EUCTR2006-006460-32-GB
Active, not recruiting
Phase 1
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
DrugsInfanrix IPV
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- GlaxoSmithKline Biologicals
- Enrollment
- 478
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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\.
Exclusion Criteria
- •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\)].
Outcomes
Primary Outcomes
Not specified
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