Dose-Finding Study of S.Pneumoniae Whole Cell Vaccine Adsorbed to Alum (PATH-wSP) in Healthy Kenyan Adults and Toddlers

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

304

Participants

Timeline

Start Date

April 30, 2014

Primary Completion Date

December 31, 2015

Study Completion Date

December 31, 2015

Conditions
Pneumonia, Pneumococcal
Interventions
BIOLOGICAL

PATH-wSP

Streptococcus pneumoniae Whole Cell Vaccine adsorbed to Alum

BIOLOGICAL

Synflorix

"1 dose (0.5 mL) contains:~1 μg of each of the following pneumococcal polysaccharide serotypes:~1, 5, 6B, 7F, 9V, 14, and 23 F~And 3 μg of the following pneumococcal polysaccharide serotypes:~4, 18C and 19F.~The serotypes are conjugated to either:~protein D (derived from Non-Typeable Haemophilus influenzae) carrier protein, tetanus toxoid carrier protein or diphtheria toxoid carrier protein"

BIOLOGICAL

Pentavac

"Each PFS contains 0.5 ml (single dose):~Diphtheria Toxoid 20 Lf to 30 Lf Tetanus Toxoid 2.5 Lf to 10 Lf B. Pertussis 4 IU HBsAg (rDNA) 10 mcg Purified capsular HIB Polysaccharide (PRP) Conjugated to Tetanus Toxoid (carrier protein) 10 mcg Adsorbed on Aluminium Phosphate, AL+++ 1.25 mg Preservative: Thiomersal 0.005 % Dose: O.5ml by intramuscular injection."

OTHER

Saline

0.9% Sodium Chloride Injection, USP

Trial Locations (1)

PO Box 54-40100

Kenya Medical Research Institute/Walter Reed Project, Kisumu

All Listed Sponsors
lead

PATH

OTHER

NCT02097472 - Dose-Finding Study of S.Pneumoniae Whole Cell Vaccine Adsorbed to Alum (PATH-wSP) in Healthy Kenyan Adults and Toddlers | Biotech Hunter | Biotech Hunter