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

NCT01777308 | Completed Phase 3 Results

• 2 other identifiers: 1167272012-002575-34
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 8

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

Keywords

Immunogenicity; Booster; Healthy; Vaccine response; Safety; Neisseria meningiditis; Antibody persistence; Meningococcal conjugate vaccine

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With Vaccine Response for Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroup A, C, W-135 and Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY)

  Vaccine response was defined as: For initially seronegative subjects (pre-vaccination rSBA titer below 1:8), antibody titer greater than or equal to (≥) 1:32 at post-vaccination; for initially seropositive subjects, antibody titer at post-vaccination ≥ 4 fold the pre-vaccination antibody titer.

  At Month 73, one month post-booster vaccination

Secondary Outcomes (12)

• Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Predefined Cut-off Values

  At Month 73, one month post-booster vaccination

• Antibody Titers Against rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY

  At Month 73, one month post-booster vaccination

• Number of Subjects With Anti-tetanus (Anti-T) Concentrations ≥ the Predefined Cut-off Values

  At Month 73, one month post-booster vaccination

• Antibody Concentrations Against Tetanus (Anti-T) Antigen

  At Month 73, one month post-booster vaccination

• Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Predefined Cut-off Values

  At Month 96, 24 months post-booster vaccination

Study Arms (2)

Menitorix Group

EXPERIMENTAL

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.

Biological: Meningococcal conjugate vaccine GSK134612

Meningitec + Hiberix Group

EXPERIMENTAL

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.

Biological: Meningococcal conjugate vaccine GSK134612

Interventions

Meningococcal conjugate vaccine GSK134612 BIOLOGICAL

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

Meningitec + Hiberix Group; Menitorix Group

Eligibility Criteria

• Age: 84 Months - 95 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (8)

GSK Investigational Site

Garran, Australian Capital Territory, 2606, Australia

Location

GSK Investigational Site

Randwick, New South Wales, 2031, Australia

Location

GSK Investigational Site

Westmead, New South Wales, 2145, Australia

Location

GSK Investigational Site

Herston, Queensland, 4029, Australia

Location

GSK Investigational Site

Sherwood, Queensland, 4075, Australia

Location

GSK Investigational Site

North Adelaide, South Australia, 5006, Australia

Location

GSK Investigational Site

Carlton, Victoria, 3053, Australia

Location

GSK Investigational Site

Subiaco, Western Australia, 6008, Australia

Location

Related Publications (1)

• 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.

  PMID: 31116180 DERIVED

MeSH Terms

Conditions

Meningococcal Infections

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2013
• First Posted: January 28, 2013
• Study Start: May 3, 2013
• Primary Completion: July 3, 2014
• Study Completion: April 20, 2016
• Last Updated: January 25, 2019
• Results First Posted: January 25, 2019

Record last verified: 2017-09

Locations

AU (8)