Status:
COMPLETED
Study of Long-term Antibody Persistence After a Booster Dose of Menitorix Vaccine
Lead Sponsor:
GlaxoSmithKline
Conditions:
Haemophilus Influenzae Type b
Neisseria Meningitidis
Eligibility:
All Genders
24-64 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate the long-term antibody persistence at 12, 24 and 48 months after the administration of a booster dose of Menitorix™, given at 12-15 months of age. The children...
Detailed Description
This multicentre \& multicountry study is open and has 2 study groups at Visits 1 and 3 (HibMenC and LicMenC). An additional control group in the UK at the time of the second year follow-up for persis...
Eligibility Criteria
Inclusion
- Subjects of groups HibMenC and LicMenC at Visits 1, 2 and 3:
- Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
- A male or female between and including 24 and 31 months of age at the time of Visit 1, between and including 40 and 43 months of age at Visit 2 and between and including 60 and 64 months at Visit 3.
- Written informed consent obtained from the parent or guardian of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Having completed the booster vaccination study 104056.
- Subjects of group NoBoost at Visit 2 (UK only):
- Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
- A male or female between and including 40 and 43 months of age at Visit 2.
- Written informed consent obtained from the parent or guardian of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Having received a 3-dose primary vaccination with a MenC conjugate vaccine and a Hib containing vaccine before the age of 8 months.
Exclusion
- Previous administration of booster dose of Hib or meningococcal serogroup C except booster study vaccines during the study 104056.
- History of H. influenzae type b or meningococcal diseases.
- For UK subjects of groups HibMenC and LicMenC only: previous administration of a booster dose of a pertussis-containing vaccine except booster study vaccines during the study 104056.
Key Trial Info
Start Date :
May 16 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 12 2007
Estimated Enrollment :
288 Patients enrolled
Trial Details
Trial ID
NCT00454987
Start Date
May 16 2007
End Date
October 12 2007
Last Update
June 16 2020
Active Locations (9)
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1
GSK Investigational Site
Bydgoszcz, Poland, 85-021
2
GSK Investigational Site
Gdansk, Poland, 80-394
3
GSK Investigational Site
Kielce, Poland, 25-711
4
GSK Investigational Site
Krakow, Poland, 31-202