An Alternative Booster Vaccine Against Meningitis and Ear Infections

Launched by UNIVERSITY OF OXFORD · Sep 28, 2011

Keywords

ClinConnect Summary

Currently in the UK, 3 doses of a vaccine called Prevenar 13 (PCV-13), which contains 13 pneumococcal serotypes attached to a carrier protein called CRM197, are given to children at 2, 4 and 12 months of age. There is some evidence that a vaccine called Synflorix (PHiD-CV) may be at least as good as the currently used vaccine when used as an alternative vaccine at 12 months of age. Although PHiD-CV contains only 10 serotypes, there is evidence that it generates cross-reactive antibodies against two of the three additional serotypes included in PCV-13 which might be enough to protect childre...

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Eligibility criteria

• Inclusion Criteria:
• • Aged 12 months (-2 weeks to +6 weeks) at time of enrolment.
• • Have received two doses of PCV-13 at less than 6 months of age with a gap of at least 6 weeks between the two vaccinations.
• • Have received all primary vaccines according to the UK routine immunisation schedule (up to, but not including, 12 months of age).
• • Available for the entire study period and whose parent/legal guardian can be reached by telephone.
• • Healthy children as determined by medical history and physical examination, done by a study nurse (and/or study doctor if required, depending on the medical history of the participant and physical assessment), and judgment of the investigator.
• • Parent/legal guardian must be able to complete all relevant study procedures during study participation.
• Exclusion Criteria:
• • Previous receipt of pneumococcal vaccine other than the 13-valent pneumococcal conjugate vaccine (Prevenar 13®, Pfizer).
• • Receipt of the routine 12 month immunisations (PCV13 (3rd dose), combined Haemophilus influenzae type b and serogroup C meningococcal glyco-conjugate vaccine (Hib-MenC) or measles, mumps and rubella vaccine (MMR)).
• • A previous anaphylactic reaction to any vaccine or vaccine-related component.
• • Contraindication to vaccination with pneumococcal conjugate vaccine.
• • Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
• • Known or suspected immune deficiency or suppression.
• • History of culture-proven invasive disease caused by S. pneumoniae.
• • Major known congenital malformation or serious chronic disorder.
• • Significant neurologic disorder or history of seizures including febrile seizure, or significant stable or evolving disorders such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorder.
• • Receipt of blood products or gamma-globulin (including hepatitis B immunoglobulin and monoclonal antibodies; e.g., Synagis B).
• • Parents who plan to move out of the geographical area where the study would be conducted.