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This clinical trial is conducted in two parts. Part One employs a randomized, partially blinded, dose-escalation, partially active-controlled design. Part Two utilizes a randomized, blinded, placebo-controlled design. Part One is divided into four stages based on age and vaccine dose levels. Part Two consists of the 2-month-old vaccine/placebo groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part I, 1A, low dose, 6 year-old | Experimental | One dose of DTcP-Hib-MCV4 on Day 0 |
|
| Part I, 2A, low dose, 18~24 month-old | Experimental | One dose of DTcP-Hib-MCV4 on Day 0 |
|
| Part I, 2B, high dose, 18~24 month-old | Experimental | One dose of DTcP-Hib-MCV4 on Day 0 |
|
| Part I, 3A, low dose, 2 month-old | Experimental | 3 doses of DTcP-Hib-MCV4 at 0, 2, and 4 months, followed by a booster dose at 18-24 months of age. |
|
| Part I, 3B, high dose, 2 month-old | Experimental | 3 doses of DTcP-Hib-MCV4 at 0, 2, and 4 months, followed by a booster dose at 18-24 months of age. |
|
| Part I, 3C, 2 month-old |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adsorbed Acellular Pertussis (3-Component) Diphtheria-Tetanus-Pertussis-Haemophilus influenzae type b (Conjugate)-Meningococcal Group ACYW135 (Conjugate) Combined Vaccine (DTcP-Hib-MCV4) | Biological | 1 dose of DTcP-Hib-MCV4 vaccine (0.5ml) on day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse reactions | Parts I and II: Within 14 days after each dose |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | Part I Sections 1A, 2A, 2B: Within 14 days after exemption | |
| Incidence of adverse events | Part I Sections 3A, 3B, 3C, 3D, 3E, 4A and Part II: Within 14 days after each dose |
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Inclusion Criteria:
General Inclusion Criteria:
Part I: Specific Inclusion Criteria:
Exclusion Criteria:
General Exclusion Criteria for First Dose:
Part I: Exclusion Criteria for the First Dose:
Part II: Specific Exclusion Criteria for the First Dose
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ying Wang | Contact | 022-58213600-6051 | ying.wang@cansinotech.com |
| Name | Affiliation | Role |
|---|---|---|
| Yanxia Wang | Henan Center for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liangyuan District Center for Disease Control and Prevention, Shangqiu City | Recruiting | Shangqiu | Henan | China |
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Part One: Partial Blind Method Design Part Two: Blind Method Design
| Active Comparator |
3 doses of DTcP at 0, 2, and 4 months, followed by a booster dose at 18-24 months of age. |
|
| Part I, 3D, 2 month-old | Active Comparator | 3 doses of Hib at 0, 2, and 4 months, followed by a booster dose at 18-24 months of age. |
|
| Part I, 3E, 2 month-old | Active Comparator | 3 doses of MCV4 at 0, 2, and 4 months, followed by a booster dose at 18-24 months of age. |
|
| Part I, 4A, 3 month-old | Active Comparator | 3 doses of MCV4 at 0, 1, and 2 months, followed by a booster dose at 12 months of age. |
|
| Part II, Vaccine Group, 2 month-old | Experimental | 3 doses of MCV4 at 0, 2, and 4 months. |
|
| Part II, Placebo Group, 2 month-old | Placebo Comparator | 3 doses of NS at 0, 2, and 4 months. |
|
| DTcP-Hib-MCV4 | Biological | 1 dose of DTcP-Hib-MCV4 vaccine (0.5ml) on day 0 |
|
| DTcP-Hib-MCV4 | Biological | 1 dose of DTcP-Hib-MCV4 vaccine (0.5ml) on day 0 |
|
| DTcP-Hib-MCV4 | Biological | 3 doses of DTcP-Hib-MCV4 (0.5ml) at 0, 2, and 4 months, followed by a booster dose at 18-24 months of age. |
|
| DTcP-Hib-MCV4 | Biological | 3 doses of DTcP-Hib-MCV4 (0.5ml) at 0, 2, and 4 months, followed by a booster dose at 18-24 months of age. |
|
| Adsorbed Acellular Pertussis (3-Component) Diphtheria-Tetanus-Pertussis (DTcP) | Biological | 3 doses of DTcP (0.5ml) at 0, 2, and 4 months, followed by a booster dose at 18-24 months of age. |
|
| Haemophilus influenzae type b (Conjugate) (Hib) | Biological | 3 doses of Hib (0.5ml) at 0, 2, and 4 months, followed by a booster dose at 18-24 months of age. |
|
| Meningococcal Group ACYW135 (Conjugate) (MCV4) | Biological | 3 doses of MCV4 (0.5ml) at 0, 2, and 4 months, followed by a booster dose at 18-24 months of age. |
|
| MCV4 | Biological | 3 doses of MCV4 (0.5ml) at 0, 1, and 2 months, followed by a booster dose at 12 months of age. |
|
| MCV4 | Biological | 3 doses of MCV4 (0.5ml) at 0, 2, and 4 months. |
|
| Sodium Chloride Injection (0.9%) (Saline Solution) (NS) | Other | 3 doses of NS (0.5ml) at 0, 2, and 4 months. |
|
| Incidence of adverse reactions/events | Part I Sections 1A, 2A, 2B: Within 30 minutes after exemption |
| Incidence of adverse reactions/events | Part I Sections 3A, 3B, 3C, 3D, 3E, 4A and Part II: Within 30 minutes after each dose |
| Incidence of adverse reactions/events | Part I Sections 1A, 2A, 2B: Within 30 days after exemption |
| Incidence of adverse reactions/events | Part I Sections 3A, 3B, 3C, 3D, 3E, 4A and Part II: Within 30 days after each dose |
| Incidence of Serious Adverse Event (SAE) | Part I Sections 1A, 2A, 2B: Within 180 days after exemption |
| Incidence of Adverse Event of Special Interest (AESI) | Part I Sections 1A, 2A, 2B: Within 180 days after exemption |
| Incidence of Serious Adverse Event (SAE) | Part I Sections 3A, 3B, 3C, 3D, 3E, 4A and Part II: Within 180 days after the first dose to the booster dose |
| Incidence of Adverse Event of Special Interest (AESI) | Part I Sections 3A, 3B, 3C, 3D, 3E, 4A and Part II: Within 180 days after the first dose to the booster dose |
| Abnormal laboratory test values | Part I Sections 1A, 2A, 2B: 4 days after exemption |
| Seroconversion Rate of A, C, Y, W135 Group Meningococcal Antibody | Part I Sections 3A, 3B, 3C, 3D, 3E, 4A: 30 days after primary vaccination, 30 days before and after booster vaccination |
| Geometric Mean Titer (GMT) of A, C, Y, W135 Group Meningococcal Antibody | Part I Sections 3A, 3B, 3C, 3D, 3E, 4A: 30 days after primary vaccination, 30 days before and after booster vaccination, at the age 3 |
| Positive Rate of A, C, Y, W135 Group Meningococcal Antibody | Part I Sections 3A, 3B, 3C, 3D, 3E, 4A: 30 days after primary vaccination, 30 days before and after booster vaccination, at the age 3 |
| Geometric mean increase (GMI) of A, C, Y, W135 Group Meningococcal Antibody | Part I Sections 3A, 3B, 3C, 3D, 3E, 4A: 30 days after primary vaccination, 30 days before and after booster vaccination, at the age 3 |
| Proportion of individuals with ≥1:128 titers for A, C, Y, W135 Group Meningococcal Antibody | Part I Sections 3A, 3B, 3C, 3D, 3E, 4A: 30 days after primary vaccination, 30 days before and after booster vaccination, at the age 3 |
| Seroconversion rates of serum anti-Pertussis Toxoid (PT), Filamentous hemagglutmin (FHA), Pertactin (PRN), Diphtheria Toxoid (DT), Tetanus Toxoid (TT) antibody | Part I Sections 3A, 3B, 3C, 3D, 3E: 30 days after primary vaccination, 30 days before and after booster vaccination, at the age 3 |
| Geometric Mean Concentration (GMC) of serum anti-PT, FHA, PRN, DT, TT antibody | Part I Sections 3A, 3B, 3C, 3D, 3E: 30 days after primary vaccination, 30 days before and after booster vaccination, at the age 3 |
| Seropositivity rate of serum anti-PT, FHA, PRN, DT, TT antibody | Part I Sections 3A, 3B, 3C, 3D, 3E: 30 days after primary vaccination, 30 days before and after booster vaccination, at the age 3 |
| GMI of serum anti-PT, FHA, PRN, DT, TT antibody | Part I Sections 3A, 3B, 3C, 3D, 3E: 30 days after primary vaccination, 30 days before and after booster vaccination, at the age 3 |
| Percentage of serum anti-Hib-Polyribosyl Ribitol Phosphate (PRP) antibody concentrations ≥0.15 μg/ml | Part I Sections 3A, 3B, 3C, 3D, 3E: 30 days after primary vaccination, 30 days before and after booster vaccination, at the age 3 |
| Percentage of serum anti-Hib-PRP antibody concentrations ≥1.0 μg/ml | Part I Sections 3A, 3B, 3C, 3D, 3E: 30 days after primary vaccination, 30 days before and after booster vaccination, at the age 3 |
| GMC of serum anti-Hib-PRP antibodies | Part I Sections 3A, 3B, 3C, 3D, 3E: 30 days after primary vaccination, 30 days before and after booster vaccination, at the age 3 |
| Seroconversion rate of serum anti-Hib-PRP antibodies | Part I Sections 3A, 3B, 3C, 3D, 3E: 30 days after primary vaccination, 30 days before and after booster vaccination, at the age 3 |
| GMI of serum anti-Hib-PRP antibodies | Part I Sections 3A, 3B, 3C, 3D, 3E: 30 days after primary vaccination, 30 days before and after booster vaccination, at the age 3 |
| ID | Term |
|---|---|
| D004165 | Diphtheria |
| D013742 | Tetanus |
| D008585 | Meningitis, Meningococcal |
| D006192 | Haemophilus Infections |
| ID | Term |
|---|---|
| D003354 | Corynebacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D003015 | Clostridium Infections |
| D016920 | Meningitis, Bacterial |
| D020806 | Central Nervous System Bacterial Infections |
| D008589 | Meningococcal Infections |
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D002494 | Central Nervous System Infections |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D008581 | Meningitis |
| D000090862 | Neuroinflammatory Diseases |
| D016871 | Pasteurellaceae Infections |
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| ID | Term |
|---|---|
| D017778 | Vaccines, Combined |
| D012965 | Sodium Chloride |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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