Lot Consistency, Immuno, Safety of Meningococcal Vaccine GSK134612 Given With Fluarix™ to 18-55 Year-Old Adults

NCT ID: NCT00453986

Last Updated: 2018-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1352 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-04-09
• Study Completion Date: 2008-05-21

Brief Summary

The purpose of this study is to demonstrate, in 18-55 year old adults, the consistency of different manufactured lots of meningococcal vaccine GSK134612, the non-inferiority of GSK134612 compared to licensed meningococcal vaccine Mencevax™, the non-inferiority of GSK134612 when given in an experimental co-administration with Fluarix™ compared to GSK134612 given alone and the immunogenicity of GSK134612 given with Fluarix™.

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

Detailed Description

Multicentre study with 5 treatment groups. Three groups will receive three different manufactured lots of GSK134612, one group will receive one lot of GSK134612 given in an experimental co-administration with Fluarix™, the control group will receive Mencevax™. The study will be conducted in a double-blind manner with respect to the 3 lots of GSK134612 vaccine. The study will be 'open' between the groups receiving GSK134612 and the group receiving GSK134612 + Fluarix™ and the Mencevax™ group.

Each subject will have 2 blood samples taken for immunogenicity analyses, one prior to vaccination and one taken 30 days later.

Conditions

Infections, Meningococcal

Study Design

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

Study Groups

Nimenrix A Group

subjects received 1 dose of Nimenrix™ Lot A at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.

Group Type: EXPERIMENTAL

Meningococcal vaccine GSK134612

Intervention Type: BIOLOGICAL

One intramuscular dose

Nimenrix B Group

subjects received 1 dose of Nimenrix™ Lot B at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.

Group Type: EXPERIMENTAL

Meningococcal vaccine GSK134612

Intervention Type: BIOLOGICAL

One intramuscular dose

Nimenrix C Group

subjects received 1 dose of Nimenrix™ Lot C at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.

Group Type: EXPERIMENTAL

Meningococcal vaccine GSK134612

Intervention Type: BIOLOGICAL

One intramuscular dose

Mencevax ACWY Group

subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.

Group Type: ACTIVE_COMPARATOR

Mencevax™ACWY

Intervention Type: BIOLOGICAL

One subcutaneous dose

Nimenrix+Fluarix Group

subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.

Group Type: EXPERIMENTAL

Meningococcal vaccine GSK134612

Intervention Type: BIOLOGICAL

One intramuscular dose

Fluarix™

Intervention Type: BIOLOGICAL

One intramuscular dose

Interventions

Meningococcal vaccine GSK134612

One intramuscular dose

Intervention Type: BIOLOGICAL

Mencevax™ACWY

One subcutaneous dose

Intervention Type: BIOLOGICAL

Fluarix™

One intramuscular dose

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

For all subjects:

• Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
• A male or female between, and including, 18 and 55 years of age at the time of the vaccination.
• Written informed consent obtained from 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 knowledge.
• If the subject is female, she must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test, and continue such precautions for 2 months after completion of the vaccination series.

Exclusion Criteria

For all subjects:

• 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 vaccine of serogroup A, C, W, and/or Y within the last five previous years.
• Previous vaccination with meningococcal polysaccharide conjugate vaccine of serogroup A, C, W, and/or Y.
• Previous vaccination with tetanus toxoid within the last month.
• History of meningococcal disease.
• 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 the 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 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.

Additional criteria for subjects receiving Fluarix™ co-administration:

• History of hypersensitivity to a previous dose of influenza vaccine.
• History of reactions or allergy likely to be exacerbated by any component of the vaccine including egg, chicken protein, formaldehyde, thimerosal, gentamicin sulfate, or sodium deoxycholate.
• History of administration of an influenza vaccine outside of this study, during current flu season.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 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

Beirut, , Lebanon

GSK Investigational Site

Cavite, , Philippines

GSK Investigational Site

City of Muntinlupa, , Philippines

GSK Investigational Site

Manila, , Philippines

Countries

Lebanon; Philippines

References

Dbaibo G, Macalalad N, Aplasca-De Los Reyes MR, Dimaano E, Bianco V, Baine Y, Miller J. The immunogenicity and safety of an investigational meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate vaccine (ACWY-TT) compared with a licensed meningococcal tetravalent polysaccharide vaccine: a randomized, controlled non-inferiority study. Hum Vaccin Immunother. 2012 Jul;8(7):873-80. doi: 10.4161/hv.20211. Epub 2012 Apr 9.

Reference Type: BACKGROUND

PMID: 22485050 (View on PubMed)

Macalalad N et al. The candidate Meningococcal serogroups A, C, W-135, Y conjugate vaccine (MenACWY-TT) and the seasonal influenza virus vaccine are immunogenic with an acceptable safety profile when co-administered in adults. Abstract presented at the 3rd Northern European Conference on Travel Medicine (NECTM) Hamburg, Germany, May 26-29, 2010.

Reference Type: BACKGROUND

Aplasca-De Los Reyes MR, Dimaano E, Macalalad N, Dbaibo G, Bianco V, Baine Y, Miller J. The investigational meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate vaccine (ACWY-TT) and the seasonal influenza virus vaccine are immunogenic and well-tolerated when co-administered in adults. Hum Vaccin Immunother. 2012 Jul;8(7):881-7. doi: 10.4161/hv.20212. Epub 2012 Apr 9.

Reference Type: BACKGROUND

PMID: 22485048 (View on PubMed)

Study Documents

Document Type: Dataset Specification

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

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Document Type: Individual Participant Data Set

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

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Document Type: Annotated Case Report Form

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

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Document Type: Informed Consent Form

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: Clinical Study Report

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

Related Links

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Other Identifiers

109067

Identifier Type: -

Identifier Source: org_study_id