Immunogenicity and safety study of 1,2 doses of GSK Biologicals meningococcal vaccine MenACWY-TT (GSK134612) in toddlers

Not Applicable

• Conditions: Nervous System Diseases; Paediatrics; Meningococcal disease

• Registration Number: PACTR201408000864165
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-08-01
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 900

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/non-registered product other than the study vaccines within 30 days and administration of immunoglobulins and/or any blood products within 3 months, both before the 1st dose of study vaccine or planned use during the study period.
Chronic administration of immunosuppressants/other immune-modifying drugs within 6 months prior to the 1st 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 and ending 30 days before and after the dose of vaccines,with the exception of a licensed inactivated influenza vaccine.MMR/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.
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/a non-investigational vaccine/product.
Previous vaccination against Neisseria meningitidis.
Previous booster vaccination against Streptococcus pneumoniae,Corynebacterium diphtheriae,Clostridium tetani and Bordetella pertussis.
History of meningococcal disease.
Any confirmed/suspected immunosuppressive or immunodeficient condition,including human immunodeficiency virus infection,based on medical history and physical examination
Note:With the exception of HIV rapid testing which will be done for subjects in South Africa.
Family history of congenital/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 except simple,single febrile seizure.
Acute disease and/or fever at the time of enrolment.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Immunogenicity with respect to components of the study vaccines in terms of rSBA titres;Immunogenicity with respect to components of the study vaccines in terms of rSBA titres;Immunogenicity with respect to components of the study vaccines in terms of rSBA titres;Immunogenicity with respect to components of the study vaccines in terms of rSBA titres;Immunogenicity with respect to components of the study vaccines in terms of rSBA titres;Immunogenicity with respect to components of the study vaccines in terms of antibody concentration