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

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ClinicalTrials.gov Identifier: NCT03896477
Recruitment Status : Recruiting
First Posted : April 1, 2019
Last Update Posted : July 23, 2019
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

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.

Condition or disease Intervention/treatment Phase
Pneumonia, Pneumococcal Biological: Pneumosil Biological: Prevenar 13 Biological: Synflorix Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 660 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official 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
Actual Study Start Date : July 18, 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pneumosil
PCV-10
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

Active Comparator: Prevenar 13
PCV-13
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

Active Comparator: Synflorix
PCV-10
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.




Primary Outcome Measures :
  1. Immunogenicity [ Time Frame: 4 weeks post booster dose ]
    Serotype-specific serum IgG GMCs

  2. Solicited local and systemic adverse events [ Time Frame: Day 0-Day 6 post vaccination ]
    Number and severity of solicited local and systemic adverse events

  3. 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


Secondary Outcome Measures :
  1. Post-booster OPA GMTs [ Time Frame: 4 weeks post booster dose ]
    Serotype-specific serum OPA GMTs

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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



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Ages Eligible for Study:   42 Days to 56 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03896477


Contacts
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Contact: Ed Clarke, MB ChB, PhD (+220) 4495442/6 eclarke@mrc.gm
Contact: Steve Lamola, MD + 1 206.302.6067 slamola@path.org

Locations
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Gambia
MRCG at LSHTM Recruiting
Banjul, West Africa, Gambia
Contact: Ed Clarke, MB ChB, PhD    (+220) 4495442/6    eclarke@mrc.gm   
Sponsors and Collaborators
PATH
Serum Institute of India Pvt. Ltd.
Medical Research Council Unit, The Gambia
University College, London
FHI 360
Investigators
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Principal Investigator: Ed Clarke, MB ChB, PhD MRCG at LSHTM

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Responsible Party: PATH
ClinicalTrials.gov Identifier: NCT03896477     History of Changes
Other Study ID Numbers: CVIA-074
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pneumonia, Pneumococcal
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Pneumonia, Bacterial
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs