Evaluate Safety of ComBe Five (Liquid) in Healthy Vietnamese Children Aged From 8 - 10 Weeks as a 3-dose Series, Interval for Each Dose is 4 Weeks
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The trial is a bridging Study to evaluate 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. 330 subjects will be enrolled in Binh Luc and Ly Nhan district, Ha Nam province. These subjects will be received 3 doses (0.5ml/dose) ComBe Five (Liquid), the first dose will be administered at 8-10 weeks of age.
The frequency, rate and severity of immediate adverse events within 30 minutes after vaccination, solicited and unsolicited AE within 28 days after vaccination, the frequency and rate of SAE within 28 days after the first vaccination will be recorded as evidences for ComBeFive (Liquid) safety assessment. The subjects to be included from this trial would be representative of the population of Vietnam.
The protocol has been reviewed and approved by Vietnam Military Medical University IRB and Vietnam Ministry of Health IEC and Vietnam Minister of Health.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Hà Nam, Vietnam, 400000
- Ha Nam Health Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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.
Exclusion Criteria:
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Pentavalent vaccine
3 Dose, interval for each dose is 4 weeks.
The first dose will be received at 8-10 weeks of age
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Frequency and rate of the adverse effects and severity of immediate adverse events (Local and General) within 30 minutes after vaccination.
Time Frame: 30 minutes after vaccination
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30 minutes after vaccination
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Frequency and rate of adverse effects and severity of solicited adverse events (Local and General) within 7 days after each vaccination
Time Frame: For 7 days after each vaccination
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For 7 days after each vaccination
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Frequency and rate of adverse effects and severity of unsolicited adverse events (Local and General) during 28 days after each vaccination
Time Frame: For 28 days after each vaccination
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For 28 days after each vaccination
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Frequency and rate of adverse effects and severity of Serious Adverse Events (Local and General) during 28 days after each vaccination
Time Frame: For 28 days after each vaccination
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For 28 days after each vaccination
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- VX.2016.03
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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