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
NCT ID: NCT02904213
Last Updated: 2017-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
330 participants
INTERVENTIONAL
2016-09-16
2017-06-24
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Pentavalent vaccine
3 Dose, interval for each dose is 4 weeks. The first dose will be received at 8-10 weeks of age
ComBe Five (Liquid)
Interventions
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ComBe Five (Liquid)
Eligibility Criteria
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Inclusion Criteria
1. Healthy children, both genders, age from 8 -12 weeks at screening visit and the first dose (visit 1)
2. Weight ≥ 3.300 gram at Screening visit and receive the first dose
3. Understand and follow the study
4. Mother of children have serum negative for HIV, HBV and HCV on blood test results or antenatal tests report book.
5. Children or mother don't participate in other clinical study scheduled during the study.
6. Parent/ legal guardian can understand and have ability to follow protocol.
7. Parent/ legal guardian voluntary write consent to participate in the study.
8. Parent/ legal guardian of subject have ability to comply with the process of study.
9. Parent/ legal guardian of subject who intends to remain in the area with the participant during the study period.
Exclusion Criteria
1. Fever (temperature ≥37.5oC) or loses temperature (≤35.5 oC) or disease/ infection chronic
2. Subjects who had received DPT
3. Subjects who had received immunosuppressant therapy
4. Subjects with a known or doubt hypersensitivity of allergic reaction to any component of the study vaccine
5. Subjects who had any signs or symptoms of functional disorder, especially central nervous system.
6. Subjects who had haemophilia or received treatment anticoagulant drug, had a risk of serious bleeding when intramuscular injection.
7. Subjects who had a family history of SIDS (Sudden Infant death syndrome)
8. Subjects intend to surgery scheduled during the study
9. Subjects who had received any blood products, corticosteroid cytotoxic drugs, radiotherapy.
10. 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.
11. Can't afford or not ready follow protocol
12. Any criteria that, in the judgment of the investigator, would interfere with or serves as a contraindication to protocol adherence
8 Weeks
10 Weeks
ALL
Yes
Sponsors
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Biological E. Limited
UNKNOWN
Institute of Clinical Research and Clinical Trial Support for Vaccine and Biological Products
OTHER
Responsible Party
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Pham Ngoc Hung
Principal Investigator
Locations
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Ha Nam Health Center
Hà Nam, , Vietnam
Countries
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Other Identifiers
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VX.2016.03
Identifier Type: -
Identifier Source: org_study_id