A Phase III open, multicentre, booster vaccination study to assess the immunogenicity, safety and reactogenicity of a booster dose of GlaxoSmithKline (GSK) Biologicals’ Haemophilus influenzae type b-meningococcal serogroup C conjugate vaccine (Hib-MenC) compared to a booster dose of INFANRIX HEXA (combined diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated polio-Hib vaccine) when given to 14-month-old subjects who were primed in study 217744/097 (DTPa-HBV-IPV-097). - Hib-MenC-TT-010 BST:DTPA-HBV-IPV-097
- Conditions
- Booster vaccination against Haemophilus influenzae type b and meningococcal serogroup C diseases.
- Registration Number
- EUCTR2004-001249-14-ES
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 468
? Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) should be enrolled in the study.
? A male or female between, and including, 13 and 14 months of age at the time of booster 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.
? Having participated in the primary vaccination study 217744/097
Are the trial subjects under 18? yes
Number of subjects for this age range:
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
? Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the booster vaccine, or planned use during the study period.
? Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. (For corticosteroids, this will mean prednisone, or equivalent, >/= 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
? Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the booster vaccine.
? Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B, polio, H. influenzae type b (Hib) and/or meningococcal serogroup C disease except if within the framework of study 217744/097.
? History of diphtheria, tetanus, pertussis, hepatitis B, polio, Hib and/or meningococcal serogroup C disease.
? Known exposure to diphtheria, tetanus, pertussis, hepatitis B, polio, Hib and/or meningococcal serogroup C disease within the last 3 months.
? Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (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 any neurologic disorders or seizures including febrile seizures (at least 2 events) in infancy.
? Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e., Oral temperature <37.5°C / Axillary temperature <37.5°C / Rectal temperature <38°C.
? Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method