Primary immunisation of healthy infants in the first year of life against diphtheria, tetanus, pertussis, hepatitis B, polio and Hib diseases.
Conditions
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A male or female between, and including, 6 and 10 weeks of age at the time of the first vaccination. Documented administration of a hepatitis B vaccine dose at birth. Subjects who the investigator believes that their parent(s)/legally acceptable representatives can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits). Written informed consent obtained from the parents/LARs of the subject. Healthy subjects as established by medical history and clinical examination before entering into the study. Born after a gestation period of at least 36 weeks. Are the trial subjects under 18? yes Number of subjects for this age range: 214 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. Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose, 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. For corticosteroids, this will mean prednisone more than or equal to 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed. Administration of a vaccine not foreseen by the study protocol, within 30 days prior to the first study visit, or planned administration during the study period, with the exception of oral human rotavirus vaccination which is al-lowed at any time during the study. 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. Evidence of previous diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Hib vaccination or disease, with the exception of a birth dose of hepatitis B vaccine and OPV as per local standard of care. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. Family history of congenital or hereditary immunodefi-ciency. History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine. Major congenital defects or serious chronic illness. Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. Acute disease and/or fever at the time of enrolment. Fever is defined as temperature more than or equal to 37.5°C/99.5°F on oral, axillary or tympanic set-ting, or more than or equal to 38.0°C/100.4°F on rectal setting. The preferred route for recording temperature in this study will be oral/axillary. Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the immunological response to the study vaccine in terms of seroprotection status for diphtheria, tetanus, polio, hepatitis B (HB) and Haemophilus influenza type b (Hib) anti-gens, and in terms of vaccine response for the pertussis (PT) antigens, one month after the third dose of the primary vacci-nation.;Secondary Objective: To assess the immunological response to the study vac-cine in terms of seroprotection/seropositivity status and antibody concentrations or titres for all antigens, one month after the third dose of the primary vaccination. To assess the immunological status towards hepatitis B, pertussis and polio antigens in terms of antibody concen-trations, before the first dose of the primary vaccination. To assess the safety and reactogenicity of the study vaccine in terms of solicited and unsolicited, local and general symptoms and serious adverse events.;Primary end point(s): Immunogenicity with respect to components of the study vaccine: Anti-diphtheria, anti-tetanus, anti-HBs, anti poliovirus type 1, anti-poliovirus type 2, anti poliovirus type 3 and anti-PRP seroprotection status. Vaccine response to PT, FHA and PRN. ;Timepoint(s) of evaluation of this end point: At Week 18/Month 7. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Immunogenicity with respect to components of the study vaccine: Anti-diphtheria, anti-tetanus, anti-HBs, anti poliovirus type 1, anti-poliovirus type 2, anti poliovirus type 3, anti-PRP, anti-PT, anti-FHA, anti-PRN antibody concentrations or titres. Anti-PT, anti-FHA, anti-PRN antibody seropositivity status. Anti-poliovirus type 1, anti-poliovirus type 2, anti poliovirus type 3, anti-PT, anti-FHA, anti-PRN and anti-HBs antibody titres or concentrations and seropositivity/seroprotection status. Occurrence of solicited local and general symptoms. Occurrence of unsolicited symptoms. Occurrence of serious adverse events (SAEs).;Timepoint(s) of evaluation of this end point: For immunogenicity with respect to components of the study vaccine: At Week 18/Month 7. For anti-poliovirus type 1, anti-poliovirus type 2, anti poliovirus type 3, anti-PT, anti-FHA, anti-PRN and anti-HBs antibody titres or concentrations and seropositivity/seroprotection status: Month 0 For occurrence of solicited local and general symptoms: During the 4-day (Day 0-Day 3) follow-up period after each vaccination. For occurrence of unsolicited symptoms: During the 31 day (Day 0-Day 30) follow-up period after each vaccination. For occurrence of serious adverse events (SAEs): From Dose 1 up to study end (Month 0 to Month 7). | — |
Countries
India
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals
Outcome results
None listed