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.: PACTR201907754270299 Date of Approval: 04/07/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Phase 3 Study of 10-valent Pneumococcal Conjugate Vaccine (PNEUMOSIL)
Official scientific title A Phase 3, Randomized, Observer-Blind Study to Evaluate the Safety, Tolerability, Immunogenicity of Serum Institute of India’s 10-Valent Pneumococcal Conjugate Vaccine Administered in a 2+1 Schedule to Healthy Infants in The Gambia
Brief summary describing the background and objectives of the trial The current Phase 3 descriptive study will provide data necessary to evaluate the safety and immunogenicity of PNEUMOSIL when administered in an alternative schedule to the 3 dose primary schedule (3+0) evaluated in the Phase 3 pivotal trial (VAC-056) – namely in a 2 dose primary and booster (2+1) schedule – and compare immunogenicity to that of both currently licensed second-generation PCVs administered in the same 2+1 schedule.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention: Vaccines
Anticipated trial start date 01/07/2019
Actual trial start date 18/07/2019
Anticipated date of last follow up 31/12/2020
Actual Last follow-up date 17/12/2020
Anticipated target sample size (number of participants) 660
Actual target sample size (number of participants) 660
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
NCT03896477 Clinicaltrials.gov
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 Permuted block randomization Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group PNEUMOSIL Two primary doses and a booster dose 6 weeks, 14 weeks and 9 months of age One single dose contains 2μg of polysaccharide for serotypes 1, 5, 6A, 7F, 9V, 14, 19A, 19F and 23F, and 4μg for serotype 6B formulated with aluminium phosphate as an adjuvant in an appropriate buffer 220
Control Group Prevenar 13 Two primary doses and a booster dose 6 weeks, 14 weeks and 9 months of age One single dose contains 2.2 µg of the following pneumococcal polysaccharides serotypes - 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F - and 4.4 µg of pneumococcal polysaccharide serotype 6B, all conjugated to CRM197 and absorbed onto aluminum phosphate 220 Active-Treatment of Control Group
Control Group Synflorix Two primary doses and a booster dose 6 weeks, 14 weeks and 9 months of age One single dose contains 1μg of polysaccharide for serotypes 1, 5, 6B, 7F, 9V, 14, and 23F, and 3μg of serotypes 4, 18C, and 19F formulated with aluminum phosphate as an adjuvant. 220 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
They are healthy infants based on medical history and clinical assessment. - They are between 6 and 8 weeks (ie 42 to 56 days) old, inclusive. - Subject's parent must provide voluntary written/thumb-printed informed consent and be willing to comply with study requirements and procedures. - Subjects must have been born full-term, have a weight-to-height Z score of ≥ -2 at the time of enrollment (WHO child growth standard), and be ≥ 3.5 kg at randomization. - Subject’s parents must be available for the duration of trial participation - Use of any investigational medicinal product prior to randomization. - Previous vaccination against or infection with S. pneumoniae. - History of anaphylactic shock or an allergic reaction to any prior vaccination. - Any fever, illness (including malaria). - Receipt of another study vaccine within 30 days of study start. - Chronic administration of an immunosuppressant or administration of immunoglobulins - History of blood disorder, primary immunodeficiency, or a sibling who has such a diagnosis or who died suddenly without apparent cause. - History of meningitis, seizures or any neurological disorder. - Exposure to HIV by history. Infant: 1 Month-23 Month 6 Week(s) 8 Week(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 14/03/2019 The Gambia Government MRCG Joint Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Atlantic Road, Fajara Banjul 0000000 Gambia
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 16/05/2019 LSHTM REC
Ethics Committee Address
Street address City Postal code Country
Keppel Street London 0000000 United Kingdom
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 14/01/2019 Western IRB
Ethics Committee Address
Street address City Postal code Country
1019 39th Avenue SE Suite 120 Puyallup 983742115 United States of America
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Serotype-specific serum IgG GMCs 4 weeks post booster dose
Primary Outcome Number and severity of solicited local and systemic adverse events Day 0-Day 6 post vaccination
Primary Outcome Number, severity and relatedness of all unsolicited AEs and serious adverse events Approximately from age of 6 weeks through 4 weeks post booster dose
Secondary Outcome Serotype-specific serum OPA GMTs 4 weeks post booster dose
Secondary Outcome Percentage of subjects with serotype-specific serum IgG concentrations ≥ 0.35 μg/mL, with serotype-specific serum IgG concentrations ≥ 1.0 µg/mL and with serotype-specific serum OPA titers ≥ 1:8 4 weeks post booster dose
Secondary Outcome Percentage of subjects with serotype-specific serum IgG concentrations ≥ 0.35 μg/mL and Serotype-specific serum IgG GMCs 4 weeks post completion of primary vaccination
Secondary Outcome Percentage of subjects with serotype-specific serum OPA titers ≥ 1:8 and Serotype-specific serum OPA GMTs 4 weeks post completion of primary vaccination
Secondary Outcome Percentage of subjects with serotype-specific serum IgG concentrations ≥ 0.35 μg/mL and Serotype-specific serum IgG GMCs Approximately 9 months of age
Secondary Outcome Percentage of subjects with serotype-specific OPA titers ≥ 1:8 and Serotype-specific serum OPA GMTs Approximately 9 months of age
Secondary Outcome Ratio of serotype-specific serum IgG GMCs measured 4 weeks post booster dose to serotype-specific IgG GMCs measured 4 weeks post completion of primary vaccination and Ratio of serotype-specific serum OPA GMTs measured 4 weeks post booster dose to serotype-specific serum OPA GMTs measured 4 weeks post completion of primary vaccination 4 weeks post booster comparison to 4 weeks post primary vaccination
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
MRCG at LSHTM Atlantic Road Banjul Gambia
FUNDING SOURCES
Name of source Street address City Postal code Country
Bill and Melinda Gates Foundation 500 Fifth Avenue North Seattle 98109 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor PATH 2201 Westlake Avenue Suite 200 Seattle 98121 United States of America Other Collaborative Groups
COLLABORATORS
Name Street address City Postal code Country
PATH 2201 Westlake Avenue Suite 200 Seattle 98121 United States of America
Serum Institute of India Private Limited 212/2, Off Soli Poonawalla Road Hadapsar, Pune 411028 India
Medical Research Council Unit The Gambia at the London School of Hygiene and Tropical Medicine Atlantic Road, Fajara PO Box 273 Banjul 000000 Gambia
WHO Pneumococcal Serology Reference Laboratory Institute of Child Health University College London 30 Guilford Street London 000000 United Kingdom
FHI360 359 Blackwell Street, Suite 200 Durham North Carolina 27701 United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ed Clarke eclarke@mrc.gm +2204495442 Atlantic road, fajara
City Postal code Country Position/Affiliation
Banjul Gambia Head of Infant Immunology Vaccines and Immunity Theme MRCG at LSHTM
Role Name Email Phone Street address
Public Enquiries Ed Clarke eclarke@mrc.gm +2204495442 Altantic Road, Fajara
City Postal code Country Position/Affiliation
Banjul Gambia Head of Infant Immunology Vaccines and Immunity Theme MRCG at LSHTM
Role Name Email Phone Street address
Scientific Enquiries Steve Lamola slamola@path.org +12063026067 2201 Westlake Avenue Suite 200
City Postal code Country Position/Affiliation
Seattle United States of America Clinical Lead PATH
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Summary results for primary and secondary objectives. Redacted protocol and SAP will be provided. Statistical Analysis Plan,Study Protocol Within 12 months of completion of study Researchers who provide a methodologically sound proposal may be provided access after Sponsor permission.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 29/11/2021
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 29/11/2021
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information