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. 2011 Mar 16;2011(3):CD008603. doi: 10.1002/14651858.CD008603.pub2

Suharyono 1992b.

Study characteristics
Methods Trial design: Randomized controlled trial (individually randomized)
Trial dates and duration: Sept to Oct 1990
Participants Number of participants: 140
Inclusion criteria: As for Suharyono 1992a
Exclusion criteria: As for Suharyono 1992a
Interventions Vaccine: CVD 103‐HgR live attenuated vaccine containing:
  • 5 x 109 CFU CVD 103HgR centrifuged

  • 5 x 1010 CFU CVD 103HgR centrifuged

  • 5 x 109 CFU CVD 103HgR filtered

  • 5 x 1010 CFU CVD 103HgR filtered

  • Half of the children in each of these groups were randomized to also receive an extra half dose of buffer


Placebo: 5 x 108 CFU inactivated E. coli K12 strain
Outcomes As for Suharyono 1992a
Notes Location: As for Suharyono 1992a
Setting:
Source of funding: As for Suharyono 1992a
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: 'the child was allocated to receive one of the nine treatment groups, according to a randomised sequence'
Comment: Study A in the same paper used a computer to generate the sequence.
Allocation concealment (selection bias) Low risk Comment: Only clearly described for study A but probably done.
Blinding (performance bias and detection bias)
Efficacy outcomes Unclear risk Not applicable as efficacy not reported
Blinding (performance bias and detection bias)
Safety outcomes Low risk Quote: 'The clinical follow‐up as well as the administration of the vaccine was double‐blind with neither the clinical staff, the patient or their parents knowing the identity of the preparation'.
Incomplete outcome data (attrition bias)
Efficacy outcomes Unclear risk Not applicable as efficacy not reported
Incomplete outcome data (attrition bias)
Safety outcomes Low risk Comment: No losses to follow up are reported
Selective reporting (reporting bias) Low risk No evidence of selective reporting
Other bias Low risk No evidence of other bias