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. 2021 Nov 22;2021(11):CD004407. doi: 10.1002/14651858.CD004407.pub5

ab‐Bloom 1975.

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:
  • Temperature elevation above normal 1.5 °F

  • Rash

  • Lymphadenopathy

  • Coryza

  • Rhinitis

  • Cough

  • Other

  • Local reaction

  • Limb and joint symptoms

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.