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

NCT03896477 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 660

Last updated 2022-04-20

Study results available
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Summary

The primary objectives of this study are to evaluate the immunogenicity (antibody response) and safety and tolerability of a 2-dose primary series and booster dose (2+1 schedule) of Pneumosil co-administered with routine pediatric vaccines in healthy infants in The Gambia.

Conditions

  • Pneumonia, Pneumococcal

Interventions

BIOLOGICAL

Pneumosil

One single dose contains 2 μg of polysaccharide for serotypes 1, 5, 6A, 7F, 9V, 14, 19A, 19F and 23F, and 4 μg for serotype 6B formulated with aluminium phosphate as an adjuvant in an appropriate buffer

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

BIOLOGICAL

Synflorix

One single dose contains 1 μg 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.

Sponsors & Collaborators

  • Serum Institute of India Pvt. Ltd.

    collaborator INDUSTRY

  • Medical Research Council Unit, The Gambia

    collaborator OTHER

  • University College, London

    collaborator OTHER

  • FHI 360

    collaborator OTHER

  • PATH

    lead OTHER

Principal Investigators

  • Ed Clarke, MB ChB, PhD · MRCG at LSHTM

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
42 Days
Max Age
56 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-07-18
Primary Completion
2020-12-17
Completion
2020-12-17

Countries

  • The Gambia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03896477 on ClinicalTrials.gov