A Phase 2 interventional study of Biological/Vaccine: Tdap Vaccine in Pregnancy, sponsored by Hospital Universitario Dr. Jose E. Gonzalez. Completed at 1 site in Mexico. Open to female participants aged 18 Years to 38 Years. Per ClinicalTrials.gov, last updated 2014-02-14.
Sponsored by Hospital Universitario Dr. Jose E. Gonzalez · Phase 2, Interventional, and Prevention
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 the safety and immunogenicity of acellular Tdap vaccine.
The experimental group will receive acellular Tdap vaccine and the control group will receive a placebo consisting of saline 0.9% Sodium Chloride solution, randomly assigned, which will be administered by the same route (intramuscular) and at the same dose (0.5 ml) that the vaccine.
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 (according to the Obstetric Risk Assessment Form), normal anatomic ultrasound performed in the second quarter of pregnancy and residence in Guadalupe, and Juarez cities in Nuevo Leon State.
The experimental group will receive acellular Tdap vaccine and the control group will receive a placebo consisting of saline (0.9% Sodium Chloride) solution, randomly assigned, which will be administered by the same route (intramuscular) and at the same dose (0.5 ml) that the vaccine by trained personnel.
For both groups, 6 blood samples will be taken. Women: Before and at least 4 weeks after the vaccine or placebo were administered, at hospital admission for delivery. Infant: collected at delivery (cord), 2, 4 and 6 months of age.
Immunogenicity will be compared in both groups by measuring the increase of three of the following antigen-specific antibodies: Pertussis toxin (PT), pertactin (PRN),and fimbriae 2 FIM 2).
Safety Assessment: Each pregnant will be observed at 30 minutes, 24 and 48 hours and one month after the application of the vaccine for side effects.
Hospital Universitario Dr. Jose E. Gonzalez is the lead sponsor of 79 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
Biological: Tdap Intervention women will receive a blinded dose of Tdap vaccine (ADACEL)
Biological: Biological/Vaccine: Tdap Vaccine
Administration of Tdap vaccine or placebo as a single 0.5 mL of Saline (0.9% NaCl) solution
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.
Also known as: ADACEL
Elevation of specific pertussis antibody levels in children of women who were administered the immunization
Elevation of at least three antibodies against either pertussis toxin (PT), pertactin (PRN), fimbrial proteins (FIM), or filamentous hemagglutinin (FHA).
Time frame: 18 months
Non interference of acellular vaccine in children
To demonstrate the acellular pertussis immunization non interference in the effective development of pertussis antibodies in children at 2, 4, and 6 months of age.
Time frame: 18 months
This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Hospital Universitario Dr. Jose E. Gonzalez