The PCV15/pcv20 StudY - London
Help prevent pneumococcal disease in children
Would you like to participate in a study which will help to guide decisions about the future UK immunisation schedule?
St. George's University Hospitals NHS Foundation Trust and St. George’s Vaccine Institute (SGVI) are inviting healthy children, who are aged 8-10 weeks who have NOT yet received their first vaccinations, to take part in this research study.
Pneumonia, meningitis, and sepsis are serious (sometimes life-threatening) illnesses. They are particularly dangerous in young children, with babies under the age of two having highest risk of developing severe complications. They are all forms of pneumococcal disease, which is an infection caused by the bacteria Streptococcus pneumoniae, more commonly referred to as pneumococcal bacteria.
The routine vaccine used currently in babies is PCV13 (Pneumococcal Conjugate Vaccine) that protects against 13 different types of pneumococcal bacteria and has proven effectiveness.
However, there are over 90 different types of pneumococcal bacteria and we have seen an increase in disease caused by types not currently covered by the PCV13 vaccine.
We want to find out if the vaccines in the study (PCV15 and PCV20) can protect against more cases of serious disease in children and the adult population, than the existing vaccine PCV13.
Children participating in the study will receive two doses of either PCV15, PCV20, or PCV13, or three doses of PCV20, as well as all their routine vaccines.
Children receiving two doses of either PCV15, PCV20, or PCV13 will have five study visits, at ages 2, 3, 4, 12 and 13 months over a period of 11 months.
Children receiving three doses of PCV20 will have six study visits at ages 2, 3, 4, 5, 12 and 13 months over a period of 11 months.
Children will receive immunisations in their own home/at the trial site for all the visits till 12 months of age.
Children receiving two doses of either PCV15, PCV20, or PCV13 will have two blood samples taken at ages 4 months and 13 months. Children receiving three doses of PCV20 will have two blood samples taken at ages 5 months and 13 months.
Before you decide whether your child should take part, it is important for you to understand exactly what the study is about and what participation would involve. Participation in the study is voluntary; if enrolled, your child may withdraw at any time. If you are interested in this study, the full Participant Information Sheet is available below.
If you have read the Participant Information Sheet and are interested in participating, please answer the questions below to see if your child is eligible to take part.
If you would like to discuss any aspect of the study, please contact us by email or phone:
Email: PCV15-PCV20study@sgul.ac.uk
Telephone: 020 8725 2316
This study site is at the St George’s Clinical Research Facility and is recruiting from the London area.
For other study site locations, please see the main study webpage