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

PATH

Status and phase: Completed; Phase 3

Conditions: Pneumonia, Pneumococcal

Treatments: Biological: Synflorix; Biological: Pneumosil

Study type: Interventional

Funder types: Other

Identifiers

NCT03197376

VAC-056

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,250 patients

Sex: All

Ages: 6 to 8 weeks old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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2,250 participants in 4 patient groups

Pneumosil Lot 1

Experimental group

Description:

Pneumosil Lot 1

Treatment:

Biological: Pneumosil

Pneumosil Lot 2

Experimental group

Description:

Pneumosil Lot 2

Treatment:

Biological: Pneumosil

Pneumosil Lot 3

Experimental group

Description:

Pneumosil Lot 3

Treatment:

Biological: Pneumosil

Synflorix

Active Comparator group

Description:

Synflorix

Treatment:

Biological: Synflorix