Pneumococcal Vaccines Early and in Combination

PHASE4CompletedINTERVENTIONAL
Enrollment

425

Participants

Timeline

Start Date

August 31, 2011

Primary Completion Date

September 21, 2017

Study Completion Date

March 15, 2018

Conditions
Otitis Media
Interventions
DRUG

Synflorix

The 10-valent vaccine contains 1 µg of purified capsular polysaccharide of pneumococcal serotypes 1, 5, 6B, 7F, 9V, 14, and 23F conjugated to protein D, 3 µg of serotype 4 conjugated to protein D, 3 µg of serotype 18C conjugated to tetanus toxoid and 3 µg of serotype 19F conjugated to diphtheria toxoid.

DRUG

Prevenar13

"The vaccine is a ready to use homogeneous white suspension for intramuscular injection, supplied as a pre-filled syringe.~Active ingredients~Each 0.5 mL dose contains:~2.2 μg of pneumococcal purified capsular polysaccharides for serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F and 23F 4.4 μg of pneumococcal purified capsular polysaccharides for serotype 6B. Each serotype is individually conjugated to non-toxic diphtheria CRM197 protein and adsorbed on aluminium phosphate (0.565 mg). CRM197 is a nontoxic variant of diphtheria toxin isolated from cultures of Corynebacterium diphtheriae strain C7 (β197) grown in a casamino acids and yeast extract-based medium."

DRUG

COMBO

COMBINATION SCHEDULE of vaccine 1 and vaccine 2: Synflorix (PHiD-CV) at 1,2,4 months then Prevenar13 (PCV13) at 6 months of age.

Trial Locations (1)

0811

Menzies School of Health Research, Darwin

All Listed Sponsors
lead

Menzies School of Health Research

OTHER

NCT01174849 - Pneumococcal Vaccines Early and in Combination | Biotech Hunter | Biotech Hunter