VIMKUNYA® Pregnancy registry: An Observational Prospective Study of the Safety of VIMKUNYA® Vaccine Exposure in Pregnant Women and their Offspring

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Evaluation of patient-reported outcomes

  Safety study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Prospective pregnancy exposure registry with primary data collection. This is a Phase 4, non-interventional, product-exposure registry designed to actively collect pregnancy and infant outcome data among women exposed to VIMKUNYA up to 28 days before conception or during pregnancy

Study drug and medical condition

• Medicinal product name:
  VIMKUNYA
• Anatomical Therapeutic Chemical (ATC) code:
  (J07BP02) chikungunya, virus-like particles

  chikungunya, virus-like particles

Population studied

• Short description of the study population:
  The study population will include women who received VIMKUNYA up to 28 days before conception or at any time during pregnancy and their offspring.
• Age groups:
  • In utero
  • Paediatric Population (< 18 years)

    • Neonate

      • Preterm newborn infants (0 – 27 days)
      • Term newborn infants (0 – 27 days)
    • Infants and toddlers (28 days – 23 months)
  • Adults (18 to < 46 years)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  46

Study design details

• Study design:
  Phase 4, noninterventional pregnancy registry with primary data collection over 5 years. Women are enrolled prospectively after VIMKUNYA exposure and before pregnancy outcome; retrospective reports are also collected. Pregnancy and infant outcomes are followed from enrolment to 1 year of age.
• Main study objective:
  -To describe pregnancy outcomes among pregnant women who received CHKV VLP vaccine up to 28 days before conception or at any time during pregnancy. ; -To describe neonatal/infant outcomes until 1 year of age among the offspring of pregnant women who received CHKV VLP vaccine up to 28 days before conception or at any time during pregnancy. ;
• Data analysis plan:
  Descriptive statistics will be used to summarize the characteristics of the pregnancy registry study population. Frequencies and proportions will be calculated for categorical variables and means, standard deviations, medians, minimums, and maximums will be used for continuous variables. Cohort formation and attrition details will also be presented to characterize participant discontinuation (if any) throughout the study. ; Missing data will not be imputed due to the limited sample size. Instead, the extent of missingness will be reported descriptively. All analyses will be conducted using SAS version 9.4 (or above).;