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

• Conditions: Booster immunisation of healthy toddlers in the second year of life against diphtheria, tetanus, pertussis, hepatitis B, polio and Haemophilus influenzae type b.

• Registration Number: EUCTR2007-005343-16-FI
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12-19
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 450

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
F.1.3.1 Number of subjects for this age range

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
One of the following adverse events having occurred after previous administration of DTP vaccine
? Hypersensitivity reaction due to the vaccine.
? Encephalopathy defined as an acute, severe central nervous system disorder occurring within 7 days following vaccination and generally consisting of major alterations in consciousness, unresponsiveness, generalised or focal seizures that persist more than a few hours, with failure to recover within 24 hours.
Warnings and precautions
? Fever = 40.5°C rectal temperature within 48 hours of vaccination.
? Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours of vaccination.
? Persistent, inconsolable crying occurring within 48 hours of vaccination and lasting = 3 hours
Convulsions with or without fever, occurring within 3 days of vaccination.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified