Haemophilus InfluenzaPhase 3NCT02692859
A Phase III Clinical Trial of a Haemophilus Influenzae Type b (Hib) Conjugate Vaccine
A Phase 3 study testing Hib conjugate vaccine in people with Haemophilus Influenza, run by Jiangsu Province Centers for Disease Control and Prevention.
Trial summary
Haemophilus influenza type b (Hib) remains a serious global health threat associated with high mortality and morbidity in young children. In China, The overall impact of Hib-related infections and the extent of coverage of Hib conjugate vaccines are unclear.Generally, vaccination has been considered the most effective… Read more about this study
- Who is it for?
- Ages 3 months to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Haemophilus Influenza
- What is being tested?
- Hib conjugate vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,992 participants
- Where
- No sites listed yet
- Study dates
- Sep 2013to Aug 2014
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 3 months to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy children aged 3-5 months/ 6-11 months/ 1-5 y for each age group
- Without vaccination history of Hib conjugate vaccine
- One of his/her guardians is able to understand and sign the informed consent
- Subjects' guardian can and will comply with the requirements of the protocol
- Subjects with temperature <=37.0°C on axillary setting
Who cannot join
- Subject who has a medical or family history of any of the following: allergic history, seizure, epilepsy, brain or mental disease
- Subject who is allergic to any ingredient of the vaccines
- Subject with damaged or low immune function which has already been known
- Subject who had a Hib disease medical history
- Subject with acute febrile illness or infectious disease
- Major congenital defects, developmental disorders or serious chronic illness
Show all 15Show fewer
- Thrombocytopenia, blood coagulation disorder or bleeding difficulties with intramuscular injection
- Subject who has serious allergic history
- Subject with other medical history not suitable for vaccination such as difficulty for blood collection
- Any prior administration of immunodepressant or corticosteroids in last 6 months
- Any prior administration of blood products in last 3 months
- Any prior administration of other research medicine/vaccine in last 30 days
- Any prior administration of any attenuated live vaccine in last 14 days
- Any prior administration of subunit or inactivated vaccines in last 7 days, such as pneumococcal vaccine
- Any medical, psychological, social or other condition judged by investigator, that may interfere subject's compliance with the protocol or his/her guardian's signature on informed consent
About this study
Official title: A Randomized, Positive-controlled, Non-inferiority Phase III Clinical Trial of a Haemophilus Influenzae Type b (Hib) Conjugate Vaccine in Healthy Infants and Children
Haemophilus influenza type b (Hib) remains a serious global health threat associated with high mortality and morbidity in young children. In China, The overall impact of Hib-related infections and the extent of coverage of Hib conjugate vaccines are unclear.Generally, vaccination has been considered the most effective way to prevent infection against Hib.In order to evaluate safety and immunogenicity of a haemophilus influenzae type b (Hib) conjugate vaccine developped by Chengdu Olymvax Biopharmaceuticals Inc. a phase III clinical trial is planned to conduct in healthy infants and children in China.
Read the detailed description
Haemophilus influenza type b (Hib) remains a serious global health threat associated with high mortality and morbidity in young children. In China, The overall impact of Hib-related infections and the extent of coverage of Hib conjugate vaccines are unclear.Generally, vaccination has been considered the most effective way to prevent infection against Hib.In order to evaluate safety and immunogenicity of a haemophilus influenzae type b (Hib) conjugate vaccine developped by Chengdu Olymvax Biopharmaceuticals Inc. a randomized, positive-controlled, non-inferiority phase III clinical trial is planned to conduct in healthy infants and children in China.
- Conditions
- Haemophilus Influenza
- Being tested
- Hib conjugate vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hib conjugate vaccineBiological
Children aged 3-5 months: 3-dose(0,28,56 d);Children aged 6-11 months: 2-dose(0,28 d);Children aged 1-5 years:one dose(0 d), 0.5ml for each dose
| Study group | Role | What they receive |
|---|---|---|
| Vaccine(Chengdu Olymvax Biopharmaceuticals Inc.) | Experimental | Hib conjugate vaccine Receives: Biological: Hib conjugate vaccine |
| Vaccine (Walvax Biotechnology Co., LTD.) | Active comparator | Hib conjugate vaccine Receives: Biological: Hib conjugate vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Solicited Adverse Reactions
Number of Participants with Solicited Adverse Reactions
Measured: 0-7 days after each dose
Proportion of Vaccinees With Anti-polyribosylribitol Phosphate (PRP) Concentrations ≥1.0μg/ml
Measured: 28 days after full course of vaccination
Secondary outcomes (5)
Incidence of Unsolicited Adverse Reactions
Measured: 0-28 days after each dose
Incidence of Serious Adverse Event (SAE) During the Whole Study Period
Measured: 0-84 days for children aged 3-5 months, 0-56 days for children aged 6-11 months and 0-28 days for children aged 1-5 y
Proportion of Vaccinees With Anti-polyribosylribitol Phosphate (PRP) Concentrations ≥0.15μg/ml
Measured: 28 days after full course of vaccination
the Anti-PRP Geometric Mean Concentrations (GMCs)
Measured: 28 days after full course of vaccination
the Anti-PRP Geometric Mean Fold Increase (GMFI)
Measured: 28 days after full course of vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2016 (estimated)
- Study startSep 2013
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Haemophilus InfluenzaStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1,992 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Province Centers for Disease Control and Prevention
- Sponsor type
- Research network
- Collaborators
- Chengdu Olymvax Biopharmaceuticals Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02692859
- Sponsor's protocol ID
- PRO-201301
- Status last verified
- Jul 2017
- First submitted
- 24 Feb 2016
- Last updated
- 20 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Positive-controlled, Non-inferiority Phase III Clinical Trial of a Haemophilus Influenzae Type b (Hib) Conjugate Vaccine in Healthy Infants and Children
- ClinicalTrials.gov ID
- NCT02692859
- Acronym / sponsor ID
- PRO-201301
- Conditions
- Haemophilus Influenza
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,992 participants (actual)
- Lead sponsor
- Jiangsu Province Centers for Disease Control and PreventionResearch network
- Collaborators
- Chengdu Olymvax Biopharmaceuticals Inc.
- Study start
- Sep 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 26 Feb 2016 (estimated)
- Results
- Posted 21 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Haemophilus influenza type b (Hib) remains a serious global health threat associated with high mortality and morbidity in young children. In China, The overall impact of Hib-related infections and the extent of coverage of Hib conjugate vaccines are unclear.Generally, vaccination has been considered the most effective way to prevent infection against Hib.In order to evaluate safety and immunogenicity of a haemophilus influenzae type b (Hib) conjugate vaccine developped by Chengdu Olymvax Biopharmaceuticals Inc. a phase III clinical trial is planned to conduct in healthy infants and children in China.
Detailed description
Haemophilus influenza type b (Hib) remains a serious global health threat associated with high mortality and morbidity in young children. In China, The overall impact of Hib-related infections and the extent of coverage of Hib conjugate vaccines are unclear.Generally, vaccination has been considered the most effective way to prevent infection against Hib.In order to evaluate safety and immunogenicity of a haemophilus influenzae type b (Hib) conjugate vaccine developped by Chengdu Olymvax Biopharmaceuticals Inc. a randomized, positive-controlled, non-inferiority phase III clinical trial is planned to conduct in healthy infants and children in China.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaccine(Chengdu Olymvax Biopharmaceuticals Inc.) | Experimental | Biological: Hib conjugate vaccineHib conjugate vaccine |
| Vaccine (Walvax Biotechnology Co., LTD.) | Active comparator | Biological: Hib conjugate vaccineHib conjugate vaccine |
Who may qualify
- Ages
- 3 months to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Healthy children aged 3-5 months/ 6-11 months/ 1-5 y for each age group
- Without vaccination history of Hib conjugate vaccine
- One of his/her guardians is able to understand and sign the informed consent
- Subjects' guardian can and will comply with the requirements of the protocol
- Subjects with temperature <=37.0°C on axillary setting
Key exclusion criteria (15 listed)
- Subject who has a medical or family history of any of the following: allergic history, seizure, epilepsy, brain or mental disease
- Subject who is allergic to any ingredient of the vaccines
- Subject with damaged or low immune function which has already been known
- Subject who had a Hib disease medical history
- Subject with acute febrile illness or infectious 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 |
|---|---|---|
| Hib conjugate vaccineChildren aged 3-5 months: 3-dose(0,28,56 d);Children aged 6-11 months: 2-dose(0,28 d);Children aged 1-5 years:one dose(0 d), 0.5ml for each dose | Biological | Vaccine (Walvax Biotechnology Co., LTD.), Vaccine(Chengdu Olymvax Biopharmaceuticals Inc.) |
Primary outcome
Number of Participants With Solicited Adverse Reactions
Time frame: 0-7 days after each dose
Number of Participants with Solicited Adverse Reactions
Proportion of Vaccinees With Anti-polyribosylribitol Phosphate (PRP) Concentrations ≥1.0μg/ml
Time frame: 28 days after full course of vaccination
5 secondary outcomes
Incidence of Unsolicited Adverse Reactions
Time frame: 0-28 days after each dose
Incidence of Serious Adverse Event (SAE) During the Whole Study Period
Time frame: 0-84 days for children aged 3-5 months, 0-56 days for children aged 6-11 months and 0-28 days for children aged 1-5 y
Proportion of Vaccinees With Anti-polyribosylribitol Phosphate (PRP) Concentrations ≥0.15μg/ml
Time frame: 28 days after full course of vaccination
the Anti-PRP Geometric Mean Concentrations (GMCs)
Time frame: 28 days after full course of vaccination
the Anti-PRP Geometric Mean Fold Increase (GMFI)
Time frame: 28 days after full course of vaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hib conjugate vaccine in people with Haemophilus Influenza, run by Jiangsu Province Centers for Disease Control and Prevention.
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 5 inclusion and 15 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 20 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 21 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Solicited Adverse Reactions (time frame: 0-7 days after each dose). The study lists 2 primary outcomes in all. 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 20 Sep 2017.