Haemophilus Influenza
Conditions
Brief 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 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.
Interventions
BIOLOGICALHib conjugate vaccine
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
Sponsors
Chengdu Olymvax Biopharmaceuticals Inc.
Jiangsu Province Centers for Disease Control and Prevention
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
3 Months to 5 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Solicited Adverse Reactions | 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 | 28 days after full course of vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of Vaccinees With Anti-polyribosylribitol Phosphate (PRP) Concentrations ≥0.15μg/ml | 28 days after full course of vaccination |
| Incidence of Unsolicited Adverse Reactions | 0-28 days after each dose |
| the Anti-PRP Geometric Mean Fold Increase (GMFI) | 28 days after full course of vaccination |
| the Anti-PRP Geometric Mean Concentrations (GMCs) | 28 days after full course of vaccination |
| Incidence of Serious Adverse Event (SAE) During the Whole Study Period | 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 |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Vaccine(Chengdu Olymvax Biopharmaceuticals Inc.) Hib conjugate vaccine
Hib conjugate vaccine: 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 | 996 |
| Vaccine (Walvax Biotechnology Co., LTD.) Hib conjugate vaccine
Hib conjugate vaccine: 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 | 996 |
| Total | 1,992 |
Baseline characteristics
| Characteristic | Vaccine (Walvax Biotechnology Co., LTD.) | Total | Vaccine(Chengdu Olymvax Biopharmaceuticals Inc.) |
|---|---|---|---|
| Age, Categorical <=18 years | 996 Participants | 1992 Participants | 996 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous 12-60 months | 37.32 months STANDARD_DEVIATION 13.92 | 37.92 months STANDARD_DEVIATION 13.44 | 38.52 months STANDARD_DEVIATION 12.84 |
| Age, Continuous 3-5 months | 4.27 months STANDARD_DEVIATION 0.83 | 4.27 months STANDARD_DEVIATION 0.83 | 4.26 months STANDARD_DEVIATION 0.82 |
| Age, Continuous 6-11 months | 8.20 months STANDARD_DEVIATION 1.8 | 8.26 months STANDARD_DEVIATION 1.8 | 8.31 months STANDARD_DEVIATION 1.8 |
| Region of Enrollment China | 996 participants | 1992 participants | 996 participants |
| Sex: Female, Male Female | 464 Participants | 945 Participants | 481 Participants |
| Sex: Female, Male Male | 532 Participants | 1047 Participants | 515 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 996 | 0 / 996 |
| serious Total, serious adverse events | 10 / 996 | 15 / 996 |
Outcome results
Primary
Number of Participants With Solicited Adverse Reactions
Number of Participants with Solicited Adverse Reactions
Time frame: 0-7 days after each dose
Population: A total of participants in aged 3-5 months,6-11months and 1-5years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vaccine(Chengdu Olymvax Biopharmaceuticals Inc.) | Number of Participants With Solicited Adverse Reactions | 507 Count of Participants |
| Vaccine (Walvax Biotechnology Co., LTD.) | Number of Participants With Solicited Adverse Reactions | 480 Count of Participants |
Primary
Proportion of Vaccinees With Anti-polyribosylribitol Phosphate (PRP) Concentrations ≥1.0μg/ml
Time frame: 28 days after full course of vaccination
Secondary
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
Secondary
Incidence of Unsolicited Adverse Reactions
Time frame: 0-28 days after each dose
Secondary
Proportion of Vaccinees With Anti-polyribosylribitol Phosphate (PRP) Concentrations ≥0.15μg/ml
Time frame: 28 days after full course of vaccination
Secondary
the Anti-PRP Geometric Mean Concentrations (GMCs)
Time frame: 28 days after full course of vaccination
Secondary
the Anti-PRP Geometric Mean Fold Increase (GMFI)
Time frame: 28 days after full course of vaccination