Status:
COMPLETED
Immuno,Safety of GSK Vaccine 134612 Given at Age of 12-15 Months 15-18 Months Post-priming With GSK Vaccine 792014
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infections, Meningococcal
Eligibility:
All Genders
6-12 years
Phase:
PHASE3
Brief Summary
The purpose of the study is to characterize the immunogenicity \& safety of a booster dose of GSK Biologicals' meningococcal vaccine 134612 given at 12-15 months of age or at 15-18 months of age (co-a...
Detailed Description
The purpose of this study is to evaluate the titer of antibody for serogroups A, C, Y and W-135 and the safety of a booster dose of GSK Biologicals' meningococcal vaccine 134612 given to toddlers who ...
Eligibility Criteria
Inclusion
- Subjects for whom the investigator believes that parents/guardians can and will comply with the requirements of the protocol.
- A male or female between, and including, 6 and 12 weeks of age (+ 6 days) at the time of the first vaccination.
- 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.
- Born after 36 weeks gestation.
- For inclusion in the booster phase, subjects must have received all three doses in the primary phase.
Exclusion
- Exclusion criteria for enrolment (primary phase)
- 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 study vaccine(s).
- Previous vaccination against Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, and/or poliovirus; more than one previous dose of hepatitis B vaccine.
- History of Neisseria meningitidis, hepatitis B, Haemophilus influenzae type b, diphtheria, tetanus, polio or pertussis diseases.
- 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 vaccines, or by 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.
- Concurrent participation in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
- Exclusion criteria for enrolment (booster phase)
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding entry into the booster phase (Visit 4), 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 entry into the booster phase (Visit 4) with the exception of Prevnar® and Hib (see the following three criteria) (Note; licensed influenza vaccine is allowed throughout the study)
- Planned administration/administration of a fourth dose of Prevnar® within 30 days of a booster dose of Infanrix®
- Previous administration of a booster dose of Hib prior to entry to the booster phase.
- Previous administration of a primary dose of Hib vaccine that is not part of the study protocol.
- Previous vaccination against Neisseria meningitidis that is not part of the study protocol.
- Previous vaccination with diphtheria, tetanus and pertussis antigens outside of the primary phase of the study.
- History of Neisseria meningitidis, Hib, diphtheria, tetanus or pertussis diseases.
- 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 vaccines, or by 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 within the past 3 months or planned administration during the study period.
- Concurrent participation in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
Key Trial Info
Start Date :
February 13 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 17 2009
Estimated Enrollment :
1558 Patients enrolled
Trial Details
Trial ID
NCT00614614
Start Date
February 13 2008
End Date
September 17 2009
Last Update
September 21 2018
Active Locations (56)
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1
GSK Investigational Site
Birmingham, Alabama, United States, 35205
2
GSK Investigational Site
Birmingham, Alabama, United States, 35244
3
GSK Investigational Site
Dothan, Alabama, United States, 36305
4
GSK Investigational Site
Benton, Arkansas, United States, 72019