| Study characteristics |
| Methods |
Cluster randomised controlled trial
Children due to receive MMR (over a 1‐year period) were assigned to receive the vaccine (MMR II) at either 13 or 15 months, depending on the random assignment of their family physician. |
| Participants |
Children receiving MMR |
| Interventions |
MMR ‐ MMRII (Merck Sharp & Dohme) administered at either 13 or 15 months |
| Outcomes |
‐ Cough
‐ Temperature
‐ Rash
‐ Eyes runny
‐ Nose runny
‐ Lymphadenopathy
‐ Hospital admission
Assessed by daily diaries (from 4 weeks before to 4 weeks postvaccination) |
| Funding Source |
Government |
| Notes |
Only ~67% of the participants (253 out of 376) completed the study. It is not explained how delays in vaccination for some participants affected the 8‐week diary. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
High risk |
Not reported ‐ there was insufficient information |
| Allocation concealment (selection bias) |
High risk |
Not reported ‐ there was insufficient information |
| Blinding (performance bias and detection bias)
All outcomes |
High risk |
Not reported ‐ there was insufficient information |
| Incomplete outcome data (attrition bias)
All outcomes |
High risk |
Not reported ‐ there was insufficient information |
| Selective reporting (reporting bias) |
Unclear risk |
Not reported ‐ there was insufficient information |
| Summary Risk of Bias assessment |
High risk |
We had concerns regarding multiple domains such that our confidence in the result is substantially lowered. |
