pentavalent vaccine.
Conditions
Interventions
Intervention 1: group 1 (case): give biofarma vaccine. Intervention 2: group 1(control): give routine pentavalent vaccine. Intervention 3: group 2 (case) : give shan5 vaccine.
Prevention
group 1 (case): give biofarma vaccine
group 1(control): give routine pentavalent vaccine
group 2 (case) : give shan5 vaccine
Sponsors
National Institute for Medical Research Development
Eligibility
Sex/Gender
All
Age
2 Months to 7 Months
Inclusion criteria
Inclusion criteria: Inclusion criteria: 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
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Safety of pentavalent vaccine. Timepoint: Adverse event of vaccine. Method of measurement: Observation. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMaryam Rajabnejad
Pediatric Infections Research Center
Outcome results
None listed