Study characteristics |
Methods |
RCT, double‐blind |
Participants |
282 children (11 months to 4 years old) absence of any history of natural measles mumps and rubella or immunisation against these diseases. Absence of any usual medical contraindication. |
Interventions |
3 lots of MMR vaccine (lot 1, 2, 3 prepared from Schwarz live attenuated measles virus, Jeryl Lynn live attenuated measles virus, and Cenedehill live attenuated measles virus) versus placebo. Vaccines contained at least 1000 TCID50 for measles and rubella and 5000 for mumps. |
Outcomes |
Observations for intercurrent illness and vaccine reactions made approximately 3 times/child between 7 to 21 days postvaccination:
|
Funding Source |
Mixed (government and pharmaceutical industry) |
Notes |
The study does not say if all children were observed at least once. |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Unclear risk |
Unclear |
Allocation concealment (selection bias) |
Unclear risk |
Unknown, but decoding and tabulation done by computer |
Blinding (performance bias and detection bias)
All outcomes |
Unclear risk |
Not mentioned |
Incomplete outcome data (attrition bias)
All outcomes |
High risk |
16% of possible total observations missing |
Selective reporting (reporting bias) |
High risk |
No explanation for excluding symptom reports |
Summary Risk of Bias assessment |
High risk |
We had concerns regarding multiple domains such that our confidence in the result is substantially lowered. |