A Double-Blind Placebo-Controlled Trial of the Safety and Immunogenicity of a Seven Valent Pneumococcal Conjugate Vaccine in Presumed HIV-Infected Infants

PHASE1CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

Not specified

Study Completion Date

October 31, 1999

Conditions
HIV InfectionsPneumococcal Infections
Interventions
BIOLOGICAL

Pneumococcal Vaccine, Polyvalent (23-valent)

Administered as an injection at 24 months of age

BIOLOGICAL

Pneumococcal Conjugate Vaccine, Heptavalent

Administered as an injection at 0, 2, 4, and 15 months of age

BIOLOGICAL

Placebo

Administered at 0, 2, 4, and 15 months of age

Trial Locations (33)

10016

NYU Med. Ctr., Dept. of Medicine, New York

10032

Columbia IMPAACT CRS, New York

Incarnation Children's Ctr., New York

10037

Harlem Hosp. Ctr. NY NICHD CRS, New York

10457

Bronx-Lebanon Hosp. IMPAACT CRS, The Bronx

11021

North Shore-Long Island Jewish Health System, Dept. of Peds., Great Neck

13210

SUNY Upstate Med. Univ., Dept. of Peds., Syracuse

21201

Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology, Baltimore

30306

Emory Univ. School of Medicine, Dept. of Peds., Div. of Infectious Diseases, Atlanta

32209

Univ. of Florida Jacksonville NICHD CRS, Jacksonville

33161

Univ. of Miami Ped. Perinatal HIV/AIDS CRS, Miami

48201

Children's Hospital of Michigan NICHD CRS, Detroit

60612

Cook County Hosp., Chicago

77030

Texas Children's Hosp. CRS, Houston

90033

Usc La Nichd Crs, Los Angeles

94110

San Francisco Gen. Hosp., San Francisco

117948111

SUNY Stony Brook NICHD CRS, Stony Brook

191044318

The Children's Hosp. of Philadelphia IMPAACT CRS, Philadelphia

212874933

Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases, Baltimore

277103499

DUMC Ped. CRS, Durham

606143394

Chicago Children's CRS, Chicago

606371470

Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease, Chicago

701122699

Tulane/LSU Maternal/Child CRS, New Orleans

920930672

UCSD Maternal, Child, and Adolescent HIV CRS, San Diego

941430105

UCSF Pediatric AIDS CRS, San Francisco

946091809

Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab., Oakland

981050371

UW School of Medicine - CHRMC, Seattle

021155724

HMS - Children's Hosp. Boston, Div. of Infectious Diseases, Boston

089030019

UMDNJ - Robert Wood Johnson, New Brunswick

071072198

NJ Med. School CRS, Newark

Unknown

Strong Memorial Hospital Rochester NY NICHD CRS, Rochester

San Juan City Hosp. PR NICHD CRS, San Juan

009365067

Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS, San Juan

All Listed Sponsors
collaborator

Lederle-Praxis Biologicals

INDUSTRY

lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH