Primary Study to Demonstrate Non-inferiority and Immunogenicity of GSK Biologicals' Meningococcal Vaccine 134612

NCT ID: NCT00465816

Last Updated: 2018-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 611 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-04-11
• Study Completion Date: 2008-04-28

Brief Summary

This study will demonstrate the non-inferiority of GSK Biologicals' meningococcal vaccine 134612 when given in an experimental co-administration versus vaccine 134612 alone and versus the experimental co-administration alone in healthy subjects aged 11 through 17 years. There will be 3 groups in this study.

Detailed Description

All subjects of groups A and B will have 4 blood samples taken, all subjects of group C will have 3 blood samples taken.

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

Conditions

Infections, Meningococcal

Study Design

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

Study Groups

Nimenrix + Twinrix Group

Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.

Group Type: EXPERIMENTAL

Nimenrix (Meningococcal vaccine 134612)

Intervention Type: BIOLOGICAL

Single dose intramuscular injection

Twinrix

Intervention Type: BIOLOGICAL

3-dose intramuscular injection. Twinrix Adult will be administered to subjects aged 16 years and above and Twinrix Junior will be administered to subjects aged from 11 years up to and including 15 years of age.

Nimenrix Group

Subjects received 1 dose of Nimenrix™ vaccine at Month 0.

Group Type: ACTIVE_COMPARATOR

Nimenrix (Meningococcal vaccine 134612)

Intervention Type: BIOLOGICAL

Single dose intramuscular injection

Twinrix Group

Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.

Group Type: ACTIVE_COMPARATOR

Twinrix

Intervention Type: BIOLOGICAL

3-dose intramuscular injection. Twinrix Adult will be administered to subjects aged 16 years and above and Twinrix Junior will be administered to subjects aged from 11 years up to and including 15 years of age.

Interventions

Nimenrix (Meningococcal vaccine 134612)

Single dose intramuscular injection

Intervention Type: BIOLOGICAL

Twinrix

3-dose intramuscular injection. Twinrix Adult will be administered to subjects aged 16 years and above and Twinrix Junior will be administered to subjects aged from 11 years up to and including 15 years of age.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Subjects who the investigator believes that they and/or their parents/guardians can and will comply with the requirements of the protocol
• A male or female between, and including, 11 and 17 years of age at the time of the first dose of vaccine.
• Written informed consent obtained from the subject/ from the parent or guardian of the subject.
• Healthy subjects as established by medical history and clinical examination before entering into the study.
• Previously completed routine childhood vaccinations to the best of his/her/the parents'/guardians' knowledge.
• If the subject is female and of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for two months after completion of the vaccination series.

Exclusion Criteria

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first 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 first vaccine dose.
• Planned administration/ administration of a vaccine not foreseen by the study protocol within one month of the dose of vaccine.
• Previous vaccination with meningococcal polysaccharide vaccine of serogroup A, C, W-135 and/or Y within the last five years.
• Previous vaccination with meningococcal polysaccharide conjugate vaccine of serogroup A, C, W-135 and/or Y.
• Previous vaccination with tetanus toxoid within the last month.
• Previous vaccination with hepatitis A and/or hepatitis B vaccine.
• Seropositivity for hepatitis A IgG, hepatitis B surface antigen, hepatitis B core antibody and/or hepatitis B surface antigen at screening.
• History of hepatitis A, hepatitis B and/or Neisseria meningitidis infection.
• Known exposure to hepatitis A and/or hepatitis B virus within three months preceding the first dose of study vaccine.
• Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including human immunodeficiency virus (HIV) infection, based on medical history and physical examination.
• 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 either vaccine.
• Major congenital defects or serious chronic illness.
• Acute disease at the time of enrolment.
• Administration of immunoglobulins and/or any blood products within the three months preceding the 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: 11 Years
• Maximum Eligible Age: 17 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

Aarhus N, , Denmark

GSK Investigational Site

Karlskrona, , Sweden

GSK Investigational Site

Linköping, , Sweden

GSK Investigational Site

Malmo, , Sweden

GSK Investigational Site

Örebro, , Sweden

GSK Investigational Site

Umeå, , Sweden

Countries

Denmark; Sweden

References

Ostergaard L, Silfverdal SA, Berglund J, Flodmark CE, West C, Bianco V, Baine Y, Miller JM. A tetravalent meningococcal serogroups A, C, W-135, and Y tetanus toxoid conjugate vaccine is immunogenic and well-tolerated when co-administered with Twinrix((R)) in subjects aged 11-17 years: an open, randomised, controlled trial. Vaccine. 2012 Jan 17;30(4):774-83. doi: 10.1016/j.vaccine.2011.11.051. Epub 2011 Nov 19.

Reference Type: BACKGROUND

PMID: 22107850 (View on PubMed)

Ostergaard L et al. The Candidate meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugated vaccine (MenACWY-TT) co-administered with a combined hepatitis A and B vaccine (HepA/B) is immunogenic with an acceptable safety profile in subjects aged 11-17 Years. Abstract presented at the 3rd Northern European Conference on Travel Medicine (NECTM). Hamburg, Germany, 26-29 May 2010.

Reference Type: BACKGROUND

Study Documents

Document Type: Dataset Specification

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

Document Type: Annotated Case Report 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: Informed Consent Form

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

Related Links

https://www.clinicalstudydatarequest.com

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

Other Identifiers

109063

Identifier Type: -

Identifier Source: org_study_id