Status:
COMPLETED
Comparison of GSKBiologicals' Hib-MenCY-TT Vaccine vs Licensed Hib Conjugate or Meningococcal Vaccine
Lead Sponsor:
GlaxoSmithKline
Conditions:
Haemophilus Influenzae Type b
Neisseria Meningitidis
Eligibility:
All Genders
6-15 years
Phase:
PHASE2
Brief Summary
This study is evaluating the safety and immunogenicity of GSK Biologicals' Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine, each administered at 2, 4, and 6 m...
Detailed Description
The non-inferiority of the immunogenicity, safety, and antibody persistence of Hib-MenCY-TT vaccine will be compared to ActHIB®, a monovalent Hib conjugate vaccine licensed in the US. All subjects wi...
Eligibility Criteria
Inclusion
- For Groups A and B
- Subjects for whom the investigator believes that parents/guardians can and will comply with the requirements of the protocol.
- Healthy 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 the study.
- Born after a gestation period between 36 and 42 weeks.
- Infants who have not received a previous dose of hepatitis B vaccine or those who have received only 1 dose of hepatitis B vaccine administered at least 30 days prior to enrollment.
- For Group C
- Subjects for whom the investigator believes that parents/guardians can and will comply with the requirements of the protocol.
- Healthy male or female between, and including, 3 and 5 years 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 the study.
Exclusion
- For Groups A and B
- 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 within six months prior to the first vaccine dose.
- Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of study 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.
- History of Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, hepatitis B, poliovirus, and/or Streptococcus pneumoniae 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.
- Major congenital defects or serious chronic illness.
- History of any neurologic disorders or seizures.
- Acute disease at time of enrollment.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- For Group C
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the 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 within six months prior to the vaccine dose.
- Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the dose of study vaccine.
- Previous vaccination against Neisseria meningitidis.
- History of Neisseria meningitidis 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, including dry natural latex rubber
- Major congenital defects or serious chronic illness.
- Acute disease at time of enrollment.
- Administration of immunoglobulins and/or any blood products within the 3 months preceding vaccination or planned administration during the study period.
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 29 2006
Estimated Enrollment :
756 Patients enrolled
Trial Details
Trial ID
NCT00129129
Start Date
August 1 2004
End Date
March 29 2006
Last Update
August 24 2018
Active Locations (27)
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1
GSK Investigational Site
Little Rock, Arkansas, United States, 72205
2
GSK Investigational Site
Fountain Valley, California, United States, 92708
3
GSK Investigational Site
Centennial, Colorado, United States, 80112
4
GSK Investigational Site
Norwich, Connecticut, United States, 06360