Assessing responses to the booster dose of pneumococcal vaccine in children who had less than the standard number of doses as babies, as well as meningococcal B vaccine as babies.

Phase 1

• Conditions: Immunological responses to vaccination in health y participants under reduced dose vaccine schedules; MedDRA version: 18.0Level: PTClassification code 10069578Term: Pneumococcal immunisationSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 18.0Level: LLTClassification code 10039242Term: Routine childhood immunisationSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2015-000817-32-GB
• Lead Sponsor: niversity of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-03-06
• Last Update Posted: 27 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Infants may only be included in the study if all the inclusion criteria are met:
•Infants due to receive their primary immunisations, aged up to 13 weeks on first vaccinations.
•Written informed consent given by parent/ guardian
Where possible consent will be sought from the mother so that permission can be given for recording any pertussis (whooping cough) containing vaccine in pregnancy. If this is not possible, i.e. if consent is given by the father or legal guardian, then this information would not be collected.
Are the trial subjects under 18? yes
Number of subjects for this age range: 200
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

Infants may not be included in the study if any of the following apply:
•Bleeding disorder
•Fulfil any of the contraindications to vaccination as specified in The Green Book [DH website]:
?At risk of invasive pneumococcal disease (IPD) defined as ‘Children with asplenia, splenic dysfunction or complement disorders’ and those born prior to 37 weeks gestation
?confirmed anaphylactic reaction to a previous dose of the vaccine, or
?confirmed anaphylactic reaction to any constituent or excipient of the vaccine(s).
?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).
?Latex hypersensitivity (the syringe cap of Bexsero may contain natural rubber latex)

If the infant has an axillary/aural temperature = 38°C on the scheduled appointment day, then vaccination and blood sampling will be postponed until resolution of fever. Blood sampling will also be postponed for seven days after completion of any antibiotic course. (NB if this occurs then this will be documented in the CRF to confirm the order of randomisation was maintained and will give the reason for postponement of treatment)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified