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. 2019 Dec 19;2019(12):CD011780. doi: 10.1002/14651858.CD011780.pub2

Soonawala 2013.

Methods Study design: single‐centre, non‐inferiority randomised controlled trial
Location: Leiden University Medical Center, the Netherlands
Duration: 19 months

  1. Start date: August 2010

  2. End date: February 2012
Participants Inclusion criteria: "Healthy dutch adult volunteers who had received exactly 6 combined DTP‐IPV vaccinations according to the National Immunization Programme were included." (quote)
Exclusion criteria: "Those who had received any IPV booster after 10 years of age were excluded. Receipt of OPV was also an exclusion criteria." (quote)
Sample size: 125; 94 included in the review
Number of withdrawals/loss to follow‐up: 1
Age:

  1. Comparator: mean = 21.1 (0.5) years (IM needle syringe arm), 21.8 (0.8) years (IM PharmaJet arm)

  2. Intervention: mean = 21.5 (0.4) years


Sex (male:female):

  1. Comparator: 24:38

  2. Intervention: 11:21
Interventions Intervention (n = 32): 0.1 mL IPV given intradermally by PharmaJet jet injector
Control (n = 62):

  1. 0.5 mL IPV given intramuscularly by needle and syringe (n = 32)*

  2. 0.5 mL IPV given intramuscularly by PharmaJet jet injector (n = 30)*

  3. 0.1 mL IPV given intramuscularly by needle and syringe**


*We combined the data from arms 1 and 2 into a single group (n = 62).
**We did not consider the data from third arm (i.e. 0.1 mL intramuscular dose of IPV, n = 31) in this review.
Outcomes

  1. Immunogenicity

  2. Tolerability


Timing of outcome assessment: 28 days after vaccination of a fractional booster dose
Notes Funding source(s): Netherlands Vaccine Institute, the Netherlands
Conflict(s) of interest: not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Comment: used random number generator to generate random sequences
Allocation concealment (selection bias) Unclear risk Comment: sealed envelopes randomly numbered, but unclear if opaque (non‐transparent)
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Comment: not blinded
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Comment: not blinded
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Comment: all participants accounted for in safety assessment and less than 5% loss to follow‐up for immunogenicity assessment
Selective reporting (reporting bias) Low risk Comment: reported on all outcomes
Other bias High risk Comment: funding agency part of the research team