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Haemophilus Influenzae Type B InfectionPhase 1NCT06621654

Clinical Trial of Lyophilized Haemophilus Influenzae Type b Conjugate Vaccine

A Phase 1 study testing Lyophilized Haemophilus Influenzae Type b Conjugate Vaccine and Haemophilus Influenzae Type b Conjugate Vaccine in people with Haemophilus Influenzae Type B Infection, run by CanSino Biologics Inc. at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This trial is a randomized, partially blinded, positively controlled phase I clinical study. A total of 160 persons aged 18-59 years, 1-5 years, 6-11 months and 2 months (60-89 days) will be recruited into the trial, and the enrollment will be done according to the progression of age groups, from the oldest to the… Read more about this study

Who is it for?
Ages 2 months to 59 yearsHealthy volunteers can take part
Conditions the study is for
Haemophilus Influenzae Type B Infection
What is being tested?
Lyophilized Haemophilus Influenzae Type b Conjugate Vaccine and Haemophilus Influenzae Type b Conjugate Vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
1 siteChina
Study dates
15 Nov 2024to Oct 2026
Phase
Phase 1
Are there results?
Not yet: the study is under way

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 59 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Subjects aged 2 months, 6-11 months, 1-5 years, and 18-59 years at the time of screening
  • Informed consent is obtained from the subject and the subject and/or guardian (attorney-in-fact) is able to sign the informed consent form
  • Subjects are able and willing to comply with the requirements of the clinical trial protocol and are able to complete the full study follow up

Who cannot join

  • 2 months old, 6 months old ~ 5 years old people have been vaccinated with Hib-containing vaccines
  • 2-month-old, 6~11-month-old infants who were born prematurely (delivered before the 37th week of gestation), low birth weight (birth weight <2500g)
  • 2-month-old, 6~11-month-old infants with abnormal labor and delivery, history of asphyxia rescue, history of neurological damage
  • Those with history of Haemophilus influenzae type b infection
  • Those with history of epilepsy, convulsions, convulsions, cerebral palsy, or history of psychiatric illness or family history or other progressive neurological diseases
  • Have been diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), juvenile rheumatoid arthritis (JRA), or other autoimmune diseases
Show all 22Show fewer
  • History of allergy to vaccines or vaccine components, severe side effects to vaccines such as urticaria, dyspnea, angioneurotic edema
  • Female with positive urine pregnancy test or breastfeeding subjects, subjects or their partners with pregnancy plan within 6 months (only for 18~59 years old)
  • Fever with axillary temperature > 37.0°C
  • Known or suspected to be suffering from acute diseases or serious chronic diseases (including: serious respiratory diseases, serious cardiovascular diseases, liver and kidney diseases, serious skin diseases, malignant tumors, tuberculosis, etc.); or in the acute exacerbation of chronic diseases
  • Those who have hypertension that cannot be controlled by medication (at the time of on-site measurement: systolic blood pressure ≥160 mmHg and diastolic blood pressure ≥100 mmHg) (only applicable to 18~59 years old)
  • Any of the routine blood biochemistry indexes during the screening period judged to be clinically significant by the investigator (only applicable to 2~5, 18~59 years old)
  • Have no spleen or functional absence of spleen
  • Suffering from thrombocytopenia, bleeding disorders, or other coagulation disorders (which may cause contraindication to intramuscular injection)
  • Immunosuppressive therapy, anti-allergy therapy, cytotoxic therapy, inhaled corticosteroids (excluding corticosteroid spray therapy for allergic rhinitis, surface corticosteroids for acute uncomplicated dermatitis) within the past 6 months
  • Received blood products within 3 months prior to receiving the experimental drug
  • Participation in other studies involving interventional studies within 1 month prior to receiving the investigational drug and/or during the study participation period
  • Having received an injectable live attenuated vaccine within 14 days or another vaccine within 7 days prior to vaccination
  • In the judgment of the investigator, due to a variety of medical, psychological, social or other conditions that are contrary to the trial protocol or that affect the subject's ability to sign informed consent
  • A vaccine-related serious adverse event occurred after the previous dose of vaccination
  • Who has experienced a Grade 3 or higher allergic reaction related to the vaccine after the previous dose of vaccination
  • Any other factors that, in the judgment of the investigator, make the subject unsuitable for continued participation in the clinical trial

Trial locations and contacts

1 site in 1 country.

China1 site

  • Jiulongpo District Center for Disease Control and Prevention

    Chongqing

Other trials in China

About this study

Official title: A Randomized, Partially Blinded, Positively Controlled Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of Lyophilized Haemophilus Influenzae Type b Conjugate Vaccine in a Population Aged 2 Months and Older

This trial is a randomized, partially blinded, positively controlled phase I clinical study. A total of 160 persons aged 18-59 years, 1-5 years, 6-11 months and 2 months (60-89 days) will be recruited into the trial, and the enrollment will be done according to the progression of age groups, from the oldest to the youngest, and the initial safety assessment will be conducted on the 8th day after the first dose of vaccination for each age group, and the next group will be enrolled only after the safety is confirmed.

Being tested
Lyophilized Haemophilus Influenzae Type b Conjugate Vaccine, Haemophilus Influenzae Type b Conjugate Vaccine
Keywords
Vaccine, Safety, Immunogenicity, 2 months of age and older
Medical subject headings
Haemophilus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lyophilized Haemophilus Influenzae Type b Conjugate VaccineBiological

    1 dose (0.5ml) of vaccine on day 0, Intramuscular injection

  • Lyophilized Haemophilus Influenzae Type b Conjugate VaccineBiological

    1 dose (0.5ml) of vaccine on day 0, Intramuscular injection

  • Haemophilus Influenzae Type b Conjugate VaccineBiological

    1 dose (0.5ml) of vaccine on day 0, Intramuscular injection

  • Lyophilized Haemophilus Influenzae Type b Conjugate VaccineBiological

    3 doses (0.5ml per dose) at day 0, 1 month, and 18 months of age, Intramuscular injection

  • Haemophilus Influenzae Type b Conjugate VaccineBiological

    3 doses (0.5ml per dose) at day 0, 1 month, and 18 months of age, Intramuscular injection

  • Lyophilized Haemophilus Influenzae Type b Conjugate VaccineBiological

    4 doses (0.5ml per dose) at day 0, 2, 4 month, and 18 months of age, Intramuscular injection

  • Haemophilus Influenzae Type b Conjugate VaccineBiological

    4 doses (0.5ml per dose) at day 0, 2, 4 month, and 18 months of age. Intramuscular injection

Study groups in NCT06621654
Study groupRoleWhat they receive
Experimental vaccine group 1AExperimentalSubjects aged 18-59 years
Receives: Biological: Lyophilized Haemophilus Influenzae Type b Conjugate Vaccine
Experimental vaccine group 2AExperimentalSubjects aged 1-5 years
Receives: Biological: Lyophilized Haemophilus Influenzae Type b Conjugate Vaccine
Control vaccine group 2BActive comparatorSubjects aged 1-5 years
Receives: Biological: Haemophilus Influenzae Type b Conjugate Vaccine
Experimental vaccine group 3AExperimentalSubjects aged 6-11 months
Receives: Biological: Lyophilized Haemophilus Influenzae Type b Conjugate Vaccine
Control vaccine group 3BActive comparatorSubjects aged 6-11 months
Receives: Biological: Haemophilus Influenzae Type b Conjugate Vaccine
Experimental vaccine group 4AExperimentalSubjects aged 2 months
Receives: Biological: Lyophilized Haemophilus Influenzae Type b Conjugate Vaccine
Control vaccine group 4BActive comparatorSubjects aged 2 months
Receives: Biological: Haemophilus Influenzae Type b Conjugate Vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse reactions in all subjects

    Measured: Within 30 days of each dose of vaccine

Secondary outcomes (9)

  1. Adverse reactions in all subjects

    Measured: Within 30 minutes of each dose of vaccine

  2. Adverse events in all subjects

    Measured: Within 30 days of each dose of vaccine

  3. Incidence of SAEs in all subjects

    Measured: From the first dose to 6 months after full vaccination

  4. Incidence of abnormal and clinically significant (CS) white blood cell counts, hemoglobin, platelet counts, Alanine aminoTransferase (ALT), Aspartate Transaminase (AST), and TBIL assays in subjects 18-59, 2-5 years of age

    Measured: Day 8 post-immunization

  5. Proportion of 2-month-old subjects with anti-Hib-PRP antibody concentrations ≥1.0 μg/ml

    Measured: 30 days after basic immunization, before booster immunization, 30 days after booster immunization

  6. Positive transfer rate of anti-Hib-PRP antibodies in 2-month-old subjects

    Measured: 30 days after basic immunization, before booster immunization, 30 days after booster immunization

  7. Positivity of anti-Hib-PRP antibodies in 2-month-old subjects

    Measured: 30 days after basic immunization, before booster immunization, 30 days after booster immunization

  8. Geometric Mean Concentration (GMC) of anti-Hib-PRP antibodies in 2-month-old subjects

    Measured: 30 days after basic immunization, before booster immunization, 30 days after booster immunization

  9. Geometric Mean Increase (GMI) of anti-Hib-PRP antibodies in 2-month-old subjects

    Measured: 30 days after basic immunization, before booster immunization, 30 days after booster immunization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2024
  2. Study start15 Nov 2024
  3. Primary completionOct 2026 (estimated)
  4. Study completionOct 2026 (estimated)

Resources

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 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06621654
Sponsor's protocol ID
CTP-DHMCV-003
Status last verified
Aug 2026
First submitted
29 Sep 2024
Last updated
6 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Lyophilized Haemophilus Influenzae Type b Conjugate Vaccine and Haemophilus Influenzae Type b Conjugate Vaccine in people with Haemophilus Influenzae Type B Infection, run by CanSino Biologics Inc. 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 3 inclusion and 22 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: under way, not looking for participants, as of the sponsor's last update on 6 Aug 2026. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

Adverse reactions in all subjects (time frame: Within 30 days of each dose of vaccine). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06621654.

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 6 Aug 2026.

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