Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Infants and Toddlers when Administered Using a 1+1 Schedule in a National Immunization Schedule Having a Meningococcal Group B Vaccine as Standard of Care.
This study has now closed to recruitment and we are completing our follow-up visits.
Aim of the study:
The MenACYW vaccine is being developed to try to protect people of all ages against meningococcal disease caused by four common groups of these germs A, C, W, and Y. It has been tested in more than 5,700 people – babies, children, adolescents, adults, and the elderly – and found to be safe and protective against meningococcal disease. The aim of the study is to show whether the immune response to the MenACYW vaccine is as strong as needed to protect against meningococcal disease when it is given alongside the childhood vaccines given routinely in the United Kingdom (UK).
Inclusion and exclusion criteria:
Inclusion Criteria
- Aged ≥ 56 to ≤ 89 days on the day of the first study visit
- Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg (or 5 lb and 8 oz)
- Informed consent form has been signed and dated by the parent(s) or other legally acceptable representative (and by an independent witness if required by local regulations)
- Subject and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures
Exclusion Criteria
- Participation at the time of study enrolment (or in the 4 weeks preceding the first trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
- Receipt of any vaccine in the 4 weeks preceding the first trial vaccination (at Visit 1) or planned receipt of any vaccine in the 4 weeks before and/or following any trial vaccination except for influenza vaccination, which may be received at a gap of at least 2 weeks before or 2 weeks after any study vaccines. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines.
- Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine (i.e., mono- or polyvalent, polysaccharide, or conjugate meningococcal vaccine containing serogroups A, C, W, or Y; or meningococcal B serogroup-containing vaccine)
- Previous vaccination (before Visit 1) with any pneumococcal, diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b (Hib), poliovirus, and/or rotavirus vaccines. Receipt of BCG vaccine at birth is acceptable.
- Receipt of immune globulins, blood or blood-derived since birth
- Known or suspected congenital or acquired immunodeficiency, including Severe Combined Immunodeficiency disorder (SCID); or receipt of immunosuppressive therapy, such as anti- cancer chemotherapy or radiation therapy; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks) since birth
- History of any neurologic disorders, including any seizures and progressive neurologic disorders or encephalopathy
- History of Neisseria meningitidis infection, confirmed either clinically, serologically, or microbiologically
- History of diphtheria, tetanus, pertussis, poliomyelitis, Hib, hepatitis B, Streptococcus pneumoniae, and/or rotavirus infection or disease
- At high risk for meningococcal infection during the trial (specifically, but not limited to, subjects with persistent complement deficiency, with anatomic or functional asplenia, or subjects travelling to countries with high endemic or epidemic disease)
- History of Guillain-Barré syndrome
- Known systemic hypersensitivity to any of the vaccine components, or history of a life- threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances including neomycin, kanamycin, polymyxin, formaldehyde, and latexa
- Hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase- isomaltase insufficiency
- History of intussusception or uncorrected congenital malformation of the gastrointestinal tract that would predispose to intussusception
- Verbal report of thrombocytopenia, contraindicating intramuscular vaccination in the investigator’s opinion
- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination
- Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completionb
- Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives, including planning to leave the area of the study site before the end of the study
- Moderate or severe acute illness/infection (according to investigator judgment), or febrile illness (temperature ≥ 38.0°C), or diarrhea or vomiting on the day of vaccination.
What participating in the study involves: All babies taking part in the study will have 5 study visits over about one year and will receive all the childhood vaccines normally given to other children in the UK. All babies will receive MenB vaccine, but the timing of the third dose will vary depending on which group they are allocated to (12 or 13 months of age). Four in every five babies (80%) will also receive two doses of the new MenACYW vaccine at 3 and 12 months of age as part of the study. The other 20% of babies will be offered a single dose of a licensed MenACYW vaccine (Nimenrix) to provide protection against meningococcal infection as a benefit for participation in this trial. This (optional) vaccination will be provided at the end of the study, free of charge. Over the course of the study we would like to take up to 3 blood samples to assess the immune response to the vaccines. We would use a local anaesthetic cream or spray on the skin whenever possible to reduce any discomfort from the blood sampling. We would also ask that participants keep a diary card to record daily temperatures and any reactions, such as redness or swelling at the injection site for a week after each vaccination, and any other illnesses or problems that occur between visits. A member of the research team will give the vaccinations at home at a time convenient to our participants.
Results (if applicable) – Results will be published here: