Clinical trial NCT01129518: Can we Reduce the Number of Vaccine Injections for Children?
Official title: An Open Label Randomised Controlled Study to Evaluate the Induction of Immune Memory Following Infant Vaccination With a Glycoconjugate Neisseria Meningitidis Serogroup C Vaccine and to Assess the Immunological Impact of Administering Routine Infant Immunisations in Consistent Versus Alternating Limbs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Invasive Meningococcal Disease
Keywords: meningococcal serogroup C
vaccine
conjugate
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: Oxford University Hospitals NHS Trust
name: GlaxoSmithKline
First posted: 2010-05-24
Enrollment: 404
Sex: ALL
Minimum age (years): 2
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility 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

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.

Primary outcomes:
measure: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: Oxford Vaccine Group
Study officials:
References:
citation: Pace D, Khatami A, Attard-Montalto S, Voysey M, Finn A, Faust SN, Heath PT, Borrow R, Snape MD, Pollard AJ. Use of a booster dose of capsular group C meningococcal glycoconjugate vaccine to demonstrate immunologic memory in children primed with one or two vaccine doses in infancy. Vaccine. 2016 Dec 7;34(50):6350-6357. doi: 10.1016/j.vaccine.2016.10.038. Epub 2016 Oct 28.
citation: Pace D, Khatami A, McKenna J, Campbell D, Attard-Montalto S, Birks J, Voysey M, White C, Finn A, Macloed E, Faust SN, Kent AL, Heath PT, Borrow R, Snape MD, Pollard AJ. Immunogenicity of reduced dose priming schedules of serogroup C meningococcal conjugate vaccine followed by booster at 12 months in infants: open label randomised controlled trial. BMJ. 2015 Apr 1;350:h1554. doi: 10.1136/bmj.h1554.
citation: Iro MA, Khatami A, Marshall AS, Pace D, Voysey M, McKenna J, Campbell D, Attard-Montalto S, Finn A, White C, Faust SN, Kent A, Heath PT, MacLeod E, Stanford E, Findlow H, Almond R, Bai X, Borrow R, Snape MD, Pollard AJ. Immunological effect of administration of sequential doses of Haemophilus influenzae type b and pneumococcal conjugate vaccines in the same versus alternating limbs in the routine infant immunisation schedule: an open-label randomised controlled trial. Lancet Infect Dis. 2015 Feb;15(2):172-80. doi: 10.1016/S1473-3099(14)71057-6. Epub 2015 Jan 8.
citation: Khatami A, Clutterbuck EA, Thompson AJ, McKenna JA, Pace D, Birks J, Snape MD, Pollard AJ. Evaluation of the induction of immune memory following infant immunisation with serogroup C Neisseria meningitidis conjugate vaccines--exploratory analyses within a randomised controlled trial. PLoS One. 2014 Jul 14;9(7):e101672. doi: 10.1371/journal.pone.0101672. eCollection 2014.