Condition category
Infections and Infestations
Date applied
22/07/2013
Date assigned
22/07/2013
Last edited
17/01/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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 participant’s 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 participant’s 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 participant’s 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

http://www.hpa.org.uk/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

17/01/2017: No publications found in PubMed, verifying study status with principal investigator.