Status:
COMPLETED
An Alternative Booster Vaccine Against Meningitis and Ear Infections
Lead Sponsor:
University of Oxford
Conditions:
Invasive Streptococcus Pneumoniae Disease
Eligibility:
All Genders
12-13 years
Phase:
PHASE3
Brief Summary
This is a study to evaluate an alternative booster for pneumococcal conjugate vaccination (PCV) for children at 12 months of age. Currently in the UK, 3 doses of a vaccine called Prevenar 13 (PCV-13),...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
178 Patients enrolled
Trial Details
Trial ID
NCT01443416
Start Date
April 1 2012
Last Update
November 9 2015
Active Locations (1)
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1
Oxford Vaccine Group
Oxford, United Kingdom