Influenza and Pertussis Vaccination Status of Women in Immediate Postpartum and Caregivers

Influenza Viral Infections Clinical Trial

— COVAGRIP  

Official title:

Influenza and Pertussis Vaccination Status of Women in Immediate Postpartum and Caregivers in the Maternity Hospital of Nancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05234229
• Other study ID #: 2021PI087
• Status: Completed
• Start date: March 1, 2022
• Est. completion date: October 30, 2023

Study information

• Verified date: February 2024
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Pertussis is a bacterial respiratory infection caused by Bordetella pertussis. Highly contagious, it is potentially serious and even fatal in infants under 6 months of age. The immunity acquired through vaccination is very limited in time, requiring regular booster shots. There is a passive protection of the newborn by the maternal-fetal transmission of maternal antibodies, but it is brief. The infant's first vaccination is given at 2 months of age and immunity is not acquired until the second injection at 4 months of age. The booster at 11 months of age is essential to prolong this immunity.

In order to protect infants under 6 months of age, France has recommended since 2004 the cocooning strategy, which consists of vaccinating people likely to be in close contact with the infant during this period. This vaccination is therefore proposed to adults who are planning to have children, to the entourage of pregnant women, and in the immediate post-partum period for the mother (and people who were not vaccinated during pregnancy). This strategy was put in place following the international recommendation of a forum of scientific experts, the Global Pertussis Initiative.

In France, vaccination against pertussis is not currently recommended during pregnancy. There is no contraindication to vaccination during pregnancy and it is recommended in many countries.

Influenza is a viral respiratory infection caused by Myxovirus influenzae, which is highly contagious.

In France, vaccination against influenza is recommended for pregnant women, regardless of the trimester of pregnancy. It is also recommended for the entourage of infants under 6 months of age with risk factors for severe influenza.

There are few recent data in the scientific literature regarding influenza and pertussis vaccination coverage among pregnant or postpartum women in France. In addition, the COVID19 pandemic has recently reopened the debate on vaccination of the general population and caregivers. Knowing the current status of vaccination coverage among pregnant women and caregivers, their knowledge and fears regarding vaccination could help improve the information provided by healthcare staff.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 254
• Est. completion date: October 30, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Person having received complete information about the research and not opposed to the study.

• Hospitalization in the post-partum service and within the last 5 days of delivery.

• women. caregivers

Exclusion Criteria:

• Female under 18 years of age,

• Woman under legal protection,

• Delivery of a stillborn child,

• Premature delivery < 35GA,

• Hospitalized newborn,

• Women who doesn't speak french.

Related Conditions & MeSH terms

• Influenza Viral Infections
• Influenza, Human
• Pertussis/Whooping Cough
• Virus Diseases
• Whooping Cough

Intervention

Other:
• Survey
Collection of immunization status by questionnaire

Locations

Country	Name	City	State
France	Maternite Regionale Universitaire CHRU NANCY	Nancy	Lorraine

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of influenza vaccination	To determine the rate of influenza immunization in immediate postpartum women and caregivers at the Nancy University Maternity Hospital in 2022 .	4 months
Primary	Prevalence of pertussis vaccination	To determine the rate of pertussis immunization in immediate postpartum and caregivers at the Nancy University Maternity Hospital in 2022	4 months
Secondary	awareness of own vaccination status	To determine the awareness of own vaccination status (yes; no; unknown) in immediate postpartum women regarding their influenza and pertussis immunization	4 months
Secondary	Knowledge about vaccination	To determine the rate of right answers to a questionnaire about knowledge of influenza and pertussis vaccination, and the possibility of vaccination during pregnancy.	4 months
Secondary	opinion on vaccination during pregnancy	To determine the rate of differences in vaccination coverage and knowledge among postpartum women and healthcare staff.	4 months
Secondary	readiness to receive pertussis and influenzae immunization	to answer the readiness (yes; no; already vaccinated) to receive immunization after answering the questionnaire	4 months