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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
260
1 dose of DTcP-Hib-MCV4 vaccine (0.5ml) on day 0
1 dose of DTcP-Hib-MCV4 vaccine (0.5ml) on day 0
1 dose of DTcP-Hib-MCV4 vaccine (0.5ml) on day 0
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.
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.
3 doses of DTcP (0.5ml) at 0, 2, and 4 months, followed by a booster dose at 18-24 months of age.
3 doses of Hib (0.5ml) at 0, 2, and 4 months, followed by a booster dose at 18-24 months of age.
3 doses of MCV4 (0.5ml) at 0, 2, and 4 months, followed by a booster dose at 18-24 months of age.
3 doses of MCV4 (0.5ml) at 0, 1, and 2 months, followed by a booster dose at 12 months of age.
3 doses of MCV4 (0.5ml) at 0, 2, and 4 months.
3 doses of NS (0.5ml) at 0, 2, and 4 months.
Liangyuan District Center for Disease Control and Prevention, Shangqiu City
Shangqiu, Henan, China
RECRUITINGIncidence of adverse reactions
Time frame: Parts I and II: Within 14 days after each dose
Incidence of adverse events
Time frame: Part I Sections 1A, 2A, 2B: Within 14 days after exemption
Incidence of adverse events
Time frame: Part I Sections 3A, 3B, 3C, 3D, 3E, 4A and Part II: Within 14 days after each dose
Incidence of adverse reactions/events
Time frame: Part I Sections 1A, 2A, 2B: Within 30 minutes after exemption
Incidence of adverse reactions/events
Time frame: Part I Sections 3A, 3B, 3C, 3D, 3E, 4A and Part II: Within 30 minutes after each dose
Incidence of adverse reactions/events
Time frame: Part I Sections 1A, 2A, 2B: Within 30 days after exemption
Incidence of adverse reactions/events
Time frame: Part I Sections 3A, 3B, 3C, 3D, 3E, 4A and Part II: Within 30 days after each dose
Incidence of Serious Adverse Event (SAE)
Time frame: Part I Sections 1A, 2A, 2B: Within 180 days after exemption
Incidence of Adverse Event of Special Interest (AESI)
Time frame: Part I Sections 1A, 2A, 2B: Within 180 days after exemption
Incidence of Serious Adverse Event (SAE)
Time frame: 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)
Time frame: 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
Time frame: Part I Sections 1A, 2A, 2B: 4 days after exemption
Seroconversion Rate of A, C, Y, W135 Group Meningococcal Antibody
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Part I Sections 3A, 3B, 3C, 3D, 3E: 30 days after primary vaccination, 30 days before and after booster vaccination, at the age 3
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.