Immunogenicity and reactogenicity of concomitantly administered hexavalent and group B meningococcal vaccines in infancy.
Conditions
Interventions
Trade Name: INFANRIX-HEXA
Product Name: INFANRIX-HEXA
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Diphtheria toxoid
Sponsors
Clinical Trials and Research Governance (CTRG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For recruitment to all study groups, participants MUST FULFILL each of the below criterion: • Parents/legal guardians are over 16 years of age, and are willing and able to consent to enrol their child/children in the study • Parents/legal guardians able comply with the requirements of the trial protocol and have internet access for the duration of the study • Parents/legal guardians are willing to allow their General Practitioner, health visitor and consultant, if appropriate, to be notified of participation in the trial. • Participants born at greater than or equal to 37 weeks gestation • Participants are due to receive their primary immunisations, aged 8 to 13 weeks (i.e. the day the child turns 13 weeks of age) at enrolment Are the trial subjects under 18? yes Number of subjects for this age range: 240 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: The participant may not enter the trial IF ANY of the following apply: • Parents/legal guardians of children are on the delegation log of this study • Confirmed or suspected immunodeficiency • Fulfil any of the contraindications to vaccination as specified in The Green Book • Confirmed anaphylactic reaction/s to any constituent/s or excipient/s of the vaccine(s) • Confirmed anaphylactic reaction to neomycin, streptomycin or polymyxin B (which may be present in trace amounts in the tetanus vaccine), kanamycin, histidine, sodium chloride or sucrose (which may be present in trace amounts in the Meningococcal B vaccine) or to gelatin (which may be present in trace amounts in the MMR vaccine) • Latex hypersensitivity (the syringe cap of the Meningococcal B vaccine Bexsero may contain natural rubber latex) • Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant’s ability to participate in the trial. • Thrombocytopenia or any other bleeding disorders. • Child is currently participating in another interventional clinical trial Temporary exclusions for all groups For a vaccination visit only (visit 1, 2, 3, and 5) • Administration of any other vaccine within 14 days prior to study vaccines. • Scheduled elective surgery, planned admission or other procedures requiring general anaesthesia within 7 days of receiving a vaccine • Febrile illness (axillary temperature =38.0°C) within the previous 24 hours or on the day of vaccination For a blood sampling visit only (visit 4 and 6) Have received parenteral or oral antibiotics within the last 7 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the immune response of the Haemophilus influenza type B (Hib) component of the 6in1-IH (Infanrix-Hexa) and 6in1-V (Vaxelis) vaccines when co-administered with 4CMenB in the UK routine immunisation schedule, as measured by blood tests taken at at 5 months of age.; Secondary Objective: - To compare the concentrations of antibodies (IgG) against the outer capsule of the Haemophilus influenza type B (Hib) bacteria at 13 months of age (i.e. 1 month after administration of the combination Hib-MenC vaccine at 12 months of age) in participants who received either 6in1-IH or 6in1-V at 2, 3 and 4 months of age. - To compare the immune responses to the other vaccine components in the routine UK infant immunisation schedule at 5 and 13 months of age in participants receiving 6in1-IH and 6in1-V - to compare the side effect profile (reactogenicity) of 6in1-IH and 6in1-V when administered in the routine UK immunisation schedule ; Primary end point(s): The primary outcome is to determine immunogenicity to Hib through anti-PRP Hib IgG concentrations at 5 months of age as measured by ELISA. The analysis on primary outcome will be conducted after the 5-month anti-PRP Hib IgG concentrations are available for all participants, while the trial will continue to follow up all participants till 13 months of age. The final analysis for the other outcomes will be carried out while the 5-month and 13-month data are available for all participants. ;Timepoint(s) of evaluation of this end point: This will be evaluated when the participants are 5 months of age which corresponds to Visit 4 of the trial study design. A blood sample is taken at Visit 4 to measure the primary outcome of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary outcomes are to determine immunogenicity to Hib through anti-PRP Hib IgG concentrations at 13 months of age, the IgG concentrations against pertussis antigens and polio virus neutralising antibodies and SBA titres against 3 reference serogroup B meningococcal strains at 5 and 13 months of age and serogroup C meningococcus at 13 months of age.;Timepoint(s) of evaluation of this end point: This will be evaluated when the participants are 13 months of age which corresponds to Visit 6 of the trial study design. A blood sample is taken at Visit 4 (5 months) and Visit 6 (13 months) to measure the secondary outcomes of the study. | — |
Countries
United Kingdom
Contacts
Public ContactProfessor Matthew Snape
Oxford Vaccine Group
Outcome results
None listed