Booster immunisation of healthy children against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b diseases.
Conditions
Sponsors
GlaxoSmithKline Biolgicals
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 should be enrolled in the study. Subjects must have completed full three-dose primary vaccination course with DTPa-HBV-IPV/Hib (new formulation/ current formulation) or DTPa-HBV-IPV in the primary study DTPa-HBV-IPV-109 (105910). A male or female between, and including 18 and 23 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: 283 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 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) of immunosuppressants or other immune-modifying drugs within six months prior to the booster dose. (For corticos-teroids, this will mean prednisone, or equivalent, more than 0.5 mg/kg/day. Inhaled and topical steroids are allowed). Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the booster dose. Participation in another clinical study, between the primary study DTPa-HBV-IPV-109 (105910) 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). Previous booster vaccination against diphtheria, tetanus, pertussis, poliomyelitis and hepatitis B since the conclusion visit of study DTPa-HBV-IPV-109 (105910). Previous booster vaccination against Haemophilus influ-enzae diseases in the DTPa-HBV-IPV/Hib groups, since the conclusion visit of study DTPa-HBV-IPV-109 (105910). History of exposure to diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and/or Haemophilus influenzae disease since the conclusion visit of study DTPa-HBV-IPV-109 (105910). Any confirmed or suspected immunosuppressive or im-munodeficient 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that the immunogenicity of the DTPa-HBV-IPV/Hib vaccine (new formulation) in terms of response to all vaccine antigens is non-inferior to that of the DTPa-HBV-IPV/Hib vaccine (current formulation), one month after the booster dose.;Secondary Objective: To assess the immunogenicity of the DTPa-HBV-IPV/Hib vaccine (new formulation) in terms of antibody response to all vaccine antigens (i.e. hepatitis B, PRP, diphtheria, tetanus and poliovirus types 1, 2 and 3, PT, FHA and PRN) before booster vaccination, in comparison with the DTPa-HBV-IPV/Hib vaccine (current formulation). To assess the immunogenicity of the DTPa-HBV-IPV vaccine in terms of antibody response to all vaccine anti-gens before and one month after booster vaccination. To assess the safety and reactogenicity of the study vaccines administered in all groups as a booster dose, in terms of solicited symptoms (local and general), unsolicited symptoms and serious adverse events (SAEs). ;Primary end point(s): Seroprotection status in the DTPA-HBV-IPV/Hib groups: Anti-HBs antibody concentrations more than or equal to 10 mIU/ml. Anti-PRP antibody concentrations more than or equal to 0.15 µg/ml. Anti-diphtheria antibody concentrations more than or equal to 0.1 IU/ml. Anti-tetanus antibody concentrations more than or equal to 0.1 IU/ml. Anti-poliovirus type 1 titers more than or equal to 8. Anti- poliovirus type 2 titers more than or equal to 8. Anti-PT, anti-FHA and anti-PRN antibody concentrations one month after the booster dose. Anti-poliovirus type 3 titers more than or equal to 8. ;Timepoint(s) of evaluation of this end point: One month after the booster dose (Month 1). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Immunogenicity endpoint 1: Anti-HBs antibody concentrations more than or equal to 100 mIU/ml. Anti-PRP antibody concentrations more than or equal to 1.0 µg/ml Anti-PT, anti-FHA and anti-PRN seropositivity (antibody concentrations more than or equal to 5 El.U/ml). Vaccine response rates to PT, FHA and PRN, de-fined as appearance of antibodies in subjects who were seronegative at the pre-vaccination time point (i.e. with concentrations < 5 El.U/ml) or at least 2-fold increase of pre-vaccination antibody concentrations in subjects who were seropositive at the pre-vaccination time point (i.e. with concentrations more than or equal to 5 El.U/ml). Anti-HBs, anti-PRP, anti-diphtheria, anti-tetanus and anti-poliovirus types 1, 2 and 3 antibody concentrations or titres. Immunogenicity endpoint 2: Anti-HBs antibody concentrations more than or equal to 10 mIU/ml and ? 100 mIU/ml Anti-PRP antibody concentrationsmore than or equal to 0.15 µg/ml Anti-diphtheria antibody concentrations more than or equal to 0.1 IU/ml Anti-tetanus antibody concentrations more than or equal to 0.1 IU/ml Anti-poliovirus type 1 titers more than or equal to 8 Anti- poliovirus type 2 titers more than or equal to 8 Anti-poliovirus type 3 titers more than or equal to 8 Anti-PT, anti-FHA and anti-PRN seropositivity (an-tibody concentrations more than or equal to 5 El.U/ml) Anti-HBs, anti-PRP, anti-diphtheria, anti-tetanus and anti-poliovirus types 1, 2 and 3, anti-PT, anti-FHA and anti-PRN antibody concentrations or titres. Occurrence of solicited local symptoms. Occurrence of solicited general symptoms. Occurrence of unsolicited symptoms. Occurrence of serious adverse events (SAEs).;Timepoint(s) of evaluation of this end point: For immunogenecity endpoint 1: One month after the booster dose in the DTPa-HBV-IPV/Hib groups (Month 1). For immunogenecity endpoint 2: Before the booster dose in the DTPa-HBV-IPV/Hib groups (Month 0). Before and after the booster | — |
Countries
Russian Federation
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biolgicals
Outcome results
None listed