Condition 1: Diphtheria vaccine. Condition 2: Tetanus vaccine. Condition 3: Pertussis vaccine. Condition 4: Haemophilus influenzae Vaccine. Condition 5: Hepititis B Veccine. Diphtheria vaccine Tetanus vaccine Pertussis vaccine Haemophilus influenzae Vaccine Viral Vaccine
Conditions
Interventions
Two blood sample will be taken from enrolled infants for measurement of antibody serum titer against Diphtheria, Pertussis, Tetanus, Hepatitis B and Hib separately, the first sample will be taken imme
Prevention
Sponsors
Biosun Farmed (Barkat Foundation)
Eligibility
Sex/Gender
All
Age
2 Months to 7 Months
Inclusion criteria
Inclusion criteria: Inclusion criteria: Healthy infants of either sex aged 2 months at the time of first dose injection; Free of obvious health problems as established by medical history and clinical exam before entering into the study; Born after normal gestational age (36-42 weeks); Written, explained, and signed informed consent form of infant’s parents; Born to sero-negative HBsAg mothers (based on pregnancy documents or mother declaration); Born to sero-negative HIV mothers (based on pregnancy documents or mother declaration); The infant should be receive vaccination of 2/4/6 months at the same clinic and should be available after last vaccination up to two months Exclusion criteria: Use of any investigational drug or vaccine other than Pentavac during the study period or within 30 days prior the first vaccine dose; Administration of immunoglobulins or any other blood products since birth; Administration of a routine vaccine 30 days before or during the study period except BCG and OPV vaccine; History of significant and persistent hematologic, hepatic, renal, cardiac or respiratory disease; Evidence of any acute infection or fever; Axillary temperature = 38.5°C; History of neurological disorders or seizure; History of allergic disease or reactions which is possibly exacerbated by any component of vaccine; Confirmed immunosuppression including HIV infection; Any congenital or hereditary immunodeficiency; Simultaneous participation in any other clinical study
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anti-Diphtheria antibody. Timepoint: One month after intervation. Method of measurement: Immunoassay.;Anti-Tetanus antibody. Timepoint: One month after intervation. Method of measurement: Immunoassay.;Anti-Hepititis B antibody (HbsAb). Timepoint: One month after intervation. Method of measurement: Immunoassay.;Anti-Haemophilus influenzae antibody. Timepoint: One month after intervation. Method of measurement: Immunoassay.;Anti-Pertussis Antibody. Timepoint: One month after intervation. Method of measurement: Immunoassay. | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse clinical symptoms of vaccinination. Timepoint: One month after vaccination. Method of measurement: Evaluation of Symptoms. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMahmood Faramarzi
Research Center of Pediatric Infectious Diseases
Outcome results
None listed