Primary immunization of healthy infants against diphtheria, tetanus, pertussis, hepatitis B, polio and Haemophilus influenzae type b diseases.
Conditions
Interventions
Trade Name: INFANRIX-IPV+HIB
Pharmaceutical Form: Powder and suspension for suspension for injection
INN or Proposed INN: NA
Other descriptive name: DIPHTHERIA TOXOID
Concentration unit: IU internatio
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must have been enrolled in the Rota-028 study. Subjects for whom the investigator believes that their par-ents/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. Written informed consent obtained from the parent or guard-ian of the subject. Free of obvious health problems as established by medical history and clinical examination before entering into the study. Subjects should have received two doses of hepatitis B vac-cine: at birth and at approximately one month of age. Are the trial subjects under 18? yes Number of subjects for this age range: 702 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: Chronic administration of immunosuppressants or other immune-modifying drugs during the study period. Planned administration/ administration of a vaccine not fore-seen by the study protocol during the period starting from 30 days before each dose of the vaccine and ending 30 days after. Any confirmed or suspected immunosuppressive or immu-nodeficient 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. All vaccines can be administered to persons with a minor illness such as diar-rhoea, 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 since birth or planned administration during the study period. A family history of congenital or hereditary immunodeficiency. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety and reactogenicity of the DTPa-HBV-IPV/Hib vaccine and DTPa-IPV/Hib vaccine.;Secondary Objective: Not applicable;Primary end point(s): Occurrence of solicited local and general adverse events. ;Timepoint(s) of evaluation of this end point: During the 4-day follow up period (Day 0 to Day 3) after vaccination. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Occurrence of unsolicited local and general adverse events. Occurrence of large swelling reactions. Occurrence of serious adverse events. ;Timepoint(s) of evaluation of this end point: For occurrence of unsolicited local and general adverse events: During the 30-day follow up period (Day 0 to Day 29) after vaccination. For occurrence of large swelling reactions: After booster dose at Visit 4 (Month 15). For occurrence of serious adverse events: During the entire study period (Day 0 to Month 21). | — |
Countries
Singapore
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals
Outcome results
None listed