Post marketing study to assess the immunogenicity and safety of DTPw-Hep B-Hib (PRP-T) vaccine (pentavac)

Phase 4

Recruiting

• Conditions: 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

• Registration Number: IRCT2016042027498N1
• Lead Sponsor: Biosun Farmed (Barkat Foundation)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 691

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

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Adverse clinical symptoms of vaccinination. Timepoint: One month after vaccination. Method of measurement: Evaluation of Symptoms.