DiphtheriaPhase 3VenusNCT02458183
Vaccine -diphthEria -tetaNus -Acellular pertUssis-inactivated polioviruS
A Phase 3 study testing DTaP-IPV combination vaccine and DTaP vaccine and IPV vaccine in people with Diphtheria and Tetanus, run by Boryung Pharmaceutical Co., Ltd at 20 sites in 2 countries.
Trial summary
The objective of this study is to assess the immunogenicity and safety of the DTaP-IPV combination vaccine compared with those of separate DTaP and IPV vaccines administered to healthy infants at 2, 4, and 6 months of age. Read more about this study
- Who is it for?
- Ages 7 to 10 weeksHealthy volunteers can take part
- Conditions the study is for
- Diphtheria, Tetanus, Pertussis
- What is being tested?
- DTaP-IPV combination vaccine and DTaP vaccine and IPV vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 476 participants
- Where
- 20 sitesin 2 countries
- Study dates
- 2 Feb 2015to 5 May 2018
- Phase
- Phase 3
- 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 7 to 10 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Parent/guardian (legally authorized representative) has given voluntary written consent to the subject's participation after being fully informed of the purpose, methods, risks, and benefits of the study.
- Male and female infants reaching at least 7 weeks of age on the day of first dose of investigational product.
- Male and female infants who are identified to be healthy based on physical examination and medical history.
Who cannot join
- Subjects who have acute febrile illness with tympanic temperature of ≥38.0 ℃ on the day of vaccination.
- Subjects who have moderate or severe acute disease (regardless of fever).
- Subjects who have any history of diphtheria, tetanus, pertussis, or poliomyelitis.
- Subjects who have major congenital defects.
- Subjects who show any evidence of continuous hematologic, hepatic, cardiac, re-nal, or respiratory disease.
- Subjects who have abnormalities in the immune system, or congenital/acquired immune deficiency.
Show all 13Show fewer
- Subjects who received immunosuppressive dose of systemic corticosteroids thera-py within 30 days before the vaccination.
- Subjects who are likely to have adverse side effects on central nervous system be-cause of the subjects' family history of genetic diseases in central nervous system such as progressive neurological problems or epilepsy.
- Subjects who are allergic to the ingredients of the investigational products.
- Subjects who have received immunoglobulins or blood products or plan to get those medications.
- Subjects who have received vaccines other than those allowed in the protocol or plan to get those prohibited vaccines during the study period.
- Subjects who are currently participating or planning to participate in other clinical studies during the study period.
- Other ineligible conditions judged at the discretion of principal investigators or subinvestigators.
Trial locations and contacts
20 sites in 2 countries.
20 sites in 2 countries
South Korea18 sites
Inje University Busan Paik Hospital
Busan
KeiMyung University Dongsan Medical Center
Daegu
Gwangmyeong Sungae Hospital
Gyeonggi-do
Wonkwang University Hospital
Iksan
Inha University Hospital
Incheon
Pusan National University Yangsan Hospital
Pusan
Asan Medical Center
Seoul
Cheil General Hospital
Seoul
Chung-Ang University Hospital
Seoul
Eulgi General Hospital
Seoul
Gangnam Sevrance Christian Hospital
Seoul
Hallym University Medical Center
Seoul
KEPCO Medical Center
Seoul
Korea Cancer Center Hospital
Seoul
KyungHee University Hospital at Gangdong
Seoul
KyungHee University Hospital
Seoul
Samsung Medical Center
Seoul
Wonju Sevrance Christian Hospital
Wŏnju
About this study
Official title: A Multinational, Multicenter, Randomized, Comparative, Open-label, Phase 3 Study to Assess the Immunogenicity and Safety of DTaP-IPV (Diphtheria-tetanus-acellular Pertussis-inactivated Poliovirus) Vaccine Administered to Healthy Infants
The objective of this study is to assess the immunogenicity and safety of the DTaP-IPV combination vaccine compared with those of separate DTaP and IPV vaccines administered to healthy infants at 2, 4, and 6 months of age.
Read the detailed description
A multinational, multicenter, randomized, comparative, open-label, phase 3 study
Primary Objective: To assess the vaccine response rates after the three-dose primary vaccination Secondary Objectives: To measure the antibody titer after the three-dose primary vaccination and to assess the safety of the investigational products
- Conditions
- Diphtheria, Tetanus, Pertussis, Poliomyelitis
- Being tested
- DTaP-IPV combination vaccine, DTaP vaccine and IPV vaccine
- Medical subject headings
- Diphtheria, Tetanus, Whooping Cough, Poliomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DTaP-IPV combination vaccineBiological
0.5-mL IM
DTaP vaccine and IPV vaccineBiological
Also called Boryung DTaP Vaccine Inj. (Prefilled syringe), IPVAX INJ. PREFILLED SYRINGE INJ
0.5-mL IM
| Study group | Role | What they receive |
|---|---|---|
| DTaP-IPV combination vaccine | Experimental | Dosage and administration: A 0.5-mL dose is administered intramuscularly in the anterol-ateral aspect of right thigh at the age of 2, 4, and 6 months Receives: Biological: DTaP-IPV combination vaccine |
| DTaP vaccine and IPV vaccine | Active comparator | Product name: : Boryung DTaP Vaccine Inj. (Prefilled syringe) (Absorbed diphtheria, tetanus toxoid, and purified pertussis combination vaccine) Dosage and administration: A 0.5-mL dose is administered 3 times intramuscularly in the anterolateral aspect of right thigh at the age of 2, 4, and 6 months.
Product name: IPVAX INJ. PREFILLED SYRINGE INJ. Dosage and administration: A 0.5-mL dose is administered intramuscularly in the anterol-ateral aspect of left thigh at the age of 2, 4, and 6 months. Receives: Biological: DTaP vaccine and IPV vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaccine response rate
Vaccine response rate of anti-diphtheria, anti-tetanus, anti-PT, anti-FHA, and anti-poliovirus type 1, 2, 3 at 4 weeks after the completion of the final vaccination
Criteria of vaccine response rate Anti-diphtheria: Antibody titer after the completion of the final vaccination ≥ 0.1 IU/mL anti-tetanus: Antibody titer after the completion of the final vaccination ≥ 0.1 IU/mL anti-PT, anti-FHA: Antibody titer at 4 weeks after the completion of the final vaccination is at least 4 times the baseline antibody titer anti-poliovirus type 1, 2, 3: Serum neutralizing antibody dilution ratio after the completion of the final vaccination ≥ 1:8
Measured: 4 weeks after the three-dose primary vaccination
Secondary outcomes (1)
Geometric mean titer (GMT)
anti-diphtheria, anti-tetanus, anti-PT, anti-FHA, and anti-poliovirus type 1, 2, 3 at 4 weeks after the completion of the final vaccination
Measured: 4 weeks after the three-dose primary vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2015 (estimated)
- Study start2 Feb 2015
- Primary completion19 Dec 2017
- Study completion5 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiphtheriaStudies of the same condition, open and under way.
- More trials run by Boryung Pharmaceutical Co., LtdThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 476 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boryung Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- HJ Jung, Study director, Boryung Pharmaceutical Co., Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02458183
- Sponsor's protocol ID
- BR-DTPP-CT-301
- Acronym
- Venus
- Status last verified
- Jun 2023
- First submitted
- 27 Apr 2015
- Last updated
- 28 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multinational, Multicenter, Randomized, Comparative, Open-label, Phase 3 Study to Assess the Immunogenicity and Safety of DTaP-IPV (Diphtheria-tetanus-acellular Pertussis-inactivated Poliovirus) Vaccine Administered to Healthy Infants
- ClinicalTrials.gov ID
- NCT02458183
- Acronym / sponsor ID
- Venus / BR-DTPP-CT-301
- Conditions
- Diphtheria, Tetanus, Pertussis, Poliomyelitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 476 participants (actual)
- Lead sponsor
- Boryung Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 2 Feb 2015 (actual)
- Primary completion
- 19 Dec 2017 (actual)
- Study completion
- 5 May 2018 (actual)
- First posted
- 1 Jun 2015 (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.
The objective of this study is to assess the immunogenicity and safety of the DTaP-IPV combination vaccine compared with those of separate DTaP and IPV vaccines administered to healthy infants at 2, 4, and 6 months of age.
Detailed description
A multinational, multicenter, randomized, comparative, open-label, phase 3 study
Primary Objective: To assess the vaccine response rates after the three-dose primary vaccination Secondary Objectives: To measure the antibody titer after the three-dose primary vaccination and to assess the safety of the investigational products
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DTaP-IPV combination vaccine | Experimental | Biological: DTaP-IPV combination vaccineDosage and administration: A 0.5-mL dose is administered intramuscularly in the anterol-ateral aspect of right thigh at the age of 2, 4, and 6 months |
| DTaP vaccine and IPV vaccine | Active comparator | Biological: DTaP vaccine and IPV vaccineProduct name: : Boryung DTaP Vaccine Inj. (Prefilled syringe) (Absorbed diphtheria, tetanus toxoid, and purified pertussis combination vaccine) Dosage and administration: A 0.5-mL dose is administered 3 times intramuscularly in the anterolateral aspect of right thigh at the age of 2, 4, and 6 months. Product name: IPVAX INJ. PREFILLED SYRINGE INJ. Dosage and administration: A 0.5-mL dose is administered intramuscularly in the anterol-ateral aspect of left thigh at the age of 2, 4, and 6 months. |
Who may qualify
- Ages
- 7 to 10 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Parent/guardian (legally authorized representative) has given voluntary written consent to the subject's participation after being fully informed of the purpose, methods, risks, and benefits of the study.
- Male and female infants reaching at least 7 weeks of age on the day of first dose of investigational product.
- Male and female infants who are identified to be healthy based on physical examination and medical history.
Key exclusion criteria (13 listed)
- Subjects who have acute febrile illness with tympanic temperature of ≥38.0 ℃ on the day of vaccination.
- Subjects who have moderate or severe acute disease (regardless of fever).
- Subjects who have any history of diphtheria, tetanus, pertussis, or poliomyelitis.
- Subjects who have major congenital defects.
- Subjects who show any evidence of continuous hematologic, hepatic, cardiac, re-nal, or respiratory disease.
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 |
|---|---|---|
| DTaP-IPV combination vaccine0.5-mL IM | Biological | DTaP-IPV combination vaccine |
| DTaP vaccine and IPV vaccineAlso: Boryung DTaP Vaccine Inj. (Prefilled syringe), IPVAX INJ. PREFILLED SYRINGE INJ0.5-mL IM | Biological | DTaP vaccine and IPV vaccine |
Primary outcome
Vaccine response rate
Time frame: 4 weeks after the three-dose primary vaccination
Vaccine response rate of anti-diphtheria, anti-tetanus, anti-PT, anti-FHA, and anti-poliovirus type 1, 2, 3 at 4 weeks after the completion of the final vaccination Criteria of vaccine response rate Anti-diphtheria: Antibody titer after the completion of the final vaccination ≥ 0.1 IU/mL anti-tetanus: Antibody titer after the completion of the final vaccination ≥ 0.1 IU/mL anti-PT, anti-FHA: Antibody titer at 4 weeks after the completion of the final vaccination is at least 4 times the baseline antibody titer anti-poliovirus type 1, 2, 3: Serum neutralizing antibody dilution ratio after the completion of the final vaccination ≥ 1:8
1 secondary outcome
Geometric mean titer (GMT)
Time frame: 4 weeks after the three-dose primary 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 28 Jun 2023.
- Individual participant dataSharing planned: No
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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.
HJ Jung study director
Boryung Pharmaceutical Co., Ltd
20 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DTaP-IPV combination vaccine and DTaP vaccine and IPV vaccine in people with Diphtheria and Tetanus, run by Boryung Pharmaceutical Co., Ltd at 20 sites in 2 countries.
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 3 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 28 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in South Korea, Thailand. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Vaccine response rate (time frame: 4 weeks after the three-dose primary vaccination). 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 28 Jun 2023.