Plain English Summary
Not provided at time of registration
Trial website
http://www.hpa.org.uk/Topics/InfectiousDiseases/InfectionsAZ/ClinicalTrials/NVECCurrentStudies/
Contact information
Type
Scientific
Primary contact
Dr Jo Southern
ORCID ID
Contact details
Centre for Infections
Health Protection Agency
61 Colindale Avenue
London
NW9 5EQ
United Kingdom
+44 20 7679 2000
jo.southern@phe.gov.uk
Additional identifiers
EudraCT number
2012-005273-31
ClinicalTrials.gov number
Protocol/serial number
14867
Study information
Scientific title
A phase III/IV randomised open-label study and comparison of the immunogenicity and safety of a single adolescent booster dose of a meningococcal group C conjugate-containing booster vaccine (Meningitec™, or Menjugate™, or NeisVac-C™, or Menitorix™), when given concurrently with an acellular pertussis-containing booster vaccine (Repevax™ or IPV-Boostrix™)
Acronym
Study hypothesis
The aim of this study is to assess how well adolescent booster dose of a meningococcal group C conjugate-containing booster vaccine is tolerated when given concurrently with an acellular pertussis-containing booster vaccine in adolescents aged between 14-17 years.
Ethics approval
13/LO/0681
Study design
Randomised interventional trial; Design type: Prevention, Treatment
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Prevention
Patient information sheet
Condition
Topic: Medicines for Children Research Network, Primary Care Research Network for England; Subtopic: All Diagnoses, Not Assigned; Disease: All Diseases
Intervention
Boostriv-IPV, Combination dTaP3/IPV vaccine
Meningitec, Meningococcal serogroup C conjugate vaccine
Menitorix, Combined meningococcal serogroup C and Hib conjugate vaccine
Menjugate, Meningococcal serogroup C conjugate vaccine
NeisVac-C, Meningococcal serogroup C conjugate vaccine
Repevax, Combined dTaP5/IPV vaccine
Follow Up Length: 1 month
Study Entry : Single Randomisation only
Intervention type
Drug
Phase
Phase IV
Drug names
Meningitec, Menitorix, Menjugate, NeisVac-C, Repevax, Boostriv-IPV
Primary outcome measure
Meningococcal serogroup C-specific and pertussis-specific immune response
Secondary outcome measures
1. Safety and tolerability of each study combination of MCC and pertussis-containing vaccine
2. Tetanus, diphtheria, and (in appropriate study arms) Hib immune response
Overall trial start date
12/08/2013
Overall trial end date
12/03/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Participant is willing and able to give written informed consent for participation. If aged below 16 years, parent/legal guardian gives consent while the participant gives written assent for participation in the study.
2. Male or female aged 14 years (+0 day) to 17 years (+364 days) on the day of consent.
3. Completed MCC and pertussis vaccination according to the UK (catch-up and/or routine) schedule appropriate for the participants age
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 880; UK Sample Size: 880; Description: 110 participants per group, over 8 groups = 880 total. To account for attrition we will use a +/10% tolerance around these figures
Participant exclusion criteria
Exclusion Criteria
The participant may not enter the study if ANY of the following apply:
1. Any contraindication to vaccination as specified in the Green Book- Immunisation against Infectious Disease, HMSO.
2. Significant illness including progressive neurological disease or seizure disorder; confirmed or suspected immunosuppressive or immunodeficient conditions; major congenital defects; or known bleeding diathesis (or any condition that may be associated with a prolonged bleeding time).
3. Any other significant condition or circumstance 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 participants ability to participate in the study.
4. History of invasive meningococcal disease or pertussis.
5. Significant contact (household or intimate exposure) to an individual with culture proven Neisseria meningitis disease or pertussis in the previous 60 days.
6. Any MCC or pertussis vaccination that is not according to the UK (catch-up or routine) schedule appropriate for the participants age.
7. Pregnancy
Temporary Exclusion Criteria
1. Fever (sublingual temperature >= 38°C)
2. Received systemic antibiotic(s) (either oral or parenteral) within the past 7 days. For all visits, if allowed by the study visit window, receipt of systemic antibiotics (either oral or parenteral) will delay venepuncture until at least 7 days after cessation of antibiotics.
3. Received any blood or blood products within the past 12 weeks.
4. 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 to the end of this study.
5. Possibility of pregnancy: All female potential participants will be assessed for the possibility of being pregnant. Assessment will be in accordance with SOP CTSOP071 (Pregnancy Testing and Exclusion from Studies). If there is a possibility of being pregnant, they will be advised to consult their own GP for a pregnancy test. They can only be considered for recruitment if they choose to take a test and are negative.
Recruitment start date
12/08/2013
Recruitment end date
12/03/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Centre for Infections
London
NW9 5EQ
United Kingdom
Sponsor information
Organisation
Health Protection Agency (HPA)
Sponsor details
Centre for Infections
61 Colindale Avenue
London
NW9 5EQ
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Department of Health - Policy Research Programme
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list