Immunogenicity, safety and reactogenicity of GSK Biologicals’ Hib-MenCY-TT vaccine 792014 compared to Merck & Co, Inc. Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) vaccine in healthy infants and toddlers.

• Conditions: Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]; invasive diseases caused by Haemophilus influenzae type b (Hib) and Neisseria meningitidis serogroups C (MenC) and Y (MenY)

• Registration Number: EUCTR2013-003459-39-Outside-EU/EEA
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07-23
• Last Update Posted: 4 August 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

•Subjects’ parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, 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(s)/LAR(s) of the subject.
•Healthy subjects as established by medical history and clinical examination before entering into the study.
•Born full-term.
•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 enrolment.
Are the trial subjects under 18? yes
Number of subjects for this age range: 602
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

•Child in care
•Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the dose of study vaccine or planned use during the study period.
•Chronic administration of immunosuppressants or other immune-modifying drugs since birth prior to the first vaccine dose. For corticosteroids, this will mean prednisone 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
•Previous vaccination against Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, rotavirus, pneumococcus, hepatitis A and/or poliovirus; more than one previous dose of hepatitis B vaccine.
•Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before and ending 30 days after the dose of vaccines. Subjects may receive inactivated influenza vaccine or pandemic influenza vaccines any time during the study according to the national recommendation. Measles, mumps, rubella and varicella vaccination are allowed 30 days before or 30 days after the final vaccination of Hib-MenCY-TT or PedvaxHIB.
•History of Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, pneumococcus, hepatitis B, hepatitis A, rotavirus, and/or poliovirus 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 vaccines, including dry natural latex rubber. Hypersensitivity to any component of the vaccines, including gelatin or neomycin.
•Major congenital defects or serious chronic illnesses.
•History of any neurologic disorders or seizures. A single, simple febrile seizure is allowed.
•Subjects with history of intussusceptions or uncorrected congenital malformation of the gastrointestinal tract that would predispose for intussusceptions.
•Acute disease and/or fever at the time of enrolment.
•Administration of immunoglobulins and/or blood products since birth or planned administration during the study period.

Study & Design

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