Acute disease at the time of enrollment.
• Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the active phase of the study (through one month after the last dose of study vaccine).

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (19)

GSK Investigational Site

Birmingham, Alabama, 35205, United States

Location

GSK Investigational Site

Benton, Arkansas, 72015, 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

Madera, California, 93637, 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, 80226, United States

Location

GSK Investigational Site

Littleton, Colorado, 80122, United States

Location

GSK Investigational Site

Littleton, Colorado, 80234, 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

Birmingham, Georgia, 35244, United States

Location

GSK Investigational Site

Canton, Ohio, 44718, United States

Location

GSK Investigational Site

Erie, Pennsylvania, 16501, United States

Location

GSK Investigational Site

Greenville, Pennsylvania, 16125, 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 N et al. Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal ACWY Tetanus Toxoid Conjugate Vaccine in Healthy Toddlers: 1-year Persistence. Abstract presented at the 51st Annual Interscience Conference on Antimicrobial Agents & Chemotherapy. Chicago, US, 17-20 September 2011.

  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

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

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: May 8, 2007
• First Posted: May 9, 2007
• Study Start: July 5, 2007
• Primary Completion: October 23, 2008
• Study Completion: November 26, 2008
• Last Updated: June 25, 2019
• Results First Posted: September 14, 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 (19)