Safety and immunogenicity of a booster dose of new formulations of GlaxoSmithKline Biologicals’ DTPa-HBV-IPV/Hib vaccine.

• Conditions: Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]; Booster immunization of healthy toddlers in the second year of life against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b (Hib) diseases).

• Registration Number: EUCTR2011-000876-33-Outside-EU/EEA
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-27
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 657

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.

Study & Design

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