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| Name | Class |
|---|---|
| Faculty of Medicine Universitas Padjadjaran | UNKNOWN |
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This trial is open label, comparative, randomized, phase I/II study, experimental, randomized, open-label, three arm parallel group study. The primary objective for phase I is to evaluate the safety of the DTwP-Hepatitis B-Hib-IPV (Bio Farma) vaccine within 7 days after each dose. The primary objective for phase II is to evaluate protectivity of DTwP-Hepatitis B-Hib-IPV (Bio Farma) vaccine.
This trial is open label, comparative, randomized, phase I/II study. For phase I, approximately 75 subjects will be recruited and will seamlessly continue to phase II recruiting 390 subject, in total 465 subjects.
In this study, DTwP-Hepatitis B-Hib-IPV (Bio Farma) vaccine will be compared to an active control (Registered DTwP-Hepatitis B-Hib Vaccine and Registered Inactivated Polio Vaccine). There are 2 formulas of DTwP-Hepatitis B-Hib-IPV Vaccine which will be used in the study. The regimen of the vaccine is 0,5 ml injected three-dose regimen with 28 days interval between doses. On the other hand, the control group will receive 0,5 ml of Registered DTwP-Hepatitis B-Hib vaccine and 0,5 ml Inactivated Bio Farma vaccine injected in three-dose regimen with 28 days interval between doses.
The safety and immunogenicity result of the Phase I study will determine the continuation of the next phase clinical trial. Clinical trial of phase II can be conducted after safety observation within 28 days after the third dose in phase I. Three hundred and ninety (390) healthy subjects aged 6-11 weeks of age will be recruited in Phase II trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula A | Experimental | 0,5 ml of DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula A injected three-dose regimen with 28 days interval between doses |
|
| DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula B | Experimental | 0,5 ml of DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula B injected three-dose regimen with 28 days interval between doses. |
|
| Registered DTwP-Hepatitis B-Hib Vaccine and IPV (Sinovac) ® | Active Comparator | 0,5 ml of DTwP-Hepatitis B-Hib Vaccine and IPV (Sinovac)® injected three-dose regimen with 28 days interval between doses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula A | Biological | 0,5 ml DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula A injected three-dose regimen with 28 days interval between doses. Vaccine is injected intramuscularly in left anterolateral thigh. |
| Measure | Description | Time Frame |
|---|---|---|
| Phase I: Safety of the DTwP-Hepatitis B-Hib-IPV (Bio Farma) vaccine within 7 days after each dose | Safety of the DTwP-Hepatitis B-Hib-IPV (Bio Farma) vaccine within 7 days after each dose | From enrollment to 7 days after first dose |
| Phase II: Immunogenicity of DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine | Protectivity of DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine | From enrollment up to 28 days after third dose |
| Measure | Description | Time Frame |
|---|---|---|
| Phase I: Safety of the vaccine within 28 days after last dose | Number and percentage of solicited and unsolicited adverse events within 28 days after each dose | From enrollment to 28 days after each dose |
| Phase I: Safety of the vaccine within 6 months after last dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rini Mulia Sari, MD | Contact | +622033755 | 14102 | rini.mulia@biofarma.co.id |
| Mita Puspita, MD | Contact | +622033755 | 5045 | mita.puspita@biofarma.co.id |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Garuda Primary Health Centre | Bandung | West Java | Indonesia | |||
| Ibrahim Adjie Priamry Health Centre |
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| DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula B | Biological | 0,5 ml injected of DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula B three-dose regimen with 28 days interval between doses. Injected intramuscularly in left anterolateral thigh. |
|
| Registered DTwP-Hepatitis B-Hib Vaccine and IPV (Sinovac)® | Biological | The control group will receive 0,5 ml of Registered DTwP-Hepatitis B-Hib vaccine and 0,5 ml IPV (Sinovac)® injected in three-dose regimen with 28 days interval between doses. Registered DTwP-Hepatitis B-Hib Vaccine are injected intramuscularly into the left antero-lateral thigh region. IPV (Sinovac)® vaccine are injected intramuscularly into the right mid-lateral thigh region |
|
Number and percentage of subjects with serious adverse events until 6 months after last dose |
| From enrollment up to 6 months after the last dose |
| Phase I: Comparison of safety within 28 days after each dose between vaccines and active control | Comparison of number and percentage of subjects with adverse events between vaccine and control group within 28 days after each dose | From enrollment to 28 days after each dose |
| Phase I: Comparison of safety until 6 months after last dose between vaccines and active control | Comparison of number and percentage of subjects with serious adverse events between vaccine and control group until 6 months after last dose | From enrollment to 6 months after last dose |
| Phase I: Routine laboratory evaluation that probably related to the vaccination | Any deviation from routine laboratory evaluation that probably related to the dosing 7 days after first dose. | From enrollment to 7 days after first dose |
| Phase I: Serological response to diphteria toxoid and tetanus toxoid | Serological response to diphtheria toxoid, tetanus toxoid: GMT, percentage of infants with titer ≥ 0.01 IU/ml, ≥ 0.1 IU/ml percentage of infants with increasing antibody titer ≥ 4 times and/or percentage of infants with transition of seronegative to seropositive. | 28 days after the last dose immunization |
| Phase I: Serological response to the pertussis component (agglutinins) | GMT, percentage of infants with titer ≥ 40, ≥ 80 and ≥ 320 (1/dil.), percentage of infants with increasing antibody titer ≥ 4 times | 28 days after the last dose immunization |
| Phase I: Geometric mean of anti-HbsAg | Percentage of infants with titer ≥ 10mIU/ml, percentage of infants with increasing antibody titer ≥ 4 times and/ or percentage of infants with transition of seronegative to seropositive. | 28 days after the last dose immunization |
| Phase I: Serological response to Hib/PRP | GMT, percentage of infants with titer ≥ 1 μg /ml; ≥ 0.15 μg /ml percentage of infants with increasing antibody titer ≥ 4 times and/or percentage of infants with transition of seronegative to seropositive | 28 days after the last dose immunization |
| Phase I: Serological response to polio type 1, 2, and 3 (humoral immunity) | GMT, percentage of infants with titer ≥ 8, percentage of infants with transition of seronegative to seropositive | 28 days after the last dose immunization |
| Phase II: Serological response to diphtheria toxoid, tetanus toxoid | GMT, percentage of infants with titer ≥ 0.01 IU/ml, ≥ 0.1 IU/ml percentage of infants with increasing antibody titer ≥ 4 times and/or percentage of infants with transition of seronegative to seropositive | 28 days after the last dose immunization |
| Phase II: Serological response to the pertussis component (agglutinins) | GMT, percentage of infants with titer ≥ 40, ≥ 80 and ≥ 320 (1/dil.), percentage of infants with increasing antibody titer ≥ 4 times | 28 days after the last dose immunization |
| Phase II: Geometric mean of anti-HbsAg | percentage of infants with titer ≥ 10mIU/ml, percentage of infants with increasing antibody titer ≥ 4 times and/ or percentage of infants with transition of seronegative to seropositive. | 28 days after the last dose immunization |
| Phase II: Serological response to Hib/PRP | GMT, percentage of infants with titer ≥ 1 μg /ml; ≥ 0.15 μg /ml percentage of infants with increasing antibody titer ≥ 4 times and/or percentage of infants with transition of seronegative to seropositive | 28 days after the last dose immunization |
| Phase II: Serological response to polio type 1, 2, and 3 (humoral immunity) | GMT, percentage of infants with titer ≥ 8, percentage of infants with transition of seronegative to seropositive | 28 days after the last dose immunization |
| Phase II: Safety of vaccine within 30 minutes after immunization | Local reaction and systemic events occurring within 30 minutes after immunization | 30 minutes after immunization |
| Phase II: Safety of vaccine within 7 days after immunization | Local reaction and systemic events occurring within 7 days after immunization | Within 7 days after immunization |
| Phase II: Safety of vaccine after 7 days to 28 days following the vaccination | Local reaction and systemic events occurring after the 7 days to 28 days following the vaccination | From 7 days to 28 days following the vaccination |
| Bandung |
| West Java |
| Indonesia |
| Puter Primary Health Centre | Bandung | West Java | Indonesia |
| ID | Term |
|---|---|
| D011054 | Poliovirus Vaccine, Inactivated |
| ID | Term |
|---|---|
| D015164 | Vaccines, Inactivated |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D023321 | Poliovirus Vaccines |
| D014765 | Viral Vaccines |
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