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The goal of this clinical trial is to evaluate the immunogenicity and safety of Minhai's 13-valent Pneumococcal Polysaccharide Conjugate Vaccine (PCV13-DT/TT) as compared to Pfizer's 13-valent Pneumococcal Conjugate Vaccine (PCV13) when co-administered with Hexavalent Vaccines at 2,4, and 12-15 months of age, to healthy infants in Indonesia. This study aims to demonstrate the non-inferiority of the serotype-specific immune responses elicited by the novel PCV13-DT/TT (Pneuminvac) as compared to PCV13(Prevenar 13) one month after the booster dose, and evaluate the safety of PCV13 co-administrated with Hexavalent Vaccine(Hexaxim).
A total of approximately 500 infants 6-8 weeks of age (WOA) will be enrolled and randomized in 1:1 ratio into the study group and control group, with 250 participants in each group.The study group will receive study PCV13 vaccine and control group will receive Prevenar13® vaccine at 2, 4 and 12-15 months of age (MOA, as early as 6 weeks of age as per WHO recommendations for administration of PCV to infants). Hexavalent vaccine will be injected at 2, 3 and 4 months of age.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PCV13-DT/TT(Pneuminvac) | Experimental | 250 infants will be administered with Minhai's PCV13-DT/TT(Pneuminvac) |
|
| PCV13(Prenenar13) | Active Comparator | 250 infants will be administered with Prenenar13 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pneumococcal disease prevention | Biological | 2P+1 programme of PCV13 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Immugenocity | 1. To evaluate the serotype-specific IgG responses 30 days after booster dose of the investigational vaccine. | 1. Percentage of participants with serotype-specific IgG concentrations ≥ 0.35 μg/mL, measured 30 days after the booster dose of the investigational vaccine. 2. GMC ratio of serotype-specific IgG responses 30 days after the booster dose of the investigat |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | 1.To assess the solicited AEs (local and systemic) occurring 0-7 days after each dose of the investigational vaccine. | 1.Incidence, severity and duration of each solicited (local and systemic) AE within 7 days after each dose of the investigational vaccine in all participants. |
| Safety |
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Inclusion Criteria:
Note: For items with an asterisk (*), If the subject does not meet the criteria, the visit may be rescheduled when the criteria is met.
Exclusion Criteria:
Note: For items with an asterisk (*), if the participant meets these exclusion criteria, the visit may be rescheduled for a time when these criteria are not met.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine Udayana University | Not yet recruiting | Denpasar | Bali | 80114 | Indonesia |
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2. To assess the unsolicited AEs occurring 0-30 days after each dose of the investigational vaccine. |
| 2. Incidence, severity, and causality of unsolicited AEs within 30 days after each dose of the investigational vaccine in all participants. |
| Safety | 3. To assess SAE from 1st dose to 6 months after booster dose of the investigational vaccine. | 3. Incidence, severity, and causality of SAEs from 1st dose to 6 months after booster dose of the investigational vaccine. |
| Immugenocity |
| 1. Percentage of participants with serotype-specific IgG concentrations ≥ 0.35 μg/mL, measured 30 days after 2nd dose of the investigational vaccine. 2. GMC of serotype-specific IgG responses 30 days after 2nd dose of the investigational vaccine. 3. Pe |
| Universitas Padjadjaran Bandung | Not yet recruiting | Bandung | Bandung | 40161 | Indonesia |
|
| Faculty of Medicine, padjadjaran University | Recruiting | Bandung | Bandung | Indonesia |
|
| ID | Term |
|---|---|
| D011008 | Pneumococcal Infections |
| ID | Term |
|---|---|
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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