Skip to main content
. 2022 Mar 16;2022(3):CD008524. doi: 10.1002/14651858.CD008524.pub4

Benn 1997.

Study characteristics
Methods Individually randomised trial conducted in Belem and Mindra, 2 districts in Bissau, Guinea‐Bissau
Participants Eligibility: infants aged 6–9 months
Excluded: children with signs of xerophthalmia; history of previous VAS; history of measles infection before 9 months of age, or who had a positive haemagglutinin‐inhibition assay titre at 9 months of age; infants reported to have had measles at 9–18 months of age
Sample: 462 infants. Mean age 8.7 months. 51% boys
Interventions 3 intervention groups
Group I: infants aged 6 months randomly allocated to receive either a dose of measles vaccine at 6 months and a dose of measles vaccine at 9 months together with vitamin A supplement or the same dosing of measles vaccine with placebo as the supplement
Group II: infants randomly allocated either poliomyelitis vaccine at 6 months and a single dose of measles vaccine at 9 months with vitamin A supplement or the same vaccines with a placebo as the supplement
Group III: infants aged > 7.5 months at the beginning of the study or who were not found at home until they reached the age of 7.5 months were included in the study at age 9 months and received a measles vaccine plus vitamin A or placebo supplement
Vitamin A was in a single dose of 100,000 IU dissolved in 1 mL of vegetable oil along with 40 IU of vitamin E.
Placebo was vitamin E 40 IU dissolved in 1 mL of vegetable oil
Outcomes Antibody response to measles vaccine, all‐cause mortality, incidence of measles
Notes Primary objective of study was to calculate the antibody response to measles vaccine when given with vitamin A. The results for antibody response to measles vaccine showed no significant difference between the groups. The study concluded that simultaneous administration of measles vaccine and vitamin A had no negative effect on measles immunity. Similarly, VAS had no significant effect on immune response of CD4 and CD8 T‐cells in children without clinical VAD. Vitamin A or placebo was given only at 9 months of age in all 3 study groups. The only difference among the groups was the frequency and type of vaccine administered. Therefore, we added the data for all 3 intervention and placebo groups to report the outcomes of interest to our review. We primarily took data from trial flow diagram and calculated the effect sizes accordingly.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "The allocation sequence was computer generated".
Allocation concealment (selection bias) Low risk Quote: "The allocation sequence was kept in sealed envelopes and only released when all clinical laboratory analyses were completed".
Blinding (performance bias and detection bias)
Blinding of participants Low risk Quote: "… because of the young age of the participants, any difference in taste was irrelevant …".
Comment: identical presentation; probably adequate.
Blinding (performance bias and detection bias)
Blinding of provider Low risk Quote: "None of the staff involved knew whether the bottles contained vitamin A or placebo …".
Blinding (performance bias and detection bias)
Blinding of outcome assessor Low risk Quote: "None of the staff involved knew whether the bottles contained vitamin A or placebo …".
Comment: blinding of treatment group assignment and treatment to study personnel likely to have been maintained throughout.
Incomplete outcome data (attrition bias) Low risk Comment: number lost to follow‐up and those excluded were explicitly described and equal in both the groups. Loss to follow‐up exceeded the number of deaths and children with measles. Reasons for missing data (migration) probably unrelated to treatment.
Selective reporting (reporting bias) Low risk Comment: some evidence of selective outcome reporting around malaria; however, deaths and prevalence of measles reported.
Other bias Unclear risk Comment: authors reported imbalance in self‐reported disease in the children aged 6 months at baseline. It is unclear how big an impact this will have had as the variable is not specific.