Status:
COMPLETED
Immunogenicity and Safety of an Acellular DPT Vaccine During Pregnancy
Lead Sponsor:
Hospital Universitario Dr. Jose E. Gonzalez
Conditions:
Pregnancy
Eligibility:
FEMALE
18-38 years
Phase:
PHASE2
Brief Summary
That is a double-blind randomized trial with parallel control to demonstrate the safety and immunogenicity of acellular Tdap vaccine in pregnant mexican women. The general objective is to determine th...
Detailed Description
Type of Study: Clinical, randomized, double-blind, parallel control study. Study Subjects: Pregnant women of 19-38years of age, gestational age of 12-24 weeks, low risk of obstetric complications (acc...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 18 to 38 years
- Pregnancy between 22 and 32 weeks of gestation
- Covered by Ministry of Health medical security
- Definitive residency in Guadalupe and Benito Juarez cities
- Pregnancy termination in the study's hospital.
- At low risk for complication as determined by the obstetrical risk assessment form (ORAF)
- Second trimester or later ultrasound with no significant abnormalities
- Intend to be available for follow up visits and phone calls access through 6 months following delivery
- Willing to give written informed consent
- Exclusion criteria:
- Serious mental illness. (Schizophrenia, psychosis, major depression).
- Serious underlying medical condition (e.g Degenerative diseases: Diabetes Mellitus,Hypertension and so on.
- Current smoking or use of drugs.
- Receipt of tetanus-diphtheria toxoid immunization within the past 2 years.
- Be considered as a high risk pregnancy for serious obstetrical complication according to the local Obstetrical Risk Assessment Form.
Exclusion
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
204 Patients enrolled
Trial Details
Trial ID
NCT01445743
Start Date
September 1 2011
End Date
February 1 2014
Last Update
February 14 2014
Active Locations (1)
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1
Hospital Regional Materno Infantil de alta especialidad, Secretaria de Salud de Nuevo Leon
Guadalupe, Nuevo León, Mexico, 66000