Baby Vaccine Study (Sched3)

Launched by UNIVERSITY OF OXFORD · Jun 23, 2015

Keywords

ClinConnect Summary

The study's primary objective is to assess antibody response to the pneumococcal vaccine after the final infant vaccinations at approximately 13 months of age, and secondary objectives include antibody response following meningococcal B and C vaccines, tetanus, diphtheria and pertussis vaccines. In addition, the effect of maternal pertussis vaccination in pregnancy on infant immune response to vaccines, the prevalence of carriage of pneumococcal serotypes at 12 and 18 months of age and reactogenecity following each vaccine will be assessed.

200 healthy children who have not yet received th...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Infants due to receive their primary immunisations , aged up to 13 weeks on first vaccinations.
• • Written informed consent given by mother who is aged \>= 16 years \[NB mother is preferable as consent also allows permission to record the date of pertussis immunisation in pregnancy, which may need to be verified in her medical record. Where mother is not available, consent may be taken from father or legal guardian and maternal pertussis status noted as not known\]
• Exclusion Criteria:
• • Bleeding disorder
• * Fulfil any of the contraindications to vaccination as specified in The Green Book \[https://www.gov.uk/government/organisations/public-health-england/series/immunisation-against-infectious-disease-the-green-book\]:
• • At risk of invasive pneumococcal disease (IPD) as defined in the Green Book pneumococcal chapter 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)