Pneumococcal disease Infections and Infestations
Conditions
Interventions
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
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Age
2 Months to 2.5 Months
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PCV13 serotype-specific serum IgG concentration measured using Enzyme-Linked Immunoassay at 13 months of age (at least 4 weeks after administration of the last dose of PCV vaccine) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. PCV20 serotype-specific serum IgG concentrations measured using Enzyme-Linked Immunoassay at 13 months of age (at least 4 weeks after administration of the last dose of PCV vaccine) 2. Solicited adverse events (AEs) collected using e-Diary recordings within 7 days 3. Unsolicited AEs and serious adverse events (SAEs) recorded when observed by the Investigator or reported by the participant’s parent/guardian during the whole study period | — |
Countries
England, United Kingdom
Contacts
Public ContactDenis Murphy
Outcome results
None listed