Status:
COMPLETED
Hib-MenCY-TT Vaccine Study Compared to Licensed Hib and Meningococcal Serogroup C Conjugate Vaccines
Lead Sponsor:
GlaxoSmithKline
Conditions:
Neisseria Meningitidis
Haemophilus Influenzae Type b
Eligibility:
All Genders
6-12 years
Phase:
PHASE2
Brief Summary
This study is evaluating the safety and immunogenicity of Hib-MenCY-TT vaccine compared to control groups receiving licensed Hib or MenC conjugate vaccines, each administered at 2, 4, 6, and 12 to 15 ...
Detailed Description
The study will be conducted in 2 stages: a 3-dose primary vaccination at 2, 4 and 6 months of age and a booster vaccination at 12 to 15 months of age. All subjects will have 3 blood samples taken. Hal...
Eligibility Criteria
Inclusion
- Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
- A male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination.
- Written informed consent obtained from the parent or guardian of the subject.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- Born after a gestation period between 36 and 42 weeks.
Exclusion
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
- Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine(s).
- Previous vaccination against Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, poliovirus, and/or Streptococcus pneumoniae; more than one previous dose of hepatitis B vaccine. Vaccination with hepatitis B at birth is accepted (although not mandatory). Influenza vaccination is allowed 30 days after administration of the third vaccine dose to 30 days preceding the booster dose.
- History of Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, hepatitis B, poliovirus, Streptococcus pneumoniae and/or varicella invasive disease.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s), including dry natural latex rubber, tetanus toxoid, diphtheria toxoid, neomycin, polymyxin.
- Major congenital defects or serious chronic illness.
- History of any neurologic disorders or seizures.
- Acute disease at the time of enrolment.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- Additional specific criteria for the booster part of the study
- History of or previous vaccination against measles, mumps, rubella or varicella.
- Previous booster vaccination with Hib or meningococcal serogroup C vaccine since the last visit of the primary phase.
Key Trial Info
Start Date :
April 11 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 21 2007
Estimated Enrollment :
1104 Patients enrolled
Trial Details
Trial ID
NCT00134719
Start Date
April 11 2005
End Date
February 21 2007
Last Update
July 19 2018
Active Locations (3)
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1
GSK Investigational Site
North Adelaide, South Australia, Australia, 5006
2
GSK Investigational Site
Carlton, Victoria, Australia, 3053
3
GSK Investigational Site
Perth, Western Australia, Australia