Immunogenicity and reactogenicity study of GlaxoSmithKline Biologicals’ Infanrix™/Hib vaccine administered as a booster dose to 18-24 months old children.

• Conditions: Healthy volunteers (Booster immunisation of healthy children in the second year of life against diphtheria, tetanus, pertussis and Haemophilus influenzae type b diseases).; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2015-001507-31-Outside-EU/EEA
• Lead Sponsor: GlaxoSmithKline Biologicals - GSK China Vaccines

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-09
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 630

Inclusion Criteria

•Subjects who 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 should have completed the full three-dose primary vaccination course in study DTPa-131 (104567).
•A male or female child between, and including, 18 and 24 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: 467
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(s) within 30 days preceding booster vaccination, 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, 0.5 mg/kg/day. 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, with the exception of measles or combined measles, mumps and rubella (MMR) vaccination.
•Concurrently participating in another clinical study, at any time during the study period, 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 and/or Haemophilus influenzae type b diseases since the end of the primary study.
•History of diphtheria, tetanus, pertussis and/or Haemophilus influenzae type b diseases.
•Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
•A family history of congenital or hereditary immunodeficiency.
•History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
•Major congenital defects or serious chronic illness.
•History of any progressive neurological disorders or seizures.
•Acute disease and/or fever at time of enrolment warrants a deferral of the vaccination pending recovery of the subject. Fever is defined as axillary temperature greater than or equal to 37.1°C.
•Administration of immunoglobulins and/or any blood products within the three months preceding the booster dose or planned administration during the study period.
•Occurrence of any of the following adverse events (AEs) after previous administration of a DTP vaccine:
-Hypersensitivity reaction due to any component of 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, generalized or focal seizures that persist more than a few hours, with failure to recover within 24 hours.
-Fever greater than or equal to 40.0 °C (axillary 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 greater than or equal to 3 hours.
-Seizures with or without fever occurring within 3 days of vaccination.

Study & Design

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