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. 2019 Dec 5;2019(12):CD011260. doi: 10.1002/14651858.CD011260.pub2

Von Magnus 1984.

Methods Study design: interrupted time series. National surveillance data from 1935 to 1980 for cases of confirmed paralytic poliomyelitis. Recollection of paired serum samples for type 1 antibodies
Setting: Denmark
Participants Sample size: 2.7 million people. In connection with the vaccination, paired serum samples from 300 individuals were collected and examined for type 1 antibodies
Age: younger than 40 years of age
Interventions Before: III from 1961‐1967
After: IIIOOO from 1968‐1973
In the years between 1962 and 1967 the polio vaccination program in Denmark consisted of three injections of inactivated poliovirus vaccine (IPV). From 1968 onwards the polio vaccination program changed to include three injections of IPV when children are five, six, and 15 months of age and three vaccinations with tOPV administered at the age of three, four, and five years.
Outcomes
  • Number of paralytic poliomyelitis cases. Cases that occurred in close relation to the vaccinations were considered as confirmed and the other as doubtful

  • Percentage of persons, by age in years, with antibodies to type 1, 2 and 3 poliovirus, 1954, 1961, and 1973

  • Geometric mean titter of serum antibodies for all 3 types

  • Acceptance rate


Follow‐up: 13 years
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
ITS: protection against secular changes Low risk Comment: intervention appears to occur independently of other changes over time
ITS: data were analysed appropriately High risk Comment: crude numbers
ITS: reason given for the number of points pre‐ and post‐intervention Low risk Comment: rationale for the yearly points is justified in the context of national surveillance system
ITS: shape of the intervention effect was specified Unclear risk Comment: data were not analysed as an ITS but we re‐analysed the data.
ITS/UBA: blinded assessment of primary outcome(s) Low risk Comment: The outcomes 'paralytic poliomyelitis cases' and 'antibody titres' are objective. The source were national information systems.
ITS/UBA: reliable primary outcome measure(s) Low risk Number of paralytic poliomyelitis cases. Cases occurred in close relation to the vaccinations were considered as confirmed and the other as doubtful. Antibody titres is a more objective outcome.
ITS: intervention unlikely to affect data collection Unclear risk Comment: sources and methods of data collection were the same before and after the intervention. The outcome variables are objective measures.
ITS: completeness of data set Unclear risk Comment: unclear report
Conflict of interest Low risk Study supported by the Epidemiology Department and the Enterovirus Department,Statens Seruminstitut, Copenhagen, Denmark.