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Comparison of Serological Test s for the Virus Chicken Pox Virus (VZV) and Correlation With the Patient's Memory of the Infection or Vaccination (VARI-IMM)

H

Hopital Foch

Status

Terminated

Conditions

Pregnancy

Treatments

Biological: Serological Test s for the Virus Chicken Pox Virus

Study type

Interventional

Funder types

Other

Identifiers

NCT02775422
2014-A00707-40 (Other Identifier)
2014/08

Details and patient eligibility

About

Comparison of the sensibility and specificity of 3 different serological tests and evaluation of chicken pox immunity in pregnant women.

Secondary goals :

  • Correlation memory / Immunity;
  • Prevalence of VZV immunity in pregnant women;
  • Evaluation of cellular and humoral immunity in cases with discrepancy between tests or between test and memory;
  • Evaluation of acceptability of vaccination in the post partum period in non immune patients.

Methods Not randomized prospective study,

Number of patients : 400 Duration : 36 months Inclusion criteria : pregnant women >18years old, agree to participate (written consent) Exclusion criteria: auto immune disease, HIV +, grafted patients

Enrollment

308 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Pregnant women aged over 18
  • Affiliated to a social protection scheme or women benefiting from such a regime
  • Women who gived a writing consent

Exclusion criteria

  • Women with a maternal disease: autoimmune disease (systemic lupus erythematosus, antiphospholipid syndrome, insulin dependent diabetes, autoimmune thyroiditis ..), it takes an immunosuppressive treatment or not.
  • HIV-positive women
  • Garfted women whatever organ

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

308 participants in 1 patient group

Pregnant women
Experimental group
Description:
Pregnant women
Treatment:
Biological: Serological Test s for the Virus Chicken Pox Virus

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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