Booster immunisation of healthy children in the second year of life against diphtheria, tetanus, pertussis, poliomyelitis and Haemophilus influenzae type b (Hib) diseases.
Conditions
Interventions
Trade Name: Infanrix+Hib
Product Code: DTPa+Hib
Pharmaceutical Form: Powder and suspension for suspension for injection
INN or Proposed INN: -
Current Sponsor code: D
Other descriptive name: DIPHTHERI
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •A male or female child between, and including, 18 and 24 months of age at the time of the booster vaccination. •Subjects who completed the full three-dose primary vaccination course in the DTPA-IPV-056 (112584) study. •Subjects who the investigator believes that their parent(s)/ LAR(s) can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for the follow-up visit). •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. Are the trial subjects under 18? yes Number of subjects for this age range: 831 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 vaccines within 30 days preceding the booster dose of the study vaccine, or planned use during the study period. •Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the booster dose. For corticosteroids, this will mean prednisone >= 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 booster vaccination, or planned administration during the study period. •Participation in another clinical study within three months prior to enrolment in the present booster study or at any time during the present booster study, 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 diphtheria, tetanus, pertussis, poliomyelitis and Hib, vaccination or disease since the con-clusion visit of primary study DTPA-IPV-056 (112584). •Serious chronic illness. •Administration of immunoglobulins and/or any blood products within the 90 days preceding the booster dose of study vaccine or planned administration during the study period. •Occurrence of any of the following adverse events (AEs) after a previous administration of a DTP vaccine. -Encephalopathy defined as an acute, severe central nervous system disorder occurring within 7 days following vaccination and generally consisting of major alterations in consciousness, unresponsiveness, generalised or focal seizures that persist more than a few hours, with failure to recover within 24 hours. -Temperature of = 40.0°C (axillary temperature) within 48 hours of vaccination, not due to another identifiable cause. -Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours of vaccination. -Persistent, inconsolable crying occurring within 48 hours of vaccination and lasting = 3 hours. -Seizures with or without fever occurring within 3 days of vaccination. •The following condition is temporary or self-limiting, and a subject may be vaccinated once the condition has resolved if no other exclusion criteria is met: Acute disease and/or fever at the time of enrolment. -Fever is defined as temperature = 37.1°C on oral, axillary or tympanic setting, or = 37.6°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 may, be enrolled at the discretion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •To assess the persistence of antibodies to all vaccine antigens before the booster dose. •To assess the immune response to the study vaccines in terms of seroprotection to diphtheria, tetanus, Haemophilus influenzae type b and poliovirus types 1, 2 and 3, and in terms of vaccine response to the pertussis antigens, one month after booster vaccination. •To assess the immune response to the study vaccines in terms of antibody concentrations or titres for all antigens, one month after the booster dose. ;Secondary Objective: •To assess the safety and reactogenicity of the booster dose of the study vaccines in terms of solicited and unsolicited, local and general symptoms and serious adverse events.;Primary end point(s): •Anti-diphtheria, anti-tetanus, anti-PRP, anti-poliovirus type 1, 2 and 3, anti-PT, anti-FHA and anti-PRN seroprotection and/or seropositivity status and antibody concentrations or titers. •Anti-diphtheria, anti-tetanus, anti-PRP, anti-poliovirus type 1, 2 and 3, anti-PT, anti-FHA and anti-PRN seroprotection and/or seropositivity status and antibody concentrations or titers. -Vaccine response to the pertussis antigens. ;Timepoint(s) of evaluation of this end point: •Anti-diphtheria, anti-tetanus, anti-PRP, anti-poliovirus type 1, 2 and 3, anti-PT, anti-FHA and anti-PRN seroprotection and/or seropositivity status and antibody concentrations or titers-Month 0. •Anti-diphtheria, anti-tetanus, anti-PRP, anti-poliovirus type 1, 2 and 3, anti-PT, anti-FHA and anti-PRN seroprotection and/or seropositivity status and antibody concentrations or titers-At Month 0 and Month 1. -Vaccine response to the pertussis antigens-Month 1. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -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 0-3) follow-up period following the booster dose of the study vaccine. -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 Month 0 to Month 1. | — |
Countries
China
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals
Outcome results
None listed