CClinicalTrials.gg
CompletedNCT05234229COVAGRIPUpdated Feb 8, 2024

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

An observational study in Pertussis/Whooping Cough and Influenza Viral Infections, sponsored by Central Hospital, Nancy, France. Completed at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-08.

Sponsored by Central Hospital, Nancy, France · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
254
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Pertussis/Whooping Cough
  • Influenza Viral Infections

Keywords

  • immunization
  • cocooning
03

In context

Influenza, Human

2,215 studies on the registry are indexed under Influenza, Human; 164 are open to participants now.

This study's enrollment of 254 is below the median of 300 across 305 observational studies indexed under Influenza, Human.

Browse Influenza, Human studies →

Lead sponsor

Central Hospital, Nancy, France is the lead sponsor of 778 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
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.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
254 participants (actual)
Patient registry
No

Groups and cohorts

  • covagrip women in immediate post partum

    women in immediate post partum

    Other: Survey

  • Caregivers

    health care personnel

    Other: Survey

Interventions

  • OtherSurvey

    Collection of immunization status by questionnaire

06

What researchers measure

Primary outcomes

  1. 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 .

    Time frame: 4 months

  2. Prevalence of pertussis vaccination

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

    Time frame: 4 months

Secondary outcomes

  1. 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

    Time frame: 4 months

  2. 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.

    Time frame: 4 months

  3. opinion on vaccination during pregnancy

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

    Time frame: 4 months

  4. readiness to receive pertussis and influenzae immunization

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

    Time frame: 4 months

07

Study locations

1 site
  • Maternite Regionale Universitaire CHRU NANCY
    Nancy, Lorraine 54035, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 8, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05234229
Lead sponsor
Central Hospital, Nancy, France
Responsible party
Jean-Michel HASCOET (Professor, Central Hospital, Nancy, France) — Principal investigator
First posted
Feb 10, 2022
Start date
Mar 1, 2022
Primary completion
Aug 31, 2023
Completion
Oct 30, 2023
Last update
Feb 8, 2024

Study contacts

Jean Michel HASCOET
study director · Maternité Régionale Universitaire CHRU NANCY

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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