Brazilian conjugated meningococcal C vaccine: safety and immunogenicity

ISRCTN	ISRCTN70123783
DOI	https://doi.org/10.1186/ISRCTN70123783
Secondary identifying numbers	0060.0.009.000-05

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

Dr Andre Perisse
Scientific

Av. Brasil 4365
Rio de Janeiro
21040-900
Brazil

Phone	+55 21 3882 9479
Email	areynaldo@bio.fiocruz.br

Study design	Open, phase 1 trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Prevention
Scientific title
Study objectives	Vaccine adverse events occur in acceptable levels for human use
Ethics approval(s)	Approved by the Committee of Evandro Chagas Clinical Research Institute on 8/08/2005, reference number: CAAE-0060.0.009.000-05
Health condition(s) or problem(s) studied	Meningococcal disease serogroup C
Intervention	1. Brazilian conjugate meningococcal C vaccine 2. Blood, urine, faeces specimens 3. Electrocardiogram (ECG), x-ray
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Phase I
Drug / device / biological / vaccine name(s)	Brazilian conjugated meningococcal C vaccine
Primary outcome measure	Safety assessment 30 days after immunization
Secondary outcome measures	Immunogenicity 30 days after immunization
Overall study start date	02/01/2006
Completion date	30/04/2006

Participant type(s)	Healthy volunteer
Age group	Adult
Lower age limit	18 Years
Upper age limit	44 Years
Sex	Both
Target number of participants	30
Key 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
Key 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
Date of first enrolment	02/01/2006
Date of final enrolment	30/04/2006

Av. Brasil 4365

Rio de Janeiro
21040-900
Brazil

Bio-Manguinhos/Fiocruz (Brazil)
Industry

Av. Brasil 4365
Rio de Janeiro
21040-900
Brazil

Industry

Bio-Manguinhos/Fiocruz

No information available

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