Safety of Hib-MenCY-TT vaccine versus licensed Hib conjugate vaccine, given at 2, 4, 6 and 12 to 15 months of age.

• Conditions: Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y; MedDRA version: 18.0Level: LLTClassification code 10028911Term: Neisseria meningitidis infection NOSSystem Organ Class: 100000004862; MedDRA version: 18.0Level: LLTClassification code 10018953Term: Haemophilus influenzae meningitisSystem Organ Class: 100000004862; MedDRA version: 18.0Level: LLTClassification code 10018952Term: Haemophilus influenzae infectionSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2005-006066-34-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: 4429

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 enrolment.
• 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: 4053
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 preced-ing 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 fore-seen by the study protocol within 30 days of the first dose of study vaccine(s).
• Previous vaccination against Neisseria meningitidis, Haemo-philus influenzae type b, diphtheria, tetanus, pertussis, and/or poliovirus; more than one previous dose of hepatitis B vaccine.
• In country(ies) where Prevnar will be provided by GSK Biologicals, previous vaccination with Prevnar.
• 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 examination.
• 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).

Study & Design

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