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Phase 3 Study of 10-valent Pneumococcal Conjugate Vaccine (PNEUMOSIL) Administered in a 2+1 Schedule to Healthy Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03896477
Recruitment Status : Active, not recruiting
First Posted : April 1, 2019
Last Update Posted : July 22, 2020
Sponsor:
Collaborators:
Serum Institute of India Pvt. Ltd.
Medical Research Council Unit, The Gambia
University College, London
FHI 360
Information provided by (Responsible Party):
PATH

Tracking Information
First Submitted Date  ICMJE March 22, 2019
First Posted Date  ICMJE April 1, 2019
Last Update Posted Date July 22, 2020
Actual Study Start Date  ICMJE July 18, 2019
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 28, 2019)
  • Immunogenicity [ Time Frame: 4 weeks post booster dose ]
    Serotype-specific serum IgG GMCs
  • Solicited local and systemic adverse events [ Time Frame: Day 0-Day 6 post vaccination ]
    Number and severity of solicited local and systemic adverse events
  • Unsolicited AEs and serious adverse events [ Time Frame: Approximately from age of 6 weeks through 4 weeks post booster dose ]
    Number, severity and relatedness of all unsolicited AEs and serious adverse events
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 28, 2019)
  • Post-booster OPA GMTs [ Time Frame: 4 weeks post booster dose ]
    Serotype-specific serum OPA GMTs
  • Post-booster seroresponse rates [ Time Frame: 4 weeks post booster dose ]
    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
  • Post-primary IgG responses [ Time Frame: 4 weeks post completion of primary vaccination ]
    Percentage of subjects with serotype-specific serum IgG concentrations ≥ 0.35 μg/mL and Serotype-specific serum IgG GMCs
  • Post-primary OPA responses [ Time Frame: 4 weeks post completion of primary vaccination ]
    Percentage of subjects with serotype-specific serum OPA titers ≥ 1:8 and Serotype-specific serum OPA GMTs
  • Persistence of post-primary IgG responses [ Time Frame: Approximately 9 months of age ]
    Percentage of subjects with serotype-specific serum IgG concentrations ≥ 0.35 μg/mL and Serotype-specific serum IgG GMCs
  • Persistence of post-primary OPA responses [ Time Frame: Approximately 9 months of age ]
    Percentage of subjects with serotype-specific OPA titers ≥ 1:8 and Serotype-specific serum OPA GMTs
  • Booster Effects [ Time Frame: 4 weeks post booster comparison to 4 weeks post primary vaccination ]
    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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase 3 Study of 10-valent Pneumococcal Conjugate Vaccine (PNEUMOSIL) Administered in a 2+1 Schedule to Healthy Infants
Official Title  ICMJE 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 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.
Detailed Description In this prospective, single center, randomized, active-controlled, observer-blind, Phase 3 descriptive study, 660 healthy Gambian pneumococcal conjugate vaccine (PCV)-naïve infants will be randomized 1:1:1 to receive 3 doses of either PNEUMOSIL, Synflorix or Prevenar 13 at 6 weeks, 14 weeks and 9 months of age. Standard EPI vaccinations in The Gambia, will be given concomitantly with all 3 doses of study vaccine.Blood will be collected 4 weeks post second dose, pre-booster and 4 weeks post booster dose for immunogenicity assessments.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Pneumonia, Pneumococcal
Intervention  ICMJE
  • Biological: Pneumosil
    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
  • Biological: Prevenar 13
    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
  • Biological: Synflorix
    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.
Study Arms  ICMJE
  • Experimental: Pneumosil
    PCV-10
    Intervention: Biological: Pneumosil
  • Active Comparator: Prevenar 13
    PCV-13
    Intervention: Biological: Prevenar 13
  • Active Comparator: Synflorix
    PCV-10
    Intervention: Biological: Synflorix
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: March 28, 2019)
660
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 42 Days to 56 Days   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Gambia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03896477
Other Study ID Numbers  ICMJE CVIA-074
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party PATH
Study Sponsor  ICMJE PATH
Collaborators  ICMJE
  • Serum Institute of India Pvt. Ltd.
  • Medical Research Council Unit, The Gambia
  • University College, London
  • FHI 360
Investigators  ICMJE
Principal Investigator: Ed Clarke, MB ChB, PhD MRCG at LSHTM
PRS Account PATH
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP