Status:
COMPLETED
Comparison of Two Meningococcal ACWY Conjugate Vaccines
Lead Sponsor:
Public Health England
Conditions:
Meningococcal Meningitis
Eligibility:
All Genders
14-21 years
Phase:
PHASE2
PHASE3
Brief Summary
There is evidence of waning immunity in individuals vaccinated against meningitis C as part of the UK infant immunisation schedule. The intention of this study is to contact participants of a previous...
Detailed Description
Between 550 and 650 subjects enrolled in a previous Meningococcal C vaccine study will be invited to join this new study looking at the boosting effects of two quadrivalent meningococcal ACWY vaccines...
Eligibility Criteria
Inclusion
- Previously enrolled on the Preschool Men C study conducted by NVEC in 1999/2000
- Participant's parent or legally authorized representative is willing and able to give written informed consent for participation after the nature of the study has been explained.
- No contraindications to vaccination as specified in the "Green Book"- Immunisation against Infectious Disease, HMSO.
- Participant who gives assent for participation in the study.
- Vaccinated with Meningitec (MCC CRM) or Menjugate (MCC CRM) or NeisVac-C (MCC TT) between 3.5-6 years of age.
- Known to be free of medical problems as determined by a medical history and clinical assessment.
- Parent or legally authorised representative is willing to allow his or her child's GP to be notified of participation in the study and contacted if required for confirmation of vaccination history.
Exclusion
- History of invasive meningococcal disease.
- Have a history of household contact or intimate exposure to an individual with culture proven Neisseria meningitis disease in the previous 60 days.
- Any vaccination against MenC disease since MCC vaccine given between 3.5 to 6 years.
- Participant is pregnant.
- Confirmed or suspected immunosuppressive or immunodeficient conditions, including human immunodeficiency virus (HIV) infection.
- Major congenital defects or serious chronic disease including progressive neurological disease or seizure disorder.
- Have a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
- Have a history of severe allergic reactions after previous vaccinations such as anaphylactic shock, asthma, urticaria, or other allergic reaction or hypersensitivity to any vaccine component.
- Have received another investigational agent within 90 days or before completion of the safety follow-up period in another study, whichever is longer, prior to enrollment and unwilling to refuse participation in another investigational trial through the end of the study.
- In the event that administration of another licensed vaccine is needed during the study, this vaccine should not be administered within 30 days of any study injection according to investigator's judgment (exception: licensed flu-vaccine should not be administered within 14 days of study vaccines).
- Have received any blood or blood products within the past 12 weeks.
- Have any other significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
- Temporary Exclusion Criteria
- • Receipt of systemic antibiotics (either oral or parenteral) will delay enrolment until at least 7 days after cessation of antibiotics.
Key Trial Info
Start Date :
June 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
91 Patients enrolled
Trial Details
Trial ID
NCT01192997
Start Date
June 1 2012
End Date
March 1 2014
Last Update
October 1 2020
Active Locations (3)
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1
Multiple General Practice surgeries
Gloucester, Gloucestershire, United Kingdom
2
Multiple General Practice surgeries
Hertford, Hertfordshire, United Kingdom
3
Health Protection Agency, Immunisation Department, Colindale
London, United Kingdom, NW9 5EQ