Condition category
Infections and Infestations
Date applied
16/02/2006
Date assigned
16/03/2006
Last edited
17/03/2006
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

Dr Andre Perisse

ORCID ID

Contact details

Av. Brasil 4365
Rio de Janeiro
21040-900
Brazil
+55 21 3882 9479
areynaldo@bio.fiocruz.br

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

0060.0.009.000-05

Study information

Scientific title

Acronym

Study hypothesis

Vaccine adverse events occur in acceptable levels for human use

Ethics approval

Approved by the Committee of Evandro Chagas Clinical Research Institute on 8/08/2005, reference number: CAAE-0060.0.009.000-05

Study design

Open, phase 1 trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Prevention

Patient information sheet

Condition

Meningococcal disease serogroup C

Intervention

1. Brazilian conjugate meningococcal C vaccine
2. Blood, urine, faeces specimens
3. Electrocardiogram (ECG), x-ray

Intervention type

Drug

Phase

Phase I

Drug names

Brazilian conjugated meningococcal C vaccine

Primary outcome measures

Safety assessment 30 days after immunization

Secondary outcome measures

Immunogenicity 30 days after immunization

Overall trial start date

02/01/2006

Overall trial end date

30/04/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. 18-44 years of age
2. Willingness to comply with protocol requirements
3. Healthy volunteers
4. Ability to understand consent form
5. Human Immunodeficiency Virus (HIV) negative
6. Non-pregnant

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

30

Participant exclusion criteria

1. Nursing women
2. Use of different substances in the previous 14-60 days such as immunosupressive therapy and other vaccines
3. Prior history of serious adverse event to vaccines
4. Prior history of chronic diseases such as hypertension and diabetes
5. Alcohol and drug abuse

Recruitment start date

02/01/2006

Recruitment end date

30/04/2006

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

Av. Brasil 4365
Rio de Janeiro
21040-900
Brazil
+55 21 3882 9305
akira@bio.fiocruz.br

Sponsor type

Industry

Website

http://www.bio.fiocruz.br

Funders

Funder type

Industry

Funder name

Bio-Manguinhos/Fiocruz

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