Can someone please tell me what the placebo is in this study?

[claddaghmom]

I went over this with DH and I feel like we are both dingalings. I can't for the life of me figure out what the placebo is in this study:

http://journals.lww.com/pidj/Fulltex...tivated.4.aspx

[carriebft]

The placebo was 0.25 mL sterile with 0.9% sodium chloride.

saline

[Marnica]

Just looking over that study. As far as saftey goes, to me this study is meaningless given that these babies were were given concomitant vaccines at the same visit as the the flu vax being studied here.
So at 2 months a baby is given not only the experimental flu vax, but 5 other vaccines. And then they report on adverse events that follow. How can they possibly know, if there is an adverse event reported, no matter how small (fever, malaise etc....) or how severe what vaccine may be causing that reaction. They can't.

[carriebft]

I think they were only given the experimental vaccine at the next visit though, b/c in the discussion of safety they talk about how there are more reactions to the first round with the other vaccines and much less the second with only the flu vaccine.

[Marnica]

Originally Posted by carriebft

I think they were only given the experimental vaccine at the next visit though, b/c in the discussion of safety they talk about how there are more reactions to the first round with the other vaccines and much less the second with only the flu vaccine.

But my point is is that at both the first and second study visit they may have been given more than just the TIV. At the second visit, they may have gotten their 2nd Hep b vaccine.

Vaccination with HepB and inactivated polio vaccine (IPV) (IPOL, sanofi pasteur) was permitted at study visits 1 or 2

as far as I can tell they do not give a breakdown of which participents received a lone TIV at the second visit and which had it done with a hep b vax. That would be useful info to know IMO

[claddaghmom]

There was a lot that bothered me about the study. But I have no idea how I overlooked the placebo ingredients lol. I thought I was going insane. I must have seen "vaccines" and skimmed over it.

[ema-adama]

At 2 months the babies received DtaP, Hib, PNC, IPV, HepB with the experimental vaccine or placebo.

At 3 months the babies received HepB and experimental vaccine or placebo.

Were both administrations randomised? As in some babies had only one dose, two doses or no doses due to random selection?

eta: I missed the fine print on HepB and IPV. Sorry

[JMJ]

The percentage of subjects who experienced at least 1 solicited systemic reaction within 3 days of TIV/placebo was 93.4% in the TIV and 92.7% in the placebo group

Is this saying that over 90% of kids have reactions to the regular vaccine schedule??? So if they're sure that 1 out of 869 kids had a serious reaction (that required immediate medical response - good thing it was only 20 minutes later) that they are sure was related to the vaccine, what happens when they vaccinate everybody? Does 1 out of every 869 kids in that age group get the flu AND need that kind of medical intervention? How can they say that this is safe and effective?

[Deborah]

So if they're sure that 1 out of 869 kids had a serious reaction (that required immediate medical response - good thing it was only 20 minutes later) that they are sure was related to the vaccine, what happens when they vaccinate everybody? Does 1 out of every 869 kids in that age group get the flu AND need that kind of medical intervention? How can they say that this is safe and effective?

It is the new "normal" I guess!