Evaluation of higher valency pneumococcal vaccines (PCV15/PCV20) compared to PCV13 given in homologous schedules at 3/4 months and 12 months (“1+1” schedule) and 2 months, 4 months and 12 months (“2+1” schedule) in infants
Pneumococcal disease
Current interventions as of 30/06/2025: Arm 1: Two doses of PCV15; first dose when the infant is 3 months of age, second dose when the infant is 12 months of age Arm 1r4: Two doses of PCV15; first dose when the infant is 4 months of age, second dose when the infant is 12 months of age Arm 2: Two doses of PCV20; first dose when the infant is 3 months of age, second dose when the infant is 12 months of age Arm 2r4: Two doses of PCV20; first dose when the infant is 4 months of age, second dose when the infant is 12 months of age Arm 3: Three doses of PCV20; first dose when the infant is 2 months of age, second dose when the infant is 4 months of age and third dose when the infant is 12 months of age Arm 4: Two doses of PCV13; first dose when the infant is 3 months of age, second dose when the infant is 12 months of age Arm 4r4: Two doses of PCV13; first dose when the infant is 4 months of age, second dose when the infant is 12 months of age Participants will be randomized to a 1:1:1:1: ratio before their first vaccination visit into four arms to receive the PCV vaccine. Participants randomised to Arms 1, 2 and 4 will be further randomised 1:1 to receive their first dose of PCV13 or PCV15 or PCV20 at 3 months (arm 1, 2 or 4) or at 4 months (arm 1r4, 2r4 or 4r4). Computer-generated randomisation lists will be prepared using stratified block randomisation. Random block sizes of 2 or 4 will be used. The randomisation list will be loaded to a central randomisation system and each site user will have a unique log-in to access their corresponding randomisation list. Six groups (1, 1r4, 2, 2r4, 4 and 4r4) will receive two PCV vaccines at 3 or 4 months and 12 months of age. One group (3) will receive three 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.
1. Infants due to receive their primary immunizations, aged up to 2 months (+ 2 weeks) at first vaccinations 2. Infants born at ≥37 weeks of gestational age 3. Parent(s) or legal guardian(s) willing and able to follow the requirements of the protocol for the duration of the study 4. Written informed consent given by parent(s) or legal guardian(s) who is aged ≥16 years
1. Prior receipt of vaccines (except for Hepatitis B or BCG vaccine) 2. Prior planned receipt of Investigation vaccines. 3. Current participation in another research study, except if the study is solely observational. 4. Children of parents who are on the delegation log for this study 5. A confirmed anaphylactic reaction to neomycin, streptomycin or polymyxin B (which may be present in trace amounts in the tetanus vaccine) and/or kanamycin, histidine, sodium chloride or sucrose (which may be present in trace amounts in the MenB vaccine). 6. Latex hypersensitivity (the syringe cap of Bexsero may contain natural rubber latex) 7. Major congenital defects or serious chronic illness 8. Presence of an evolving or changing neurological disorder 9. Presence of central nervous system disease or convulsions in the infant. 10. Bleeding disorder 11. Confirmed or suspected immunodeficiency 12. A family history of congenital or hereditary immunodeficiency 13. Receipt of more than 1 week of immune-suppressants or immune-modifying drugs (e.g., oral prednisolone >0.5 ml/kg/day or intravenous glucocorticoid steroid). Nasal, topical or inhaled steroids are allowed 14. Administration of immunoglobulin and/or any blood products since birth or planned administration during the study period 15. History of allergy to any component of the vaccines. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk through participation in the study, or may influence the result of the study or the participant’s ability to participate in the study