The PCV15/PCV20 Study
Research type
Research Study
Full title
Evaluation of higher valency pneumococcal vaccines (PCV15/PCV20) compared to PCV13 given in homologous schedules at 3 months and 12 months (“1+1” schedule) and 2 months, 4 months and 12 months ("2+1" schedule) in infants
IRAS ID
1009039
Contact name
Dominic Kelly
Contact email
Sponsor organisation
University of Oxford, Research Governance, Ethics & Assurance (RGEA) Team
ISRCTN Number
ISRCTN17673117
Research summary
Pneumonia, meningitis, and sepsis are serious, sometimes life-threatening illnesses. They are particularly dangerous in young children, with those under the age of two being at highest risk of severe complications. They are forms of pneumococcal disease, which is an infection caused by the pneumococcal bacteria.
Vaccines have been developed to protect children from pneumococcal infections. The pneumococcal conjugate vaccine (PCV) is commonly given to infants and young children. It provides immunity against some of the 90 existing types of the pneumococcal bacteria and significantly reduces the risk of severe infections.
In the UK, infants are currently given a vaccine – PCV13 – which protects against 13 types of the pneumococcus bacteria. PCV13 is given at 3 months and 12 months of age.
Two new approved vaccines, PCV15 and the PCV20 which respectively cover 15 and 20 types of the bacteria, will be studied for their immune response in UK babies when given at 3 and 12 months of age compared to the PCV13 vaccine. This will find out if these new vaccines are as effective, with a wider range of protection, as the currently used PCV13 vaccine. In addition, the immune response after three doses of PCV20 at 2, 4 and 12 months of age will also be studied.
Participants will be enrolled in the study at the age of 2 months. They will be allocated randomly into one of four groups and vaccinated with the PCV vaccine that is assigned to each group. Three groups will receive 2 PCV vaccines at 3 months and 12 months of age. One group will receive 3 PCV vaccines at 2, 4 and 12 months of age. Blood samples will be taken after vaccination (a maximum of 4 ml and 6 ml per sample), to assess immune responses to the study vaccines. Nasal samples will be collected at the first PCV vaccination and a month after each vaccine.
During the study, the children will also receive all other routine immunisations up to the age of 12 months, as per the UK immunisation programme.REC name
South Central - Hampshire A Research Ethics Committee
REC reference
24/SC/0222
Date of REC Opinion
6 Aug 2024
REC opinion
Further Information Favourable Opinion