Allow newborn to be in vaccine trial?

[MummaBear4321]

I have a 5 week old DD. I got a letter through the door today asking if she would participate in a vaccine trial testing a new type of meningitis vaccine along with her routine vaccines between now and 12 months.

I am very much not anti vax. She will be getting all her routine vaccines as did her sister. However, the thought of testing something on my newborn makes me nervous. I do understand that the only reason my DD has access to amazing vaccines against polio, meningitis and measles is because it was tested on babies before her, but I cant help but think "what if she has a horrendous reaction and she could die". Then the logical part of me says "they wouldnt get to the testing stage without being sure it wouldnt kill them or cause major damage ..... right?".

What would you do? Let her be part of the trial or be an overly cautious and protective mother and say no? I am genuinely torn.

I think I'd do it because I'd forever regret turning it down if she later contracted that type of meningitis. But the argument works perfectly well the other way, too.

Is it a legitimate trial? I say this because I work in clinical trials and I can't imagine 'putting a letter through someone's door' as a means of recruiting participants. Unless you mean it came in the post? Normally, we would go through the clinical service involved in the trial, so it would possibly come in a letter from your GP or the GP would supply the contact details and we would send a letter in the post. A letter through the door sounds a bit odd to me.

That said, clinical trials in development stage, that is in really early safe trials, typically don't take place on children for ethical reasons. So it's possible that it's a legitimate trial, but it would be a fairly well developed vaccine if they are seeking infants as participants, because that is really difficult to get approval for. Have they provided you with a website to find out more or a participant information sheet with details of the study and the vaccine? I would start there to understand what they are doing and what stage of testing they are at.

I would speak to your gp and ask what they know about it. Then speak to the people running the trial.

What did the letter say? I was approached about a clinical trial when my Dad was poorly, but the Dr involved spoke to me directly. A letter is a bit random, you would expect to be contacted by a clinician initially. Trials in children are VERY hard to get approved.

I would look into it but my initial response would be yes as long as I was sure all was above board

DD was in part of a vaccine pilot scheme for meningitis when she was 16. Can't recall exactly what it was but I jumped at the chance that she could be better protected and she had it with no ill effects.

I'd find out more about it but assuming you're reassured then I'd go for it - anything to minimise a serious illness is a no-brainer in my book.

I'd find out more about it first. What makes this new? Is it testing one that is stored differently or made differently, different composition etc.

@ScatteredMama82

What did the letter say? I was approached about a clinical trial when my Dad was poorly, but the Dr involved spoke to me directly. A letter is a bit random, you would expect to be contacted by a clinician initially. Trials in children are VERY hard to get approved.

I don’t think a letter is that random. I got a letter a few months back from the children’s hospital DS is treated at about him taking part in a trial. I have since spoken to and emailed the team involved but initial contact was via letter

It was in the post with my daughters name. It has proper NHS headed paper and said they have contacted me based on my daughters date of birth and got my contact details from my gp as I opted to share my details with other nhs services. It seems very legit. It says if I dont want to do it I just have to ignore the letter. If I want more information I just send a slip back and someone will call me.

It says it's a trial for a 4 in 1 meningitis vaccine called MenACYW

My daughter was in drugs trials for a new/revised diptheria and/or polio vaccine some years ago. It went on for some years and was exceptionally well carried out. Some lovely nurses came to the house and she really loved being made a fuss of. It always felt very safe and follow up was great. I never had a moment's concern.

My father was a polio victim and I have always felt it's important to help improve vaccines.

I would do it, because I'm interested in trials, find the process fascinating, and it matters to me to support science and medicine in this way. I was part of a trial of screening for preeclampsia risk, and then of low-dose aspirin to prevent preeclampsia, in my first pregnancy and I really enjoyed it and feel proud that I influenced, in my own tiny way, best practice for protecting mothers and babies.

If you just don't feel comfortable, decline. You're under no obligation. If you even think you might be interested though, why not have the callback and get your questions answered.