Immunogenicity and Safety of an Acellular DPT Vaccine During Pregnancy

PHASE2CompletedINTERVENTIONAL
Enrollment

204

Participants

Timeline

Start Date

September 30, 2011

Primary Completion Date

August 31, 2012

Study Completion Date

February 28, 2014

Conditions
Pregnancy
Interventions
BIOLOGICAL

Biological/Vaccine: Tdap Vaccine

Biological: Tdap Intervention comprises 104 randomly assigned pregnant women who will receive a blinded dose of Tdap vaccine (ADACEL) containing 2.5 ug of detoxified pertussis toxin (PT), filamentous haemagglutinin 5 ug, 3 ug Pertactina; 5 ug Fimbriae type 2 and 3, (in addition to Tetanus Toxoid (5 Lf) and diphtheria toxoid (2Lf) as a single 0.5 mL intramuscular injection into the deltoid.

Trial Locations (1)

66000

Hospital Regional Materno Infantil de alta especialidad, Secretaria de Salud de Nuevo Leon, Guadalupe

All Listed Sponsors
lead

Hospital Universitario Dr. Jose E. Gonzalez

OTHER

NCT01445743 - Immunogenicity and Safety of an Acellular DPT Vaccine During Pregnancy | Biotech Hunter | Biotech Hunter