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

Phase 3 Study of 10-valent Pneumococcal Conjugate Vaccine (PNEUMOSIL) in 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03197376
Recruitment Status : Recruiting
First Posted : June 23, 2017
Last Update Posted : June 29, 2017
Information provided by (Responsible Party):

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.

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)
Estimated 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
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 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
Biological: Synflorix
Pneumococcal conjugate vaccine (Non-Typeable Haemophilus influenzae (NTHi) protein D, diphtheria or tetanus toxoid conjugates) adsorbed

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

  2. Percentage of subjects with serotype-specific IgG ≥ 0.35 μg/mL [ Time Frame: 4 weeks after the third dose ]
  3. Number of Solicited Adverse Events [ Time Frame: 7 days after the vaccination ]

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

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 identifier (NCT number): NCT03197376

Contact: Ed Clarke (+220) 4495442/6

Medical Research Council (MRC) Unit, The Gambia Recruiting
Fajara, Gambia
Contact: Ed Clarke, MB ChB PhD    (+220) 4495442/6   
Principal Investigator: Ed Clarke, MB ChB PhD         
Sponsors and Collaborators
Principal Investigator: Ed Clarke Medical Research Council (MRC) Unit, The Gambia

Responsible Party: PATH Identifier: NCT03197376     History of Changes
Other Study ID Numbers: VAC-056
First Posted: June 23, 2017    Key Record Dates
Last Update Posted: June 29, 2017
Last Verified: June 2017

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

Additional relevant MeSH terms:
Pneumonia, Pneumococcal
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