Clinical Trial of Lyophilized Haemophilus Influenzae Type b Conjugate Vaccine

NCT06621654 | Active Not Recruiting Phase 1

• 1 other identifier: CTP-DHMCV-003
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Haemophilus Influenzae Type B Infection

Keywords

Vaccine; Safety; Immunogenicity; 2 months of age and older

Outcome Measures

Primary Outcomes (1)

• Adverse reactions in all subjects

  Within 30 days of each dose of vaccine

Secondary Outcomes (9)

• Adverse reactions in all subjects

  Within 30 minutes of each dose of vaccine

• Adverse events in all subjects

  Within 30 days of each dose of vaccine

• Incidence of SAEs in all subjects

  From the first dose to 6 months after full vaccination

• 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

  Day 8 post-immunization

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

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

Study Arms (7)

Experimental vaccine group 1A

EXPERIMENTAL

Subjects aged 18-59 years

Biological: Lyophilized Haemophilus Influenzae Type b Conjugate Vaccine

Experimental vaccine group 2A

EXPERIMENTAL

Subjects aged 1-5 years

Biological: Lyophilized Haemophilus Influenzae Type b Conjugate Vaccine

Control vaccine group 2B

ACTIVE COMPARATOR

Subjects aged 1-5 years

Biological: Haemophilus Influenzae Type b Conjugate Vaccine

Experimental vaccine group 3A

EXPERIMENTAL

Subjects aged 6-11 months

Biological: Lyophilized Haemophilus Influenzae Type b Conjugate Vaccine

Control vaccine group 3B

ACTIVE COMPARATOR

Subjects aged 6-11 months

Biological: Haemophilus Influenzae Type b Conjugate Vaccine

Experimental vaccine group 4A

EXPERIMENTAL

Subjects aged 2 months

Biological: Lyophilized Haemophilus Influenzae Type b Conjugate Vaccine

Control vaccine group 4B

ACTIVE COMPARATOR

Subjects aged 2 months

Biological: Haemophilus Influenzae Type b Conjugate Vaccine

Interventions

Lyophilized Haemophilus Influenzae Type b Conjugate Vaccine BIOLOGICAL

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

Experimental vaccine group 1A

Haemophilus Influenzae Type b Conjugate Vaccine BIOLOGICAL

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

Control vaccine group 2B

Eligibility Criteria

• Age: 2 Months - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• months old, 6 months old \~ 5 years old people have been vaccinated with Hib-containing vaccines
• month-old, 6\~11-month-old infants who were born prematurely (delivered before the 37th week of gestation), low birth weight (birth weight \<2500g)
• 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

Sponsors & Collaborators

• CanSino Biologics Inc.: lead

Study Sites (1)

Jiulongpo District Center for Disease Control and Prevention

Chongqing, China

Location

MeSH Terms

Conditions

Haemophilus Infections

Condition Hierarchy (Ancestors)

Pasteurellaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Hongying Li

  Chongqing Center for Disease Control and Prevention (Chongqing Academy of Preventive Medicine)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2024
• First Posted: October 1, 2024
• Study Start: November 15, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: July 29, 2025

Record last verified: 2024-08

Locations

CN (1)