Haemophilus Influenzae Type b InfectionsPhase 3NCT02560272
Safety and Immunogenicity of Haemophilus Influenzae Type b Conjugate Vaccine，Freeze-dried
A Phase 3 study testing Minhai-HIB and Act-HIB® in people with Haemophilus Influenzae Type b Infections, run by Beijing Minhai Biotechnology Co., Ltd at 1 site in China.
Trial summary
The study will evaluate the safety and immunogenicity of a haemophilus influenzae type b conjugate vaccine (Hib) in Healthy Children 2 Months to 5 Years of Age who have not been previously immunized with a Hib vaccine. 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 Infections
- What is being tested?
- Minhai-HIB and Act-HIB®
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,560 participants
- Where
- 1 siteChina
- Study dates
- Sep 2014to Jun 2016
- 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 2 months to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy permanent residence 2 months to 5 years old.
- Subjects who the investigator believes will comply with the requirements of the protocol should be enrolled in the study.
- Subjects and parent/guardian able to attend all scheduled visits and comply with all study procedures.
- Axillary temperature ≤37.0 ℃.
Who cannot join
- History of Haemophilus influenzae type b infection or vaccination of Haemophilus influenzae type b conjugate vaccine.
- Allergic history or any SAE after vaccination, such as allergy, urticaria, dyspnea, angioedema, celialgia.
- Receipt of blood or blood-derived products in the 3 months preceding vaccination
- Participation in another clinical study investigating a vaccine, drug in the 30 days preceding vaccination.
- Receipt of any live virus vaccine in the 15 days preceding vaccination.
- Receipt of any subunit vaccine and inactivated vaccine in the 7 days before vaccination.
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- Febrile illness (temperature ≥ 38°C) in the 3 days or any acute illness/infection in the 7 days preceding vaccination.
- Thrombocytopenia.
- History of treatment for thyroid gland disease.
- Functional or anatomic asplenia.
- History of eclampsia, epilepsy, encephalopathy and mental disease or family disease.
- Any condition that, in the judgment of investigator, may affect trial assessment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Henan Provincial Center for Disease Control and Prevention
Zhengzhou, Henan
shengli xia, 86-371-68089128, xiasl@hncdc.com.cn
About this study
Official title: A Phase III, Double Blind, Parallel-controlled, Randomised Study to Evaluate the Safety and Immunogenicity of Haemophilus Influenzae Type b Conjugate Vaccine in Healthy Children 2 Months to 5 Years of Age
The study will evaluate the safety and immunogenicity of a haemophilus influenzae type b conjugate vaccine (Hib) in Healthy Children 2 Months to 5 Years of Age who have not been previously immunized with a Hib vaccine. Children 2 to 5 months of age will receive 3 doses of Hib vaccine, Children 6 to 11 months of age will receive 2 doses of Hib vaccine, Children 1 to 5 years of age will receive 1 dose of Hib vaccine, with each dose given approximately 1 month apart.
- Conditions
- Haemophilus Influenzae Type b Infections
- Being tested
- Minhai-HIB, Act-HIB®
- Keywords
- vaccine, haemophilus influenzae 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.
Minhai-HIBBiological
0.5ml, intramuscular
Act-HIB®Biological
0.5ml, intramuscular
| Study group | Role | What they receive |
|---|---|---|
| Minhai-HIB | Experimental | Participants at age 1 to 5 years of enrollment will receive one dose on Hib vaccine. Participants at age 6 to 11 months of enrollment will receive 2 doses on Hib vaccine at one months apart. Participants at age 2 to 5 months of enrollment will receive 3 doses on Hib vaccine at one months apart. Receives: Biological: Minhai-HIB |
| Act-HIB® | Active comparator | Participants at age 1 to 5 years of enrollment will receive one dose on Hib vaccine. Participants at age 6 to 11 months of enrollment will receive 2 doses on Hib vaccine at one months apart. Participants at age 2 to 5 months of enrollment will receive 3 doses on Hib vaccine at one months apart. Receives: Biological: Act-HIB® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to (≥) 0.15 Microgram Per Milliliter (µg/mL) and ≥ 1.0 µg/mL
Measured: 28 days after last dose of primary vaccination
Secondary outcomes (3)
Number of Subjects With Any Solicited Local and General Symptoms
Measured: Within 7 days after any vaccination
Number of Subjects With Any Unsolicited Adverse Events (AEs)
Measured: Within 28 days after any vaccination
Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations
Measured: 28 days after last dose of primary vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2015 (estimated)
- Study startSep 2014
- Primary completionDec 2015 (estimated)
- Study completionJun 2016 (estimated)
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 InfectionsStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,560 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Minhai Biotechnology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- shengli xia, Principal investigator, Henan Provincial Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02560272
- Sponsor's protocol ID
- 2014L00216
- Status last verified
- Sep 2015
- First submitted
- 19 Sep 2015
- Last updated
- 25 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Double Blind, Parallel-controlled, Randomised Study to Evaluate the Safety and Immunogenicity of Haemophilus Influenzae Type b Conjugate Vaccine in Healthy Children 2 Months to 5 Years of Age
- ClinicalTrials.gov ID
- NCT02560272
- Acronym / sponsor ID
- 2014L00216
- Conditions
- Haemophilus Influenzae Type b Infections
- Keywords
- vaccine, haemophilus influenzae type b
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,560 participants (estimated)
- Lead sponsor
- Beijing Minhai Biotechnology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 25 Sep 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 study will evaluate the safety and immunogenicity of a haemophilus influenzae type b conjugate vaccine (Hib) in Healthy Children 2 Months to 5 Years of Age who have not been previously immunized with a Hib vaccine. Children 2 to 5 months of age will receive 3 doses of Hib vaccine, Children 6 to 11 months of age will receive 2 doses of Hib vaccine, Children 1 to 5 years of age will receive 1 dose of Hib vaccine, with each dose given approximately 1 month apart.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minhai-HIB | Experimental | Biological: Minhai-HIBParticipants at age 1 to 5 years of enrollment will receive one dose on Hib vaccine. Participants at age 6 to 11 months of enrollment will receive 2 doses on Hib vaccine at one months apart. Participants at age 2 to 5 months of enrollment will receive 3 doses on Hib vaccine at one months apart. |
| Act-HIB® | Active comparator | Biological: Act-HIB®Participants at age 1 to 5 years of enrollment will receive one dose on Hib vaccine. Participants at age 6 to 11 months of enrollment will receive 2 doses on Hib vaccine at one months apart. Participants at age 2 to 5 months of enrollment will receive 3 doses on Hib vaccine at one months apart. |
Who may qualify
- Ages
- 2 months to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Healthy permanent residence 2 months to 5 years old.
- Subjects who the investigator believes will comply with the requirements of the protocol should be enrolled in the study.
- Subjects and parent/guardian able to attend all scheduled visits and comply with all study procedures.
- Axillary temperature ≤37.0 ℃.
Key exclusion criteria (12 listed)
- History of Haemophilus influenzae type b infection or vaccination of Haemophilus influenzae type b conjugate vaccine.
- Allergic history or any SAE after vaccination, such as allergy, urticaria, dyspnea, angioedema, celialgia.
- Receipt of blood or blood-derived products in the 3 months preceding vaccination
- Participation in another clinical study investigating a vaccine, drug in the 30 days preceding vaccination.
- Receipt of any live virus vaccine in the 15 days preceding vaccination.
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 |
|---|---|---|
| Minhai-HIB0.5ml, intramuscular | Biological | Minhai-HIB |
| Act-HIB®0.5ml, intramuscular | Biological | Act-HIB® |
Primary outcome
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to (≥) 0.15 Microgram Per Milliliter (µg/mL) and ≥ 1.0 µg/mL
Time frame: 28 days after last dose of primary vaccination
3 secondary outcomes
Number of Subjects With Any Solicited Local and General Symptoms
Time frame: Within 7 days after any vaccination
Number of Subjects With Any Unsolicited Adverse Events (AEs)
Time frame: Within 28 days after any vaccination
Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations
Time frame: 28 days after last dose of primary vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2015.
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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.
shengli xia principal investigator
Henan Provincial Center for Disease Control and Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Minhai-HIB and Act-HIB® in people with Haemophilus Influenzae Type b Infections, run by Beijing Minhai Biotechnology Co., Ltd at 1 site 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 4 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 25 Sep 2015. 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 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guifan Li (86-10-59613591, guifan@sohu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to (≥) 0.15 Microgram Per Milliliter (µg/mL) and ≥ 1.0 µg/mL (time frame: 28 days after last dose of 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 25 Sep 2015.