EUCTR2007-005343-16-FI
Active, not recruiting
Not Applicable
A phase II, open, study to assess the immunogenicity and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ combined DTPa-HBV-IPV/Hib vaccine when administered as a booster dose to children aged 16-20 months, previously primed with GSK Biologicals’ combined DSSITGDPa-HBV-IPV/Hib vaccine, containing diphtheria toxoid from the Statens Serum Institute (SSI) of Denmark and tetanus toxoid from GSK Biologicals’ Kft [GD] or with GSK Biologicals licensed DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™) in the primary vaccination study DTPa-HBV-IPV-116 (106786). - DTPa-HBV-IPV-120 BST:116
DrugsInfanrix Hexa
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Booster immunisation of healthy toddlers in the second year of life against diphtheria, tetanus, pertussis, hepatitis B, polio and Haemophilus influenzae type b.
- Sponsor
- GlaxoSmithKline Biologicals
- Enrollment
- 450
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects for whom 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.
- •Subjects must have completed the full three\-dose primary vaccination course with one of the formulations of the DTPa\-HBV\-IPV/Hib vaccine in primary study DTPa\-HBV\-IPV\-116 (106786\).
- •A male or female between, and including, 16 and 20 months of age at the time of booster vaccination.
- •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.
- •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
Exclusion Criteria
- •Use of any investigational or non\-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the booster dose of study 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 booster vaccine dose. (For corticosteroids, this will mean prednisone, or equivalent, ? 0\.5 mg/kg/day. Inhaled and topical steroids are allowed).
- •Participation in another clinical study, between the primary study DTPa\-HBV\-IPV\-116 (106786\) and the present booster study, or at any time during the study, in which the subject has been or will be exposed to an investigational or a non\-investigational product (pharmaceutical product or device).
- •Planned administration / administration of a vaccine not foreseen by the study protocol during the period starting 30 days before the administration of the booster dose and ending 30 days after the booster dose.
- •Evidence of previous diphtheria, tetanus, pertussis, polio, hepatitis B and/or Hib booster vaccination or disease since the conclusion visit of study DTPa\-HBV\-IPV\-116\.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on physical examination (no laboratory testing required).
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
- •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. axillary temperature \< 37\.5°C.
- •Administration of immunoglobulins and/or any blood products within the three months preceding the booster dose or planned administration during the study period.
- •Absolute contraindications
Outcomes
Primary Outcomes
Not specified
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