Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201408000864165 Date of Approval: 01/08/2014
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Immunogenicity and safety study of 1,2 doses of GSK Biologicals meningococcal vaccine MenACWY-TT (GSK134612) in toddlers
Official 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
Brief summary describing the background and objectives of the trial The purpose of this study is to compare the immediate and longterm (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 Pfizers Prevenar 13 adversely impacts the immunogenicity of either of the vaccines.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Meningococcal disease,Nervous System Diseases,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention: Vaccines
Anticipated trial start date 15/08/2014
Actual trial start date
Anticipated date of last follow up 15/11/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 900
Actual target sample size (number of participants) 0
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
116892 Protocol Number
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group ACWY1d group 1 Subjects will receive 1 dose of the MenACWY-TT vaccine 200
Experimental Group ACWY2d group 2 Subjects will receive 2 doses of the MenACWY-TT vaccine 2 months apart 200
Experimental Group Co-ad group 1 Subjects will receive 1 dose of the MenACWY-TT vaccine co-administered with Prevenar 13¿ 200
Control Group PCV-13 group 1 Subjects will receive 1 dose of Prevenar 13¿ and 1 dose of the MenACWY-TT vaccine 2 months later 200 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
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. 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. 12 Month(s) 14 Month(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 24/07/2014 University Of the Witwatersrand Human Research Ethics Committee (Medical)
Ethics Committee Address
Street address City Postal code Country
Suite 189, Private Bag X2600, Houghton, 2041 Johannesburg 2041 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Immunogenicity with respect to components of the study vaccines in terms of rSBA titres 1 month after administration of 1 dose of MenACWY-TT in the ACWY1d, ACWY2d and Co-ad groups (Month 1)
Primary Outcome Immunogenicity with respect to components of the study vaccines in terms of rSBA titres 1 month after administration of 2 doses of MenACWY-TT in the ACWY2d group (Month 3)
Primary Outcome Immunogenicity with respect to components of the study vaccines in terms of rSBA titres At Year 1
Primary Outcome Immunogenicity with respect to components of the study vaccines in terms of rSBA titres At Year 3
Primary Outcome Immunogenicity with respect to components of the study vaccines in terms of rSBA titres At Year 5
Primary Outcome Immunogenicity with respect to components of the study vaccines in terms of antibody concentration 1 month after administration of Prevenar 13 (Month 1)
Secondary Outcome Immunogenicity with respect to components of the study vaccines (on secondary readouts) in terms of hSBA titres 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).
Secondary Outcome Immunogenicity with respect to components of the study vaccines (on secondary readouts) in terms of rSBA titres 1 month after administration of 1 dose of MenACWY-TT (Month 1)
Secondary Outcome Immunogenicity with respect to components of the study vaccines (on secondary readouts) in terms of rSBA titres 1 month after administration of 1 dose of MenACWY-TT (Month 1)
Secondary Outcome Immunogenicity with respect to components of the study vaccines (on secondary readouts) in terms of hSBA titres At Years 1, 3 and 5
Secondary Outcome Immunogenicity with respect to components of the study vaccines (on secondary readouts) in terms of rSBA titres At Years 1, 3 and 5
Secondary Outcome Immunogenicity with respect to components of the study vaccines (on secondary readouts) in terms of antibody concentration One month after administration of Prevenar 13 (Month 1)
Secondary Outcome Immunogenicity with respect to components of the study vaccines (on secondary readouts) in terms of OPA titres One month after administration of Prevenar 13 (Month 1)
Secondary Outcome Occurrence of solicited local and general symptoms Within 4 days (Day 0 ¿ Day 3) after each study vaccination
Secondary Outcome Occurrence of unsolicited adverse events Within 31 days (Day 0 ¿ Day 30) after any study vaccination
Secondary Outcome Occurrence of serious adverse events (SAEs) From Month 0 to Month 9
Secondary Outcome Occurrence of SAEs related to study vaccine administration From the first receipt of study vaccine until study end (Year 5)
Secondary Outcome Occurrence of New Onset Chronic Illnesses (NOCIs) From Month 0 to Month 9
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Respiratory and Meningeal Pathogens Research Unit Chris Hani Road, Chris Hani Baragwanath Hospital, 11th Floor Central-West Wing, Nurses¿ Residence, PO Bertsham, Soweto Johannesburg 2013 South Africa
Setshaba Research Centre 2088 Block H, Soshanguve Pretoria 0152 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
GlaxoSmithKline Rue de l'Institut 89 Rixensart 1330 Belgium
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor GlaxoSmithKline Biologicals Rue de l'Institut 89 Rixensart 1330 Belgium Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Not applicable
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Dr Clinical Disclosure Advisor Call center GSKClinicalSupportHD@gsk.com 001-877-379-3718 Rue de l Institut, 89
City Postal code Country Position/Affiliation
Rixensart 1330 Belgium Clinical Disclosure Advisor
Role Name Email Phone Street address
Public Enquiries Dr Clinical Disclosure Advisor Call center GSKClinicalSupportHD@gsk.com 001-877-379-3718 Rue de l Institut, 89
City Postal code Country Position/Affiliation
Rixensart 1330 Belgium Clinical Disclosure Advisor
Role Name Email Phone Street address
Scientific Enquiries Dr Clinical Disclosure Advisor Call center GSKClinicalSupportHD@gsk.com 001-877-379-3718 Rue de l Institut, 89
City Postal code Country Position/Affiliation
Rixensart 1330 Belgium Clinical Disclosure Advisor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information