title: Adverse events following primary and secondary immunisation with whole-cell pertussis: a systematic review protocol.
abstract: Pertussis is a contagious respiratory illness caused by the bacterium Bordetella pertussis. Two types of vaccines are currently available against the disease: whole-cell pertussis (wP) and acellular pertussis (aP). With the shift of high-income countries from wP to aP as a result of adverse events following immunisation (AEFI), an upsurge in reported cases of pertussis has been noticed. Owing to this, it is proposed to use wP as a prime and aP for boost vaccination strategy. However, a comparison of the AEFI with the first doses of wP and aP are not clearly documented.
  
  
  
  The primary outcomes of interest are AEFI with dose 1 of wP, subsequent doses of wP and dose 1 of aP. As a secondary outcome frequency of AEFI with wP will be compared with the AEFI of doses 2 and 3 of wP and dose 1 of aP. Electronic databases will be searched and two authors will screen the titles and abstracts of the output. Full texts will then be independently reviewed by the first author and two other authors. Qualifying studies will then be formally assessed for quality and risk of bias using a scoring tool. Following standardised data extraction, statistical analysis will be carried out using STATA. Where data are available, subgroup analyses will be performed. Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines will be followed in reporting the findings of the systematic review and meta-analysis.
  
  
  
  No ethics approval is required as the systematic review will use only published data already in the public domain. Findings will be disseminated through publication in a peer-reviewed journal.
  
  
  
  This protocol has been registered with the International Prospective Register of Systematic Reviews (PROSPERO), registration number CRD42016035809.
authors.affiliation: Vaccines for Africa Initiative, Division of Medical Microbiology, University of Cape Town, Observatory, South Africa.|Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Observatory, South Africa.
authors.forename: Jenna
authors.initials: J
authors.lastname: Patterson
authors.affiliation: Vaccines for Africa Initiative, Division of Medical Microbiology, University of Cape Town, Observatory, South Africa.|Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Observatory, South Africa.
authors.forename: Benjamin M
authors.initials: BM
authors.lastname: Kagina
authors.affiliation: Discipline of Paediatrics, Women's and Children's Health Network, University of Adelaide, Adelaide, South Australia, Australia.
authors.forename: Michael
authors.initials: M
authors.lastname: Gold
authors.affiliation: Vaccines for Africa Initiative, Division of Medical Microbiology, University of Cape Town, Observatory, South Africa.|Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Observatory, South Africa.
authors.forename: Gregory D
authors.initials: GD
authors.lastname: Hussey
authors.affiliation: Department of Paediatrics and Child Health, Groote Schuur Hospital, University of Cape Town, Observatory, South Africa.
authors.forename: Rudzani
authors.initials: R
authors.lastname: Muloiwa
mesh_terms: D015721:Diphtheria-Tetanus-Pertussis Vaccine / Q000009:adverse effects*; D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines / Q000009:adverse effects; D006801:Humans; D007114:Immunization / Q000009:adverse effects*; D007117:Immunization, Secondary / Q000009:adverse effects*; D000078202:Systematic Reviews as Topic; D014917:Whooping Cough / Q000517:prevention & control*
chemical_list: D015721:Diphtheria-Tetanus-Pertussis Vaccine; D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines
keywords: EPIDEMIOLOGY; PUBLIC HEALTH