Healthy volunteers (Booster immunisation of healthy children in the second year of life against diphtheria, tetanus, pertussis and Haemophilus influenzae type b diseases).
Conditions
Interventions
Trade Name: Infanrix-Hib
Product Code: DTPa-Hib
Pharmaceutical Form: Powder and suspension for suspension for injection
INN or Proposed INN: -
Current Sponsor code: D
Other descriptive name: DIPHTHERI
Sponsors
GlaxoSmithKline Biologicals - GSK China Vaccines
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the immune response to all vaccine antigens, i.e. diphtheria and tetanus toxoids, pertussis toxoid (PT), filamentous haemagglutinin (FHA), pertactin (PRN), and polyribosyl-ribitol-phosphate (PRP), one month after booster vaccination with the DTPa/Hib vaccine or with the DTPa and Hib vaccines administered separately.;Secondary Objective: •To evaluate the persistence of antibodies to all vaccine antigens at the pre-booster time point in subjects previously vaccinated with three doses of the DTPa/Hib vaccine or with three doses of the DTPa and Hib vaccines administered separately. •To evaluate the safety and reactogenicity of a booster dose of the DTPa/Hib vaccine and the separately administered DTPa and Hib vaccines in terms of solicited symptoms (local and general), unsolicited symptoms and serious adverse events (SAEs) during the study period. ;Primary end point(s): Immunogenicity: •Anti-PRP antibody concentrations greater than or equal to 0.15 µg/ml and greater than or equal to 1.0 µg/ml. •Anti-diphtheria toxoid antibody concentrations greater than or equal to 0.1 IU/ml and greater than or equal to 1.0 IU/ml. •Anti-tetanus toxoid antibody concentrations greater than or equal to 0.1 IU/ml. •Anti-PT, anti-FHA and anti-PRN antibody concentrations greater than or equal to 20 EL.U/ml. •Anti-PRP, anti-diphtheria, anti-tetanus, anti-PT, anti-FHA, and anti-PRN antibody concentrations;Timepoint(s) of evaluation of this end point: One month after booster vaccination. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Before booster vaccination;Secondary end point(s): Immunogenicity: •Anti-PRP antibody concentration greater than or equal to 0.15 µg/ml and greater than or equal to 1.0 µg/ml. •Anti-diphtheria toxoid antibody concentrations greater than or equal to 0.1 IU/ml and greater than or equal to 1.0 IU/ml. •Anti-tetanus toxoid antibody concentrations greater than or equal to 0.1 IU/ml. •Anti-PT, anti-FHA and anti-PRN antibody concentrations greater than or equal to 20 EL.U/ml. •Anti-PRP, anti-diphtheria, anti-tetanus, anti-PT, anti-FHA and anti-PRN antibody concentrations. | — |
Countries
China
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals
Outcome results
None listed