Primary and booster immunisation of healthy infants in the first two years of life against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, Haemophilus influenzae type b, rotavirus and pneumococcal diseases. MedDRA version: 12.1 Level: LLT Classification code 10043376 Term: Tetanus MedDRA version: 12.1 Level: LLT Classification code 10013023 Term: Diphtheria MedDRA version: 12.1 Level: LLT Classification code 10034738 Term: Pertussis MedDRA version: 12.1 Level: LLT Classification
Conditions
Interventions
Product Name: Reduced-antigen-content tri-component acellular pertussis vaccine
Product Code: PA-TRICOMP
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Pertussis toxoid
Other descr
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All subjects must satisfy ALL the following criteria at study entry: -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 follow-up visits). -Written informed consent obtained from the parent(s)/LAR(s) of the subject. -A male or female infant between, and including, 0 and 7 days of age at the time of randomisation. -Subjects who are born after an uncomplicated gestation period of 36 to 42 weeks inclusive. -Subjects born to a mother seronegative for hepatitis B surface antigen. -Subjects with a birth weight >= 2.5 kg. -Subjects with a 5-minute Apgar score >= 7. -Healthy subjects as established by medical history and clinical examination. 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: The following criteria should be checked at the time of study entry. If ANY exclusion criterion applies, the subject must not be included in the study: -Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines since birth, or planned use during the study period. -Born to a mother known or suspected to be seropositive for HIV (testing not required for inclusion). -Family history of congenital or hereditary immunodeficiency. -Children in care. -Neonatal jaundice requiring systemic treatment (light therapy is allowed). -Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. -Administration of any vaccine since birth or planned administration during the study period with the exception of inactivated influenza vaccines, which can be administered seven days away from any dose of the study vaccine. The administration of routinely recommended vaccines (e.g. meningococcal serogroup C conjugate vaccine, measles-mumps-rubella vaccine) is allowed during the period ffrom completion of all study-related procedures at study Visit 7 to 30 days before study Visit 8. -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). -History of seizures or progressive neurological disease. -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. -Major congenital defects or serious chronic illness, including perinatal brain damage. 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: -Current febrile illness or temperature >= 37.5°C on axillary setting, or >= 38.0°C on rectal setting, or other moderate to severe illness within 24 hours of study vaccine administration
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The co-primary objectives will be assessed sequentially. A co-primary objective can only be met if the statistical criteria for this particular objective, as well as those for all previous objectives are met. - To demonstrate that, the immune response in the “Pa” group is superior to that in the “Control” group for at least one pertussis antigen, one month after the first dose of primary vaccination. -To demonstrate that the percentage of subjects with seroprotective concentrations of antibodies to Hib and hepatitis B in the “Pa” group is non-inferior to that in the “Control” group, one month after the third dose of primary vaccination. ;Secondary Objective: -To assess the immune response to the study vaccines in terms of seroprotection / seropositivity and antibody GMC/GMTs, one month after the second dose of primary vaccination, one month after the third dose of primary vaccination, and one month after booster vaccination. -To assess the safety and reactogenicity of the study vaccines 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 vaccines. -Anti-PT, anti-FHA and anti-PRN antibody concentrations, one month after the first dose of primary vaccination. -Anti-PRP and anti-HBs seroprotection status, one month after the third dose of primary vaccination. | — |
Countries
Belgium, Netherlands, United Kingdom
Outcome results
None listed