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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list