Condition category
Infections and Infestations
Date applied
18/11/2010
Date assigned
10/03/2011
Last edited
10/03/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Tatiana Guimarães de Noronha

ORCID ID

Contact details

Av. Brasil
4365
Manguinhos
Rio de Janeiro
21040-360
Brazil
+55 21 3882 9479
tnoronha@bio.fiocruz.br

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

4670

Study information

Scientific title

Immunogenicity and safety in children 1 - 9 years of a vaccine against meningococcal serogroup C strain 2135 produced with tetanus toxoid conjugate

Acronym

Meningococcal C Conjugate Vaccine Brazilian

Study hypothesis

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

Local ethics committee (Comitê de Ética em Pesquisa [CEP] ENSP) approved on the 3rd August 2010 (ref: 0139.0.031.000-10)

Study design

Single centre phase II randomised single-blind trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Va-Mengoc.BC®, NeisVac®

Primary outcome measures

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 trial start date

25/11/2010

Overall trial end date

25/04/2011

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

360 children: 240 will receive the vaccine under test and 120 the vaccine NeisVac®

Participant 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

Recruitment start date

25/11/2010

Recruitment end date

25/04/2011

Locations

Countries of recruitment

Brazil

Trial participating centre

Av. Brasil, 4365
Rio de Janeiro
21040-360
Brazil

Sponsor information

Organisation

The Immunobiological Technology Institute (Bio-Manguinhos) (Brazil)

Sponsor details

Avenida Brazil
4365
Manguinhos
Rio de Janeiro
21040-360
Brazil
+55 21 3882 9479
tnoronha@bio.fiocruz.br

Sponsor type

Research organisation

Website

http://www.bio.fioruz.br

Funders

Funder type

Research organisation

Funder name

Bio-Manguinhos/Fiocruz (Brazil)

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