Immunogenicity, safety and reactogenicity study of GlaxoSmithKline (GSK) Biologicals’ Hib-MenCY-TT vaccine compared to monovalent Hib vaccine in healthy infants at 2, 4, 6, and 12 to 15 months of age.

• Conditions: Invasive disease caused by Haemophilus type b and Neisseria meningitidis serogroups C and Y; MedDRA version: 18.0Level: LLTClassification code 10028910Term: Neisseria meningitides meningitisSystem Organ Class: 100000004862; MedDRA version: 18.0Level: LLTClassification code 10051931Term: Neisseria infection NOSSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2005-002352-18-Outside-EU/EEA
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-01
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 4441

Inclusion Criteria

•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.
Are the trial subjects under 18? yes
Number of subjects for this age range: 4441
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•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 immuno-deficient condition based on medical history and physical ex-amination (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 adminis-tered 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified