Booster immunization of healthy children in the second year of life against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, Haemophilus influenzae type b (Hib) and serogroup C meningococcal (Men C) diseases.
Conditions
Interventions
Product Code: DTPa-HBV-IPV/Hib-MenC-TT
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Purified diphtheria toxoid (D)
Concentration unit: IU international unit(s)
Concentration type
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Subjects who the investigator believes that parent(s)/ Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits). - Subjects who have completed the full three-dose primary vaccination course according to their group allocation in the primary study DTPa-HBV-IPV=Hib-MenC-TT-002 (112157). - A male or female between, and including, 12 and 18 months of age at the time of booster 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. Are the trial subjects under 18? yes Number of subjects for this age range: 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 dose of 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 vaccination. For corticosteroids, this will mean prednisone =0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed. - Planned administration/administration of immunoglobulins and/or any blood products within three months before the booster dose, or during the study period. - Planned administration/administration of any vaccine not foreseen by the study protocol during the period starting 30 days before and ending 30 days after the booster dose. - Participation in another clinical study since the primary study DTPa-HBV-IPV/Hib-MenC-TT-002 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, hepatitis B, poliomyelitis, Hib, pneumococcal and MenC vaccination or disease since the conclusion visit of study DTPa-HBV-IPV/Hib-MenC-TT-002 (Pneumococcal vaccination is allowed in the MnC-CRM Group). - Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). - History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines. - The following adverse event having occurred after previous administration of 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, generalized or focal seizures that persist more than a few hours, with failure to recover within 24 hours. - Temperature of = 40.5°C (rectal 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 = 37.5°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 may, be enrolled at the discretion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Note: Objectives are conditional to having met all the primary and secondary objectives in study DTPa-HBV-IPV=Hib-MenC-TT-002 (112157). - To demonstrate that GSK Biologicals’ DTPa-HBV-IPV/Hib-MenC-TT vaccine is non-inferior to Menjugate co-administered with Infanrix hexa in terms of seroprotection to MenC one month after the booster dose. - To demonstrate that GSK Biologicals’ DTPa-HBV-IPV/Hib-MenC-TT vaccine is non-inferior to Infanrix hexa co-administered with NeisVac-C in terms of seroprotection to PRP and MenC, one month after the booster dose.;Secondary Objective: - To demonstrate that GSK Biologicals’ DTPa-HBV-IPV/Hib-MenC-TT vaccine is non-inferior to Infanrix hexa co-administered with NeisVac-C in terms of seroprotection to diphtheria, tetanus, hepatitis B, and poliovirus types 1, 2 and 3, and in terms of antibody GMCs to pertussis antigens one month after the booster dose. - To assess the persistence of the immune response to the study vaccines in terms of seroprotection/seropositivity rates and geometric mean concentrations/titres (GMCs/Ts) for all antigens, before the booster dose. - To assess the immune response to the study vaccines in terms of seroprotection/seropositivity, GMCs/Ts to all antigens, in terms of booster response to pertussis antigens and GMC fold change in rSBA-MenC titres and anti-PRP concentrations. - To assess the safety and reactogenicity of the study vaccines in terms of solicited, unsolicited, local and general symptoms and serious adverse events.;Primary end point(s): - Immune response to the study vaccine antigens. One month after the booster dose: - anti-PRP antibody concentrations = 0.15 µg/ml, - rSBA-MenC antibody titres = 8. | — |
Countries
Poland
Outcome results
None listed