Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06114160
Other study ID # 2023_RIPH_015_Coqueluche-Vac
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date December 1, 2023
Est. completion date May 1, 2024

Study information

Verified date October 2023
Source Université de Reims Champagne-Ardenne
Contact Barbe Coralie, DR
Phone 0326913665
Email coralie.barbe@univ-reims.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In France, it has been recommended since 2022 that pregnant women be vaccinated against pertussis from 20 to 36 weeks' gestation. This vaccination schedule is inspired by the Anglo-Saxon model and studies showing the effectiveness of this practice. The aim of this vaccine is to protect the newborn by transferring antibodies from the fetus to the placenta, because Pertussis is a particularly serious disease in newborns.


Description:

The aim is to describe pregnant women's knowledge concerning pertussis, vaccination against pertussis during pregnancy and the cocooning strategy.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 500
Est. completion date May 1, 2024
Est. primary completion date February 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Pregnant between 20 and 41 weeks of amenorrhea - Primiparous - aged more than 18 - Agreed to participate in the study Exclusion Criteria: - Multiparous - Protected by law (guardianship, guardianship, safeguarding of justice) - Not agreed to participate in this study

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Data collection
Data collection

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Université de Reims Champagne-Ardenne

Outcome

Type Measure Description Time frame Safety issue
Primary recommendation of vaccination against pertussis Knowledge of pregnant women's concerning recommendation of vaccination against pertussis from 20 to 36 weeks' gestation : does the woman know or not the recommandation concerning the vaccination day0
See also
  Status Clinical Trial Phase
Not yet recruiting NCT04056728 - A Phase IV Study to Assess the Safety of EupentaTM Inj Phase 4
Completed NCT02453048 - Study of BPZE1 (High Dose) Nasal Live Attenuated B. Pertussis Vaccine Phase 1
Completed NCT01917357 - A Comparison of the Immunogenicity and Safety of Quinvaxem in Mono-dose Vials and Uniject Phase 3
Completed NCT02526394 - Pertussis and Meningitis C Concomitant Vaccination in Adolescents Phase 4
Completed NCT01689324 - Study of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine (ADACEL®) as a Booster in Adolescents Phase 1/Phase 2
Completed NCT01214889 - Study of PENTAXIM™ Vaccine Versus TETRAXIM™ Vaccine Given With ACTHIB™ Vaccine in South Korean Infants. Phase 3
Completed NCT00804284 - Database Surveillance Safety Study of PENTACEL® Vaccine N/A
Completed NCT00514709 - Immunogenicity Study of Antibody Persistence and Booster Effect of DTaP-HB PRP~T Combined Vaccine in Filipino Infants Phase 3
Completed NCT00534833 - Immunogenicity Study of Antibody Persistence and Booster Effect of DTaP-HB-PRP~T Combined Vaccine or Tritanrix-HepB/Hib™ Phase 3
Completed NCT00524732 - Assessment of the Reactogenicity of ADACEL® (TdcP Vaccine) in Children and Adolescents 7 to 19 Years of Age N/A
Completed NCT00772369 - Retrospective Survey of Safety of Fourth Dose Pentacel® in Children Phase 4
Completed NCT01457495 - Immunogenicity and Safety of DTPa-HBV-IPV/Hib Compared to DTPa-IPV/Hib and HBV Administered Concomitantly Phase 2
Completed NCT01267058 - Booster Study of Combined Diphtheria-tetanus-acellular Pertussis Vaccine in Healthy Adults Phase 3
Completed NCT00004800 - Phase III Randomized, Double-Blind, Placebo-Controlled Study of Acellular and Whole-Cell Pertussis Vaccines Phase 3
Completed NCT02858440 - A Study to Assess the Immunogenicity and Safety of GSK Biologicals' Infanrix-IPV/Hib Vaccine Administered as a Three-dose Vaccination Course at 3, 4.5 and 6 Months of Age and a Booster Dose at 18 Months of Age in Healthy Infants in Russia Phase 3
Recruiting NCT04023929 - Sources of COmplement in Meningococcal and Pertussis Serum Bactericidal Antibody Assays
Completed NCT02946190 - The PertADO Geneva Trial Phase 2
Completed NCT03541499 - Safety and Immunogenicity of Intranasal BPZE1 Vaccination in Healthy Adults Phase 2
Completed NCT02587520 - Study of Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed in Healthy Subjects Phase 1/Phase 2
Completed NCT04589312 - Maternal Pertussis Wholecell Responses Phase 2