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.: PACTR202102724115194 Date of Approval: 01/02/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title SERUM PNEUMOCOCCAL IgG LEVELS IN INFANTS OF MOTHERS VACCINATED WITH PNEUMOCOCCAL CONJUGATE VACCINE IN THE THIRD TRIMESTER
Official scientific title SERUM PNEUMOCOCCAL IgG LEVELS IN INFANTS OF MOTHERS VACCINATED WITH PNEUMOCOCCAL CONJUGATE VACCINE IN THE THIRD TRIMESTER
Brief summary describing the background and objectives of the trial The study aim is to compare cord-blood levels of pneumococcal-specific Immunoglobulin G in new-borns whose mothers received the pneumococcal conjugate vaccine in the third trimester of pregnancy with matched controls whose mothers do not receive the vaccine and to determine what proportion of infants of vaccinated mothers have serum pneumococcal-specific IgG levels equaling or exceeding the W. H. O. - proposed immunological correlate of protection against pneumococcal disease at 6 weeks of life. SPECIFIC OBJECTIVES The objectives of the study are to: Determine and compare the mean pneumococcal specific IgG levels in cord-blood of new-borns whose mothers were vaccinated with pneumococcal conjugate vaccine in the third trimester of pregnancy with new-borns whose mothers were vaccinated with placebo (controls). Determine and compare the proportion of new-borns of vaccinated mothers and new-borns of controls with cord-blood geometric mean concentrations of pneumococcal-specific IgG equal to or exceeding 0.35 µg/ml (the immunologic correlate of protection for pneumococcal disease). Determine the proportion of infants whose mothers were vaccinated with the pneumococcal conjugate vaccine in the third trimester of pregnancy with geometric mean concentrations of pneumococcal-specific IgG equal to or exceeding 0.35 µg/ml (the immunological correlate of protection for pneumococcal disease) at 6 weeks of life.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Pneumococcal Disease
Purpose of the trial Prevention: Vaccines
Anticipated trial start date 21/01/2021
Actual trial start date
Anticipated date of last follow up 28/05/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 110
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
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 randomization using a randomization table created by a computer software program Numbered containers Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group PCV Single dose of 13-valent Pneumococcal Conjugate Vaccine (0.5ml) and single dose of Tetanus Toxoid vaccine (0.5ml) Once (Single dose) Single dose of 13-valent Pneumococcal Conjugate Vaccine (0.5ml) and single dose of Tetanus Toxoid vaccine (0.5ml) 55
Control Group TTCONTROL Single dose of Tetanus Toxoid vaccine (0.5ml) Once (Single dose) Single dose of Tetanus Toxoid vaccine (0.5ml) 55 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Gestational age from 30weeks 0 days to 34 weeks 6 days. Pregnant women aged 18 to 40 years An uncomplicated pregnancy. No identified risk for complicated labor. No previous history of preterm delivery (< 37 completed weeks). No previous history of delivery of neonate with major congenital malformation. Major or lethal congenital fetal anomaly. Intrauterine fetal death. Pregnancy which has not been dated by obstetric ultrasound. Previous history of vaccination with the pneumococcal polysaccharide or conjugate vaccines. Known allergies to any constituents of vaccine. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 18 Year(s) 40 Year(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 29/11/2019 LASUTH HEALTH RESEARCH ETHICS COMMITTEE
Ethics Committee Address
Street address City Postal code Country
1-5 Oba Akinjobi road, Ikeja, G. R. A., Lagos Ikeja PMB21005 Nigeria
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 22/12/2020 LASUTH HEALTH RESEARCH ETHICS COMMITTEE
Ethics Committee Address
Street address City Postal code Country
1-5 Oba Akinjobi road, Ikeja, G.R.A., Lagos Ikeja PMB21005 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Geometric mean concentration of Pneumococcal-specific IgG in cord blood of newborns At birth
Primary Outcome Geometric mean concentration of Pneumococcal-specific IgG in serum of infants whose mothers received Pneumococcal Conjugate Vaccine in the third trimester at 6 weeks of age. 6 weeks of age
Secondary Outcome Cord blood concentration of Pneumococcal-specific IgG in relation to duration of vaccination to delivery interval. At delivery
Secondary Outcome Adverse events such vaccination site pain, fever, seizures, and pregnancy outcomes such as preterm birth, fetal loss, etc From vaccination to delivery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
General Hospital Ifako Ijaiye MCC 14 College Road, Off Iju Rd, Ifako Agege, Lagos Agege Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Ayodeji Akinola 13 Babatunde Ladega Street, Omole phase 1, Ileja Ikeja Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Akinola Ayodeji 13 Babatunde Ladega Street, Omole Ikeja Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
There are no collaborators 13 Babatunde Ladega Street, Omole phase 1 Ikeja Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ayodeji Akinola daygee22@hotmail.com +2347080146586 13 Babatunde Ladega Street, Omole phase 1, Ikeja, Lagos
City Postal code Country Position/Affiliation
Ikeja Nigeria Resident Doctor
Role Name Email Phone Street address
Public Enquiries Ayodeji Akinola daygee22@hotmail.com +2347080146586 13 Babatunde Ladega Street, Omole phase 1, Ikeja, Lagos
City Postal code Country Position/Affiliation
Ikeja Nigeria Resident Doctor
Role Name Email Phone Street address
Scientific Enquiries Ayodeji Akinola daygee22@hotmail.com +2347080146586 13 Babatunde Ladega Street, Omole phase 1, Ikeja, Lagos
City Postal code Country Position/Affiliation
Ikeja Nigeria Resident Doctor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes text, tables, figures, and appendices Clinical Study Report,Statistical Analysis Plan,Study Protocol Immediately following publication, indefinitely. Open, anyone who wishes to access
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
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