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Japan - Early report H5N1 vaccine clinical study

erick127

New member
First post here....Hope its OK. This topic interests me.

I noticed this report (with embedded TV clip) which is only in Japanese (I could not find an english language report yet). In 2008 the Japan ministry of health decided to carry out a ~6000 subject clinical study with its new H5N1 pre-pandemic vaccines that had recently been approved. I had someone help me translate this report, but I believe it says that of 5561 subjects inoculated, 3676 (66.1%) reported significant local (arm) pain; 120 people (2.2%) reported fevers; and 5 people (0.1%) were hospitalized (presumably for high fever). The study was designed to be 2 injections (as most pandemic vaccines are). But 292 people in this study refused the second inoculation.

I believe that this would be the largest single H5N1 human study ever carried out (correct?). Interesting to see what else comes from this.


http://www.fnn-news.com/news/headlines/articles/CONN00147839.html

1-20-2009 インフルエンザの「プレパンデミックワクチン」接種受けた人の2.2%が発熱訴え
新型インフルエンザの発生が懸念される中、「プレパンデミックワクチン」の安全性を確認している厚生労働省は、接種を受けた人の2.2%が発熱を訴えたことを明らかにした。
ワクチンの接種は2回行われ、1回目の接種を受けた5,561人のうち、66.1%にあたる3,676人が腕の痛みなどを、2.2%にあたる120人が37.5度以上の発熱を訴え、0.1%にあたる5人が入院したという。
また、1回目の接種を受けた人のうち292人は、2回目のワクチン接種を拒否したという。
厚労省の研究班は「痛みや発熱については、因果関係がある。今後も、安全性について追加調査を行う」としている。
 
Re: Japan - Early report H5N1 vaccine clinical study

First post here....Hope its OK. This topic interests me.

I noticed this report (with embedded TV clip) which is only in Japanese (I could not find an english language report yet). In 2008 the Japan ministry of health decided to carry out a ~6000 subject clinical study with its new H5N1 pre-pandemic vaccines that had recently been approved. I had someone help me translate this report, but I believe it says that of 5561 subjects inoculated, 3676 (66.1%) reported significant local (arm) pain; 120 people (2.2%) reported fevers; and 5 people (0.1%) were hospitalized (presumably for high fever). The study was designed to be 2 injections (as most pandemic vaccines are). But 292 people in this study refused the second inoculation.

I believe that this would be the largest single H5N1 human study ever carried out (correct?). Interesting to see what else comes from this.


http://www.fnn-news.com/news/headlines/articles/CONN00147839.html

1-20-2009 インフルエンザの「プレパンデミックワクチン」接種受けた人の2.2%が発熱訴え
新型インフルエンザの発生が懸念される中、「プレパンデミックワクチン」の安全性を確認している厚生労働省は、接種を受けた人の2.2%が発熱を訴えたことを明らかにした。
ワクチンの接種は2回行われ、1回目の接種を受けた5,561人のうち、66.1%にあたる3,676人が腕の痛みなどを、2.2%にあたる120人が37.5度以上の発熱を訴え、0.1%にあたる5人が入院したという。
また、1回目の接種を受けた人のうち292人は、2回目のワクチン接種を拒否したという。
厚労省の研究班は「痛みや発熱については、因果関係がある。今後も、安全性について追加調査を行う」としている。
Here are 87 clinical trials

http://clinicaltrials.gov/ct2/results?term=h5n1
 
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