Evaluation of the immunogenicity of thepentavalent vaccine
- Conditions
- pentavalent vaccine.
- Registration Number
- IRCT2015051222234N1
- Lead Sponsor
- ational Institute for Medical Research Development
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 1200
1.Healthy 2 -month-old infant boy or girl who is referred for routine vaccination
2.Infant disease is not identified at the time of visit
3.Upon arriving at the physical examination is normal nursing
4.Parents of infants in the study were successful login and sign the informed consent form
5.infants with gestational age of 38 weeks of a normal pregnancy and birth weight = 2.5 kg
Exclusion criteria:
1.The use of any vaccine or drug, vaccine research studies except during the study period or 30 days prior to study entry
2.History of blood transfusions or blood products or immunoglobulin consumption
3.History of heart, respiratory, kidney, liver and blood disease
4.Known genetic or congenital immune deficiency
5.Participation in other clinical studies
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Determination of antibody (IgG) titer against each of components of the vaccine (Diphtheria, Tetanus, Pertussis, Hepatitis B and H.influenzae) following vaccination with pentavalent vaccine in ages of 2, 4 and 6 months. Timepoint: 2, 7 months after intervention. Method of measurement: ELISA.
- Secondary Outcome Measures
Name Time Method Safety of pentavalent vaccine. Timepoint: Adverse event of vaccine. Method of measurement: Observation.