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Could a Freeze-Dried vaccine shield all ages from hib?

NCT ID NCT06621654

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 06, 2026 · Last updated Aug 07, 2026 · Updated 1 time

Summary

This early-stage trial is testing a new freeze-dried version of the Haemophilus influenzae type b (Hib) vaccine to see if it is safe and triggers a protective immune response. The study includes healthy people aged 2 months, 6-11 months, 1-5 years, and 18-59 years, with younger groups enrolled only after older groups show initial safety. Participants receive one or more doses of the vaccine, and researchers monitor for side effects and immune markers.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Lyophilized Haemophilus influenzae type b (Hib) conjugate vaccine
What this could lead to
If successful, this could lead to a more stable, freeze-dried Hib vaccine that protects infants and adults from serious bacterial infections like meningitis and pneumonia.
What could go wrong
This is an early-phase trial with a small number of participants, so the vaccine may not produce a strong immune response or may cause unexpected side effects. Further studies are needed before it could be widely used.
Why investors are watching

CanSino Biologics is running a phase 1 trial of its Haemophilus influenzae type b (Hib) conjugate vaccine, testing safety and immune response in 160 people across four age groups, from adults down to 2-month-old infants. For a small company, this early-stage readout matters because it is the first test of whether the vaccine is safe enough to keep developing, and a clear safety signal in infants would support moving to larger trials.

If it works: A positive safety result could let CanSino advance the vaccine into later-stage studies, adding a new product to its pipeline and potentially broadening its vaccine portfolio. Success here would also validate the company's ability to run a complex age-tiered trial, which could strengthen its standing with partners or regulators.

If it fails: Phase 1 trials often fail or reveal safety problems, and a poor result in any age group, especially infants, could halt the program and waste the company's resources. Delays in enrolling or confirming safety between age groups could also push back timelines and raise costs for a small-cap company.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

160 people

The number who actually took part.

Started

Nov 2024

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 months to 59 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion criteria for first dose: * 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 * 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 Exclusion criteria for subsequent doses * 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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Jiulongpo District Center for Disease Control and Prevention

    Chongqing, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.