Active immunisation of children for the prevention of invasive diseases caused by Neisseria meningitidis serogroup C, Streptococcus pneumoniae, diphtheria, tetanus, pertussis, poliomyelitis and invasive infections caused by Haemophilus influenzae type b. MedDRA version: 12.0 Level: LLT Classification code 10028911 Term: Neisseria meningitidis infection NOS MedDRA version: 12.1 Level: LLT
Conditions
Interventions
Trade Name: Menjugate Kit
Pharmaceutical Form: Powder and solvent for suspension for injection
CAS Number: 0
Other descriptive name: Neisseria meningiti
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Healthy male or female infants aged 6-12 weeks at the time of the first vaccination and who were born between 37 and 42 weeks of gestation • Infants who are known to be free from medical problems as determined by a medical history and clinical examination • Parents or guardians who are willing for their child to participate and who would be expected to comply with the requirements of the protocol • Parents/guardians who have given informed consent for their child’s participation in 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: • History of invasive meningococcal C disease • Previous vaccination against meningococcal serogroup C disease • Planned administration/administration of vaccines, since birth, other than the study vaccines (with the exception of oral rotavirus vaccine, Hepatitis B vaccine and BCG). • Receipt of investigational vaccines/drugs, other than the vaccines used in the study, within 30 days prior to receiving the first dose of the vaccines or their planned use during the study period • Confirmed or suspected immunosuppressive or immunodeficient conditions, including human immunodeficiency virus (HIV) infection. • A family history of congenital or hereditary immunodeficiency. • Receipt of more than 2 weeks of immunosuppressants or immune modifying drugs, (e.g. prednisolone >0.5mg/kg/day) • History of allergy to any component of the vaccines. • Major congenital defects or serious chronic illness. • History of any neurologic disorders or seizures • Acute disease at the time of recruitment as defined by the presence of a moderate or severe illness with or without fever with the exception of minor illnesses such as diarrhoea, mild upper respiratory infection without fever. In such situations enrolment should be postponed until the participant has recovered. • Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period • Parents who plan to move out of the geographical area where the study would be conducted.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to demonstrate non-inferiority of the geometric mean titres (GMTs) of meningococcal serogroup C (MenC) specific serum bactericidal antibodies, using rabbit complement (rSBA), 1 month after a 12 month dose of Hib-MenC vaccine in children receiving a single dose of MenC-CRM197vaccine at 3 months of age (single dose priming) compared with those receiving 2 doses at 3 and 4 months of age (2 dose priming). Non-inferiority of the MenC serum bactericidal antibody geometric mean titres (SBA GMTs) would imply that the reduced schedule of MenC immunisation would be a more cost effective method of providing sustained immunity against MenC disease through childhood.; Secondary Objective: To compare MenC SBA GMTs at 13 months of age in children previously receiving single dose MenC-CRM197 vaccine priming to those receiving no priming doses of MenC vaccine. To compare the MenC SBA GMTs at day 6 after the 12 month dose of vaccine in a subset of participants to discriminate between 'primed' and 'unprimed' immune responses. To assess MenC SBA GMTs at 5 and 24 months of age in all groups. To measure the numbers of MenC specific memory B cells in the blood at 5 and 12 months, 6 days following the 12 month booster dose, and at 13 and 24 months on a subset of participants. To assess the local and systemic adverse reactions experienced by participants in the four groups after immunisation with each dose of the MenC-CRM197, MenC-TT and Hib-MenC vaccines. To compare the immune response to all 13 PCV13 serotypes, and to Hib and tetanus at 5, 12, 13 and 24 months of age in children receiving vaccines in a consistent limb vs those receiving vaccines in alternating limbs. ;Primary end point(s): The difference in the MenC rSBA GMTs between the participants primed with two doses of MenC-CRM197 (Two dose MenC Group) and with one dose o | — |
Countries
United Kingdom
Outcome results
None listed