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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

2250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-21

Study Completion Date

2019-05-09

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pneumonia, Pneumococcal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Pneumosil Lot 1

Group Type EXPERIMENTAL

Pneumosil

Intervention Type BIOLOGICAL

10-Valent Pneumococcal Conjugate Vaccine

Pneumosil Lot 2

Group Type EXPERIMENTAL

Pneumosil

Intervention Type BIOLOGICAL

10-Valent Pneumococcal Conjugate Vaccine

Pneumosil Lot 3

Group Type EXPERIMENTAL

Pneumosil

Intervention Type BIOLOGICAL

10-Valent Pneumococcal Conjugate Vaccine

Synflorix

Group Type ACTIVE_COMPARATOR

Synflorix

Intervention Type BIOLOGICAL

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

Interventions

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Pneumosil

10-Valent Pneumococcal Conjugate Vaccine

Intervention Type BIOLOGICAL

Synflorix

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

6 Weeks

Maximum Eligible Age

8 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes