Vaccination and long-term follow-up study in infants to demonstrate non-inferiority, persistence & immunogenicity of Hib-MenC vaccine.

• Conditions: Healthy volunteers (for primary immunization against meningococcal serogroup C and booster immunization against Haemophilus influenzae type b diseases of healthy children aged 12-18 months); MedDRA version: 18.0Level: LLTClassification code 10028911Term: Neisseria meningitidis infection NOSSystem Organ Class: 100000004862; MedDRA version: 18.0Level: LLTClassification code 10070120Term: Haemophilus influenzae test positiveSystem Organ Class: 100000004848; MedDRA version: 18.0Level: LLTClassification code 10070124Term: Neisseria meningitidis test positiveSystem Organ Class: 100000004848; MedDRA version: 18.0Level: LLTClassification code 10018953Term: Haemophilus influenzae meningitisSystem Organ Class: 100000004862; MedDRA version: 18.0Level: PTClassification code 10069533Term: Haemophilus influenzae type b immunisationSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 18.0Level: LLTClassification code 10018952Term: Haemophilus influenzae infectionSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2011-005032-26-Outside-EU/EEA
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-25
• Last Update Posted: 4 August 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 433

Inclusion Criteria

• Subjects whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
• A male or female between, and including, 12 and 18 months of age at the time of 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 into the study.
• Previously completed routine childhood vaccinations to the best of his/her parents’/guardians knowledge.
• Having completed primary vaccination with two doses of Hib-OMP containing vaccine OR three doses of DTPa/Hib containing vaccine at least 6 months before the study start.
Are the trial subjects under 18? yes
Number of subjects for this age range: 433
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 other than the study vaccine(s) within 30 days preceding the first dose of study vaccine or planned use during the study period
• Chronic or planned administration of immuno-suppressants or other immune-modifying drugs within six months prior to vaccination
• Planned administration/administration of a vaccine not foreseen by the protocol during the period starting from 30 days before and ending 30 days after vaccination
• Administration of a meningococcal vaccine not foreseen by the study protocol during the period starting at birth and ending at first dose
• Previous administration of a booster dose of Hib vaccine
• Previous vaccination against measles, mumps, rubella
• History of H. influenzae type b, meningococcal serogroup C and/or confirmed measles, mumps or rubella diseases
• Known exposure to measles, mumps or rubella within 30 days prior to the start of the study
• Any confirmed or suspected immunosuppressive or immunodeficient condition, including HIV infection
• A family history of congenital or hereditary immunodeficiency
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine
• Major congenital defects or serious chronic illness
• History of neurological disorders or more than one episode of febrile convulsion
• Acute disease at the time of enrolment
• Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period
For the long-term persistence phase:
• Previous administration of a booster dose of Hib, meningococcal serogroup C vaccines
• History of H. influenzae type b, meningococcal serogroup C diseases

Study & Design

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