HealthyPhase 4NCT01761136
The Safety and Immunogenicity of Haemophilus Influenzae Type b Vaccine in Different Injection Site
A Phase 4 study testing Inoculation in upper arm deltoid and Inoculation in vastus lateralis muscle in people with Healthy, run by Beijing Center for Disease Control and Prevention at 5 sites in China.
Trial summary
The objective of this study was to evaluate the safety and immunogenicity of Haemophilus influenzae type b vaccine in different injection site. Read more about this study
- Who is it for?
- Ages 2 to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Inoculation in upper arm deltoid and Inoculation in vastus lateralis muscle
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 680 participants
- Where
- 5 sitesChina
- Study dates
- Nov 2011to Mar 2013
- 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 to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- participants were under 1 years old, and were in good healthy
- participants were full-time pregnancy and birth weight were more than 2.5 kg
Who cannot join
- current infectious fever or acute disease
- a history of hypersensitivity to study vaccine components especially tetanus toxoid
- a history of allergy, autoimmune, convulsions, seizures heredity disease
- a history of Hib vaccination or Hib disease
- a history of congenital deformity, developmental disorders or serious chronic diseases, muscle injection contradiction, and immunosuppressive agents, hormone or immunoglobulin received.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Beijing Huaxin Hospital
Beijing, Beijing Municipality
Beijing Chaoyang Women's and Children's Hospital
Beijing
Beijing Dongba Hospital
Beijing
Cuigezhuang community health service centers
Beijing
Xiaohongmen community health service centers
Beijing
About this study
Official title: Phase 4 Study of Haemophilus Influenzae Type b Vaccine in Different Injection Site
The objective of this study was to evaluate the safety and immunogenicity of Haemophilus influenzae type b vaccine in different injection site.
Read the detailed description
A randomized trial was conducted in 680 healthy infants with Hib vaccine of two brands. The different sub-groups were selected randomly based on the plan to inoculate vaccines in the upper arm deltoid or vastus lateralis muscle. The safety and immunogenicity were assessed after three or two doses.
- Conditions
- Healthy
- Being tested
- Inoculation in upper arm deltoid, Inoculation in vastus lateralis muscle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inoculation in upper arm deltoidBiological
Inoculation of Hib vaccine of two brands in upper arm deltoid
Inoculation in vastus lateralis muscleBiological
Inoculation of Hib vaccine of two brands in vastus lateralis muscle
| Study group | Role | What they receive |
|---|---|---|
| Inoculation in upper arm deltoid | Active comparator | Inoculation of Hib vaccine of two brands in upper arm deltoid Receives: Biological: Inoculation in upper arm deltoid; Biological: Inoculation in vastus lateralis muscle |
| Inoculation in vastus lateralis muscle | Experimental | Inoculation of Hib vaccine of two brands in vastus lateralis muscle Receives: Biological: Inoculation in upper arm deltoid; Biological: Inoculation in vastus lateralis muscle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of adverse events of Haemophilus influenzae type b vaccine in different injection site
Measured: one year
Secondary outcomes (1)
Antibody titre of Haemophilus influenzae type b vaccine in different injection site
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2013 (estimated)
- Study startNov 2011
- Primary completionDec 2012
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 680 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Center for Disease Control and Prevention
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Nianmin Shi, Principal investigator, Beijing Chaoyang District Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01761136
- Sponsor's protocol ID
- BJCDPC-4
- Status last verified
- Mar 2013
- First submitted
- 3 Jan 2013
- Last updated
- 28 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study of Haemophilus Influenzae Type b Vaccine in Different Injection Site
- ClinicalTrials.gov ID
- NCT01761136
- Acronym / sponsor ID
- BJCDPC-4
- Conditions
- Healthy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 680 participants (actual)
- Lead sponsor
- Beijing Center for Disease Control and PreventionOther government
- Study start
- Nov 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 4 Jan 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.
The objective of this study was to evaluate the safety and immunogenicity of Haemophilus influenzae type b vaccine in different injection site.
Detailed description
A randomized trial was conducted in 680 healthy infants with Hib vaccine of two brands. The different sub-groups were selected randomly based on the plan to inoculate vaccines in the upper arm deltoid or vastus lateralis muscle. The safety and immunogenicity were assessed after three or two doses.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inoculation in upper arm deltoid | Active comparator | Biological: Inoculation in upper arm deltoid, Biological: Inoculation in vastus lateralis muscleInoculation of Hib vaccine of two brands in upper arm deltoid |
| Inoculation in vastus lateralis muscle | Experimental | Biological: Inoculation in upper arm deltoid, Biological: Inoculation in vastus lateralis muscleInoculation of Hib vaccine of two brands in vastus lateralis muscle |
Who may qualify
- Ages
- 2 to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- participants were under 1 years old, and were in good healthy
- participants were full-time pregnancy and birth weight were more than 2.5 kg
Key exclusion criteria (5 listed)
- current infectious fever or acute disease
- a history of hypersensitivity to study vaccine components especially tetanus toxoid
- a history of allergy, autoimmune, convulsions, seizures heredity disease
- a history of Hib vaccination or Hib disease
- a history of congenital deformity, developmental disorders or serious chronic diseases, muscle injection contradiction, and immunosuppressive agents, hormone or immunoglobulin received.
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 |
|---|---|---|
| Inoculation in upper arm deltoidInoculation of Hib vaccine of two brands in upper arm deltoid | Biological | Inoculation in upper arm deltoid, Inoculation in vastus lateralis muscle |
| Inoculation in vastus lateralis muscleInoculation of Hib vaccine of two brands in vastus lateralis muscle | Biological | Inoculation in upper arm deltoid, Inoculation in vastus lateralis muscle |
Primary outcome
Incidence rate of adverse events of Haemophilus influenzae type b vaccine in different injection site
Time frame: one year
1 secondary outcome
Antibody titre of Haemophilus influenzae type b vaccine in different injection site
Time frame: one year
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 Mar 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.
Nianmin Shi principal investigator
Beijing Chaoyang District Center for Disease Control and Prevention
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 Inoculation in upper arm deltoid and Inoculation in vastus lateralis muscle in people with Healthy, run by Beijing Center for Disease Control and Prevention at 5 sites in China.
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 5 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 Mar 2013. 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 China. 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?
Incidence rate of adverse events of Haemophilus influenzae type b vaccine in different injection site (time frame: one year). 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 Mar 2013.