Status:
COMPLETED
Immunogenicity of a Reduced Primary Schedule for Pneumococcal Conjugate Vaccine in UK Infants
Lead Sponsor:
Public Health England
Conditions:
Streptococcus Pneumoniae
Eligibility:
All Genders
7-18 years
Phase:
PHASE2
Brief Summary
The purpose of the trial is to determine the minimum of doses of a new nine valent pneumococcal conjugate vaccine required to protect UK infants and toddlers
Detailed Description
A new vaccine against pneumococcal infection is now available in the UK and has already been in routine use in the US for five years. The purpose of the trial is to determine the minimum number of doe...
Eligibility Criteria
Inclusion
- Informed consent by parent/guardian for receipt of study vaccines and for blood samples
- Age at first dose: Infants 7-11 weeks; toddlers 12-18 months
Exclusion
- Previous bacteriologically confirmed pneumococcal or meningococcal disease
- Contraindications for pneumococcal, meningococcal, Hib, DTP, MMR immunisations as listed in the UK handbook, "Immunisation Against Infectious Disease" Edition 1996.
- Language difficulty in parents sufficient to preclude adequate comprehension of the information sheet, consent form and study nurses' explanation of the study
- Children participating in any other clinical trial
- Immunocompromised
- Acute systemic illness or fever \> 38C on day of vaccination - deferral
Key Trial Info
Start Date :
September 1 2000
Trial Type :
INTERVENTIONAL
End Date :
January 1 2004
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00197769
Start Date
September 1 2000
End Date
January 1 2004
Last Update
August 29 2018
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