Overview

This trial is active, not recruiting.

Condition infections, meningococcal
Treatments meningococcal vaccine gsk134612, prevenar 13™
Phase phase 3
Sponsor GlaxoSmithKline
Start date October 2013
End date December 2019
Trial size 900 participants
Trial identifier NCT01939158, 116892, 2013-001083-28

Summary

The purpose of this study is to compare the immediate and long term (up to 5 years) immunogenicity and safety of GSK Biologicals' MenACWY-TT vaccine when given as a single dose or as 2 doses to toddlers aged 12 to 14 months. Also, this study will also assess if co-administration of GSK Biologicals' MenACWY-TT with the booster dose of Pfizer's Prevenar 13 adversely impacts the immunogenicity of either of the vaccines.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
Subjects will receive 1 dose of the MenACWY-TT vaccine
meningococcal vaccine gsk134612
1 or 2 doses administered intramuscularly in the left anterolateral thigh or deltoid region
(Experimental)
Subjects will receive 2 doses of the MenACWY-TT vaccine 2 months apart
meningococcal vaccine gsk134612
1 or 2 doses administered intramuscularly in the left anterolateral thigh or deltoid region
(Experimental)
Subjects will receive 1 dose of the MenACWY-TT vaccine co-administered with Prevenar 13™
meningococcal vaccine gsk134612
1 or 2 doses administered intramuscularly in the left anterolateral thigh or deltoid region
prevenar 13™
1 dose administered intramuscularly in the right anterolateral thigh or deltoid region
(Active Comparator)
Subjects will receive 1 dose of Prevenar 13™ and 1 dose of the MenACWY-TT vaccine 2 months later
meningococcal vaccine gsk134612
1 or 2 doses administered intramuscularly in the left anterolateral thigh or deltoid region
prevenar 13™
1 dose administered intramuscularly in the right anterolateral thigh or deltoid region

Primary Outcomes

Measure
Immunogenicity with respect to components of the study vaccines in terms of rSBA titres
time frame: 1 month after administration of 1 dose of MenACWY-TT in the ACWY1d, ACWY2d and Co-ad groups (Month 1)
Immunogenicity with respect to components of the study vaccines in terms of rSBA titres
time frame: At Year 1
Immunogenicity with respect to components of the study vaccines in terms of rSBA titres
time frame: At Year 3
Immunogenicity with respect to components of the study vaccines in terms of rSBA titres
time frame: At Year 5
Immunogenicity with respect to components of the study vaccines in terms of antibody concentration
time frame: 1 month after administration of Prevenar 13 (Month 1)
Immunogenicity with respect to components of the study vaccines in terms of rSBA titres
time frame: 1 month after administration of 2 doses of MenACWY-TT in the ACWY2d group (Month 3)

Secondary Outcomes

Measure
Immunogenicity with respect to components of the study vaccines (on secondary readouts) in terms of hSBA titres
time frame: 1 month after administration of 1 dose of MenACWY-TT in a subset of subjects in the ACWY1d and ACWY2d groups (Month 1) and 2 doses in the ACWY2d group (Month 3)
Immunogenicity with respect to components of the study vaccines (on secondary readouts) in terms of rSBA titres
time frame: 1 month after administration of 1 dose of MenACWY-TT (Month 1)
Immunogenicity with respect to components of the study vaccines (on secondary readouts) in terms of rSBA titres
time frame: 1 month after administration of 1 dose of MenACWY-TT (Month 1)
Immunogenicity with respect to components of the study vaccines (on secondary readouts) in terms of hSBA titres
time frame: At Years 1, 3 and 5
Immunogenicity with respect to components of the study vaccines (on secondary readouts) in terms of rSBA titres
time frame: At Years 1, 3 and 5
Immunogenicity with respect to components of the study vaccines (on secondary readouts) in terms of antibody concentration
time frame: One month after administration of Prevenar 13 (Month 1)
Immunogenicity with respect to components of the study vaccines (on secondary readouts) in terms of OPA titres
time frame: One month after administration of Prevenar 13 (Month 1)
Occurrence of solicited local and general symptoms
time frame: Within 4 days (Day 0 - Day 3) after each study vaccination
Occurrence of unsolicited adverse events
time frame: Within 31 days (Day 0 - Day 30) after any study vaccination
Occurrence of serious adverse events (SAEs)
time frame: From Month 0 to Month 9
Occurrence of SAEs related to study vaccine administration
time frame: From the first receipt of study vaccine until study end (Year 5)
Occurrence of New Onset Chronic Illnesses (NOCIs)
time frame: From Month 0 to Month 9

Eligibility Criteria

Male or female participants from 12 months up to 14 months old.

Inclusion Criteria: - Subjects' parent(s)/Legally Acceptable Representative(s) [LAR(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, 12 and 14 months of age at the time of the first vaccination. - Written informed consent obtained from the parent(s)/LAR(s) of the subject. - Healthy subjects as established by medical history and clinical examination before entering into the study. - Vaccination records showing the completion of the full primary vaccination schedule with Prevenar 13 and Diphtheria, Tetanus and Pertussis (DTP) containing vaccine according to local recommendations at least 5 months before the study entry. Exclusion Criteria: - Child in care. - Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines 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 in total) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. For corticosteroids, this will mean prednisone 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed. - Planned administration/administration of a vaccine not foreseen by the study protocol within the period starting 30 days before and ending 30 days after the dose of vaccines, with the exception of a licensed inactivated influenza vaccine. Measles, Mumps Rubella (MMR) vaccine or Measles Mumps Rubella and Varicella (MMRV) vaccine can be co-administered with MenACWY-TT and/or Prevenar 13. A DTPa containing vaccine can be administered after the last blood sampling (at Visit 2 or 4 depending on the group). - 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 (pharmaceutical product or device). - Previous vaccination against Neisseria meningitidis. - Previous booster vaccination against Streptococcus pneumoniae. - Previous booster vaccination against Corynebacterium diphtheriae, Clostridium tetani and Bordetella pertussis. - 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)* - Note: With the exception of HIV rapid testing which will be done for subjects in South Africa. - Family history of congenital or hereditary immunodeficiency. - History of any reaction or hypersensitivity, including to diphtheria toxoid, likely to be exacerbated by any component of the vaccines. - Major congenital defects or serious chronic illness. - History of any neurological disorders or seizures, including Guillain-Barré syndrome (GBS). History of a simple, single febrile seizure is permitted. - Acute disease and/or fever at the time of enrollment. - Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.

Additional Information

Official title Immunogenicity and Safety Study of 1 and 2 Doses of GSK Biologicals' Meningococcal Vaccine GSK134612 in Toddlers, Persistence up to 5 Years After Vaccination and Co-administration With Pfizer's Pneumococcal Vaccine Prevenar 13™
Description The Medicines Control Council (MCC) authorities requested that subjects be screened for HIV testing prior to study enrolment in South Africa to ensure that only HIV negative participants are enrolled. As such, HIV rapid test was added at Visit 1 only for subjects in South Africa. Subjects previously screened HIV positive will be excluded.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by GlaxoSmithKline.