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Trial record 4 of 33 for:    "Pneumonia, Pneumococcal"

Phase 3 Study of 10-valent Pneumococcal Conjugate Vaccine (PNEUMOSIL) in Healthy Infants

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ClinicalTrials.gov Identifier: NCT03197376
Recruitment Status : Active, not recruiting
First Posted : June 23, 2017
Last Update Posted : January 16, 2019
Sponsor:
Information provided by (Responsible Party):
PATH

Brief Summary:
This study will examine the consistency of 3 batches of the Pneumosil vaccine by looking at the immune response in infants. In addition, the study will compare the immunogenicity of the Pneumosil vaccine to another WHO-prequalified vaccine, Synflorix.

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

Detailed Description:

This is a randomized, active-controlled, double-blind, Phase 3 study in 2,250 healthy infants (6 to 8 weeks of age). Subjects will receive 3 doses of either PNEUMOSIL (3 groups receiving vaccine from different lots) or Synflorix (1 group) at 6, 10, and 14 weeks of age. The first 675 randomized subjects will receive a booster dose of either PNEUMOSIL or Synflorix at 9 months of age that matches the treatment assignment for the priming phase. Standard EPI vaccinations in The Gambia will be given concomitantly with all 4 doses of the study vaccines. Out of the 675 booster subjects, subjects who consented for further evaluation will participate for the assessment of immune persistence 12 (+1) months after the booster vaccination

The primary objectives are to demonstrate that the three lots of the Pneumosil vaccine is consistent by evaluating the immune responses, and to demonstrate that the immune responses generated by Pneumosil are non-inferior to those generated by Synflorix. The safety and tolerability of Pneumosil will also be evaluated.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase 3, Randomized, Double-Blind Study of the Safety, Tolerability, Lot-to-Lot Consistency, Immunogenicity & Non-Interference With Concomitant Vaccinations of Serum Institute of PNEUMOSIL in Healthy Infants in The Gambia
Actual Study Start Date : June 21, 2017
Actual Primary Completion Date : June 6, 2018
Estimated Study Completion Date : December 2019

Arm Intervention/treatment
Experimental: Pneumosil Lot 1
Pneumosil Lot 1
Biological: Pneumosil
10-Valent Pneumococcal Conjugate Vaccine

Experimental: Pneumosil Lot 2
Pneumosil Lot 2
Biological: Pneumosil
10-Valent Pneumococcal Conjugate Vaccine

Experimental: Pneumosil Lot 3
Pneumosil Lot 3
Biological: Pneumosil
10-Valent Pneumococcal Conjugate Vaccine

Active Comparator: Synflorix
Synflorix
Biological: Synflorix
Pneumococcal conjugate vaccine (Non-Typeable Haemophilus influenzae (NTHi) protein D, diphtheria or tetanus toxoid conjugates) adsorbed




Primary Outcome Measures :
  1. IgG GMC (lot consistency) [ Time Frame: 4 weeks after the third dose ]
    Serotype-specific immunoglobulin G (IgG) geometric mean concentration (GMC)

  2. IgG (non-inferiority) [ Time Frame: 4 weeks after the third dose ]
    Percentage of subjects with serotype-specific IgG ≥ 0.35 μg/mL and Serotype-specific immunoglobulin G (IgG) geometric mean concentration (GMC)

  3. EPI non-interference [ Time Frame: 4 weeks after the third dose ]
    Percentage of subjects: 1) with anti-diphtheria toxoid (DT) and anti-tetanus toxoid (DT) IgG concentration ≥ 0.1 IU/mL 2) anti-Hepatitis B surface antigen (HBsAg) IgG concentration ≥ 10 mIU/mL 3) anti-Hib (polyribosylribitol phosphate [PRP]) IgG concentration ≥ 0.15 µg/mL 4) anti-poliovirus types 1, 2 and 3 neutralizing antibody titers ≥ 1:8 5) anti-rotavirus IgA concentration ≥ 20 U/mL. Also Anti-pertussis toxoid and fimbriae IgG GMCs

  4. Safety, Tolerability [ Time Frame: Till day 6 post each vaccination ]
    Number and severity of solicited local and systemic AEs (reactogenicity events [REs])

  5. Safety, Tolerability [ Time Frame: 4 weeks post last vaccination ]
    Number, severity and relatedness of all AEs and SAEs


Secondary Outcome Measures :
  1. IgG (superiority) [ Time Frame: 4 weeks after the third dose ]
    Percentage of subjects with serotype-specific IgG concentrations ≥ 0.35 µg/mL and • Serotype-specific IgG GMC

  2. OPA (functional response) [ Time Frame: 4 weeks after the third dose ]
    Percentage of subjects with OPA titer ≥ 1:8 and OPA geometric mean titer (GMT)

  3. Booster immune response [ Time Frame: 4 weeks post booster vaccination to 4 weeks post Vaccination 3 ]
    Ratio of IgG GMCs and Ratio of OPA GMTs

  4. EPI non interference [ Time Frame: 4 weeks post booster vaccination ]
    Percentage of subjects with anti-measles IgG concentration ≥ 150 mIU/mL, Percentage of subjects with anti-yellow fever neutralizing antibody titers ≥ 1:8 and Percentage of subjects with anti-rubella IgG concentration ≥ 4 IU/mL



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Weeks to 8 Weeks   (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.

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 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 of suddenly without apparent cause.
  • History of meningitis, seizures or any neurological disorder.

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): NCT03197376


Locations
Gambia
Medical Research Council (MRC) Unit, The Gambia
Fajara, Gambia
Sponsors and Collaborators
PATH
Investigators
Principal Investigator: Ed Clarke Medical Research Council (MRC) Unit, The Gambia

Responsible Party: PATH
ClinicalTrials.gov Identifier: NCT03197376     History of Changes
Other Study ID Numbers: VAC-056
First Posted: June 23, 2017    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 2019

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Pneumonia, Pneumococcal
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Pneumonia, Bacterial
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs