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IRCT2016042027498N1 IRCT 2016-06-10 Biosun Farmed (Barkat Foundation) Post marketing study to assess the immunogenicity and safety of DTPw-Hep B-Hib (PRP-T) vaccine (pentavac) A Phase IV, Multicenter, Open label, Post marketing study to assess the immunogenicity and safety of DTPw-Hep B-Hib (PRP-T) vaccine (pentavac) (adsorbed) manufactured by Serum Institute of India ltd. in infants aged 2-7 months in Alborz Province, Iran 2016-06-21 anticipated 691 Complete https://irct.ir/trial/22510 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Prevention, Other design features: ---------. 4 Condition 1: Diphtheria vaccine. Condition 2: Tetanus vaccine. Condition 3: Pertussis vaccine. Condition 4: Haemophilus influenzae Vaccine. Condition 5: Hepititis B Veccine. 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 immediately before first dose injection of vaccine and the second sample will be taken 4-6 weeks after third dose injection..
public Mahmood Faramarzi
Sattar khan St, Niayesh St, Hazrat-e-Rasool Akram Hospital
Tehran Iran (Islamic Republic of) +98 21 6651 6049 Faramarzimahmood@yahoo.com Research Center of Pediatric Infectious Diseases scientific Hossein Masoumi-Asl
Sattar khan St, Niayesh St, Hazrat-e-Rasool Akram Hospital
Tehran Iran (Islamic Republic of) +98 21 6651 6049 Dr_masoumiasl@yahoo.com Research Center of Pediatric Infectious Diseases Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) 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 2 months 7 months Both Y58.5 Y58.4 Y58.6 P23.6 Y59.0 Diphtheria vaccine Tetanus vaccine Pertussis vaccine Haemophilus influenzae Vaccine Viral Vaccine Prevention 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 immediately before first dose injection of vaccine and the second sample will be taken 4-6 weeks after third dose injection. 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. Adverse clinical symptoms of vaccinination. Timepoint: One month after vaccination. Method of measurement: Evaluation of Symptoms. Biosun Farmed (Barkat Foundation) Approved 2015-12-15 Iran Univerity of Mediacl University (IUMS) Besides Milad Tower, Hemmat Expressway Tehran Iran (Islamic Republic of)