EUCTR2011-000876-33-Outside-EU/EEAActive, not recruitingNot Applicable
A phase II, double-blind, multicentre study to evaluate the safety and immunogenicity of a booster dose of new formulations of GlaxoSmithKline Biologicals’ combined DTPa-HBV-IPV/Hib vaccine in healthy toddlers, previously primed with three doses of the same vaccine in study 113948 (DTPA-HBV-IPV-124 PRI). - DTPA-HBV-IPV-125 BST:124
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- GlaxoSmithKline Biologicals
- Enrollment
- 657
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Subjects who participated in the study 113948 (DTPA-HBV-IPV-124 PRI) and received three doses of the new or licensed DTPa-HBV-IPV/Hib study vaccine.
- •A male or female child between, and including, 12 and 15 months of age at the time of the booster vaccination.
- •Subjects who the investigator believes that parent(s)/ LAR(s) can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visit).
- •Written informed consent obtained from the parent(s)/LAR(s) 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: 657
- •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
- •Child in care.
- •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines 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 in total) of immunosuppressants or other immune-modifying drugs within six months prior to the booster dose. (For corticosteroids, this will mean prednisone = 0.5 mg/kg/day, or equivalent). Inhaled and topical steroids are allowed.
- •Administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination, or planned administration during the study period.
- •Participation in another clinical study within three months prior to enrolment in the present booster study or at any time during the present booster study, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
- •Evidence of previous or intercurrent diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Hib vaccination or disease since the conclusion visit of study 113948 (DTPA-HBV-IPV-124 PRI).
- •Serious chronic illness.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- •History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
- •History of any neurological disorders or seizures.
Investigators
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