Active not recruitingPHASE1, PHASE2INTERVENTIONAL

Safety and Immunogenicity of an Investigational Pentavalent Meningococcal ABCYW Vaccine Against Meningococcal Disease in Children, Toddlers, and Infants

This study is looking at a new vaccine called Pentavalent Meningococcal ABCYW. It aims to protect children under 10 against meningococcal disease, a serious infection. This is the first time Sanofi, the company making it, is testing this vaccine in this age group. The researchers will compare two versions of the new vaccine to already approved meningococcal vaccines. They will check if it's safe and if it helps the body build protection. It will be given to children on its own and also to toddlers and babies alongside their usual vaccinations. Participants will be involved in the study for up to 12 or 19 months, depending on their age group.

At a glance

Status

Active not recruiting

Phase

PHASE1, PHASE2

Sponsor

Sanofi Pasteur, a Sanofi Company

Enrolment target

750

Start

05 Nov 2024

Estimated completion

17 May 2027

Meningococcal Immunization Healthy Volunteers

What is this study about?

This study is about a new vaccine designed to protect against meningococcal disease. Meningococcal disease is a serious illness caused by bacteria, and it can lead to conditions like meningitis (swelling around the brain and spinal cord) or blood poisoning (sepsis). Vaccines are a really important way to prevent these serious infections.

The new vaccine being tested is called the Pentavalent Meningococcal ABCYW vaccine. "Pentavalent" means it's designed to protect against five different types of meningococcal bacteria (A, B, C, Y, and W). This study is a very important step because it's the first time this particular vaccine is being tested in children under 10 years old. The main goals are to make sure the vaccine is safe and that it encourages the body to produce protective antibodies, which is how vaccines work.

Researchers will be looking at two slightly different forms of this new vaccine. They will compare these new vaccines to meningococcal vaccines that are already approved and widely used. This helps them understand how well the new vaccine works. They're testing it in three different age groups: older children, toddlers, and babies. For toddlers and babies, they'll also see how the new vaccine works when given at the same time as their routine childhood immunisations, like those for diphtheria, tetanus, polio, and measles. This helps ensure that the new vaccine can fit easily into existing vaccination plans.

Key takeaways

This study is testing a new 5-in-1 vaccine against meningococcal disease in children under 10.
It's a 'Phase 1/2' study, meaning scientists are checking safety and how well the body responds.
The new vaccine is being compared to existing meningococcal vaccines and sometimes given with other routine childhood shots.
Participation involves regular clinic visits for vaccinations, health checks, and blood tests.
The total time commitment varies from up to 12 months for older children to up to 19 months for babies.
Your child's health will be closely monitored throughout the study.

Who may be eligible?

To join this study, children need to be healthy overall. There are different age groups: children aged 2 to 9 years, toddlers aged 12 to 15 months, and very young babies aged 56 to 89 days (about 2 to 3 months old).

For babies and toddlers, they must have been born around their due date (at least 37 weeks) and weigh at least 2.5 kg, or if born a bit early (28 to 36 weeks), they need to weigh at least 1.5 kg. Most importantly, the doctor needs to confirm they are medically stable, meaning they don't have any ongoing serious health issues.

Some things would mean someone can't join the study. These include having a known problem with their immune system, having had certain types of strong medicines like chemotherapy, or having had meningitis before. Also, if a child is at high risk of getting meningococcal infection during the study, has severe allergies to vaccine ingredients, or has a history of specific rare conditions like Guillain-Barré syndrome or (for babies) a bowel problem called intussusception, they won't be able to take part. Children who have already been vaccinated against meningococcal disease (types A, B, C, W, or Y) are also not eligible.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Is my child between 2 and 9 years old, or 12-15 months old, or 2 to 3 months old?
Is my child generally healthy with no serious ongoing medical conditions?
Has my child NOT had any known problems with their immune system?
Has my child never had meningitis?
Has my child NOT already received any meningococcal vaccines (A, B, C, W, or Y)?
For babies/toddlers: Was my child born at full term or close to it, and stable since birth?

Answer every question to see your result.

What does participation involve?

If you decide to take part, your child will be involved in the study for different lengths of time depending on their age group. Children and toddlers will be in the study for up to 12 months, while babies will be followed for a bit longer, between 16 and 19 months. During this time, your child will receive the study vaccines and potentially some routine childhood vaccines, depending on their age group and the study plan.

The study involves several visits to the clinic for vaccinations, blood tests (to check how the vaccine is working and for safety), and general health checks by the study doctor or nurse. You'll likely be asked to keep a record of any side effects your child experiences after vaccination. The healthcare team will tell you exactly how many visits are needed and what will happen at each one.

Potential risks and benefits

Taking part in a clinical trial like this may offer some benefits. Your child would receive study vaccines that could protect them against meningococcal disease. You would also receive close medical attention and monitoring throughout the study. However, there's no guarantee the new vaccine will ultimately be approved or work better than existing vaccines. Like all medicines and vaccines, the study vaccines can have side effects. These are usually mild, such as soreness, redness, or swelling where the injection was given, or a mild fever. More serious reactions are rare, but possible, and the study team will monitor your child closely. You have the right to withdraw your child from the study at any time, for any reason, without it affecting your child's future medical care.

Locations (39)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Hospital das Clínicas da Universidade Federal de Minas Gerais- Site Number : 0760001
Verified postcode
Belo Horizonte, Brazil
Private Practice - Dr. Nelson Rosário- Site Number : 0760004
Verified postcode
Curitiba, Brazil
Investigational Site Number : 2030003
Verified postcode
Jindřichův Hradec, Czechia
Investigational Site Number : 2030004
Verified postcode
Ostrava, Czechia
Investigational Site Number : 2030007
Verified postcode
Pilsen, Czechia
Investigational Site Number : 2030008
Verified postcode
Prague, Czechia
Investigational Site Number : 2030009
Verified postcode
Prague, Czechia
Investigational Site Number : 2080002
Verified postcode
Hvidovre, Denmark
Investigational Site Number : 2080003
Verified postcode
Odense, Denmark
Investigational Site Number : 2460006
Verified postcode
Espoo, Finland
Investigational Site Number : 2460001
Verified postcode
Helsinki, Finland
Investigational Site Number : 2460008
Verified postcode
Helsinki, Finland

Common questions

What is meningococcal disease?

It's a serious bacterial infection that can cause meningitis (infection of the brain and spinal cord lining) or blood poisoning. It can be life-threatening.

Is this vaccine already available?

No, this specific Pentavalent vaccine is still being tested in a study. It's not yet approved for general use.

Will my child get other vaccines too?

Yes, for babies and toddlers, the study vaccine may be given alongside their usual childhood vaccinations, like those for diphtheria, tetanus, and polio.

How long does the study last for each child?

It depends on the age group. It could be up to 12 months for children and toddlers, or up to 19 months for babies.

What happens if I change my mind?

You can withdraw your child from the study at any time, for any reason, without it affecting their medical care.