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

• Register: PACTR
• Last refreshed on: 29 May 2023
• Main ID: PACTR201408000864165
• Date of registration: 01/08/2014
• Prospective Registration: Yes
• Primary sponsor: GlaxoSmithKline Biologicals
• Public title: Immunogenicity and safety study of 1,2 doses of GSK Biologicals meningococcal vaccine MenACWY-TT (GSK134612) in toddlers
• Scientific 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 Pfizers pneumococcal vaccine Prevenar 13
• Date of first enrolment: 15/08/2014
• Target sample size: 900
• Recruitment status: Pending
• URL: https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=864
• Study type: Interventional
• Study design: Parallel: different groups receive different interventions at same time during study,Randomised,simple randomisation using a randomistaion table created by a computer software program,Central randomisation on Internet
• Phase: Not Applicable

Countries of recruitment

South Africa

Contacts

• Name: Dr Clinical Disclosure Advisor Call center
• Affiliation: Clinical Disclosure Advisor

• Name: Dr Clinical Disclosure Advisor Call center
• Affiliation: Clinical Disclosure Advisor

Key inclusion & exclusion criteria

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.

Age minimum: 12 Month(s)
Age maximum: 14 Month(s)
Gender: Both

Health Condition(s) or Problem(s) studied

Nervous System Diseases
Paediatrics
Meningococcal disease

Meningococcal disease

Nervous System Diseases

Paediatrics

Intervention(s)

Co-ad group

ACWY2d group

ACWY1d group

PCV-13 group

Primary Outcome(s)

Immunogenicity with respect to components of the study vaccines in terms of antibody concentration

Immunogenicity with respect to components of the study vaccines in terms of rSBA titres

Secondary Outcome(s)

Immunogenicity with respect to components of the study vaccines (on secondary readouts) in terms of rSBA titres

Immunogenicity with respect to components of the study vaccines (on secondary readouts) in terms of hSBA titres

Immunogenicity with respect to components of the study vaccines (on secondary readouts) in terms of antibody concentration

Immunogenicity with respect to components of the study vaccines (on secondary readouts) in terms of OPA titres

Occurrence of solicited local and general symptoms

Occurrence of New Onset Chronic Illnesses (NOCIs)

Occurrence of unsolicited adverse events

Occurrence of serious adverse events (SAEs)

Occurrence of SAEs related to study vaccine administration

Secondary ID(s)

116892

Source(s) of Monetary Support

GlaxoSmithKline

Ethics review

Status: Approved
Approval date: 24/07/2014
Contact:

University Of the Witwatersrand Human Research Ethics Committee (Medical)