Key result
The abstract describes methodological changes for continuation studies following a 1951 pilot test of gamma globulin versus gelatin for poliomyelitis prophylaxis in 5,767 children.
Why the study?
Does gamma globulin prevent poliomyelitis in children during an epidemic?
RCT (n=5,767)
Random order
Does gamma globulin prevent poliomyelitis in children during an epidemic?
Describes methodological improvements, including disposable preloaded syringes, for large-scale trials of gamma globulin prophylaxis against poliomyelitis.
Methodological refinements in the 1951 pilot leave gamma globulin efficacy unresolved; extends standards for large-scale infectious disease prophylaxis trials.
As a result of experience in the 1951 pilot test in Utah (see this issue, page 739), in which 5,767 children were injected with either gamma globulin or gelatin during a poliomyelitis epidemic, several minor changes in the original plan were proposed for the continuation studies. The following changes were the more important ones. Through arrangements with the Becton-Dickinson Company, a disposable syringe with a preloaded cartridge containing 4,7, or 11 cc. was perfected. This would allow for much faster operation of the clinics. These syringe units of gamma globulin or gelatin would be assembled and packaged in random order and given serial numbers for identification in the same way as the vial units used in Utah. The label bearing the serial number would be slipped into the extra length of the glass cartridge in the disposable unit and not affixed with adhesive. This label would be removed by the
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William McD. Hammon (1952) conducted an RCT in Poliomyelitis (n=5,767). Red Cross Gamma Globulin vs. Gelatin was evaluated. The abstract describes methodological changes for continuation studies following a 1951 pilot test of gamma globulin versus gelatin for poliomyelitis prophylaxis in 5,767 children.
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