Streptococcus Pneumoniae Infection
Conditions
Keywords
Vaccine, Individuals aged 2 months (minimum 6 weeks) and older, Polysaccharide binding, Safety, Immunogenicity
Brief summary
This clinical trial consists of Phase I and Phase II. The objective is to evaluate the safety and immunogenicity of the 24-valent pneumococcal polysaccharide conjugate vaccine (CRM197/tetanus toxoid) in individuals aged 2 months (minimum 6 weeks) and older.
Detailed description
Phase I employs a randomized, blinded, dose-escalation, positive-control design with a total sample size of 310 participants. The study population is divided into five age groups: the 18-49 age group is an open-label design with M and H dose groups; The 7-23-month, 2-5-year-old, and ≥50-year-old groups will use a positive-control, blinded design with M and H dose groups; the 2-month-old (minimum 6 weeks) group will use a positive-control, dose-escalation, and blinded design with L, M, and H dose groups. The Phase II study was divided into two age groups. The ≥50-year-old group: a randomized, blinded, active-controlled design with a total sample size of 160 participants, who were randomly assigned to the treatment and control groups in a 1:1 ratio; the 2-month-old (minimum 6 weeks) group: a randomized, blinded, active-controlled design with a total sample size of 384 participants. Participants were randomly assigned in a 3:1 ratio to the treatment groups (doses L, M, and H) and the control group.
Interventions
BIOLOGICAL24-valent pneumococcal polysaccharide conjugate vaccine (CRM197/tetanus toxoid) (referred to as PCV24) (dose M)
1 dose ( 0.5ml) of PCV24 vaccine (dose M)
BIOLOGICALPCV24 vaccine (dose H)
1 dose ( 0.5ml) of PCV24 vaccine (dose H)
BIOLOGICALPCV24 vaccine (dose M)
1 dose ( 0.5ml) of PCV24 vaccine (dose M)
BIOLOGICAL23-valent pneumococcal polysaccharide vaccine (referred to as PPV23)
1 dose ( 0.5ml) of PPV23 vaccine
BIOLOGICAL13-valent pneumococcal polysaccharide conjugate vaccine (referred to as PCV13)
1 dose ( 0.5ml) of PCV13 vaccine
BIOLOGICALPPV23 vaccine
1 dose ( 0.5ml) of PPV23 vaccine
BIOLOGICALPCV13 vaccine
1 dose ( 0.5ml) of PCV13 vaccine
BIOLOGICALPCV24 vaccine (dose L)
The primary vaccination series consists of 3 doses ( 0.5ml) of the PCV24 vaccine ( dose L) , administered 2 months apart; a single booster dose is administered at 12 to 15 months of age.
BIOLOGICALPCV24 vaccine (dose L or M or H)
1 dose ( 0.5ml) of PCV24 vaccine (dose L or M or H)
Sponsors
CanSino Biologics Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Weeks to No maximum
Healthy volunteers
Yes
Inclusion criteria
Phase I: * Individuals aged 2 months (minimum 6 weeks), 7 months to 5 years, and 18 years and older who are willing to provide identification * The trial participant and/or guardian (legal representative) has voluntarily signed the informed consent form after providing informed consent * Children aged 5 and under who have not previously received a pneumococcal vaccine * People aged 18 and older who have not received a pneumonia vaccine in the past five years Phase II (age ≥50 group): * People aged 50 and older who are willing to provide identification documents * The trial participants voluntarily signed the informed consent form after providing their informed consent * People aged 50 and older who have not received a pneumonia vaccine in the past five years Phase II (2-month-old group (minimum 6 weeks)): * Individuals aged 2 months or older (minimum 6 weeks) who are willing to provide identification documents * The guardian (authorized representative) of the trial participant has voluntarily signed the informed consent form after providing informed consent. * Infants aged 2 months (minimum 6 weeks) who have not previously received a pneumococcal vaccine
Exclusion criteria
*
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I: Incidence of adverse reactions | Within 7 days of receiving each dose of the vaccine |
| Phase I: Incidence of serious adverse event (SAE) | Within 180 days of receiving the first dose of the vaccine through completion of the full vaccination series for each group |
| Phase I: Incidence of abnormalities in urinalysis | 4 days after vaccination |
| Phase I: Incidence of abnormalities in complete blood count | 4 days after vaccination |
| Phase I: Incidence of abnormalities in blood chemistry | 4 days after vaccination |
| Phase I: Incidence of abnormalities in coagulation function | 4 days after vaccination |
| Phase II (≥50 years old group): Geometric mean concentration (GMC) of serotype-specific pneumococcal IgG antibodies | 30 days after vaccination |
| Phase II (≥50 years old group): ≥4-fold increase of serotype-specific pneumococcal IgG antibodies | 30 days after vaccination |
| Phase II (≥50 years old group): Geometric mean increment (GMI) of serotype-specific pneumococcal IgG antibodies | 30 days after vaccination |
| Phase II (≥50 years old group): Serotype-specific pneumococcal OPA antibody titers in some trial participants | 30 days after vaccination |
| Phase II (≥50 years old group): Proportion of trial participants with serotype-specific pneumococcal OPA antibody titers ≥1:8 | 30 days after vaccination |
| Phase II (≥50 years old group): Incidence of adverse reactions | Within 7 days of vaccination |
| Phase II (2-month-old group [minimum 6 weeks]): Positive rate of vaccine-serotype-specific pneumococcal IgG antibodies (antibody concentration ≥ 0.35 μg/ml) | 30 days after the primary series, before the booster dose, and 30 days after the booster dose |
| Phase II (2-month-old group [minimum 6 weeks]): Proportion with vaccine-serotype-specific pneumococcal IgG antibody concentrations ≥ 1.0 μg/ml | 30 days after the primary series, before the booster dose, and 30 days after the booster dose |
| Phase II (2-month-old group [minimum 6 weeks]): GMC of serotype-specific pneumococcal IgG antibodies | 30 days after the primary series, before the booster dose, and 30 days after the booster dose |
| Phase II (2-month-old group [minimum 6 weeks]): GMI of serotype-specific pneumococcal IgG antibodies | 30 days after the primary series, before the booster dose, and 30 days after the booster dose |
| Phase II (2-month-old group [minimum 6 weeks]): Serotype-specific pneumococcal OPA antibody titers in some trial participants | 30 days after the primary series; 30 days after the booster dose |
| Phase II (2-month-old group [minimum 6 weeks]): Proportion of trial participants with serotype-specific pneumococcal OPA antibody titers ≥1:8 | 30 days after the primary series; 30 days after the booster dose |
| Phase II (2-month-old group [minimum 6 weeks]): Incidence of adverse reactions | Within 7 days of each dose |
Secondary
| Measure | Time frame |
|---|---|
| Phase I: Incidence of adverse reactions | Within 30 days of receiving each dose of the vaccine |
| Phase I (2-month-old group [minimum 6 weeks]): Positive rate of vaccine-serotype-specific pneumococcal IgG antibodies (antibody concentration ≥ 0.35 μg/ml) | 30 days after the primary series, 30 and 180 days after the booster dose |
| Phase I (2-month-old group [minimum 6 weeks]): Proportion with vaccine-serotype-specific pneumococcal IgG antibody concentrations ≥ 1.0 μg/ml | 30 days after the primary series, 30 and 180 days after the booster dose |
| Phase I (2-month-old group [minimum 6 weeks]): GMC of serotype-specific pneumococcal IgG antibodies | 30 days after the primary series, 30 and 180 days after the booster dose |
| Phase I (2-month-old group [minimum 6 weeks]): GMI of serotype-specific pneumococcal IgG antibodies | 30 days after the primary series, 30 and 180 days after the booster dose |
| Phase I (2-month-old group [minimum 6 weeks]): Serotype-specific pneumococcal OPA antibody titers | 30 days after the primary series; 30 days after the booster dose |
| Phase I (2-month-old group [minimum 6 weeks]): Proportion of serotype-specific pneumococcal OPA antibody titers ≥1:8 | 30 days after the primary series; 30 days after the booster dose |
| Phase I (≥50 years old group): GMC of Serotype-specific pneumococcal IgG antibody | 30 days after vaccination |
| Phase I (≥50 years old group): ≥4-fold increaseof Serotype-specific pneumococcal IgG antibody | 30 days after vaccination |
| Phase I (≥50 years old group): GMI of Serotype-specific pneumococcal IgG antibody | 30 days after vaccination |
| Phase I (≥50 years old group): Serotype-specific pneumococcal OPA antibody titers | 30 days after vaccination |
| Phase I (≥50 years old group): Proportion of serotype-specific pneumococcal OPA antibody titers ≥1:8 | 30 days after vaccination |
| Phase II (≥50 years old group): Incidence of adverse reactions | Within 30 days of vaccination |
| Phase II (≥50 years old group): Incidence of SAE | Within 180 days of vaccination |
| Phase II (2-month-old group [minimum 6 weeks]): Incidence of adverse reactions | Within 30 days of each dose |
| Phase II (2-month-old group [minimum 6 weeks]): Incidence of SAE | Within 180 days of receiving the first dose of the vaccine through the booster shot |
Countries
China
Contacts
CONTACTHaojie Liu
PRINCIPAL_INVESTIGATORZhiqiang Xie, Master
Henan Provincial Center for Disease Control and Prevention
Outcome results
None listed