U. Louisville Seeks 50 Infants to Test New Six in One Vaccine
Astounding! Are you ready to submit your infant to 6 vaccinations in one shot? It's a great way to trick parents into ignoring how many vaccines the pediatrician is giving their baby. I've already named the vaccine, "Hexahell." It's not the testing that is so jarring - every drug needs testing - it's the six in one sleigh of hand played by Merck, Sanofi and the AAP.
The University of Louisville Pediatric Clinical Trials Unit is recruiting about 50 infants for a study of a combination vaccine designed to protect kids against a half-dozen diseases.
The vaccine — developed by Merck and Sanofi Pasteur — is intended to help kids sidestep diphtheria, tetanus, whooping cough (pertussis), polio, invasive Haemophilus influenza type b disease and hepatitis B. Read more University of Louisville Seeks Test Subjects YOU CAN COMMENT ON THE ARTICLE AT THEIR SITE.
They might as well change now the definition of coincidence; to, the relationship of the shots the 50 infants will have received to the litany of encephalopathies, autoimmunities, syndromes and disorders that will follow.
Posted by: Shawn Siegel | June 01, 2011 at 06:45 AM
I think, actually, I HAVE to believe that this will backfire on them. It is a crime how many more children have to hurt before doctors start to ask questions. The real dirty trick is tying other shot/shots in with polio cause "everyone remembers how horrible polio was...." Sometimes I think that is the crux of unraveling their crap lies. That's the vaccine everyone hails. I will pray for the kids in this trial and pray for the parents who are never going to get a fair one after it. I think God everyday for what I know now, even if it means having to work to get my kids better. It could be so much worse if I were unaware!
Posted by: angie | May 31, 2011 at 06:20 PM
Would like to see the study and length of follow-up because if it is less than two years I doubt if the autism connection can be made - and the other auto-immune dysfunctions??? God help those kids.
Posted by: Page Kurtz | May 31, 2011 at 05:47 PM
Compare the messed up plan for the U.S. trial (link in my previous comment) with the european arm of the study being run by Sanofi: A head-to-head comparison of the new 6 in one (V419)vax compared to Infanrix when both are given at 2, 3, 4, 12 months along with Prevnar, RotaTeq, and ProQuad (at 12 mos). Equally awful, maybe moreso because of the ProQuad, but at least the study design is straightforward. Note too the more stringent exclusion criteria, and the listing of the researchers' actual names.
http://www.clinicaltrials.gov/ct2/show/NCT01341639?term=v419&rank=3
These are both phase III studies; there have been phase II studies on V419 going back to 2001 but no published results of any of them. I wonder why? Trade secrets or hiding AEs?
Posted by: Garbo | May 31, 2011 at 05:24 PM
According to Dr. Paul "Profit", infants can get 10,000 vaccines at one time (or was it 100,000?). Just waiting to see what that trial entails!
Posted by: Cody Jordan | May 31, 2011 at 05:19 PM
I can' believe that there will be parents volunteering to sacrifice their children for profits of pharma mafia, but homeless or very poor parent they may be coerced.
Posted by: veritas | May 31, 2011 at 05:16 PM
http://articles.timesofindia.indiatimes.com/2011-05-29/india/29596453_1_vaccine-deaths-aefi-deaths-public-sector-vaccine-units
"CHENNAI: More children in India are dying every year soon after being vaccinated, and the government has no clue why. Union health ministry statistics obtained under the Right to Information Act show that 128 children died in 2010 due to adverse effects after immunization (AEFI). That count has risen in the past three years, with 111 such deaths in 2008 and 116 in 2009.
AEFI is a general term that covers various reasons, including bad vaccine quality due to breaks in the cold chain, contamination and complications due to pre-existing conditions of the child. Coincidentally, AEFI deaths in 2008, when the government closed down all three public sector vaccine units and began buying from private suppliers, were three times the figure for 2007. TOI first reported in March this year that up to 2009, the toll was moving upwards. The 2010 figures confirm the trend....Experts feel the actual number could be even more than what government statistics show. "Many vaccine deaths reported in the media do not find a mention in the government statistics," says Dr Jacob M Puliyel, head of paediatrics at St Stephen's Hospital, Delhi. He says the government doesn't follow the Brighton Collaboration criteria on AEFI deaths adopted by WHO, under which the vaccine should be considered a "probable reason" for death if no other is established."
Posted by: Carol | May 31, 2011 at 04:26 PM
Here's the link at Clinical Trials.gov
http://www.clinicaltrials.gov/ct2/show/NCT01337167?spons=%22Merck%22&spons_ex=Y&state1=NA%3AUS%3AKY&age=0&phase=2&rank=2
Also in Pittsburgh. Giving 6 in one along with RotaTeq and Prevnar, so 8 antigens at 2, 4, 6 months, plus birth dose of HepB, plus more boosters at 15 months. "Control" group is Pentacel, Prevnar, RotaTeq at 2, 4, 6 months plus something called "modified process Hep B" at 2 and 6 months. Then different boosters at 15 months (ACTHIB instead of PedVaxHib).
Not only don't they have a true control group (no vax) for safety issues, they won't be able to determine which variable might have caused problems with safety or immunogenicity from one group to the next because there is more than one variable changed between groups, different HepB, different boosters, different primary vax.
Is it just me, or is this plain stupid and wrong? Who at NIH approved this GIGO?
Posted by: Garbo | May 31, 2011 at 03:47 PM
Has anybody been able to find out what the exclusion criteria are and the study parameters re: follow up period? I assume no preemies, no low birthweight, no family history of autoimmune diseases, etc. It would seem important to be very clear about exactly how far they will go to skew the results. Of course no true placebo group possible (saline/no vax); that would be immoral. Wouldn't it be awesome if a bunch of non-vaxing parents at those clinics demanded to be included?
Posted by: Garbo | May 31, 2011 at 03:17 PM
I had calculated that in order for a 200 lb adult to get the same mercury exposure per kg of bodyweight as my children got in the late 90's they would have to have been injected with 3,190 micrograms over 18 months. I think the testing should be done on the medical students that includes antigen and ingredient amounts increased proprotionally per kg of bodyweight of infants, then if that is passed the infant children and grandchildren of ACIP Committee members and vaccine manufacturers shoud be the first in line.
They need to "put their money where their mouths are".
Posted by: Tim Kasemodel | May 31, 2011 at 01:24 PM
So those parents who opt for an alternative schedule will be out of luck? Sorry, we only have the six in one. All or nothing. I can hardly wait for the 10 in one.
Anne Dachel
Media
Posted by: Anne McElroy Dachel | May 31, 2011 at 11:56 AM
As if Proquad wasn't bad enough.
Posted by: 4Bobby | May 31, 2011 at 09:28 AM
Where is the outrage that this is being tested on infants?
How are adverse events supposed to be reported? By the parents? Doesn't that make it just "anecdotal?"
Posted by: Becky | May 31, 2011 at 08:33 AM
Although I didn't realize it at the time, my child received 31 vaccines before he was 21 months old. These 31 included his first AND second MMR shots, as well a mercury containing flu shot.
I have a video of him at ~ 18 months, where he was a typically toddler. I have more video of him at 24 months, where his vaccine damage (.. .or autism as the doctor who administered those vaccines likes to call it ) was clearly evident.
In the 6 month period between those 2 videos, he had received 10 vaccines, including his second MMR at 21 months of age. He received 6 in a single doctors visit at 19 months, and 4 in a single doctors visit exactly 2 months later at 21 months. I'm not sure how his little body fought off the 21 vaccines before those 19 month shots, but something between 19 months and 24 months clearly pushed him past an internal tipping point.
I agree with a previous poster who suggested the first test subjects should be FULL GROWN adults, preferably starting with Dr. Offit and Dr. Nancy. But for Dr. Offit, I would recommend a little extra care and compassion. Just to make sure he's in tip top shape for the trial, I would enure that he got 100,000 of those safe mercury containing flu vaccines, administrated in single "well adult" visit, a day or two 2 before the trail got started.
Posted by: Barry | May 31, 2011 at 07:48 AM
I wonder if the researchers are aware of how not reassuring a study will be that compares getting this shot at 2, 4, and 6 months to getting "a more standard regimen?" Is this a sort of first--a "control group" that will probably be receiving HepB, DTaP, Hib, and Polio, possibly the flu shot also? Will both of the groups also have had HepB at birth? Will the follow-up last more than weeks and try to look for differences between groups that will then eventually receive MMR, or MMRV, or...? Are they figuring with this 6-in-1 they can't do worse (or at least not much) and maybe they will even find an astonishing "protective" effect against asthma, allergies, SIDS, autism and other LDs, ...?
"U of L will recruit most, if not all, of the healthy, 2-month-old participants from two clinics: the U of L Children & Youth Project and U of L Pediatrics-Broadway, Marshall said."
I wonder how aware the parents will be their infants are involved in a study, assuming parents are involved in care choices for these children?
https://louisville.edu/medschool/pediatrics/research/pctu
"The total number of newborns seen in these clinics approximates 120 per month, and the number of children assigned to these clinics is close to 20,000. The research staff have permanent offices in each clinic with direct access to patients, and subject recruitment and retention is excellent."
Posted by: JenB | May 31, 2011 at 03:27 AM
Gosh I wonder if this new vaccine will be as safe as the Australian Fluvax?
Posted by: Twyla | May 31, 2011 at 03:10 AM
Australia
What next - an octavalent??
Elizabeth - AussieMum
Posted by: AussieMum | May 30, 2011 at 11:39 PM
Gee, I wonder if my kids' old peditricians will be involved in this vaccine test too? After all they did so good with experimenting on their little (lab rats) I mean children for the chicken pox vaccine.
Posted by: Benedetta | May 30, 2011 at 10:38 PM
"Mamas don't let your babies grow up to be kid docs"
Posted by: Waylon & Willie fan | May 30, 2011 at 10:23 PM
Gross! I know too many kids who developed seizure disorders just after the hep b vaccine, alone!!
Posted by: Jen | May 30, 2011 at 10:13 PM
Will they ever, ever, stop ???
Do they ever, ever, ever, think "the mothers might begin to catch on" and politely say the hell with them ???
The first test subjects should be FULL GROWN adults. I would suggest Dr. Offit and Dr. Nancy on the Today show. What a great way to kick off a new vaccine...
I would suppose this means a new vaccine patent and exclusive rights and profits.
Can these children be tracked by someone other than Merck and friends ???
Posted by: cmo | May 30, 2011 at 09:47 PM
Why don't 40-50 of US sign up for this. Then when the day comes for us to show up, they will be disappointed to see not only no babies, but also a bunch of banners with: Dr Wakefield/Callous Disregard, Safe Minds, Generation Rescue, and Canaries, on them. We can give them our fav Blaxill/Holland/Kirby books and have Dr. Martha Herbert personally hand them the latest vaccine non-safety studies. How about that idea?
Posted by: AutismDad in PA | May 30, 2011 at 09:43 PM
When you read the article, you can see their premise -- they want to make sure that you don't have a choice to space out your child's vaccines. This just burns me up.
Posted by: Marie | May 30, 2011 at 09:30 PM
Test -- what does that mean? Test it to see if they survive? Because we know if the kids get a chronic illness (asthma, diabetes, autism, severe allegies, etc.) they will not conclude that it was from the vaccine. Will they go back and look at these kids when they are 4 or 5 years old to see how their health is? Wow, that's a dumb question. But I must admit -- nothing surprises me anymore.
Posted by: Marie | May 30, 2011 at 09:27 PM
Unconscionable. Yet another reason to boycott pediatricians. It's astoundingly clear they could care less about the health of the individual.
Posted by: Josh Day | May 30, 2011 at 09:03 PM