Haemophilus Influenzae Type B InfectionPhase 4NCT01404962
Safety of Haemophilus Influenza Type b Vaccine When Administered to Korean Children
A Phase 4 study testing Haemophilus influenza type b conjugate vaccine in people with Haemophilus Influenzae Type B Infection, run by Novartis Vaccines at 5 sites in South Korea.
Trial summary
This is a multicenter, post marketing surveillance study which aims to evaluate the safety profile of haemophilus influenza type b vaccine when administered to Korean children according to the product insert. Read more about this study
- Who is it for?
- Ages 2 months to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Haemophilus Influenzae Type B Infection
- What is being tested?
- Haemophilus influenza type b conjugate vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 764 participants
- Where
- 5 sitesSouth Korea
- Study dates
- Aug 2011to Jul 2012
- Phase
- Phase 4
- 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 2 months to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Male and female children 2 months to 5 years of age scheduled to receive vaccination
Who cannot join
- Contraindications to Vaxem™Hib Korean Prescribing information
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
South Korea5 sites
Moon's Pediatrics Clinic
Gyeonggi-do, 449-812
Wooriai Pediatrics clinic
Incheon, 407-818
KyungHee University Hospital
Seoul, 130-702
Hanil General Hospital
Seoul, 132-703
Yonsei Pediatrics Clinic
Seoul, 134-734
About this study
Official title: A Post Marketing Surveillance Study to Monitor the Reactogenicity and Safety of Vaxem™Hib When Administered According to the Prescribing Information in Korea
This is a multicenter, post marketing surveillance study which aims to evaluate the safety profile of haemophilus influenza type b vaccine when administered to Korean children according to the product insert.
- Conditions
- Haemophilus Influenzae Type B Infection
- Being tested
- Haemophilus influenza type b conjugate vaccine
- Keywords
- Haemophilus influenza type b, children, Korea, vaccine, Prevention of haemophilus influenza type b
- Medical subject headings
- Haemophilus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Haemophilus influenza type b conjugate vaccineBiological
Primary series is 3 doses given to infants beginning at 2 months of age with an interval of 2 months apart (i.e. 2, 4 and 6 months of age). Booster vaccination consists of 1 dose and is given to toddlers 16 to 20 months of age. In this study, subjects will receive vaccination from routine primary care.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Other | Not described Receives: Biological: Haemophilus influenza type b conjugate vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Adverse Events 28 days following vaccination
Measured: 29 days to 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2011 (estimated)
- Study startAug 2011
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Haemophilus Influenzae Type B InfectionStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 764 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Vaccines
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01404962
- Sponsor's protocol ID
- V37_11
- Status last verified
- Sep 2012
- First submitted
- 25 Jul 2011
- Last updated
- 1 Dec 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post Marketing Surveillance Study to Monitor the Reactogenicity and Safety of Vaxem™Hib When Administered According to the Prescribing Information in Korea
- ClinicalTrials.gov ID
- NCT01404962
- Acronym / sponsor ID
- V37_11
- Conditions
- Haemophilus Influenzae Type B Infection
- Keywords
- Haemophilus influenza type b, children, Korea, vaccine, Prevention of haemophilus influenza type b
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 764 participants (actual)
- Lead sponsor
- Novartis VaccinesIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 28 Jul 2011 (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.
This is a multicenter, post marketing surveillance study which aims to evaluate the safety profile of haemophilus influenza type b vaccine when administered to Korean children according to the product insert.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Other | Biological: Haemophilus influenza type b conjugate vaccine |
Who may qualify
- Ages
- 2 months to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Male and female children 2 months to 5 years of age scheduled to receive vaccination
Key exclusion criteria (1 listed)
- Contraindications to Vaxem™Hib Korean Prescribing information
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 |
|---|---|---|
| Haemophilus influenza type b conjugate vaccinePrimary series is 3 doses given to infants beginning at 2 months of age with an interval of 2 months apart (i.e. 2, 4 and 6 months of age). Booster vaccination consists of 1 dose and is given to toddlers 16 to 20 months of age. In this study, subjects will receive vaccination from routine primary care. | Biological | Group 1 |
Primary outcome
Number of participants with Adverse Events 28 days following vaccination
Time frame: 29 days to 5 months
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 1 Dec 2016.
Related trials for Haemophilus Influenzae Type B Infection
Active, not recruitingPhase 2/3
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Diphtheria, Tetanus
Not yet recruitingPhase 3
Study of BK1803 in Healthy Infants
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Active, not recruitingPhase 1
Clinical Trial of Lyophilized Haemophilus Influenzae Type b Conjugate Vaccine
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Clinical Trial of the Adsorbed Acellular Pertussis (Tricomponent) DTaP-Haemophilus Influenzae Type b (Conjugate)-ACYW135 Group Meningococcal (Conjugate) Combined Vaccine
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Haemophilus influenza type b conjugate vaccine in people with Haemophilus Influenzae Type B Infection, run by Novartis Vaccines at 5 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 1 inclusion and 1 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 1 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Number of participants with Adverse Events 28 days following vaccination (time frame: 29 days to 5 months). 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 1 Dec 2016.