An open label randomised controlled study to evaluate the induction of immune memory following infant vaccination with a glyco-conjugate Neisseria meningitidis serogroup C vaccine and to assess the immunological impact of administering routine infant immunisations in consistent versus alternating limbs - Can we reduce the number of vaccine injections for children?

Phase 1

• Conditions: 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 Classification code 10042194 Term: Streptococcus pneumoniae meningitis; MedDRA version: 12.1 Level: LLT Classification code 10042195 Term: Streptococcus pneumoniae pneumonia; MedDRA version: 12.1 Level: LLT Classification code 10035648 Term: Pneumococcal pneumonia [Streptococcus pneumoniae pneumonia]; MedDRA version: 12.1 Level: LLT Classification code 10042197 Term: Streptococcus pneumoniae septicaemia; MedDRA version: 12.1 Level: LLT Classification code 10018952 Term: Haemophilus influenzae infection; MedDRA version: 12.1 Level: LLT Classification code 10018953 Term: Haemophilus influenzae meningitis; MedDRA version: 12.1 Level: LLT Classification code 10035680 Term: Pneumonia due to Haemophilus influenzae (H. influenzae); MedDRA version: 12.1 Level: LLT Classification code 10058214 Term: Septicaemia due to haemophilus influenzae (H. influenzae)

• Registration Number: EUCTR2009-016579-31-GB
• Lead Sponsor: niversity of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-06-25
• Study Completion: 2014-10-13
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 509

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

•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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified