Healthy InfantsPhase 3NCT01896739
A Phase III Study to Assess the Immunogenicity and Safety of Eutravac (DTap-HB Combined Vaccine) With DTaP and Hepatitis B Vaccines in Healthy Infants
A Phase 3 study testing Eutravac in people with Healthy Infants, run by LG Life Sciences at 7 sites in South Korea.
Trial summary
To evaluate and compare the immunogenicity of Eutravac (Diphtheria-Tetanus-acellular Pertussis [DTaP] Hepatitis B [HB] combined) vaccine with separate but simultaneous administrations of DTaP and HB vaccine each administered to healthy infants, as measured by seroprotection/vaccine response rates 4-8 weeks post-final… Read more about this study
- Who is it for?
- Ages Up to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Healthy Infants
- What is being tested?
- Eutravac
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 289 participants
- Where
- 7 sitesSouth Korea
- Study dates
- Aug 2009to Nov 2011
- 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 Up to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Were healthy, male or female infants born at full term pregnancy (≥37 weeks) with a birth weight ≥2.5 kg to mothers with a negative HBsAg serology, documented prior to giving birth as per routine, site-specific ante-natal care procedures.
- Signed parental or legally acceptable representative's informed consent was obtained
Who cannot join
- Evidence of an acute febrile illness with axillary temperature ≥37.5℃ on the day of the vaccination. Infants with symptoms of minor illness eg, mild gastroenteritis, mild upper respiratory tract infection and who did not have a temperature ≥37.5℃ on the day of the vaccination could be included at the Investigator's discretion
- History of diphtheria, tetanus, pertussis or hepatitis B disease
- History of any vaccine-related hypersensitivity or anaphylactic reaction after previous administration of Euvax B
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
South Korea7 sites
Daejeon St. Mary's Hospital
Daejeon, Daejeon, 301-723
Inha University Hospital
Incheon, Incheon, 400-711
Jeju National University Hospital
Jeju City, Jeju-do, 690-767
Kyung Hee University Hospital
Seoul, Seoul, 130-872
Cha Hospital
Seoul, Seoul, 135-913
Korea Cancer Center Hospital
Seoul, Seoul, 139-709
The Catholic University of Korea ST. Vincent's Hospital
Suwon, Gyeonggi-do, 442-723
About this study
Official title: A Multicentre, Comparative, Open-label, Randomized, Phase III Study to Assess the Immunogenicity and Safety of EutravacTMinj (DTaP-HB Combined Vaccine) Administered at 2,4, 6 Months of Age Compared With DTaP Vaccine at 2, 4, 6 Months of Age Combined Administered Monovalent Hepatitis B Vaccine Administered at Birth, 1, 6 Months of Age in Healthy Infants.
To evaluate and compare the immunogenicity of Eutravac (Diphtheria-Tetanus-acellular Pertussis [DTaP] Hepatitis B [HB] combined) vaccine with separate but simultaneous administrations of DTaP and HB vaccine each administered to healthy infants, as measured by seroprotection/vaccine response rates 4-8 weeks post-final immunisation.
- Conditions
- Healthy Infants
- Being tested
- Eutravac
- Keywords
- Healthy infants with over than 37 weeks gestation periods., over than 2.5Kg at at birth weight.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EutravacBiological
Also called LG DTaP Vaccine Inj. (DTaP), Euvax B (Hepatitis B), Hepavax (Hepatitis B)
| Study group | Role | What they receive |
|---|---|---|
| Experimental group with 0-2-4-6 schedule | Experimental | HB at 0, Eutravac at 2-4-6 Receives: Biological: Eutravac |
| Active comparator group with 0-2-4-6 schedule | Active comparator | Separate injection of DTaP and HB at 2-4-6 (for DTaP) and 0-1-6 (HB) Receives: Biological: Eutravac |
| Experimental group with 2-4-6 schedule | Experimental | Eutravac at 2-4-6 Receives: Biological: Eutravac |
| Active comparator group with 2-4-6 schedule | Active comparator | Separate injection of DTaP and HB at 2-4-6 (for DTaP) and 0-1-6 (HB) Receives: Biological: Eutravac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroprotection rate
Measured: After final immunisation at 4-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2013 (estimated)
- Study startAug 2009
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy InfantsStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 289 participants (actual)
Sponsor and investigators
- Lead sponsor
- LG Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01896739
- Sponsor's protocol ID
- LG-VACL004
- Status last verified
- Jul 2013
- First submitted
- 8 Jul 2013
- Last updated
- 11 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Comparative, Open-label, Randomized, Phase III Study to Assess the Immunogenicity and Safety of EutravacTMinj (DTaP-HB Combined Vaccine) Administered at 2,4, 6 Months of Age Compared With DTaP Vaccine at 2, 4, 6 Months of Age Combined Administered Monovalent Hepatitis B Vaccine Administered at Birth, 1, 6 Months of Age in Healthy Infants.
- ClinicalTrials.gov ID
- NCT01896739
- Acronym / sponsor ID
- LG-VACL004
- Conditions
- Healthy Infants
- Keywords
- Healthy infants with over than 37 weeks gestation periods., over than 2.5Kg at at birth weight.
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 289 participants (actual)
- Lead sponsor
- LG Life SciencesIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 11 Jul 2013 (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.
To evaluate and compare the immunogenicity of Eutravac (Diphtheria-Tetanus-acellular Pertussis [DTaP] Hepatitis B [HB] combined) vaccine with separate but simultaneous administrations of DTaP and HB vaccine each administered to healthy infants, as measured by seroprotection/vaccine response rates 4-8 weeks post-final immunisation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Experimental group with 0-2-4-6 schedule | Experimental | Biological: EutravacHB at 0, Eutravac at 2-4-6 |
| Active comparator group with 0-2-4-6 schedule | Active comparator | Biological: EutravacSeparate injection of DTaP and HB at 2-4-6 (for DTaP) and 0-1-6 (HB) |
| Experimental group with 2-4-6 schedule | Experimental | Biological: EutravacEutravac at 2-4-6 |
| Active comparator group with 2-4-6 schedule | Active comparator | Biological: EutravacSeparate injection of DTaP and HB at 2-4-6 (for DTaP) and 0-1-6 (HB) |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Were healthy, male or female infants born at full term pregnancy (≥37 weeks) with a birth weight ≥2.5 kg to mothers with a negative HBsAg serology, documented prior to giving birth as per routine, site-specific ante-natal care procedures.
- Signed parental or legally acceptable representative's informed consent was obtained
Key exclusion criteria (3 listed)
- Evidence of an acute febrile illness with axillary temperature ≥37.5℃ on the day of the vaccination. Infants with symptoms of minor illness eg, mild gastroenteritis, mild upper respiratory tract infection and who did not have a temperature ≥37.5℃ on the day of the vaccination could be included at the Investigator's discretion
- History of diphtheria, tetanus, pertussis or hepatitis B disease
- History of any vaccine-related hypersensitivity or anaphylactic reaction after previous administration of Euvax B
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 |
|---|---|---|
| EutravacAlso: LG DTaP Vaccine Inj. (DTaP), Euvax B (Hepatitis B), Hepavax (Hepatitis B) | Biological | Active comparator group with 0-2-4-6 schedule, Active comparator group with 2-4-6 schedule, Experimental group with 0-2-4-6 schedule, Experimental group with 2-4-6 schedule |
Primary outcome
Seroprotection rate
Time frame: After final immunisation at 4-8 weeks
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 11 Jul 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Eutravac in people with Healthy Infants, run by LG Life Sciences at 7 sites in South Korea.
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 2 inclusion and 3 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 11 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in South Korea. 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?
Seroprotection rate (time frame: After final immunisation at 4-8 weeks). 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 11 Jul 2013.