Safety and immunogenicity of meningococcus C conjugate vaccine
| ISRCTN | ISRCTN37262487 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN37262487 |
| Protocol serial number | ASCLIN/01/2008 |
| Sponsor | Bio-Manguinhos/Fiocruz (Brazil) |
| Funder | Brazilian Ministry of Science and Technology (MCT) (Brazil) - Financing Agency for Studies and Projects (Financiadora de Estudos e Projetos [FINEP]) |
- 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
Scientific
Av. Brasil 4365
Manguinhos
Rio de Janeiro
21040-900
Brazil
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled blinded study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Meningococcus C conjugate vaccine |
| Primary outcome measure(s) |
Frequency/intensity of adverse events during 30 days after vaccination. |
| Key secondary outcome measure(s) |
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) |
| Completion date | 01/12/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 50 Years |
| Sex | All |
| Target sample size at registration | 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
21040-900
Brazil
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
