Immunogenicity and safety of combined diphtheria tetanus whole cell pertussis hepatitis B/ Haemophilus influenzae type b vaccine in Indian infants.

OBJECTIVE: To evaluate the immunogenicity of the Hepatitis B and Haemophilus influenzae type b components and the overall safety and reactogenicity of the DTPw-HBV/Hib vaccine when given as primary vaccination to Indian infants. DESIGN AND METHODS: At 3 centers in India, 225 healthy infants (who had received HBV at birth) received three doses of DTPw-HBV/Hib vaccine at 6, 10 and 14 weeks of age. Serum anti-HBs and anti-PRP antibody levels were measured prior to vaccination and one month post dose 3. Solicited local and general symptoms reported during the 4-day follow-up period and unsolicited adverse event reported during the 30-day follow-up period after each dose were recorded. Serious adverse events were recorded throughout the study. RESULTS: A total of 219 subjects completed the study. 2.7% and 11.5% of all administered doses led to redness and swelling >20 mm, respectively; only 3.6% of doses were followed by severe pain (cried when limb was moved, spontaneously painful) within 4 days after vaccination. Fever exceeding 39.5C was recorded following only one dose in one subject. The percentage of doses followed by severe solicited general symptoms (symptoms that prevented normal activity) did not exceed 0.8%. Two SAEs were reported, neither of which were considered as related to vaccination. One month post-dose 3, all subjects had seroprotective antiPRP antibody concentrations (> or =0.15 microgram/mL) and 98.6% had concentrations > or =1 microgram/mL; 99% were seropositive for antiHBs (concentrations > or = 3 mIU/mL) and 99% were seroprotected (concentrations > or = 10 mIU/mL). CONCLUSION: The combination DTPw-HBV/Hib vaccine is immunogenic (for the antigens tested), safe and well tolerated in Indian infants.

Safety and reactogenicity of a low dose diphtheria tetanus acellular pertussis vaccine (Boostrix) in pre-school Indian children.

OBJECTIVE: To evaluate the safety and reactogenicity of a reduced-antigen-content combined Diphtheria Tetanus Acellular Pertussis (dTpa) vaccine in Indian preschool children. METHODS: GlaxoSmithKline Biologicals combination dTpa vaccine was administered as a single booster dose to 347 children aged 46 years in seven centers across India. All children were subsequently followed up for two weeks for safety and reactogenicity assessment. RESULTS: A total of 345 subjects completed the study and two subjects were lost to follow-up. One serious adverse event (head injury) unrelated to vaccination was reported. Otherwise, all subjects were in good health throughout the study period. Three subjects (0.9%) reported transient general symptoms (such as irritability and drowsiness), which prevented normal activity. Pain at injection site, swelling and redness was reported in 31.1%, 18.2% and 8.9% subjects respectively. Five subjects (1.4%) reported severe pain preventing normal movement. This resolved within 48 hours in all cases. There were no other severe local reactions including large injection site reactions. CONCLUSION: The reduced antigen content combined dTpa vaccine is safe and well tolerated in Indian pre-school children.

Angioplasty for chronic total coronary occlusions: safety and efficacy.

OBJECTIVE: To determine the short term results and safety of angioplasty in chronic coronary occlusions. METHODS: Eighty consecutive patients undergoing percutaneous transluminal coronary angioplasty (PTCA) for chronic coronary occlusions were prospectively analyzed for acute success rate and safety of the procedure. RESULTS: The mean age was 46.7 years (range 30-78 years). There were 72 males and eight females. Clinical presentation was recent myocardial infarction (MI) in four cases (5%), unstable angina in 20 (25%), chronic stable angina in 24 (30%) and past history of MI in 32 (40%) cases. Vessel distribution was left anterior descending artery (LAD) in 40 (50%), left circumflex artery (LCx) in 12 (15%) and right coronary artery (RCA) in 28 (35%) cases. Lesion length varied from 8 mm to 37 mm with a mean of 16.7 mm. Acute success rate was 70% (56/80). Twenty four cases (30%) had unsuccessful result due to failure to cross with wire (18 cases) or inability to cross with the balloon (six cases). One major complication in the form of type III coronary perforation was encountered which was successfully managed surgically. CONCLUSION: Percutaneous transluminal coronary angioplasty (PTCA) in chronic total occlusion has a reasonable success rate and very low complication rate.