Can we Reduce the Number of Vaccine Injections for Children? (NCT01129518) | Clinical Trial Compass
CompletedPhase 4
Can we Reduce the Number of Vaccine Injections for Children?
United Kingdom404 participantsStarted 2010-06
Plain-language summary
This open label randomised controlled study will evaluate the induction of immunity following varying schedules of vaccination with glyco-conjugate Neisseria meningitidis serogroup C (MenC) vaccines in infancy. 498 infants will be enrolled in this multi-centre trial. Participants will receive either 0, 1, or 2 priming doses of a MenC-CRM197 conjugate vaccine or 1 priming dose of a MenC-TT conjugate vaccine in the first year of life, with all groups receiving a dose of a combination Hib-MenC-TT vaccine at 12 months, as well as all other concurrent routine vaccinations. All groups will also be further divided into 2 groups to receive their routine vaccines in either consistent or alternating limbs to assess the immune response to the concurrent infant routine immunisations administered in consistent versus alternating limbs. Immune responses will be assessed at 5, 12, 12months +6 days, 13 and 24 months of age.
Who can participate
Age range2 Months – 3 Months
SexALL
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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
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
* Acut…
What they're measuring
1
Geometric mean titres (GMTs) of meningococcal serogroup C (MenC) specific serum bactericidal antibodies, using rabbit complement (rSBA)
Timeframe: 1 month after a 12 month dose of Hib-MenC vaccine