Booster vaccination against Streptococcus pneumoniae, Neisseria meningitidis and Haemophilus influenzae type b in healthy infants 11 to18 months of age who were previously primed with three doses of pneumococcal conjugate vaccine co-administered with three doses of DTPa-combined and MenC or Hib-MenC vaccines.
Conditions
Interventions
TT:14-DT:9
Trade Name: Menitorix
Product Name: Menitorix
Product Code: HibMenC
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Haemophilus B-TT and neisseria m
TT: 10
Trade Name: Prevenar
Product Name: Prevenar
Pharmaceutical Form: Suspension for injection
Trade Name: Meningitec
Product Name: Meningitec
Pharmaceutical Form: Suspension for injection
Trade
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All subjects must satisfy the following criteria at study entry: • Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) should be enrolled in the study. • A male or female between, and including, 11-18 months of age at the time of the booster vaccination. • A male or female who previously participated in study 10PN-PD-DIT-011 (107005) and received three doses of pneumococcal conjugate vaccine. • Written informed consent obtained from the parent or guardian of the subject. • Free of obvious health problems 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: subject must not be included in the study: • Concurrently participating in another clinical study, at any time during the study period (active phase and extended safety follow-up), in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device). • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within one month (30 days) preceding the booster dose of study vaccines, or planned use during the entire study period (active phase and extended safety follow-up). • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the booster dose of study vaccines. (For corticosteroids, this will mean prednisone, or equivalent, ? 0.5 mg/kg/day. Inhaled and topical steroids are allowed.) • Planned administration/administration of a vaccine not foreseen by the study protocol, during the period starting one month (30 days) before the booster dose of study vaccines (Visit 1) and up to the follow-up visit (Visit 2). • Administration of any pneumococcal, diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, MenC and/or Hib-MenC vaccines other than the study vaccines from study 10PN-PD-DIT-011 (107005). • History of , or intercurrent, diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, meningococcal serogroup C disease. • History of allergic disease or reactions likely to be exacerbated by any component of the vaccines. • History of seizures (subjects who have had a single, uncomplicated febrile convulsion in the past can be included) or progressive neurological disease. • Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhea or mild upper respiratory infections with or without low-grade febrile illness, i.e. oral/axillary/tympanic temperature <37.5°C / rectal temperature <38.0°C). • Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing required). • A family history of congenital or hereditary immunodeficiency. • Major congenital defects or serious chronic illness. • Administration of immunoglobulins and/or any blood products within three months preceding the booster dose of study vaccines or planned administration during the active phase of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of the study is to demonstrate that a booster dose GSK Biologicals’ 10-valent pneumococcal conjugate vaccine is non-inferior to Prevenar, both co-administered with DTPa-HBV-IPV and Hib-MenC vaccines, in terms of post-immunization febrile reactions with rectal fever > 39.0°C in children at 11 to 18 months of age. Criteria for safety: Non-inferiority will be demonstrated if the upper limit of the 95% CI of the difference (Group 10Pn + Hib-MenC minus Group Prevenar), in terms of percentage of subjects with rectal fever >39.0°C, is lower than 10%. ;Secondary Objective: • To assess the safety and reactogenicity of a booster dose of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine, when co-administered with a DTPa-combined and MenC or Hib-MenC vaccines at 11 to 18 months of age. • To assess, one month post booster vaccination, the immunogenicity (in a subset of subjects) of a booster dose of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine, when co-administered with a DTPa-combined and MenC or Hib-MenC vaccines at 11 to 18 months of age. • To assess the antibody persistence (in a subset of subjects) induced by GSK Biologicals’ 10-valent pneumococcal conjugate vaccine or Prevenar and Hib-MenC, 5-12 months after completion of the 3-dose immunization course • To assess the immunogenicity (in a subset of subjects) of a booster dose of GSK Biologicals’ Hib-MenC conjugate vaccine when co-administered with GSK Biologicals’ 10-valent pneumococcal conjugate vaccine or Prevenar and DTPa-HBV-IPV at 11-18 months of age.;Primary end point(s): Safety • Occurrence of rectal fever >39°C within 4 days (day 0-day 3) after the booster vaccination. | — |
Countries
Germany, Poland, Spain
Outcome results
None listed