Primary immunisation of healthy infants in the first year of life against diphtheria, tetanus, pertussis, hepatitis B, polio, Haemophilus influenzae type b diseases.
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 infant between, and including, 6 to 10 weeks of age at the time of the first vaccination. 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. Born after a normal gestation period Should have received a birth dose of hepatitis B vaccine, as evidenced by vaccination/ immunisation certificate. Are the trial subjects under 18? yes Number of subjects for this age range: 224 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 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 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 30 days before the administration of the first vaccine dose and ending 30 days after the last dose. Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis and Haemophilus influenzae type b diseases. Known exposure to diphtheria, tetanus, Bordetella pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b diseases since birth. Known immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection. A family history of congenital or hereditary immunodeficiency. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. Major congenital defects or serious chronic illness. History of any neurologic disorders or seizures. Acute disease at the time of enrolment. 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. Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Seroprotection defined as: anti-HBs antibody concentration more than or equal to 10 mIU/ml. anti-PRP antibody concentration more than or equal to 0.15 microgm/ml and more than or equal to 1.0 µg/ml. Anti-diphtheria and anti-tetanus antibody concentrations more than or equal to 0.1 IU/ml. Anti-diphtheria, anti-tetanus, anti-PT, anti-FHA, anti-PRN, anti-HBs, anti-poliovirus 1, 2 and 3 and anti-PRP antibody concentrations or titres. Occurrence of solicited local and general symptoms. Occurrence of unsolicited symptoms. Occurrence of serious adverse events.;Timepoint(s) of evaluation of this end point: Seroprotection status: One month after third dose of vaccination in both the groups (Week 18/Month 7). Occurrence of solicited local and general symptoms: For 4 days [Day 0 – Day3]after each vaccination dose. Occurrence of unsolicited symptoms: For 31 days [Day 0 – Day30] after each vaccination dose. Occurrence of serious adverse events:During the entire study period (Month 0 to Week 18/Month 7). | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the antibody response to pertussis toxin (PT), filamentous haemagglutinin (FHA), pertactin (PRN) and poliovirus types 1, 2, 3 after a three-dose primary vaccination course with Infanrix hexa.;Secondary Objective: To assess the antibody response to recombinant hepatitis B surface antigen, diphtheria toxoid, tetanus toxoid and Haemophilus influenzae type b (Hib) capsular poly-saccharide polyribosyl-ribitol phosphate (PRP) after a three-dose primary vaccination course with Infanrix? hexa. To evaluate the reactogenicity and safety of GSK Biologicals’ Infanrix™ hexa when administered as a three-dose primary vaccination course. ;Primary end point(s): Vaccine response to PT, FHA, and PRN. Seroprotection against poliovirus types 1, 2, and 3, defined as anti-poliovirus neutralizing antibody titres more than or equal to 8 for all three types.;Timepoint(s) of evaluation of this end point: One month after third dose of vaccination in both the groups (Week 18/Month 7). | — |
Countries
India
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals
Outcome results
None listed