Safety, Pentavalent VaccineNCT02904213
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 study testing ComBe Five (Liquid) in people with Safety, Pentavalent Vaccine, run by Institute of Clinical Research and Clinical Trial Support for Vaccine and Biological Products at 1 site in Vietnam.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 8 to 10 weeksHealthy volunteers can take part
- Conditions the study is for
- Safety, Pentavalent Vaccine
- What is being tested?
- ComBe Five (Liquid)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 1 siteVietnam
- Study dates
- 16 Sep 2016to 24 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 10 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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
Read the 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.
- Conditions
- Safety, Pentavalent Vaccine
- Being tested
- ComBe Five (Liquid)
- Keywords
- vaccine, ComBe Five, Vietnam, pentavalent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ComBe Five (Liquid)Biological
| Study group | Role | What they receive |
|---|---|---|
| Pentavalent vaccine | Experimental | 3 Dose, interval for each dose is 4 weeks. The first dose will be received at 8-10 weeks of age Receives: Biological: ComBe Five (Liquid) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and rate of the adverse effects and severity of immediate adverse events (Local and General) within 30 minutes after vaccination.
Measured: 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
Measured: 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
Measured: 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
Measured: For 28 days after each vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2016 (estimated)
- Study start16 Sep 2016
- Primary completion19 Dec 2016
- Study completion24 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety, Pentavalent VaccineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Clinical Research and Clinical Trial Support for Vaccine and Biological Products
- Sponsor type
- University, hospital or other
- Collaborators
- Biological E. Limited
- Responsible party
- Principal investigator, Pham Ngoc Hung, Vietnam Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02904213
- Sponsor's protocol ID
- VX.2016.03
- Status last verified
- Dec 2017
- First submitted
- 8 Sep 2016
- Last updated
- 18 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02904213
- Acronym / sponsor ID
- VX.2016.03
- Conditions
- Safety, Pentavalent Vaccine
- Keywords
- vaccine, ComBe Five, Vietnam, pentavalent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- Institute of Clinical Research and Clinical Trial Support for Vaccine and Biological ProductsUniversity, hospital or other
- Collaborators
- Biological E. Limited
- Study start
- 16 Sep 2016 (actual)
- Primary completion
- 19 Dec 2016 (actual)
- Study completion
- 24 Jun 2017 (actual)
- First posted
- 16 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pentavalent vaccine | Experimental | Biological: ComBe Five (Liquid)3 Dose, interval for each dose is 4 weeks. The first dose will be received at 8-10 weeks of age |
Who may qualify
- Ages
- 8 to 10 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ComBe Five (Liquid) | Biological | Pentavalent vaccine |
Primary outcome
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Safety, Pentavalent Vaccine
Active, not recruitingPhase 1/2
Assessing the Safety, Immune Response, and Early Efficacy of a Candida Vaccine in Women With Recurrent Vulvovaginal Candidiasis: A Randomized Controlled Study
Recurrent Vulvovaginal Candidiasis
RecruitingPhase 4
Phase IV Clinical Study of sIPV Administration in Adolescent and Adult Populations
Poliomyelitis
Active, not recruitingPhase 1/2
Safety and Immunogenicity of an Investigational Pentavalent Meningococcal ABCYW Vaccine Against Meningococcal Disease in Children, Toddlers, and Infants
Meningococcal Immunization, Healthy Volunteers
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ComBe Five (Liquid) in people with Safety, Pentavalent Vaccine, run by Institute of Clinical Research and Clinical Trial Support for Vaccine and Biological Products at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2017.