9-valent CRM 197 Pneumococcal

PHASE2CompletedINTERVENTIONAL
Enrollment

180

Participants

Timeline

Start Date

November 30, 2000

Primary Completion Date

December 31, 2002

Study Completion Date

December 31, 2002

Conditions
Pneumococcal Infection
Interventions
DRUG

Placebo

Saline placebo administered in a volume of 0.5 ml intramuscularly.

BIOLOGICAL

PNU-IMUNE®23

The 23-valent pneumococcal vaccine (PS) vaccine will contain a mixture of 25 micrograms purified, pneumococcal polysaccharide of each of 23 serotypes of Streptococcus pneumoniae per 0.5 ml dose in isotonic saline and 0.01% thimerosal. The vaccine will be administered in a volume of 0.5 ml intramuscularly.

BIOLOGICAL

Nine-valent pneumococcal conjugate (PNCRM9)

Cross-reactive material 197 (CRM 197) is a product of the Corynebacterium diphtheria C7. Vaccine is prepared from pneumococcal polysaccharides of types 1, 4, 5, 9V, 14, 18C, 19F, 23F (2 mcg each) and 6B (4 mcg) covalently linked to CRM197 by reductive amination. The protein-polysaccharide combination is prepared as a lyophilized powder with aluminum phosphage which is reconsitituted before use. The vaccine will be administered in a volume of 0.5 ml intramuscularly.

Trial Locations (2)

14642

University of Rochester, Rochester

45229-3039

Cincinnati Children's Hospital Medical Center, Cincinnati

All Listed Sponsors
lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT00133549 - 9-valent CRM 197 Pneumococcal | Biotech Hunter | Biotech Hunter