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author:("phade, MA")
1.  A comparative clinical study to assess safety and reactogenicity of a DTwP-HepB+Hib vaccine 
Hepatitis B and Haemophilus influenzae type b (Hib) infections are major public health problems in developing countries, including India. Hence, combination vaccines containing DTwP, recombinant hepatitis B and Hib conjugate vaccines have been developed. Here, we report a Phase IV study which assessed safety and reactogenicity of a new DTwP-HepB+Hib vaccine. Three doses of DTwP-HepB+Hib vaccine (Pentavac, Serum Institute of India Ltd) or Tritanrix-HB+Hib (GlaxoSmithKline Beecham) were administered to infants at 6, 10 and 14 weeks of age in 2:1 ratio. The subjects were followed till one month after the third dose for safety assessment. Adverse events were captured in structured diaries and physical examinations were performed on each visit. The study was conducted in 1510 infants. Both vaccines caused injection site local and systemic reactions and the incidence was similar in both the groups. The incidence of local solicited reactions was: tenderness 35.9 %–33.6 %; redness 18.1 %–17.2 %; swelling 23.7 %–22.4 %; induration 12.8 % –13.7 %. The percentage of systemic solicited reactions were: diarrhea 2.2 %–2.2 %; drowsiness 3.3 %–3.4 %; fever 14.0 %–11.2 %; irritability 28.1 %–25.4 %; loss of appetite 6.6 %–5.6 %; persistent crying 17.7 %–15.7 %; vomiting 3.5 %–3.0 %. No serious adverse event was caused by the vaccines. The new DTwP-HepB+Hib combination vaccine showed similar safety profile to that of an imported vaccine in Indian infants.
doi:10.1080/21645515.2015.1010953
PMCID: PMC4514211  PMID: 25933183
DTwP-HepB+Hib vaccine; infants; reactogenicity; safety
2.  Optimizing the HIV/AIDS informed consent process in India 
BMC Medicine  2004;2:28.
Background
While the basic ethical issues regarding consent may be universal to all countries, the consent procedures required by international review boards which include detailed scientific and legal information, may not be optimal when administered within certain populations. The time and the technicalities of the process itself intimidate individuals in societies where literacy and awareness about medical and legal rights is low.
Methods
In this study, we examined pregnant women's understanding of group education and counseling (GEC) about HIV/AIDS provided within an antenatal clinic in Maharashtra, India. We then enhanced the GEC process with the use of culturally appropriate visual aids and assessed the subsequent changes in women's understanding of informed consent issues.
Results
We found the use of visual aids during group counseling sessions increased women's overall understanding of key issues regarding informed consent from 38% to 72%. Moreover, if these same visuals were reinforced during individual counseling, improvements in women's overall comprehension rose to 96%.
Conclusions
This study demonstrates that complex constructs such as informed consent can be conveyed in populations with little education and within busy government hospital settings, and that the standard model may not be sufficient to ensure true informed consent.
doi:10.1186/1741-7015-2-28
PMCID: PMC509426  PMID: 15287983

Results 1-2 (2)