NCT01445743

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
204

participants targeted

Target at P50-P75 for phase_2 pregnancy

Timeline
Completed

Started Sep 2011

Typical duration for phase_2 pregnancy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

September 23, 2011

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 4, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

February 14, 2014

Status Verified

February 1, 2014

Enrollment Period

11 months

First QC Date

September 23, 2011

Last Update Submit

February 12, 2014

Conditions

Pregnancy

Keywords

Tdap VaccinePregnant womanPertussis

Outcome Measures

Primary Outcomes (1)

  • 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).

    18 months

Secondary Outcomes (1)

  • Non interference of acellular vaccine in children

    18 months

Study Arms (2)

Biological/Vaccine: Tdap Vaccine

EXPERIMENTAL

Biological: Tdap Intervention women will receive a blinded dose of Tdap vaccine (ADACEL)

Biological: Biological/Vaccine: Tdap Vaccine

Placebo Comparator: Physiologic Saline solution

PLACEBO COMPARATOR

Administration of Tdap vaccine or placebo as a single 0.5 mL of Saline (0.9% NaCl) solution

Biological: Biological/Vaccine: Tdap Vaccine

Interventions

Biological/Vaccine: Tdap VaccineBIOLOGICAL

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
Biological/Vaccine: Tdap VaccinePlacebo Comparator: Physiologic Saline solution

Eligibility Criteria

Age18 Years - 38 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Guadalupe, Nuevo León, 66000, Mexico

Location

MeSH Terms

Conditions

Whooping Cough

Interventions

Biological Productsadacel

Condition Hierarchy (Ancestors)

Bordetella InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsRespiratory Tract InfectionsRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Complex Mixtures

Study Officials

  • Jose M Ramirez, MD; PhD

    Proffesor of Family Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 23, 2011

First Posted

October 4, 2011

Study Start

September 1, 2011

Primary Completion

August 1, 2012

Study Completion

February 1, 2014

Last Updated

February 14, 2014

Record last verified: 2014-02

Locations

ME(1)