Immunogenicity, Reactogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' MenACWY-TT Vaccine Administered 6 Years Post-MenC Primary Vaccination in Healthy Subjects Who Were 12-18 Months at Primary Vaccination

NCT ID: NCT01777308

Last Updated: 2019-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 156 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-03
• Study Completion Date: 2016-04-20

Brief Summary

The purpose of this study is to evaluate the immunogenicity, reactogenicity and safety of a booster dose of GSK Biologicals' MenACWY-TT vaccine administered at 6 years post-primary vaccination with either GSK Biologicals' Hib-MenC-TT vaccine (Menitorix™) or Hiberix™ and Meningitec™, in healthy subjects aged 12-18 months at primary vaccination and to evaluate the long-term antibody persistence at 2 years after MenACWY-TT booster vaccination.

This is an extension study of the Hib-MenC-TT-016 study (NCT number: NCT00326118).

Conditions

Infections, Meningococcal

Study Design

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

Study Groups

Menitorix Group

Subjects who were primed with Menitorix™ (Hib-MenC-TT) + Priorix™ (MMR) vaccines in the primary study HIB-MENC-TT-016 (NCT00326118) received one dose of Nimenrix™ (MenACWY-TT) booster vaccine at Month 72 post primary vaccination (booster visit 1).

The MenACWY-TT vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm.

Group Type: EXPERIMENTAL

Meningococcal conjugate vaccine GSK134612

Intervention Type: BIOLOGICAL

Single dose to be administrated intramuscularly in the deltoid of the non-dominant arm

Meningitec + Hiberix Group

Subjects who were primed with Meningitec™ (MCC) + Hiberix™ (Hib) + Priorix™ (MMR) vaccine in the primary study HIB-MENC-TT-016 (NCT00326118) received one dose of Nimenrix™ (MenACWY-TT) booster vaccine at Month 72 post primary vaccination (booster visit 1).

The MenACWY-TT vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm.

Group Type: EXPERIMENTAL

Meningococcal conjugate vaccine GSK134612

Intervention Type: BIOLOGICAL

Single dose to be administrated intramuscularly in the deltoid of the non-dominant arm

Interventions

Meningococcal conjugate vaccine GSK134612

Single dose to be administrated intramuscularly in the deltoid of the non-dominant arm

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Subjects' parent(s)/Legally Acceptable Representative(s) who, in the opinion of the investigator, can and will comply, with the requirements of the protocol.
• A male or female between, and including, 84 and 95 months of age at the time of the booster vaccination.
• Written informed consent obtained from the parent(s)/LAR(s) of the subject and written informed assent obtained from the subject in accordance with local laws and regulations.
• Healthy subjects as established by medical history and history-directed physical examination before entering into the study.
• Having completed the vaccination in the study [Hib-MenC-TT-016 (106445)] as per protocol.

Exclusion Criteria

• Child in care.
• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period.
• Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose. For corticosteroids, this will mean prednisone ≥ 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
• Administration of a vaccine not foreseen by the study protocol within the period starting 30 days before and ending 30 days after the study vaccine dose, with the exception of a licensed inactivated influenza vaccine which can be administered at any time during the study according to the local recommendations.
• Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product.
• Previous vaccination with meningococcal vaccine except the meningococcal vaccination received in the Hib-MenC-TT-016 study.
• 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 (no laboratory testing required).
• Family history of congenital or hereditary immunodeficiency.
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine, and history of serious allergic reaction (anaphylaxis) following the administration of vaccine(s).
• Major congenital defects or serious chronic illness.
• History of any neurological disorders or seizures, including GBS. History of a simple, single febrile seizure is permitted.
• Acute disease and/or fever at the time of enrollment.

• Fever is defined as temperature ≥ 37.5°C for oral, axillary or tympanic route, or ≥ 38.0°C for rectal route. The preferred route for recording temperature in this study will be oral.
• Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator.
• Administration of immunoglobulins and/or any blood products within the 3 months preceding the study vaccination or planned administration during the booster vaccination phase of the study (i.e. between Visit 1 and Visit 2) and within 3 months preceding the blood sampling at Visit 3.

The following criteria should be checked for the long-term persistence phase at two years after booster vaccination (Visit 3):

In case an exclusion criterion becomes applicable, the subject will not enter the long-term follow-up and the reason will be documented.

• Previous administration of a meningococcal vaccine with the exception of the meningococcal vaccination given in the primary study and the booster vaccination in this particular study.
• History of meningococcal disease.

• Minimum Eligible Age: 84 Months
• Maximum Eligible Age: 95 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

Garran, Australian Capital Territory, Australia

GSK Investigational Site

Randwick, New South Wales, Australia

GSK Investigational Site

Westmead, New South Wales, Australia

GSK Investigational Site

Herston, Queensland, Australia

GSK Investigational Site

Sherwood, Queensland, Australia

GSK Investigational Site

North Adelaide, South Australia, Australia

GSK Investigational Site

Carlton, Victoria, Australia

GSK Investigational Site

Subiaco, Western Australia, Australia

Countries

Australia

References

Nolan T, Booy R, Marshall HS, Richmond P, Nissen M, Ziegler JB, Baine Y, Traskine M, Jastorff A, Van der Wielen M. Immunogenicity and Safety of a Quadrivalent Meningococcal ACWY-tetanus Toxoid Conjugate Vaccine 6 Years After MenC Priming as Toddlers. Pediatr Infect Dis J. 2019 Jun;38(6):643-650. doi: 10.1097/INF.0000000000002334.

Reference Type: DERIVED

PMID: 31116180 (View on PubMed)

Other Identifiers

2012-002575-34

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

116727

Identifier Type: -

Identifier Source: org_study_id