Primary immunization of healthy infants in the first year of life against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis diseases and, if applicable, Haemophilus influenzae type b disease.
Conditions
Sponsors
GlaxoSmithKline Biologicals
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. A male or female between, and including, 11 and 17 weeks of age at the time of the first vaccination. Infant born to known hepatitis B surface antigen seronegative mother. Born after a normal gestation period. Written informed consent obtained from the parent or guardian of the subject. Free of obvious health problems 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: 417 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 other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. Any chronic drug therapy to be continued during the study period. Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of study vaccine and ending 30 days after the last vaccine dose. Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and/or Haemophilus influenzae diseases. Known history of or exposure to diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and/or Haemophilus influenzae diseases since birth. History of allergic disease or reactions likely to be exacerbated by any component of the vaccines. Any confirmed or suspected immunosuppressive or im-munodeficient condition, based on medical history and physical examination. A family history of congenital or hereditary immunodefi-ciency. Major congenital defects or serious chronic illness. History of any neurologic disorders or seizures. Acute or chronic, clinically significant pulmonary, cardio-vascular, hepatic or renal functional abnormality, as determined by physical examination. Hepatomegaly, right upper quadrant abdominal pain or tenderness. Acute disease at the time of enrolment. Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. Other conditions which in the opinion of the investigator may potentially interfere with interpretation of study outcomes.
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 a three-dose primary vaccination course.;Secondary Objective: To assess the immunogenicity of all vaccine antigens (i.e. hepatitis B [HB], polyribosyl-ribitol phosphate [PRP] , diphtheria, tetanus and poliovirus types 1, 2 and 3, per-tussis toxin [PT], filamentous haemagglutinin [FHA] and pertactin [PRN]) in the two DTPa-HBV-IPV/Hib groups. To assess the immunogenicity of all vaccine antigens (i.e. hepatitis B, diphtheria, tetanus and poliovirus types 1, 2 and 3, PT, FHA and PRN) in the DTPa-HBV-IPV group. To assess the safety and reactogenicity of the study vaccines administered in all groups as a three-dose primary vaccination course, in terms of solicited symptoms (local and general), unsolicited symptoms and serious adverse events (SAEs). ;Primary end point(s): Seroprotection status defined as: 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-poliovirus type 3 titers more than or equal to 8. Anti-PT, anti-FHA and anti-PRN antibody concentrations.;Timepoint(s) of evaluation of this end point: One month after the third vaccine dose (Month 3). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Immunogenicity endpoints: 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. Anti-HBs, anti-PRP, anti-diphtheria, anti-tetanus antibody concentrations and anti-poliovirus types 1, 2 and 3 titres. Safety endpoints: 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: Immunogenecity endpoints: One month after the third vaccine dose (Month 3). Safety endpoints: For occurence of solicited local and general symptoms: During the 4-day (Day 0- Day 3) follow-up period after each vaccination. For occurence of unsolicited symptoms: During the 31-day (Day 0- Day 30) follow-up period after each vaccination. For occurence of serious adverse events: During the entire study period (Month 0 to Month 3). | — |
Countries
Russian Federation
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals
Outcome results
None listed