Diphtheria, Tetanus and Acellular Pertussis, Epidemic Meningitis, Haemophilus Influenzae Type B Infection
Conditions
Keywords
Combined Vaccine, Safety, Immunogenicity, Ages 2 months to 6 years
Brief summary
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.
Interventions
BIOLOGICALAdsorbed Acellular Pertussis (3-Component) Diphtheria-Tetanus-Pertussis-Haemophilus influenzae type b (Conjugate)-Meningococcal Group ACYW135 (Conjugate) Combined Vaccine (DTcP-Hib-MCV4)
1 dose of DTcP-Hib-MCV4 vaccine (0.5ml) on day 0
BIOLOGICALDTcP-Hib-MCV4
1 dose of DTcP-Hib-MCV4 vaccine (0.5ml) on day 0
BIOLOGICALAdsorbed Acellular Pertussis (3-Component) Diphtheria-Tetanus-Pertussis (DTcP)
3 doses of DTcP (0.5ml) at 0, 2, and 4 months, followed by a booster dose at 18-24 months of age.
BIOLOGICALHaemophilus influenzae type b (Conjugate) (Hib)
3 doses of Hib (0.5ml) at 0, 2, and 4 months, followed by a booster dose at 18-24 months of age.
BIOLOGICALMeningococcal Group ACYW135 (Conjugate) (MCV4)
3 doses of MCV4 (0.5ml) at 0, 2, and 4 months, followed by a booster dose at 18-24 months of age.
BIOLOGICALMCV4
3 doses of MCV4 (0.5ml) at 0, 1, and 2 months, followed by a booster dose at 12 months of age.
OTHERSodium Chloride Injection (0.9%) (Saline Solution) (NS)
3 doses of NS (0.5ml) at 0, 2, and 4 months.
Sponsors
CanSino Biologics Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Part One: Partial Blind Method Design Part Two: Blind Method Design
Eligibility
Sex/Gender
ALL
Age
2 Months to 6 Years
Healthy volunteers
Yes
Inclusion criteria
General Inclusion Criteria: * Participants aged 2 months (60-89 days), 3 months (90-119 days), 18-24 months, and 6 years of age, with legal guardians or authorized representatives willing to provide identification documentation; * Legal guardians or authorized representatives provide informed consent, voluntarily sign the informed consent form, and are able to comply with the requirements of the clinical trial protocol; Part I: Specific Inclusion Criteria: * Individuals aged 18-24 months who have completed a 3-dose DTaP-containing vaccine series and a meningococcal-containing vaccine primary series, but have not received a DTaP-containing booster dose; * Individuals aged 6 years who have completed 4 doses of DTaP-containing vaccine but have not received the 5th DTaP-containing vaccine dose; and have only completed the first meningococcal-containing vaccine booster dose, without receiving the second meningococcal-containing vaccine booster dose at age 6.
Exclusion criteria
General
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse reactions | Parts I and II: Within 14 days after each dose |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse reactions/events | Part I Sections 1A, 2A, 2B: Within 30 minutes after exemption |
| 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 |
| 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 |
| Incidence of adverse events | Part I Sections 1A, 2A, 2B: Within 14 days after exemption |
| 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 |
| 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 |
Countries
China
Contacts
Primary ContactYing Wang
Outcome results
None listed