Table 3.

Study design of the repeated dose toxicity study with Haemophilus influenza b vaccine

Parameter	Signs looked for		Days
Clinical observations	- Erythema - Haematoma - Edema - Body weights - Food intake - Skin changes		0–63 At least ones daily
Haematology	- hemoglobin - packed cell volume - red blood cell count - reticulocytes - thrombocyte count - total white blood cell count - differential white blood cell count	- Prothrombin time - mean corpuscular volume - mean corpuscular hemoglobin - mean corpuscular hemoglobin concentration	1, 29, 57, 63, (77)
Clinical Chemistry	- alkaline phosphate activity - alanine aminotransferase activity - aspartate aminotransferase activity - gamma glutamyl transferase activity - total protein - albumin - ratio Albumin to Globulin - urea	- creatinine bilirubin - Cholesterol - triglycerides - phospholipids - calcium - sodium - potassium - chloride - inorganic phosphate	1, 29, 57, 63, (77)
Pathology	Isolation, macroscopy, organ weight		The day of necropsy (63 or 77)
Histopathology	- spleen - thymus - bone and bone marrow - muscle at the injection sites(hind legs) and untreated muscle (left fore leg) - draining popliteal lymph nodes - draining, inguinal lymph nodes - gross lesions		The day of necropsy (63 or 77)