Immunogenicity and Safety of Meningococcal Vaccine GSK134612 vs. Menactra® in Healthy Adolescent/Adults Aged 10-25 Years.

NCT ID: NCT00454909

Last Updated: 2018-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 873 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-04-23
• Study Completion Date: 2008-04-11

Brief Summary

The purpose of the study is to characterize the safety and immunogenicity of 1 dose of GSK Biologicals' meningococcal vaccine GSK134612 as compared to Menactra® in adolescents/adults 11-25 years of age.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

The protocol posting has been updated following a protocol amendment.

Detailed Description

Subjects 11-25 years of age will be randomized to receive either the meningococcal vaccine GSK134612 or Menactra®. An additional non-randomized group of subjects aged 10 years (< 11 years of age) will be enrolled to receive meningococcal vaccine GSK134612 only (At the time the study begun, Menactra® was only licensed in the United States for individuals above 11 years of age and therefore could not be used as a control vaccine in subjects less than 11 years old).

This study will be single-blind for the subjects 11 to 25 years of age and open for the subjects 10 to < 11 years of age.

Conditions

Infections, Meningococcal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Group A

Subjects aged 10 years (\< 11 years) vaccinated with meningococcal vaccine GSK134612.

Group Type: EXPERIMENTAL

Meningococcal vaccine 134612

Intervention Type: BIOLOGICAL

Single dose intramuscular injection.

Group B

Subjects aged 11 to 25 years vaccinated with meningococcal vaccine GSK134612.

Group Type: EXPERIMENTAL

Meningococcal vaccine 134612

Intervention Type: BIOLOGICAL

Single dose intramuscular injection.

Group C

Subjects aged 11 to 25 years vaccinated with Menactra®.

Group Type: ACTIVE_COMPARATOR

Menactra®

Intervention Type: BIOLOGICAL

Single dose intramuscular injection.

Interventions

Meningococcal vaccine 134612

Single dose intramuscular injection.

Intervention Type: BIOLOGICAL

Menactra®

Single dose intramuscular injection.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Subjects whom the investigator believes can and will comply with the requirements of the protocol.
• A male or female between, and including, 10 and 25 years of age (has not attained his/her 26th birthday) at the time of the vaccination.
• 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 and clinical examination before entering into the study.
• If the subject is female, she must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception (including abstinence) for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after vaccination.

Exclusion Criteria

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the dose of study vaccine, 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 one month of the dose of vaccine(s).
• Previous vaccination with meningococcal polysaccharide or conjugate vaccine of serogroup A, C W-135, and/or Y.
• Previous vaccination with tetanus and diphtheria toxoids within the last month (i.e., Tdap, Td, and TT-containing vaccine within the last month).
• History of meningococcal disease due to serogroup A, C, W-135, or Y.
• 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 allergic disease or reactions likely to be exacerbated by any component of the vaccine.
• Hypersensitivity to latex.
• Major congenital defects or serious chronic illness.
• History of any neurologic disorders or seizures.
• Previous history of Guillain-Barré Syndrome.
• Bleeding disorders, such as hemophilia or thrombocytopenia, or subjects on anti-coagulant therapy.
• 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 study period.
• Pregnant or lactating female.
• History of chronic alcohol consumption and/or drug abuse.
• Female planning to become pregnant or planning to discontinue contraceptive precautions.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 25 Years
• 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

Daly City, California, United States

GSK Investigational Site

Fairfield, California, United States

GSK Investigational Site

Redwood City, California, United States

GSK Investigational Site

Sacramento, California, United States

GSK Investigational Site

Vallejo, California, United States

GSK Investigational Site

Walnut Creek, California, United States

GSK Investigational Site

Honolulu, Hawaii, United States

GSK Investigational Site

Honolulu, Hawaii, United States

GSK Investigational Site

Waianae, Hawaii, United States

GSK Investigational Site

Waipio, Hawaii, United States

Countries

United States

References

Baxter R, Baine Y, Ensor K, Bianco V, Friedland LR, Miller JM. Immunogenicity and safety of an investigational quadrivalent meningococcal ACWY tetanus toxoid conjugate vaccine in healthy adolescents and young adults 10 to 25 years of age. Pediatr Infect Dis J. 2011 Mar;30(3):e41-8. doi: 10.1097/INF.0b013e3182054ab9.

Reference Type: BACKGROUND

PMID: 21200360 (View on PubMed)

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.

Reference Type: BACKGROUND

Study Documents

Document Type: Study Protocol

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: Dataset Specification

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: Clinical Study Report

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: Annotated Case Report Form

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

109377

Identifier Type: -

Identifier Source: org_study_id