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

NCT ID: NCT00471081

Last Updated: 2019-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 385 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-05
• Study Completion Date: 2008-11-26

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.

Detailed Description

The protocol posting has been amended to reflect changes as a consequence of an amendment to the protocol and also to comply with the FDA amendment Act, Sep 2007. Sections impacted are Brief Title, Official Title of the study, Brief Summary, Key Inclusion & Exclusion criteria.

Conditions

Infections, Meningococcal

Study Design

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

Study Groups

Group A

Single dose GSK134612.

Group Type: EXPERIMENTAL

Meningococcal vaccine GSK134612

Intervention Type: BIOLOGICAL

One or 2 intramuscular injections.

Group B

Two doses of GSK134612.

Group Type: EXPERIMENTAL

Meningococcal vaccine GSK134612

Intervention Type: BIOLOGICAL

One or 2 intramuscular injections.

Interventions

Meningococcal vaccine GSK134612

One or 2 intramuscular injections.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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).

• Minimum Eligible Age: 9 Months
• Maximum Eligible Age: 9 Months
• 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

Birmingham, Alabama, United States

GSK Investigational Site

Benton, Arkansas, United States

GSK Investigational Site

Little Rock, Arkansas, United States

GSK Investigational Site

Antioch, California, United States

GSK Investigational Site

Fremont, California, United States

GSK Investigational Site

Hayward, California, United States

GSK Investigational Site

Madera, California, United States

GSK Investigational Site

Santa Rosa, California, United States

GSK Investigational Site

Vacaville, California, United States

GSK Investigational Site

Lakewood, Colorado, United States

GSK Investigational Site

Littleton, Colorado, United States

GSK Investigational Site

Littleton, Colorado, United States

GSK Investigational Site

Westminster, Colorado, United States

GSK Investigational Site

Wheat Ridge, Colorado, United States

GSK Investigational Site

Birmingham, Georgia, United States

GSK Investigational Site

Canton, Ohio, United States

GSK Investigational Site

Erie, Pennsylvania, United States

GSK Investigational Site

Greenville, Pennsylvania, United States

GSK Investigational Site

Amarillo, Texas, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 23348814 (View on PubMed)

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.

Reference Type: BACKGROUND

Study Documents

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

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Other Identifiers

109375

Identifier Type: -

Identifier Source: org_study_id