A phase IV, open, multicenter, multicountry study to assess the long-term antibody persistence of a booster dose of GlaxoSmithKline (GSK) Biologicals’ Haemophilus influenzae type b – meningococcal serogroup C conjugate (Hib-MenC) vaccine given at 12-15 months of age to subjects who were primed in primary study 103974 (HIB-MENC-TT-012) and boosted in study 104056 (HIB-MENC-TT-013 BST:012). - Hib-MenC-TT-027, 028, 029
- Conditions
- Persistence of antibodies after a 3-dose primary vaccination (in infancy) with or without a booster vaccination (in the second year of life) against Haemophilus influenzae type b disease and meningococcal disease due to serogroup C
- Registration Number
- EUCTR2006-006460-32-GB
- Lead Sponsor
- GlaxoSmithKline Biologicals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 478
All subjects must satisfy the following criteria at study entry:
Subjects of groups HibMenC and LicMenC at Visits 1, 2 and 3:
•Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g. return for follow-up visits) should be enrolled in the study.
•A male or female between and including 24 and 31 months of age at the time of Visit 1, between and including 40 and 43 months of age at Visit 2 and between and including 60 and 64 months at Visit 3.
•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.
•Having completed the booster vaccination study HIB-MENC-TT-013 BST:012.
Subjects of group NoBoost at Visit 2 (UK only):
•Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
•A male or female between and including 40 and 43 months of age at Visit 2.
•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
•Having received a 3-dose primary vaccination with a MenC conjugate vaccine and a Hib containing vaccine before the age of 8 months.
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
The following criteria should be checked at the time of study entry. If any apply, the subject must not be included in the study:
Subjects of groups HibMenC and LicMenC at Visits 1, 2 and 3:
•Previous administration of a booster dose of Hib or meningococcal serogroup C except booster study vaccines during the study HIB-MENC-TT-013 BST:012.
•History of H. influenzae type b or meningococcal diseases.
•UK subjects only: previous administration of a booster dose of a pertussis-containing vaccine, except booster study vaccines during the study HIB-MENC-TT-013 BST:012 (104056)
Subjects of group NoBoost at Visit 2 (UK only):
•Previous administration of a booster dose of Hib or meningococcal serogroup C vaccine
•History of H. influenzae type b or meningococcal diseases
The following criteria should be checked at each visit subsequent to the first visit for subjects in groups HibMenC and LicMenC:
•History of H. influenzae type b, meningococcal or pertussis diseases* since the previous long-term persistence visit [for the Visit1 - since the last visit of the booster vaccination study 104056 (HIB-MENC-TT-013 BST:012)].
* Subjects with a history of pertussis disease will be eliminated from the pertussis analyses only. See Section 9.3.
•Previous administration of a booster dose of Hib or meningococcal serogroup C vaccines since the previous long-term persistence visit.
•UK subjects only: Prior to Visit 2: previous administration of pertussis containing vaccine as booster vaccination.
•Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since the last visit. (For corticosteroids, this will mean prednisone, or equivalent, ?0.5 mg/kg/day. Inhaled and topical steroids are allowed.).
•Administration of immunoglobulins and/or any blood products since the last visit.
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