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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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8 January 2018 |
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Main ID: |
NCT02904213 |
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Date of registration:
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08/09/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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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
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Scientific title:
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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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Date of first enrolment:
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September 16, 2016 |
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Target sample size:
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330 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02904213 |
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Study type:
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Interventional |
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Study design:
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Intervention model: Single Group Assignment. Primary purpose: Prevention. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Vietnam
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Key inclusion & exclusion criteria
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Inclusion Criteria:
Subject must meet all criteria below to participate in study:
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:
Subject have one of criteria below must not participate in study:
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
Age minimum:
8 Weeks
Age maximum:
10 Weeks
Gender:
All
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Health Condition(s) or Problem(s) studied
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Safety, Pentavalent Vaccine
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Intervention(s)
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Biological: ComBe Five (Liquid)
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Primary Outcome(s)
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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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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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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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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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Secondary ID(s)
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VX.2016.03
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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