| Study characteristics |
| Methods |
Multicentre RCT, double‐blind |
| Participants |
A total of 1481 healthy children from different countries in North and South America were allocated. |
| Interventions |
3 lots of MMR vaccine (Liutrin, Do Chemical containing live attenuated measles strain Schwarz, at least 1000 TCID50; mumps live strain Jeryl Lynn, at least 5000 TCID50; live rubella Cenedehill strain, at least 1000 TCID50)
versus
Placebo
1 dose subcutaneously administered |
| Outcomes |
Axillary and rectal temperature, rash, lymphadenopathy, conjunctivitis, otitis media, coryza, rhinitis, pharyngitis, cough, headache, parotitis, orchitis, arthralgia, paraesthesia, site adverse events, hypersensitivity. Each child was observed for adverse events approximately 3 times between 7 and 21 days. |
| Funding Source |
Mixed (government and pharmaceutical industry) |
| Notes |
‐ Age restriction (1 to 4 years) was not enforced.
‐ A large number of participants were missing from all observations. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Not described |
| Allocation concealment (selection bias) |
Unclear risk |
Inadequate ‐ not described |
| Blinding (performance bias and detection bias)
All outcomes |
Low risk |
Double‐blind |
| Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
There was insufficient information. |
| Selective reporting (reporting bias) |
Unclear risk |
There was insufficient information. |
| Summary Risk of Bias assessment |
Unclear risk |
We had concerns regarding at least 1 domain such that some doubt is raised about the results. |
