Multiboost - MCC plus pertussis booster in adolescents
| ISRCTN | ISRCTN18766300 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18766300 |
| EudraCT/CTIS number | 2012-005273-31 |
| Secondary identifying numbers | 14867 |
- Submission date
- 22/07/2013
- Registration date
- 22/07/2013
- Last edited
- 21/06/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Jo Southern
Scientific
Scientific
Centre for Infections
Health Protection Agency
61 Colindale Avenue
London
NW9 5EQ
United Kingdom
| Phone | +44 20 7679 2000 |
|---|---|
| jo.southern@phe.gov.uk |
Study information
| Study design | Randomised interventional trial; Design type: Prevention, Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Prevention |
| 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™) |
| Study objectives | 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(s) | 13/LO/0681 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | 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 study start date | 12/08/2013 |
| Completion date | 12/03/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | 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 |
| Total final enrolment | 388 |
| Key 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 |
| Key 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. |
| Date of first enrolment | 12/08/2013 |
| Date of final enrolment | 12/03/2015 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Centre for Infections
London
NW9 5EQ
United Kingdom
NW9 5EQ
United Kingdom
Sponsor information
Health Protection Agency (HPA)
Government
Government
Centre for Infections
61 Colindale Avenue
London
NW9 5EQ
United Kingdom
| Website | http://www.hpa.org.uk/ |
|---|---|
"ROR" |
https://ror.org/03sbpja79 |
Funders
Funder type
Government
Department of Health - Policy Research Programme
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 21/06/2019 | No | No | ||
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
21/06/2019: Added clinicaltrialsregister.eu link to basic results (scientific). Added total final enrollment.
17/01/2017: No publications found in PubMed, verifying study status with principal investigator.
