Safety and Immunogenicity Study of Hib-MenCY-TT Vaccine Compared to Licensed Hib Conjugate Vaccine

Completed · Phase 3

Conditions studied: Haemophilus Influenzae Type b, Neisseria Meningitidis

In brief

This study evaluates the immunogenicity and consistency of 3 Hib-MenCY-TT vaccine lots and the safety and immunogenicity of Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine, when each are co-administered with Pediarix® to healthy infants at 2, 4, and 6 months of age. The study will also evaluate the safety and immunogenicity of Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine, when each are co-administered with M-M-R® II and Varivax® at 12 to 15 months of age.

Key facts

Study ID

NCT00289783

Run by

GlaxoSmithKline

People needed

4441

Starts

2006-02-22

Expected to finish

2008-02-26

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…

• 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 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.
• 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.
• Infants may have received a birth dose of Bacillus Calmette-Guérin (BCG) vaccine.

You may not qualify if…

• 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). (Synagis® [palivizumab, MedImmune], Prevnar (Prevenar), rotavirus vaccine, and influenza vaccine are allowed.
• 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, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, hepatitis B, and/or poliovirus disease.
• Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required).
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, 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.
• 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).
• Additional specific criteria for the US subjects in Cohort 1. In addition, for Cohorts 2 and 3, subjects should not be administered M-M-R II and Varivax if any of these criteria apply:
• History of measles, mumps, rubella or varicella.
• Previous vaccination against measles, mumps, rubella or varicella.
• Hypersensitivity to any component of the vaccines, including gelatin or neomycin.
• Patients receiving immunosuppressive therapy.
• Individuals with blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems.
• Individuals with primary and acquired immunodeficiency states.
• Individuals with a family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated.
• Individuals with active tuberculosis.
• Acute disease at time of booster vaccination.

Where it is running

• GSK Investigational Site — Birmingham, Alabama, United States
• GSK Investigational Site — Phoenix, Arizona, United States
• GSK Investigational Site — Bryant, Arkansas, United States
• GSK Investigational Site — Fayetteville, Arkansas, United States
• GSK Investigational Site — Little Rock, Arkansas, United States
• GSK Investigational Site — Little Rock, Arkansas, United States
• GSK Investigational Site — East Artesia, California, United States
• GSK Investigational Site — Fountain Valley, California, United States
• GSK Investigational Site — Fresno, California, United States
• GSK Investigational Site — Fresno, California, United States
• GSK Investigational Site — Fresno, California, United States
• GSK Investigational Site — La Jolla, California, United States
• GSK Investigational Site — Oakland, California, United States
• GSK Investigational Site — Paramount, California, United States
• GSK Investigational Site — Rolling Hills Estates, California, United States
• GSK Investigational Site — Sacramento, California, United States
• GSK Investigational Site — West Covina, California, United States
• GSK Investigational Site — Longmont, Colorado, United States
• GSK Investigational Site — Norwich, Connecticut, United States
• GSK Investigational Site — Cocoa Beach, Florida, United States
• GSK Investigational Site — Melbourne, Florida, United States
• GSK Investigational Site — Pembroke Pines, Florida, United States
• GSK Investigational Site — Rockledge, Florida, United States
• GSK Investigational Site — Nampa, Idaho, United States
• GSK Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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