Healthy volunteers (Immunogenicity of the DTPa-HBV-IPV/Hib and DTPa-IPV/Hib vaccines in terms of persistence of antibodies to diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and Hib vaccine antigens). MedDRA version: 13.1 Level: PT Classification code 10043376 Term: Tetanus System Organ Class: 10021881 - Infections and infestations MedDRA version: 13.1 Level: LLT Classification code 10018952 Term: Haemophilus influenzae infection System Organ Class: 10021881 - Infections and infesta
Conditions
Interventions
Trade Name: Infanrix Hexa
Pharmaceutical Form: Powder and suspension for suspension for injection
Other descriptive name: PERTUSSIS TOXOID ADSORBED ON ALUMINIUM HYDROXIDE, HYDRATED
Concentration unit:
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Subjects who had received 3 doses of Infanrix hexa or Infanrix-IPV/Hib in the study 10PN-PD-DIT-002 (105539). •Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol. •A male or female subject aged 5 years at the time of study entry (from the 5th birthday until but excluding the 6th birthday). •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: 150 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: •Child in care. •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). •Use of any investigational or non-registered product (drug, vaccine or device) within 30 days prior to blood sampling. •Evidence of previous or intercurrent diphtheria, tetanus, pertussis, polio, hepatitis B, and Hib vaccination or disease since the study 10PN-PD-DIT-002 (105539), with the exception of hepatitis B vaccination in the DTPa-IPV/Hib group. •Administration of immunoglobulins and/or any blood products within the 3 months prior to blood sampling. •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required) . •Family history of congenital or hereditary immunodeficiency.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the immunogenicity of the DTPa-HBV-IPV/Hib and DTPa-IPV/Hib vaccines in terms of persistence of antibodies to all vaccine antigens in 5-year-old children. ;Secondary Objective: -;Primary end point(s): •Immunogenicity with respect to the components of the study vaccines in terms of antibody persistence at 5 years of age. ?- Anti-D, anti-T, anti-PT, anti-FHA, anti-PRN, anti-poliovirus type 1, anti-poliovirus type 2, anti-poliovirus type 3 and anti-PRP antibody concentrations or titres and seroprotection or seropositivity status, in both groups. ?- Anti-HBs antibody concentration and seroprotection status, in the DTPa-HBV-IPV/Hib group. ;Timepoint(s) of evaluation of this end point: Visit 1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -;Timepoint(s) of evaluation of this end point: - | — |
Countries
Norway, Sweden
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals
Outcome results
None listed