Booster vaccination against Haemophilus influenzae type b and meningococcal serogroup C diseases.
Conditions
Interventions
Product Name: Hib-MenC conjugate vaccine
Product Code: Hib-MenC-TT
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Polirribosil Ribitol Fosfato (PRP) de Hib conjugado con t
Sponsors
GlaxoSmithKline
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? 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, 13 and 14 months of age at the time of booster vaccination. ? 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. ? Having participated in the primary vaccination study 217744/097 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: ? Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the booster vaccine, or planned use during the study period. ? Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. (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 within 30 days of the booster vaccine. ? Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B, polio, H. influenzae type b (Hib) and/or meningococcal serogroup C disease except if within the framework of study 217744/097. ? History of diphtheria, tetanus, pertussis, hepatitis B, polio, Hib and/or meningococcal serogroup C disease. ? Known exposure to diphtheria, tetanus, pertussis, hepatitis B, polio, Hib and/or meningococcal serogroup C disease within the last 3 months. ? Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection. ? A family history of congenital or hereditary immunodeficiency. ? History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. ? Major congenital defects or serious chronic illness. ? History of any neurologic disorders or seizures including febrile seizures (at least 2 events) in infancy. ? 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, mild upper respiratory infection with or without low-grade febrile illness, i.e., Oral temperature <37.5°C / Axillary temperature <37.5°C / Rectal temperature <38°C. ? Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Co-primary objectives In subjects primed in the previous primary vaccination study 217744/097: ? One month after booster vaccination with a Hib-MenC conjugate vaccine, to evaluate the non-inferiority of the Hib component (anti-PRP >/= 1 mcg/ml) in toddlers aged 13-14 months and primed in infancy with 3 doses of Hib-MenC + DTPa-IPV-HBV or 2 doses of NeisVac-C + DTPa-(HBV)-IPV/Hib compared with infants primed with 3 doses of Meningitec and DTPa-HBV-IPV/Hib and boosted with DTPa-HBV-IPV/Hib. ? In the same subjects, to evaluate the immunogenicity in terms of the Men C component of the booster vaccine (SBA-MenC titer >/= 1:128). ;Primary end point(s): One month after the booster vaccination: In all subjects Anti-PRP antibody concentration >/=1µg/ml In subjects boosted with the Hib-MenC vaccine SBA-MenC titre >/= 1:128 ;Secondary Objective: To evaluate: ? The non-inferiority of the Hib-MenC booster versus the control group (anti-PRP >/= 1 mcg/ml) and the immunogenicity (SBA-Men C >/= 1:128). ? The persistence of Hib, MenC and tetanus antibodies after primary vaccination (13-14 months of age). ? The persistence to diphtheria, hepatitis B, polio and pertussis antibodies in 50% of subjects. ? The Hib, MenC and tetanus immune responses in all subjects induced by the booster dose. ? Safety and reactogenicity of the booster dose. | — |
Countries
Spain
Outcome results
None listed