Assessment of post booster antibody responses in UK infants given a reduced priming schedule of meningococcal serogroup B and 13 valent pneumococcal conjugate vaccines - Baby Vaccine Study (Sched3)

niversity of Oxford0 个研究点目标入组 200 人开始时间: 2015年3月6日最近更新: 2020年7月27日

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•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

•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)

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