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

December 15, 2017 updated by: Pham Ngoc Hung, Institute of Clinical Research and Clinical Trial Support for Vaccine and Biological Products

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
330

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Vietnam
      • Hà Nam, Vietnam, 400000
        • Ha Nam Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

3 years to 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Pentavalent vaccine
3 Dose, interval for each dose is 4 weeks. The first dose will be received at 8-10 weeks of age
Biological: ComBe Five (Liquid)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
30 minutes after vaccination
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
For 7 days after each vaccination
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
For 28 days after each vaccination
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
For 28 days after each vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Institute of Clinical Research and Clinical Trial Support for Vaccine and Biological Products

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Biological E. Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 16, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 19, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 24, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 8, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 15, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 16, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 18, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 15, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VX.2016.03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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