Meningococcal C Conjugate Brazilian Vaccine Project
| ISRCTN | ISRCTN72642831 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN72642831 |
| Secondary identifying numbers | 4670 |
- Submission date
- 18/11/2010
- Registration date
- 10/03/2011
- Last edited
- 10/03/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mrs Tatiana Guimarães de Noronha
Scientific
Scientific
Av. Brasil, 4365
Manguinhos
Rio de Janeiro
21040-360
Brazil
| Phone | +55 21 3882 9479 |
|---|---|
| tnoronha@bio.fiocruz.br |
Study information
| Study design | Single centre phase II randomised single-blind trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Immunogenicity and safety in children 1 - 9 years of a vaccine against meningococcal serogroup C strain 2135 produced with tetanus toxoid conjugate |
| Study acronym | Meningococcal C Conjugate Vaccine Brazilian |
| Study objectives | This a non-inferiority study to test that the experiment vaccine confers the same amount of protection as the reference vaccine. Moreover, it is expected that the experiment vaccine is as safe as the reference vaccine. |
| Ethics approval(s) | Local ethics committee (Comitê de Ética em Pesquisa [CEP] ENSP) approved on the 3rd August 2010 (ref: 0139.0.031.000-10) |
| Health condition(s) or problem(s) studied | Meningitis C |
| Intervention | The vaccine under test and the product used by the control group are intramuscular (deltoid muscle of the left arm) at a dose of 0.5 ml in a single application, in accordance with the standards of the Manual of Procedures of the Ministry of Vaccination Health (Ministry of Health, 2001). We hope to add about 6 volunteers per day or approximately 120 volunteers per month. Each participant will have an estimated time to participate in the study of about two months which will include a total of four planned visits to the study site in addition to four telephone contacts with people involved in the project. Visits and contacts can be made in extraordinary case of any problem perceived by volunteers or by the study team. Volunteer recruitment methods will be employed during the first contact with the volunteer in study, including information about the project. After assessing the eligibility criteria, will read the term of informed consent (TCLE). Only children whose parents/guardians sign the TCLE will be included in the study. We will carry out a small evaluation after presenting the TCLE, in order to ensure that all parents/guardians of children enrolled have understood what was explained. The ways in which the volunteer's response does not demonstrate full understanding will be explained a second time and the corresponding item of the assessment will be resubmitted. Will only be asked to sign the informed consent parents/guardians who demonstrate understanding of a minimum set of aspects of the study. The initial consultation (screening) will be to clarify about the project, reading/explanation of TC, the test pre-TCLE, and finally signing the TCLE if parents/guardians agree to participate. After signing the TCLE will be made clinical evaluation on volunteers, even as part of the eligibility analysis of the likely participants. Children who meet the eligibility criteria will then be referred for vaccination. Vaccines and diluents will be labelled for the clinical trial in the same way and the diluent to be coupled to the corresponding product. Due to the different presentation of the vaccine - the vaccine is lyophilised and must be diluted before application and the reference vaccine (Neisvac-C®) is already mounted in a syringe ready for use, the study will be the study will be single blind (or partially blind). The volunteer, after collection of blood will be taken to vaccinate. If the participant fails to appear for the query on the appointed day, attempts will be made telephone calls to bring the volunteer to the study site. Phone calls will be given once a week to complete the last collection time for 30 days after vaccination. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Va-Mengoc.BC®, NeisVac® |
| Primary outcome measure | The immunogenicity of the vaccine under test seroconversion (from seronegative to seropositive) or 4-fold elevation of titres targeted bactericidal for the strain used and/or heterologous strain meningococcal C, compared to pre-vaccination titres. Measured through a blood sampling before vaccination and another 30 days after vaccination. |
| Secondary outcome measures | Total antibodies, measured by enzyme-linked immunosorbent assay (ELISA) through a blood sampling before vaccination and another 30 days after vaccination |
| Overall study start date | 25/11/2010 |
| Completion date | 25/04/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 12 Months |
| Upper age limit | 10 Years |
| Sex | Both |
| Target number of participants | 360 children: 240 will receive the vaccine under test and 120 the vaccine NeisVac® |
| Key inclusion criteria | 1. Have 12 months of age less than 10 years and have not yet been vaccinated against meningitis C or B (Va-Mengoc.BC®) 2. Be accompanied by a parent or other custodian to confirm the ability and willingness to return to the clinic on the dates for the second and third visits 3. Be accompanied by a parent or other legal guardian who can provide the information necessary for the research team contact during follow-up 4. Be accompanied by a parent or other responsible person legally qualified to give informed consent to participate 5. Be users or siblings of children enrolled, in the health unit for routine immunisation or other medical care 6. Keep up with routine vaccines officially recommended for the first year of life in Brazil, except meningitis C vaccine and any type of flu shot within the 28 days preceding the vaccination study 7. Having good health, according to medical history, physical examination (documented as FRC) and review of the research team 8. Are not participating in any other clinical study |
| Key exclusion criteria | Not to be included, children whose legal guardians: 1. Cannot or do not wish to give their informed consent to participate 2. Cannot be contacted by phone (the phone itself or the house or neighbour) by the research team for monitoring adverse events and/or in the event of non-attendance at the second and third visits 3. Unable to complete the log of adverse events, measure and record the child's temperature, measure the largest diameter of any adverse reactions at the injection site, or read and understand instructions or have other difficulties, according to the research team, justify the exclusion from the study 4. Are participating in another clinical study Also not included are children who: 5. Have received another vaccine injections 30 days before the day of vaccination study or shall take such vaccines within 30 days after vaccination in the study. Vaccines programmed and not received before inclusion in this study can be administered after the last blood collection. 6. Have taken at least one dose of vaccine against meningitis C or BC (Cuban vaccine) in the past 7. Have received vaccinations, allergy-free injection in the last 14 days 8. Have had any type of meningitis 9. Have been treated with antibiotics in the last 10 days 10. Have been treated with benzathine penicillin in the last 30 days 11. Have fever on the first visit (greater than 37.5°C in the armpit) or 3 days earlier 12. Suffering from chronic disease 13. Had acute illness in the last 30 days 14. Have a history of anaphylaxis, asthma, urticaria or other allergic reaction to previous vaccinations or who have an allergy or hypersensitivity to vaccine components of the study 15. Have a history of severe asthma hospitalisation 16. Are receiving systemic therapy with high doses of steroids (e.g., 1 mg/kg/day of prednisone or equivalent), or have chronic use of inhaled corticosteroids, high power (e.g., 800 mg per day of fluticasone) 17. Have a diagnosed disorder haemophilia or any other disorder associated with prolonged bleeding 18. Have sickle cell anaemia 19. Have undergone splenectomy 20. Have a history of epilepsy, seizures or neurodevelopmental disorders such as autism 21. Have received blood, blood products or immunoglobulin preparations intravenously 22. Have any disorder, in the opinion of the investigator, may interfere with the evaluation of the objectives of the study |
| Date of first enrolment | 25/11/2010 |
| Date of final enrolment | 25/04/2011 |
Locations
Countries of recruitment
- Brazil
Study participating centre
Av. Brasil, 4365
Rio de Janeiro
21040-360
Brazil
21040-360
Brazil
Sponsor information
The Immunobiological Technology Institute (Bio-Manguinhos) (Brazil)
Research organisation
Research organisation
Avenida Brazil, 4365
Manguinhos
Rio de Janeiro
21040-360
Brazil
| Phone | +55 21 3882 9479 |
|---|---|
| tnoronha@bio.fiocruz.br | |
| Website | http://www.bio.fioruz.br |
"ROR" |
https://ror.org/04jhswv08 |
Funders
Funder type
Research organisation
Bio-Manguinhos/Fiocruz (Brazil)
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 |
