A Randomized, Partially Blinded, Dose-Exploratory, Active/Placebo-Controlled Phase I Clinical Trial Evaluating the Safety and Immunogenicity of the Adsorbed Acellular Pertussis (Tricomponent) DPT-Hib (Conjugate)-ACYW135-Group B Meningococcal (Conjugate) Combined Vaccine in Individuals Aged 2 Months to 6 Years
Status: Recruiting
Location: See location...
Intervention Type: Biological, Other
Study Type: Interventional
Study Phase: Phase 1
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 2 months
Maximum Age: 6
Healthy Volunteers: t
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• 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.
Locations
Other Locations
China
Liangyuan District Center for Disease Control and Prevention, Shangqiu City
RECRUITING
Shangqiu
Contact Information
Primary
Ying Wang
ying.wang@cansinotech.com
022-58213600-6051
Time Frame
Start Date:2025-12-19
Estimated Completion Date:2029-02
Participants
Target number of participants:260
Treatments
Experimental: Part I, 1A, low dose, 6 year-old
One dose of DTcP-Hib-MCV4 on Day 0
Experimental: Part I, 2A, low dose, 18~24 month-old
One dose of DTcP-Hib-MCV4 on Day 0
Experimental: Part I, 2B, high dose, 18~24 month-old
One dose of DTcP-Hib-MCV4 on Day 0
Experimental: Part I, 3A, low dose, 2 month-old
3 doses of DTcP-Hib-MCV4 at 0, 2, and 4 months, followed by a booster dose at 18-24 months of age.
Experimental: Part I, 3B, high dose, 2 month-old
3 doses of DTcP-Hib-MCV4 at 0, 2, and 4 months, followed by a booster dose at 18-24 months of age.
Active_comparator: Part I, 3C, 2 month-old
3 doses of DTcP at 0, 2, and 4 months, followed by a booster dose at 18-24 months of age.
Active_comparator: Part I, 3D, 2 month-old
3 doses of Hib at 0, 2, and 4 months, followed by a booster dose at 18-24 months of age.
Active_comparator: Part I, 3E, 2 month-old
3 doses of MCV4 at 0, 2, and 4 months, followed by a booster dose at 18-24 months of age.
Active_comparator: Part I, 4A, 3 month-old
3 doses of MCV4 at 0, 1, and 2 months, followed by a booster dose at 12 months of age.
Experimental: Part II, Vaccine Group, 2 month-old
3 doses of MCV4 at 0, 2, and 4 months.
Placebo_comparator: Part II, Placebo Group, 2 month-old