Booster vaccination of healthy toddlers in the second year of life against diphtheria, tetanus, pertussis, poliomyelitis and Haemophilus influenzae type b diseases
Conditions
Interventions
Trade Name: Infanrix-IPV+Hib
Product Code: DTPa-IPV/Hib
Pharmaceutical Form: Powder and suspension for suspension for injection
INN or Proposed INN: -
Current Sponsor code: D
Other descriptive name: D
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits). •A male or female between, and including, 12 and 24 months of age at the time of vaccination. •Written informed consent obtained from the parent(s)/LAR(s) of the subject. •Healthy subjects as established by medical history and clinical examination before entering into the study. •Subjects who were primed with three doses of a DTP and polio vaccine in the first 6 months of life, and who have received the last dose of the primary vaccination at least six months before the receipt of study vaccine. Are the trial subjects under 18? yes Number of subjects for this age range: 321 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 (drug or vaccine) other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period. •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. •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). •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 (pharmaceutical product or device). •Evidence of previous or intercurrent booster vaccination against diphtheria, tetanus, pertussis, poliomyelitis and/or Hib disease or vaccination. •History of any neurological disorders or seizures. •History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine. •Major congenital defects or serious chronic illness. •Acute disease and/or fever at the time of enrolment. The subject may be vaccinated at a later date, within the time window specified in the protocol. -Fever is defined as temperature >= 37.5°C on oral, axillary or tympanic setting, or >= 38.0°C on rectal setting. The preferred route for recording temperature in this study will be axillary. -Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever maybe enrolled at the discretion of the investigator. •Administration of immunoglobulins and/or any blood products within the three months preceding vaccination or planned administration during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety and reactogenicity of the study vaccine in terms of solicited symptoms, unsolicited symptoms and serious adverse events (SAEs).;Secondary Objective: Not applicable;Primary end point(s): Safety and reactogenicity after booster vaccination. -Occurrence of solicited local and general symptoms. -Occurrence of unsolicited adverse events. -Occurrence of Serious Adverse Events.;Timepoint(s) of evaluation of this end point: -Occurrence of solicited local and general symptoms-During the 4-day (Day 0–Day 3) follow-up period after booster vaccination. -Occurrence of unsolicited adverse events-During the 31-day (Day 0-30) follow-up period following the booster dose of the study vaccine. -Occurrence of Serious Adverse Events-From Day 0 to Day 30. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Not applicable;Secondary end point(s): Not applicable | — |
Countries
Vietnam
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals
Outcome results
None listed