Testing of adsorbed diphtheria-pertussis-tetanus (DPT) vaccine for freedom from abnormal toxicity.
A total of 112 samples of adsorbed DPT vaccine were tested in mice for freedom from abnormal toxicity by three procedures: (a) single human dose by intraperitoneal route; (2) single human dose by subcutaneous route; and (3) half the single human dose by intraperitoneal route. The percentage of samples passing by the three methods was 25, 90 and 54.5, respectively. Method 3, which is being recommended now by the World Health Organization, is supported by the results of this study to be neither very stringent nor very lenient to pass the adsorbed DPT vaccine for freedom from abnormal toxicity.
Bhandari
S K
SK
Biological Standardization and Quality Control Division, Central Research Institute, Kasauli, India.
Gupta
R K
RK
Sharma
S B
SB
Pandey
K
K
Maheshwari
S C
SC
Ahuja
S
S
Saxena
S N
SN
D000818:Animals; D001835:Body Weight / Q000187:drug effects; D015721:Diphtheria-Tetanus-Pertussis Vaccine / Q000633:toxicity*; D005260:Female; D006168:Guinea Pigs; D007274:Injections, Intraperitoneal; D007279:Injections, Subcutaneous; D008297:Male; D051379:Mice
D015721:Diphtheria-Tetanus-Pertussis Vaccine