Vacunación primaria frente a las enfermedades producidas por Haemophilus influenzae tipo b y meningococo del serogrupo C en lactantes prematuros y nacidos a término en los 6 primeros meses de vida, con un recuerdo en el segundo año de vida. Primary vaccination against Haemophilus influenzae type b and meningococcal serogroup C diseases of preterm and full-term infants in the first 6 months of life with a booster in the second year of life.
Conditions
Interventions
Trade Name: Menitorix
Product Name: Menitorix
Product Code: Hib-MenC-TT
Pharmaceutical Form: Powder for suspension for injection
INN or Proposed INN: Haemophilus influenza type b polysaccharide (PRP)
Sponsors
GlaxoSmithKline S.A.
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, 8 and 12 weeks of age at the time of the first vaccination. • Written informed consent obtained from the parent or guardian of the subject. All Preterm subjects must satisfy the following criteria at study entry: • Born after a gestation period of less than or equal to 36 weeks (=259 days and =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 apply, the subject must not be included in the study: • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth. (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 in the period starting 30 days before the first dose of vaccine until the last study visit, except measles-mumps-rubella (MMR) and varicella vaccines which may be given according to local immunisation practices (although still outside a 30-day window before and after the day of administration of study vaccine) and except rotavirus oral vaccine which is allowed at anytime during the study after hospital discharge as per prescribing information. • Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, meningococcal serogroup C and or Streptococcus pneumoniae disease, with the exception of hepatitis B vaccine or BCG vaccine given in the first month of life according to the national recommendations (although BCG and hepatitis B vaccines should be given outside a 30-day window from the first administration of study vaccines). • History of diphtheria, tetanus, pertussis, polio, hepatitis B, H. influenzae type b, meningococcal disease and or S. pneumoniae disease. • Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection, based on medical history and physical examination (no laboratory testing required). • A family history of congenital or hereditary immunodeficiency. • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s). • Major congenital defects or serious chronic illness. • History of any neurologic disorders or seizures (one episode of febrile convulsion does not constitute an exclusion criterion). • 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 diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. Rectal temperature <38°C / Axillary temperature <37.5°C). • Administration of immunoglobulins and/or any blood products in the period starting from birth and ending at the last study visit with the exception of monoclonal antibodies against respiratory syncytial virus (RSV). Specific criteria for the booster part of the study (to be checked at Visit 5, study month 14): • History of diphtheria, tetanus, pertussis, polio, hepatitis B, H. influenzae type b, meningococcal disease and or S. pneumoniae disease. • Previous vaccination, except the study vaccines and hepatitis birth dose, against diphtheria, tetanus, pertussis, polio, hepatitis B, H. influenzae type b, meningococcal disease and or S. pneumoniae disease. • Previous booster vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, H. influenzae type b, meningococcal disease and/or S. pneumoniae disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): One month after the third vaccination (Post 3): • Seroprotection against Haemophilus influenzae type b disease defined as anti-PRP concentration >=0.15 microg/ml • Seroprotection against meningococcal serogroup C disease defined as rSBA-MenC titre >=1:8.;Main Objective: Primary vaccination At one month after the third dose (Post dose 3) in preterm and full-term infants: •To evaluate the immunogenicity of GSK Biologicals’ Hib-MenC vaccine when given concomitantly with GSK Biologicals’ DTPa-HBV-IPV vaccine and Wyeth’s 7-valent pneumococcal vaccine, in terms of percentage of subjects with: - Anti-PRP concentration >=0.15 microg/ml - rSBA-MenC titre >=1:8 ;Secondary Objective: To evaluate in preterm & full-term infants: Primary vaccination at 1 month after dose 3: •immunogenicity of GSK’s Hib-MenC vaccine given with GSK’s DTPa-HBV-IPV & Wyeth’s 7-valent pneumococcal vaccines, in terms of anti-PRP concentrations, rSBA-MenC titres & anti-PSC concentrations •reactogenicity & safety of all vaccines administered. Persistence prior to booster dose: •persistence of anti-PRP, SBA-MenC & anti-PSC antibodies after a 3-dose primary vaccination course (at 2, 4, 6 months of age) with GSK’s Hib-MenC vaccine given with GSK’s DTPa-HBV-IPV & Wyeth’s 7-valent pneumococcal vaccines. Booster vaccination at 1 month after booster dose: •immunogenicity of booster dose of GSK’s Hib-MenC booster co-administered with GSK’s DTPa-IPV & Wyeth’s 7-valent pneumococcal vaccines, in terms of anti-PRP concentrations, rSBA-MenC titres & anti-PSC concentrations •reactogenicity & safety of booster dose of all vaccines | — |
Countries
Spain
Outcome results
None listed