Vaccination; Infection Clinical Trial
Official title:
Immunogenicity and Reactogenicity of Concomitantly Administered Hexavalent and Group B Meningococcal Vaccines in Infancy
In 2017 the hepatitis B vaccine was added to the United Kingdom (UK) routine immunisation
programme.An infection with the hepatitis B virus can cause severe inflammation of the liver
and can cause severe long term liver damage.So that the hepatitis B vaccine can be introduced
to the UK's childhood immunisation schedule without increasing the number of vaccine
injections, the previously used '5-in-1' vaccine was replaced by a '6-in-1' vaccine. The
'6-in-1' vaccine protects against diphtheria, tetanus, poliovirus, whooping cough
(pertussis), hepatitis B and Haemophilus influenzae b (Hib). There are two licensed
'6-in-1'vaccines available and these are called Infanrix hexa (6in 1(IH)and Vaxelis (6 in
1(V)).
The Infanrix hexa vaccine is currently used routinely in the UK. We know from previous
research studies that this vaccine works well with the other vaccines in the UK schedule,
including the meningococcal B vaccine (MenB or Bexsero). At present we do not have this
information for the Vaxelis vaccine, and it is important to check this as the components of
Vaxelis are slightly different from Infanrix hexa. If we can show that immunisation with
Vaxelis creates a similar response from the immune system to Infanrix hexa and is just as
safe when given in the immunisation schedule along with the MenB vaccine, the National Health
Service (NHS) in the UK will be able to use either vaccine for children in the UK. This will
increase the flexibility and resilience of the UK's routine immunisation schedule.
Status | Not yet recruiting |
Enrollment | 240 |
Est. completion date | April 30, 2022 |
Est. primary completion date | October 30, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 8 Weeks to 13 Weeks |
Eligibility |
Inclusion Criteria: - Healthy infants aged 8 to 13+0 weeks who are yet to receive their routine 2 month immunisations - 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 equal to or greater than 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 Exclusion Criteria: - Parents/legal guardians of children are on the delegation log of this study - Confirmed or suspected immunodeficiency - Fulfill 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 measles-mumps-rubella (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. - Child is currently participating in another interventional clinical trial |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Centre for Clinical Vaccinology & Tropical Medicine (CCVTM) | Oxford | Oxfordshire |
Lead Sponsor | Collaborator |
---|---|
University of Oxford | MCM Vaccines B.V. |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Compare the immunogenicity of the Hib component of 6 in 1(Infanrix hexa) and 6 in 1(Vaxelis) when co-administered with 4CMenB in the UK routine immunisation schedule at 5 months of age. | Measurement of anti-polyribosylribitol phosphate (PRP) (Hib) immunoglobulin G (IgG) concentrations at 5 months of age as measured by ELISA. | At 5 months of age (at least 4 weeks after administration of the last dose of either 6 in 1(IH) and 6 in 1(V) primary immunisations). | |
Secondary | Compare the anti-PRP(Hib) IgG concentrations at 13 months of age (1 month after administration of Hib-meningococcal C (MenC) at 12 months of age) in participants primed with 6 in 1(Infanrix hexa) and6 in 1(Vaxelis). | Measurement the anti-PRP (Hib) IgG concentrations at 13 months of age as measured by ELISA. | At 13 months of age (at least 4 weeks after the Hib-MenC vaccination at 12 months of age). | |
Secondary | The immunogenicity of the other antigens in the routine immunisation schedule incorporating either 6 in 1(Infanrix hexa) or 6 in 1(Vaxelis). | Measurement the IgG concentrations at 5 and 13 months of: a) Diphtheria-toxoid, b)Tetanus toxoid, c) Hepatitis B virus, d) Vaccine-serotype pneumococcal capsule antigens, e) Pertussis antigens, f) Poliovirus neutralising antibodies. Measure serum bactericidal titres at 5 and 13 months of age of: a) 3 reference serogroup B meningococcal strains, b) Serogroup C meningococcus. |
At 5 and 13 months of age (approximately 4 weeks after completion of the primary routine immunisations and approximately 4 weeks after the booster doses in the routine immunisation schedule). | |
Secondary | The reactogenicity of 6 in 1(Infanrix hexa) and 6 in 1(Vaxelis) when administered in the routine UK immunisation schedule. | Record solicited local and systemic adverse events within 5 days of immunisations. | In the 5 days post immunisation as recorded in participant diaries. |
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