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

PHASE3CompletedINTERVENTIONAL
Enrollment

660

Participants

Timeline

Start Date

July 18, 2019

Primary Completion Date

December 17, 2020

Study Completion Date

December 17, 2020

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.

Trial Locations (1)

Unknown

Medical Research Council Unit, The Gambia at the London School of Hygiene and Tropical Medicine (MRCG at LSHTM), Banjul

All Listed Sponsors
collaborator

Serum Institute of India Pvt. Ltd.

INDUSTRY

collaborator

Medical Research Council Unit, The Gambia

OTHER

collaborator

University College, London

OTHER

collaborator

FHI 360

OTHER

lead

PATH

OTHER

NCT03896477 - Study of 10-valent Pneumococcal Conjugate Vaccine (Pneumosil) Administered in a 2+1 Schedule to Healthy Infants | Biotech Hunter | Biotech Hunter