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This is a Phase 3 randomized, observation-blinded, active-controlled, parallel-group clinical trial designed to evaluate the immunogenicity, safety, and functional antibody response of the experimental vaccine versus the control vaccine in healthy Thailand infants vaccinated at a 2+1 schedule (2 months, 4 months and 12-15 months). The trial will enroll approximately 600 healthy infants aged 2 months (at least 6 weeks) who will be randomly assigned in a 1:1 ratio to receive either the experimental or control vaccine, with 100 in each group (200 in total) randomized to subgroups and subject to additional immunogenicity assessments. All participants will be evaluated for solicited adverse events for 7 days and unsolicited adverse events for 30 days post each vaccination. Immunogenicity evaluation will be performed in all participants at baseline and post the booster dose, while the sub-cohort participants will be evaluated for post primary series immunogenicity additionally.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 13-valent Pneumococcal Polysaccharide Conjugate Vaccine (CRM197/TT) (PCV13i) | Experimental | Intramuscular Injection, 0.5ml |
|
| Pneumococcal 13-valent Conjugate Vaccine (Prevnar 13) | Active Comparator | Intramuscular Injection, 0.5ml |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PCV13i | Biological | 3 doses: 2 months (Dose 1) months (Dose 2), 12-15 months (Booster dose) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants achieving serotype-specific IgG antibody concentrations ≥ 0.35 µg/mL | 30 days after the booster dose | |
| Incidence of solicited local and systemic adverse events (AEs) | Within 7 days after each dose of vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of unsolicited adverse events | Within 30 days after each dose of vaccination | |
| The number of serious adverse events (SAEs) | Through study completion, an average of 16-19 months | |
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Inclusion Criteria:
Exclusion Criteria for the first dose:
Individual termination criteria for subsequent doses:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Meixu Yan | Contact | 022-58213600-6051 | meixu.yan@cansinotech.com | |
| Lina Wang | Contact | 022-58213600-6051 | lina.wang@cansinotech.com |
| Name | Affiliation | Role |
|---|---|---|
| Supattra Rungmaitree, Doctor of Medicine | Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine Siriraj Hospital, Mahidol University | Recruiting | Bangkok | Thailand |
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| Prevnar 13 | Biological | 3 doses: 2 months (Dose 1) months (Dose 2), 12-15 months (Booster dose) |
|
| The geometric mean concentration (GMC) of Serotype-specific IgG in all participants |
| Before vaccination and 30 days after the booster dose |
| Proportion of participants achieving serotype-specific IgG antibody concentrations ≥ 0.35 µg/mL in Sub-cohort A participants | 30 days after the primary series |
| Proportion of participants achieving serotype-specific IgG antibody concentrations ≥ 0.35 µg/mL in Sub-cohort B participants | Before the booster dose |
| The geometric mean concentration (GMC) of Serotype-specific IgG in Sub-cohort A participants | 30 days after the primary series |
| The geometric mean concentration (GMC) of Serotype-specific IgG in Sub-cohort B participants | Before the booster dose |
| King Chulalongkorn Memorial Hospital | Recruiting | Bangkok | Thailand |
|
| Phramongkutklao Hospital | Recruiting | Bangkok | Thailand |
|
| ID | Term |
|---|---|
| D011008 | Pneumococcal Infections |
| D013290 | Streptococcal Infections |
| D001424 | Bacterial Infections |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C538862 | 13-valent pneumococcal vaccine |
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