Condition category
Infections and Infestations
Date applied
02/12/2008
Date assigned
10/12/2008
Last edited
10/12/2008
Prospective/Retrospective
Prospectively 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

Dr Reinaldo Martins

ORCID ID

Contact details

Av. Brasil 4365
Manguinhos
Rio de Janeiro
21040-900
Brazil

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ASCLIN/01/2008

Study information

Scientific title

Safety and immunogenicity of conjugate vaccine for meningococcal C disease: a randomised study

Acronym

Study hypothesis

Bio-Manguinhos conjugate vaccine against meningococcus C is safe and immunogenic in young healthy adults.

Ethics approval

Ethics Committee of Evandro Chagas Institute for Clinical Research (Comitê de Ética do Instituto de Pesquisa Clínica Evandro Chagas) gave approval on the 15th February 2008 (ref: CAAE 0068.0.009.000-07)

Study design

Randomised controlled blinded study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

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

Condition

Meningococcus C disease

Intervention

1. 30 volunteers will receive meningococcus C vaccine conjugate to tetanus toxoid from Bio-Manguinhos, single 0.5 ml dose (10 µg) IM (intramuscularly)
2. 30 volunteers will receive a similar commercial vaccine (reference vaccine), same dose and schedule

Intervention type

Drug

Phase

Not Specified

Drug names

Meningococcus C conjugate vaccine

Primary outcome measures

Frequency/intensity of adverse events during 30 days after vaccination.

Secondary outcome measures

1. Serological conversion, defined as prevaccinal sera non-reactive to meningococcus C, and post-immunisation sera reactive (titre greater than or equal to 8, reciprocal of dilution)
2. Titre of antibodies to meningococcus C after immunisation (intensity of immune response)
3. Measurement of antibodies just before and 30 days after vaccination

Overall trial start date

01/01/2009

Overall trial end date

01/12/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Healthy
2. Both sexes
3. Aged between 18 and 50 years
4. Capable of understanding and signing Free and Informed Consent Form
5. Intellectual level which permits filling out records of adverse events at home
6. Capable of understanding risks of the experiment
7. Willing test for human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV)
8. Clinical examination without significant abnormalities
9. Laboratorial tests within normal range, or only with clinically non-significant alterations
10. Pre-vaccinal level of antibodies against tetanus below 5 IU/mL
11. Negative pregnancy test

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60

Participant exclusion criteria

1. Pregnancy or breastfeeding
2. Personal history of meningitis, any kind
3. Previous serious adverse event to any vaccination
4. Severe adverse event to tetanus toxoids
5. Vaccination against tetanus in the last 2 years
6. Anti-allergic vaccines 14 days or less before vaccination
7. Blood products in the last 12 months
8. Any vaccination 30 days or less before vaccination in test
9. Chronic use of any medication, except trivial ones
10. Previous use of cytotoxic or immunosuppressive therapy
11. Asthma which requires hospital care
12. Serious angioedema or anaphylaxis

Recruitment start date

01/01/2009

Recruitment end date

01/12/2009

Locations

Countries of recruitment

Brazil

Trial participating centre

Av. Brasil 4365
Rio de Janeiro
21040-900
Brazil

Sponsor information

Organisation

Bio-Manguinhos/Fiocruz (Brazil)

Sponsor details

Dr Akira Homma
Av. Brasil 4365
Manguinhos
Rio de Janeiro
21040-900
Brazil

Sponsor type

Industry

Website

http://www.bio.fiocruz.br

Funders

Funder type

Government

Funder name

Brazilian Ministry of Science and Technology (MCT) (Brazil) - Financing Agency for Studies and Projects (Financiadora de Estudos e Projetos [FINEP])

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