Prevnar 13???? - Page 2

[nia82]

My nephew received Prevnar 13 as part of a trial in 2008 in Germany. The parents were fully aware of being part of a trial. Must be the end-phase as it is obviously not double-blind.

[mamakay]

Originally Posted by carriebft

the men c vaccine was licensed and used in the UK in november of 1999. what year was this trial? are we even sure it was an investigational vaccine when the UK was already using it at the time that this paper was written? hence it is written as "investigational group" not the vaccine itself is investigational. like i said, it was in use elsewhere already.

It was the CDC that described the meningococcal vaccine placebo as an "investigational vaccine".

[carriebft]

sorry i read that wrong, somehow i was reading the word group twice , as in the 'investigational group' was given the 'group c meningitis vaccine.' but i suppose i would have to ask the cdc why it was investigational when it was already been used around the world. investigational because it wasnt used in the USA maybe? maybe it was phase V when this was phase III? that still wouldn't make sense though with others using it...I have no idea. clinicaltrials and google scholar both pull up a bunch of pcv7 safety studies phase iii-V and post licensure, so there are other ones out there. I didn't go through them for placebo references though.

[mamakay]

Assuming it's the same meningococcal vax that was introduced in the UK in 1999...here's the trial the ACIP referenced:

http://www.fimp.org/wyeth/documenti/black1.pdf

We report the results of the Kaiser Permanente trial
evaluating the efficacy, safety and immunogenicity of
the heptavalent pneumococcal conjugate vaccine
(Wyeth; PNCRM7) conducted in Northern California
between October, 1995, and August, 1998, and the
posttrial blinded efficacy follow-up through April 20,
1999.

So the Prevnar safety trial started 4 years before the meningococcal vax was introduced in the UK.

[carriebft]

i dont know if there was a men c before the one in the UK, i just knew the UK date off the top of my head becuase I had been looking into men c vaccines after reading about the hib + men C combo that is being trialed at the moment for release here in the USA. a lot of the lit on Men c vaccine came from UK friends of mine, so that date stuck with me.

if the men c vaccine here was not tested before the trial with pcv 7, then that would seem very strange to me. but somehow i feel like i am not getting the whole picture...either there were other safety trials that were sufficient or the men C was considered safe through its trials. and I have no idea who you could even ask on that; i am not sure its something google degree can tell me, kwim?

[mamakay]

You could email the CDC?

[carriebft]

i'm almost curious enough to just see if they would take me seriously and answer me in a coherent and educated manner (instead of simply linking me pcv7/13 page). perhaps we should take bets?

5$ on pcv7 page!

I might try tomorrow though. I need to figure out how I want to word the question

[mamakay]

I bet you'll get a good answer. A long tme ago Peter Doshi wrote about his experience emailing/calling them about their flu mortality stats, and his question got sent to someone pretty high up who explained their thinking quite well.
I've known other people who emailed them, too, and none were blown off.

Why not just email them with the MMWR link, and the quote about the investigational vaccine, and ask why a a vaccine described as "investigational" was used as the placebo?

[LisaSedai]

I think I remember reading somewhere that the additional 6 types added to the vaccine were types common in Africa, not the US. Anyone know if there is any truth to that assertion? I will try to find where I read it and post a llink if possible.

[mommaof2boyz]

i hope your baby is better now...i am sure the fever was from the vaccine. i only gave my first son hep B and a couple polio shots and when i did more research in depth decided to do no more. my second baby is 15 months and i gave him no shots. doctors are such liars...you can't trust them...