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The current study is a follow-up to 2 previous parent studies, a dose-selection study with 3 different dose-levels of the altSonflex1-2-3 vaccine in a schedule of 3 vaccinations (H06_01TP study [NCT05073003, 212149]) and a study with an alternate 2 vaccination schedule H06_02TP study [NCT06663436, 219449]). The current study aims to assess the longevity of the immune response to the selected dose of the altSonflex1-2-3 vaccine 1, 2, and 3 years after the last vaccination in African children. The study involves no new vaccinations but will collect immunogenicity blood samples from participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| H06_01TP Study_Infants_Selected dose | Experimental | Infants who received 3 doses of the altSonflex1-2-3 vaccine on Day 1, Day 85, and Day 253 in the H06_01TP parent study. |
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| H06_01TP Study_ ST2_Infants_Control | Active Comparator | Infants who received 2 doses of the Menveo vaccine on Day 1 and Day 85, and 1 dose of the Infanrix hexa vaccine on Day 281 in the H06_01TP parent study. |
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| H06_02TP Study_Infants_Selected dose | Experimental | Infants who received 2 doses of the altSonflex1-2-3 vaccine on Day 1 and Day 169 in the H06_02TP parent study. |
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| H06_02TP Study_ Infants_Control | Active Comparator | Infants who received 1 dose of the TYPHIBEV vaccine on Day 1 and 1 dose of the Infanrix hexa vaccine on Day 169 in the H06_02TP parent study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AltSonflex1-2-3 | Biological | No intervention is administered in this extension study. The selected dose of altSonflex1-2-3 vaccine was administered intramuscularly in the participants' thigh during the H06_01TP (212149) parent study on Day 1, Day 85, and Day 253; or on Day 1 and Day 169 during the H06_02TP (219449) study. |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-serotype specific Shigella lipopolysaccharide (LPS)/O-antigen (OAg) serum immunoglobulin G (IgG), as measured by GVGH enzyme-linked immunosorbent assay . (ELISA) | S. sonnei, S. flexneri 1b, S. flexneri 2a, and S. flexneri 3a serotypes will be tested. | At Visit 1 of the current study (12 months after last vaccination in the parent studies) |
| Anti-serotype specific Shigella LPS/OAg serum IgG, as measured by GVGH ELISA | S. sonnei, S. flexneri 1b, S. flexneri 2a, and S. flexneri 3a serotypes will be tested. | At Visit 2 of the current study (24 months after last vaccination in the parent studies) |
| Anti-serotype specific Shigella LPS/OAg serum IgG, as measured by GVGH ELISA | S. sonnei, S. flexneri 1b, S. flexneri 2a, and S. flexneri 3a serotypes will be tested. | At Visit 3 of the current study (36 months after last vaccination in the parent studies) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| US GSK Clinical Trials Call Center | Contact | 877-379-3718 | GSKClinicalSupportHD@gsk.com | |
| EU GSK Clinical Trials Call Center | Contact | +44 (0) 20 89904466 | GSKClinicalSupportHD@gsk.com |
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Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About\_GSK\_Patient\_Level\_Data\_Sharing\_Final\_13July2023.pdf
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.
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| ID | Term |
|---|---|
| D003967 | Diarrhea |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D022401 | Meningococcal Vaccines |
| C541235 | diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine |
| D013745 | Tetanus Toxoid |
| D017325 | Hepatitis B Vaccines |
| ID | Term |
|---|---|
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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This is an open-label study.
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| Menveo | Biological | No intervention is administered in this extension study. The Menveo vaccine was administered intramuscularly in the participants' thigh on Day 1 and Day 85 during the H06_01TP (212149) parent study. |
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| Infanrix hexa | Biological | No intervention is administered in this extension study. The Infanrix hexa vaccine was administered intramuscularly in the participants' thigh on Day 281 during the H06_01TP (212149) study; or on Day 169 during the H06_02TP (219449) parent study. |
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| TYPHIBEV | Biological | No intervention is administered in this extension study. The TYPHIBEV vaccine was administered intramuscularly in the participants' thigh on Day 1 during the H06_02TP (219449) parent study. |
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| D014121 |
| Toxoids |
| D014761 | Viral Hepatitis Vaccines |
| D014765 | Viral Vaccines |