Safety and Immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) in HIV-Infected Subjects 6 Years of Age or Older Who Are Naive to Pneumococcal Vaccine

PHASE3CompletedINTERVENTIONAL
Enrollment

303

Participants

Timeline

Start Date

March 31, 2010

Primary Completion Date

April 30, 2013

Study Completion Date

April 30, 2013

Conditions
HIV InfectionsPneumococcal Infections
Interventions
BIOLOGICAL

13-valent Pneumococcal Conjugate Vaccine (13vPnC)

13vPnC; 3 vaccinations given at approximately 1 month intervals at visits 1-3

BIOLOGICAL

23-valent Pneumococcal Polysaccharide Vaccine (23vPS)

23vPS; 1 vaccination given at visit 4 (approximately 1 month after visit 3)

PROCEDURE

Blood draw

Blood draw; 5 blood draws approximately 1 month apart taken prior to vaccination at visits 1-4 and visit 5 (approximately 1 month after visit 4).

PROCEDURE

Blood draw

1 or 2 blood draws for CD4+ T cell count and HIV viral load at least 6 weeks apart, if subject does not have 2 CD4+ T cell counts and HIV viral load counts within 6 months before visit 1.

Trial Locations (11)

1818

Pfizer Investigational Site, Soweto

2013

Pfizer Investigational Site, Johannesburg

3000

Pfizer Investigational Site, Dundee

6850

Pfizer Investigational Site, Worcester

7626

Pfizer Investigational Site, Paarl

9301

Pfizer Investigational Site, Bloemfontein

900709

Pfizer Investigational Site, Constanța

021105

Pfizer Investigational Site, Bucharest

030303

Pfizer Investigational Site, Bucharest

0083

Pfizer Investigational Site, Pretoria

0122

Pfizer Investigational Site, Pretoria

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY