Comparison of current and new pneumococcal conjugate vaccines used for infant immunisatio

Phase 4

• Conditions: Pneumococcal disease; Infections and Infestations

• Registration Number: ISRCTN17673117
• Lead Sponsor: niversity of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-07
• Last Update Posted: 19 August 2024
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 600

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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) <br>2. Solicited adverse events (AEs) collected using e-Diary recordings within 7 days<br>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