NCT01654263View on ClinicalTrials.gov

A Phase IIb, Open-Label, Dose Ranging Study of 13-Valent Pneumococcal Conjugate Vaccine in Adults 55 Through 74 Years of Age Previously Vaccinated With 23-Valent Pneumococcal Polysaccharide Vaccine

PHASE2CompletedINTERVENTIONAL
Enrollment

884

Participants

Timeline

Start Date

October 10, 2012

Primary Completion Date

August 21, 2015

Study Completion Date

August 21, 2015

Conditions
Pneumococcal Infection
Interventions
BIOLOGICAL

Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]

Prevnar 13 (PCV13) 13-valent pneumococcal conjugate vaccine. All doses given on Day 0. Group IA and IB (open-label): 0.5 mL intramuscular (IM) injection; Group IIA (open-label, randomized): 0.5 mL IM injection; Group IIB (open-label, randomized): 0.5 mL IM injection in the right arm and 0.5 mL IM in the left arm.

Trial Locations (7)

30030-1705

Emory Vaccine Center - The Hope Clinic, Decatur

52242-2600

University of Iowa - Vaccine Research and Education Unit, Iowa City

63104-1015

Saint Louis University - Center for Vaccine Development, St Louis

45229-3039

Cincinnati Children's Hospital Medical Center - Infectious Diseases, Cincinnati

37232-2573

Vanderbilt University - Pediatric - Vanderbilt Vaccine Research Center, Nashville

77030-3411

Baylor College of Medicine - Molecular Virology and Microbiology, Houston

98101-1466

Group Health Research Institute - Seattle - Vaccines and Infectious Diseases, Seattle

All Listed Sponsors
lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT01654263 - A Phase IIb, Open-Label, Dose Ranging Study of 13-Valent Pneumococcal Conjugate Vaccine in Adults 55 Through 74 Years of Age Previously Vaccinated With 23-Valent Pneumococcal Polysaccharide Vaccine | Biotech Hunter | Biotech Hunter