Three-dose primary vaccination course with a haemophilus influenzae type B and meningococcal serogroup C conjugate vaccine of infants starting between 6 to 12 weeks of age with one month interval between doses and a single booster dose at 12 to 15 months of age.
Conditions
Interventions
Product Name: Hib-MenC conjugate vaccine
Product Code: Hib-MenC-TT
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: N. mening
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects for whom 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, 6 to 12 weeks of age at the time of the first 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. Born after a gestation period between 36 and 42 weeks. Vaccination with hepatitis B at birth and at 6 to 12 weeks (concomitantly with the first study vaccine) is accepted although not mandatory. 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 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 since birth, with the exception of Bacille Calmette Guerin (BCG) and hepatitis B vaccines (as per-country recommendations on immunization). History of Haemophilus influenzae type b and /or meningococcal serogroup C disease. Previous vaccination against meninogococcal serogroup C disease, diphtheria, tetanus, pertussis, polio or Hib disease. 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 (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 <38.0°C / Axillary temperature <37.5°C). Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. Additional specific criteria for the booster part of the study (to be checked at Visit 5, study month 10) History of measles, mumps, rubella, Hib and/or meningococcal serogroup C disease. Previous vaccination against measles, mumps or rubella. Previous booster vaccination with a Hib vaccine. Previous booster vaccination with a serogroup C meningococcal vaccine. Known exposure to measles, mumps or rubella within 30 days prior to start of the booster part.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The co-primary objectives of the primary & booster phases will be assessed in a sequential fashion: One month after the primary vaccination course, to demonstrate the non-inferiority of the -meningococcal serogroup C and -Hib immune response induced by GSK Biologicals’ Hib-MenC conjugate vaccine given concomitantly with Infanrix™-IPV compared to a licensed meningococcal serogroup C vaccine given concomitantly with Pediacel™ when given as a 3-dose primary vaccination in infants at 2, 3 and 4 months of age. 42 days after the booster vaccination, to evaluate the immunogenicity in terms of the percentage of subjects with -SBA-MenC titres >= 1:128 and -anti-PRP antibody concentration >= 1 µg/ml induced by a booster dose of GSK Biologicals’ Hib-MenC vaccine given concomitantly with Priorix™ in toddlers aged 12 to 15 months who have been primed with either 3 doses of Infanrix™-IPV and Hib-MenC or Pediacel™ and a licensed meningococcal serogroup C vaccine. ; Secondary Objective: 1 month after primary vaccination course, to evaluate the immune response induced by Infanrix™-IPV, given concomitantly with GSK Biologicals’ Hib-MenC conjugate vaccine versus Pediacel™, given concomitantly with a licensed meningococcal serogroup C vaccine (Lic MenC). To compare the safety & reactogenicity of 3 doses of Hib-MenC given concomitantly with Infanrix™-IPV using Lic MenC given concomitantly with Pediacel™ as benchmark. Prior to the administration of a booster dose of Hib-MenC, at 12 to 15 months of age, to evaluate the persistence of the Hib, MenC, D, T, Pa and IPV antibodies induced by a 3 dose primary vaccination course with Hib-MenC given concomitantly with Infanrix™-IPV versus Pediacel™ given concomitantly with Lic MenC. To evaluate the safety and reactogenicity of a b | — |
Countries
United Kingdom
Outcome results
None listed