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Completed

NCT Number: NCT05234229

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Maternite Regionale Universitaire CHRU NANCY

Nancy, Lorraine, 54035, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Survey

Other

Collection of immunization status by questionnaire

Primary outcomes

  1. Prevalence of influenza vaccination

    Time frame: 4 months

    To determine the rate of influenza immunization in immediate postpartum women and caregivers at the Nancy University Maternity Hospital in 2022 .

  2. Prevalence of pertussis vaccination

    Time frame: 4 months

    To determine the rate of pertussis immunization in immediate postpartum and caregivers at the Nancy University Maternity Hospital in 2022

Secondary outcomes

  1. awareness of own vaccination status

    Time frame: 4 months

    To determine the awareness of own vaccination status (yes; no; unknown) in immediate postpartum women regarding their influenza and pertussis immunization

  2. Knowledge about vaccination

    Time frame: 4 months

    To determine the rate of right answers to a questionnaire about knowledge of influenza and pertussis vaccination, and the possibility of vaccination during pregnancy.

  3. opinion on vaccination during pregnancy

    Time frame: 4 months

    To determine the rate of differences in vaccination coverage and knowledge among postpartum women and healthcare staff.

  4. readiness to receive pertussis and influenzae immunization

    Time frame: 4 months

    to answer the readiness (yes; no; already vaccinated) to receive immunization after answering the questionnaire

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

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

Acronym: COVAGRIP

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 10, 2022
Registry last updated
Feb 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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