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:
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 |