Immunogenicity & reactogenicity study of a new formulation of GSK Biologicals’ DTPa-HBV-IPV/Hib vaccine administered as a booster dose to 18-23 months old children.
- Conditions
- Booster immunisation of healthy children against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b diseases.Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2012-002428-34-Outside-EU/EEA
- Lead Sponsor
- GlaxoSmithKline Biolgicals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active
- Sex
- All
- Target Recruitment
- 283
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.
Subjects must have completed full three-dose primary vaccination course with DTPa-HBV-IPV/Hib (new formulation/ current formulation) or DTPa-HBV-IPV in the primary study DTPa-HBV-IPV-109 (105910).
A male or female between, and including 18 and 23 months of age at the time of the 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: 283
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
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) of immunosuppressants or other immune-modifying drugs within six months prior to the booster dose. (For corticos-teroids, this will mean prednisone, or equivalent, more than 0.5 mg/kg/day. Inhaled and topical steroids are allowed).
Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the booster dose.
Participation in another clinical study, between the primary study DTPa-HBV-IPV-109 (105910) 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).
Previous booster vaccination against diphtheria, tetanus, pertussis, poliomyelitis and hepatitis B since the conclusion visit of study DTPa-HBV-IPV-109 (105910).
Previous booster vaccination against Haemophilus influ-enzae diseases in the DTPa-HBV-IPV/Hib groups, since the conclusion visit of study DTPa-HBV-IPV-109 (105910).
History of exposure to diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and/or Haemophilus influenzae disease since the conclusion visit of study DTPa-HBV-IPV-109 (105910).
Any confirmed or suspected immunosuppressive or im-munodeficient 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.
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