Pertussis in Pregnancy Safety (PIPS) Study

Study identification

• EU PAS number:
  EUPAS5418
• Study ID:
  6031
• Official title and acronym:
  Pertussis in Pregnancy Safety (PIPS) Study
• DARWIN EU® study:
  No
• Study countries:
  New Zealand
• Study description:
  This is a three-component observational study that will collect data both retrospectively and prospectively. Data for all pregnant women and their infants in NZ between 2009 and 2013 will be obtained and pertussis vaccine exposure during pregnancy verified (Study One). Two sub-studies will actively follow mothers who received Tdap during pregnancy with one also following their infants for one year after birth (Study Two and Three). Study One will involve de-identified data linkage for all pregnant women and their infants for the period 2009–2013 and the intensive monitoring studies (i.e., Study Two and Three) will prospectively follow up the mother for one month after vaccination (Study Two) with a further group being followed for both maternal and infant outcomes for one year from the birth of the infant (Study Three).
• Study status:
  Ongoing

Research institutions and networks

Institutions

University of Auckland

Immunisation Advisory Centre

University of Otago Christchurch, New Zealand

Study timelines

Date when funding contract was signed

Actual:03/12/2013

Study start date

Planned:03/02/2014

Actual:16/01/2014

Date of final study report

Planned:30/01/2015

Sources of funding

Pharmaceutical company and other private sector 

Other

More details on funding

GlaxoSmithKline, Canterbury District Health Board

Regulatory

• Was the study required by a regulatory body?:
  No