An open label, non-comparative bridging study to evaluate the safety of pentavalent vaccine
ComBe Five (Liquid) made in India, in healthy Vietnamese children aged from 8 - 10 weeks as a
3-dose series, interval for each dose is 4 weeks
Biological: ComBe Five (Liquid)
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Locations near you
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Full eligibility criteria for NCT02904213
Ages eligible for Study
8 Weeks to 10 Weeks
Genders eligible for Study
Accepts Healthy Volunteers
Subject must meet all criteria below to participate in study:
Healthy children, both genders, age from 8 -12 weeks at screening visit and the first dose (visit 1)
Weight ≥ 3.300 gram at Screening visit and receive the first dose
Understand and follow the study
Mother of children have serum negative for HIV, HBV and HCV on blood test results or antenatal tests report book.
Children or mother don't participate in other clinical study scheduled during the study.
Parent/ legal guardian can understand and have ability to follow protocol.
Parent/ legal guardian voluntary write consent to participate in the study.
Parent/ legal guardian of subject have ability to comply with the process of study.
Parent/ legal guardian of subject who intends to remain in the area with the participant during the study period.
Subject have one of criteria below must not participate in study:
Fever (temperature ≥37.5oC) or loses temperature (≤35.5 oC) or disease/ infection chronic
Subjects who had received DPT
Subjects who had received immunosuppressant therapy
Subjects with a known or doubt hypersensitivity of allergic reaction to any component of the study vaccine
Subjects who had any signs or symptoms of functional disorder, especially central nervous system.
Subjects who had haemophilia or received treatment anticoagulant drug, had a risk of serious bleeding when intramuscular injection.
Subjects who had a family history of SIDS (Sudden Infant death syndrome)
Subjects intend to surgery scheduled during the study
Subjects who had received any blood products, corticosteroid cytotoxic drugs, radiotherapy.
Subjects and mother who had participated in other clinical trial within 30 days priors to vaccination with study drug, or those who had another clinical trial scheduled during the study.
Can't afford or not ready follow protocol
Any criteria that, in the judgment of the investigator, would interfere with or serves as a contraindication to protocol adherence
All locations for NCT02904213
Ha Nam Health Center
Hà Nam, Vietnam, 400000
View full eligibility
Tris trial is registered with FDA with number: NCT02904213. The sponsor of the trial is Institute of Clinical Research and Clinical Trial Support for Vaccine and Biological Products and it is looking for 330 volunteers for the current phase.
Official trial title: A Bridging Study to Evaluate Safety of ComBe Five (Liquid) (Combined Pentavalent DTwP-rHepB-Hib Vaccine) Made in India, in Healthy Vietnamese Children Aged From 8 - 10 Weeks as a 3-dose Series, Interval for Each Dose is 4 Weeks
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