Influenza and Pertussis Vaccination Status of Women in Immediate Postpartum and Caregivers (COVAGRIP)

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

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.

Study Overview

• Status: Completed
• Conditions: Influenza Viral Infections; Pertussis/Whooping Cough
• Intervention / Treatment: Other: Survey

• Study Type: Observational
• Enrollment (Actual): 254

Contacts and Locations

Study Locations

• France
  • Lorraine
    • Nancy, Lorraine, France, 54035
      • Maternite Regionale Universitaire CHRU NANCY

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Women over 18 years old, delivery after 35GA and healthcare staff of the University Maternity Hospital of Nancy in 2022. Person having received complete information about the research and not opposed to the study.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
covagrip women in immediate post partum; women in immediate post partum	Other: Survey; Collection of immunization status by questionnaire
Caregivers; health care personnel	Other: Survey; Collection of immunization status by questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
opinion on vaccination during pregnancy	To determine the rate of differences in vaccination coverage and knowledge among postpartum women and healthcare staff.	4 months
readiness to receive pertussis and influenzae immunization	to answer the readiness (yes; no; already vaccinated) to receive immunization after answering the questionnaire	4 months

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Investigators: Study Director: Jean Michel HASCOET, Maternite Regionale Universitaire CHRU NANCY

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): August 31, 2023
• Study Completion (Actual): October 30, 2023

Study Registration Dates

• First Submitted: February 1, 2022
• First Submitted That Met QC Criteria: February 1, 2022
• First Posted (Actual): February 10, 2022

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 7, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: immunization; cocooning
• Additional Relevant MeSH Terms: RNA Virus Infections; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Orthomyxoviridae Infections; Whooping Cough; Virus Diseases; Influenza, Human
• Other Study ID Numbers: 2021PI087

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No