Safety and immunogenicity of meningococcus C conjugate vaccine

ISRCTN	ISRCTN37262487
DOI	https://doi.org/10.1186/ISRCTN37262487
Secondary identifying numbers	ASCLIN/01/2008

Submission date: 02/12/2008
Registration date: 10/12/2008
Last edited: 10/12/2008

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

Dr Reinaldo Martins
Scientific

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

Study information

Study design	Randomised controlled blinded study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
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	Safety and immunogenicity of conjugate vaccine for meningococcal C disease: a randomised study
Study objectives	Bio-Manguinhos conjugate vaccine against meningococcus C is safe and immunogenic in young healthy adults.
Ethics approval(s)	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)
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	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 study start date	01/01/2009
Completion date	01/12/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	50 Years
Sex	Both
Target number of participants	60
Key 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
Key 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
Date of first enrolment	01/01/2009
Date of final enrolment	01/12/2009

Locations

Countries of recruitment

Brazil

Study participating centre

Av. Brasil 4365

Rio de Janeiro
21040-900
Brazil

Sponsor information

Bio-Manguinhos/Fiocruz (Brazil)
Industry

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

Website	http://www.bio.fiocruz.br
"ROR"	https://ror.org/05gj5j117

Funders

Funder type

Government

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

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