Abbreviato A study in children to assess a 2-dose primary vaccination followed by a booster vaccination of GlaxoSmithKline Biologicals vaccine against Haemophilus influenzae type b and meningococcal C diseases given together with GSK Biological s Infanrix penta versus a commercially available MenC vaccine given together with Infanrix hexa. - Hib-MenC-TT-014; Hib-MenC-TT-015 BST 014

• Conditions: Two-dose primary immunization course in healthy infants in the first year of life with a booster dose at 11 months of age against Haemophilus influenzae type b and meningococcal serogroup C diseases.; MedDRA version: 6.1Level: SOCClassification code 10021881

• Registration Number: EUCTR2005-005421-59-IT
• Lead Sponsor: GLAXOSMITHKLINE BIOLOGICALS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03-15
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 684

Inclusion Criteria

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 healthy male or female subject, 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 prior to the study entry. Free of obvious health problems as established by medical history and clinical examination before entering into the study. Born after a gestation period between and including 36 and 42 weeks.
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

Exclusion Criteria

Use of any investigational or non-registered product drug or vaccine other than the study vaccine s since birth or planned use during the study period. Chronic administration defined as more than 14 days of immunosuppressant or other immune-modifying drugs since birth. For corticosteroids, this will mean prednisone, or equivalent, ge 0.5 mg/kg/day. Inhaled and topical steroids are allowed. Planned administration/ administration of a vaccine not foreseen by the study protocol since birth, with exception of BCG. Previous vaccination against meningococcal serogroup C disease, diphtheria, tetanus, pertussis, polio, pneumococcal, Hepatitis B or Hib disease History of Haemophilus influenzae type b and /or meningococcal serogroup C disease. 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. 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 diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. Rectal temperature 38 C. Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. Additional specific criteria for the booster phase of the study to be checked at Visit 4 Previous booster vaccination with a Hib vaccine. Previous booster vaccination with a serogroup C meningococcal vaccine. Previous booster vaccination with a DTP containing vaccine. Previous booster vaccination with a IPV containing vaccine. Previous booster vaccination with a Hep B containing vaccine.

Study & Design

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