Comparison of GSKBiologicals' Hib-MenCY-TT Vaccine vs Licensed Hib Conjugate or Meningococcal Vaccine

Completed · Phase 2

Conditions studied: Haemophilus Influenzae Type b, Neisseria Meningitidis

In brief

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 months of age, and compared to licensed meningococcal serogroups A, C, Y, and W-135 polysaccharide vaccine administered at 3 to 5 years of age. The safety and immunogenicity of a booster dose of Hib-MenCY-TT vaccine will be compared to a booster dose of licensed Hib conjugate vaccine, each administered at 12 to 15 months of age. The group primed with the Hib conjugate vaccine will re-randomized at 12-15 months of age to receive a booster dose of Hib-MenCY-TT or a booster dose of the Hib conjugate vaccine.

Key facts

Study ID

NCT00129129

Run by

GlaxoSmithKline

People needed

756

Starts

2004-08-01

Expected to finish

2006-03-29

Last updated by the study team

2018-08-24

Who can join

Age: 0 and older, up to 1. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• GSK Investigational Site — Little Rock, Arkansas, United States
• GSK Investigational Site — Fountain Valley, California, United States
• GSK Investigational Site — Centennial, Colorado, United States
• GSK Investigational Site — Norwich, Connecticut, United States
• GSK Investigational Site — Marietta, Georgia, United States
• GSK Investigational Site — Des Moines, Iowa, United States
• GSK Investigational Site — Bardstown, Kentucky, United States
• GSK Investigational Site — Louisville, Kentucky, United States
• GSK Investigational Site — Louisville, Kentucky, United States
• GSK Investigational Site — Bossier City, Louisiana, United States
• GSK Investigational Site — Boston, Massachusetts, United States
• GSK Investigational Site — Boston, Massachusetts, United States
• GSK Investigational Site — New Bedford, Massachusetts, United States
• GSK Investigational Site — Rochester, New York, United States
• GSK Investigational Site — The Bronx, New York, United States
• GSK Investigational Site — Boardman, Ohio, United States
• GSK Investigational Site — University Heights, Ohio, United States
• GSK Investigational Site — Beaver Falls, Pennsylvania, United States
• GSK Investigational Site — Erie, Pennsylvania, United States
• GSK Investigational Site — Greenville, Pennsylvania, United States
• GSK Investigational Site — Norristown, Pennsylvania, United States
• GSK Investigational Site — Pittsburgh, Pennsylvania, United States
• GSK Investigational Site — Pittsburgh, Pennsylvania, United States
• GSK Investigational Site — Pittsburgh, Pennsylvania, United States
• GSK Investigational Site — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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