U.S. CitiesCity-Data Forum Index
Go Back   City-Data Forum > General Forums > Health and Wellness
 [Register]
Please register to participate in our discussions with 2 million other members - it's free and quick! Some forums can only be seen by registered members. After you create your account, you'll be able to customize options and access all our 15,000 new posts/day with fewer ads.
View detailed profile (Advanced) or search
site with Google Custom Search

Search Forums  (Advanced)
Closed Thread Start New Thread
 
Old 01-13-2019, 03:08 PM
 
8,261 posts, read 5,673,662 times
Reputation: 15361

Advertisements

Promising trials so far

http://www.medicaleconomics.com/infl...enior-patients

 
Old 01-13-2019, 03:13 PM
 
626 posts, read 163,737 times
Reputation: 1140
No thanks. They can keep it.
 
Old 01-13-2019, 03:19 PM
 
Location: Southern California
20,594 posts, read 6,861,207 times
Reputation: 13874
I thought the current shots are just fine for those who indulge.
 
Old 01-13-2019, 03:37 PM
 
5,179 posts, read 1,706,362 times
Reputation: 8287
How many people will be in the control group so they can compare people who get the investigational drug to people who do not?
 
Old 01-13-2019, 04:01 PM
 
Location: Georgia, USA
21,947 posts, read 26,792,257 times
Reputation: 27313
Quote:
Originally Posted by newtovenice View Post
How many people will be in the control group so they can compare people who get the investigational drug to people who do not?
The first study:

https://www.clinicaltrials.gov/ct2/s...nanoflu&rank=1

"This is a Phase 1/2, randomized, observer-blinded, active-controlled trial. Approximately 330 eligible subjects will be enrolled and randomized into 1 of 3 treatment groups as shown in the Trial Design table below. Each group will consist of approximately 110 subjects total, stratified by age, gender, and history of receipt of 2016 - 17 influenza vaccine. On Day 0, subjects in Groups A and B will be administered an IM injection of NanoFlu at one of two dose levels; subjects in Group C will receive the preconfigured comparator (Fluzone HD) at the manufacturer's recommended dose and volume. On Day 21, all Group A and B subjects will be administered a rescue injection with a licensed seasonal influenza vaccine, while all Group C subjects will be administered an injection with sterile saline placebo to maintain trial blind. Trial follow-up for each subject will span approximately 1 year from the Day 0."

There were two doses being evaluated. The comparison group got the standard flu vaccine followed by a saline shot. The two dose groups for the new vaccine were given a standard vaccine three weeks after the investigational vaccine.

The study was designed to assess safety and immunogenicity, not efficacy.

The study reported in the OP will test versions with and without adjuvant.

Last edited by suzy_q2010; 01-13-2019 at 04:13 PM..
 
Old 01-13-2019, 04:06 PM
 
5,179 posts, read 1,706,362 times
Reputation: 8287
Quote:
Originally Posted by suzy_q2010 View Post
The new vaccine was compared to the standard vaccine to test for how well it stimulated antibody production. It is at a point in development when safety and immunogenicity are being determined.

https://www.nejm.org/doi/full/10.1056/NEJMc1803554
Right.

When will a control group be involved so we can see how well it works when compared to a placebo, like other drugs?

That way anyone can have that info of to get it or not to get it and know how well it will work. It'd be great to know how many people get the flu in each group.
 
Old 01-13-2019, 04:14 PM
 
Location: Georgia, USA
21,947 posts, read 26,792,257 times
Reputation: 27313
Quote:
Originally Posted by jaminhealth View Post
I thought the current shots are just fine for those who indulge.
Current flu vaccines vary in effectiveness for reasons that I suspect you already know. That is why we need better flu vaccines.
 
Old 01-13-2019, 04:21 PM
 
Location: Central IL
14,015 posts, read 7,602,428 times
Reputation: 32707
Quote:
Originally Posted by newtovenice View Post
Right.

When will a control group be involved so we can see how well it works when compared to a placebo, like other drugs?

That way anyone can have that info of to get it or not to get it and know how well it will work. It'd be great to know how many people get the flu in each group.
Nothing is proven in a single trial - safety is tested FIRST, later trials get at efficacy. Would you rather the safety trials be skipped?
 
Old 01-13-2019, 04:25 PM
 
Location: Georgia, USA
21,947 posts, read 26,792,257 times
Reputation: 27313
Quote:
Originally Posted by newtovenice View Post
Right.

When will a control group be involved so we can see how well it works when compared to a placebo, like other drugs?

That way anyone can have that info of to get it or not to get it and know how well it will work. It'd be great to know how many people get the flu in each group.
Because new drugs are not compared to placebo when there is a comparable drug already in use. A new flu vaccine is tested against an existing flu vaccine, just as a new medication for hypertension is not tested against a placebo or a new antibiotic tested against a placebo or a new cancer chemotherapy drug tested against a placebo.

A new treatment is tested against the best existing treatment.

Efficacy studies come after the safety and immunogenicity studies are completed. That is a Phase 3 study and will probably start later this year.
 
Old 01-13-2019, 04:26 PM
 
5,179 posts, read 1,706,362 times
Reputation: 8287
Quote:
Originally Posted by suzy_q2010 View Post
The first study:

https://www.clinicaltrials.gov/ct2/s...nanoflu&rank=1

"This is a Phase 1/2, randomized, observer-blinded, active-controlled trial. Approximately 330 eligible subjects will be enrolled and randomized into 1 of 3 treatment groups as shown in the Trial Design table below. Each group will consist of approximately 110 subjects total, stratified by age, gender, and history of receipt of 2016 - 17 influenza vaccine. On Day 0, subjects in Groups A and B will be administered an IM injection of NanoFlu at one of two dose levels; subjects in Group C will receive the preconfigured comparator (Fluzone HD) at the manufacturer's recommended dose and volume. On Day 21, all Group A and B subjects will be administered a rescue injection with a licensed seasonal influenza vaccine, while all Group C subjects will be administered an injection with sterile saline placebo to maintain trial blind. Trial follow-up for each subject will span approximately 1 year from the Day 0."

There were two doses being evaluated. The comparison group got the standard flu vaccine followed by a saline shot. The two dose groups for the new vaccine were given a standard vaccine three weeks after the investigational vaccine.

The study was designed to assess safety and immunogenicity, not efficacy.

The study reported in the OP will test versions with and without adjuvant.
Moderator cut: removed rude remark There is NO strictly placebo group.

All groups are getting some form of drug. Just depends on what group you are in which drug and dose you get.

So again: Where is the control group that gets NOTHING? You know, like all other drug trials. Show me the saline + saline group.

I can wait.

Last edited by in_newengland; Today at 05:33 AM..
Please register to post and access all features of our very popular forum. It is free and quick. Over $68,000 in prizes has already been given out to active posters on our forum. Additional giveaways are planned.

Detailed information about all U.S. cities, counties, and zip codes on our site: City-data.com.


Closed Thread


Over $104,000 in prizes was already given out to active posters on our forum and additional giveaways are planned!

Go Back   City-Data Forum > General Forums > Health and Wellness
Follow City-Data.com founder on our Forum or

All times are GMT -6.

2005-2019, Advameg, Inc.

City-Data.com - Archive 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35 - Top