A/H1N1 pandemic vaccines and pregnancy outcomes

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Other
• If ‘other’, further details on the scope of the study:
  Setting up a network for drug safety in pregnancy evaluation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Systematic review and meta-analysis

Study drug and medical condition

• Name of medicine, other:
  INFLUENZA VIRUS, TYPE A, H1N1 7.0 LOG 10 FFU (FLUORESCENT FOCUS UNITS) PER DOSE
• Medical condition to be studied:
  Exposure during pregnancy

Population studied

• Short description of the study population:
  Pregnant women
• Age groups:
  Preterm newborn infants (0 – 27 days)

  Term newborn infants (0 – 27 days)

  Infants and toddlers (28 days – 23 months)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  2

Study design details

• Main study objective:
  to identify all studies of H1N1 vaccine safety in pregnancy, to conduct meta analyses of the studies identified as appropriate, and to set up a network for evaluation of drug safety in pregnancy.
• Outcomes:
  1) inventory of studies, 2) quantification of adverse pregnancy outcomes, 3) establishment of network
• Data analysis plan:
  We will establish whether it is appropriate to pool the data and to analyse the pooled data where appropriate. Heterogeneity in study results between participating centres will be identified, evaluated, and where necessary we will go back to the data suppliers for any additional verification exercises required. When appropriate, a pooled analysis will be carried out.