Immuno,Safety of GSK Vaccine 134612 Given at Age of 12-15 Months 15-18 Months Post-priming With GSK Vaccine 792014

Completed · Phase 3

Conditions studied: Infections, Meningococcal

In brief

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-administered with Infanrix®) in healthy toddlers primed with GSK Biological's Hib-meningococcal vaccine 792014. This study is single-blinded for the primary phase and open-label for the booster phase.

Key facts

Study ID

NCT00614614

Run by

GlaxoSmithKline

People needed

1558

Starts

2008-02-13

Expected to finish

2009-09-17

Last updated by the study team

2018-09-21

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• GSK Investigational Site — Birmingham, Alabama, United States
• GSK Investigational Site — Dothan, Alabama, United States
• GSK Investigational Site — Benton, Arkansas, United States
• GSK Investigational Site — Fayetteville, Arkansas, United States
• GSK Investigational Site — Jonesboro, Arkansas, United States
• GSK Investigational Site — Little Rock, Arkansas, United States
• GSK Investigational Site — Fountain Valley, California, United States
• GSK Investigational Site — Fresno, California, United States
• GSK Investigational Site — Huntington Beach, California, United States
• GSK Investigational Site — West Covina, California, United States
• GSK Investigational Site — Plantation, Florida, United States
• GSK Investigational Site — West Palm Beach, Florida, United States
• GSK Investigational Site — Marietta, Georgia, United States
• GSK Investigational Site — Woodstock, Georgia, United States
• GSK Investigational Site — Nampa, Idaho, United States
• GSK Investigational Site — Des Moines, Iowa, United States
• GSK Investigational Site — West Des Moines, Iowa, United States
• GSK Investigational Site — Arkansas City, Kansas, United States
• GSK Investigational Site — Bardstown, Kentucky, United States
• GSK Investigational Site — Lexington, Kentucky, United States
• GSK Investigational Site — Bossier City, Louisiana, United States
• GSK Investigational Site — Boston, Massachusetts, United States
• GSK Investigational Site — Fall River, Massachusetts, United States
• GSK Investigational Site — Kalamazoo, Michigan, United States
• GSK Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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