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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-512846-41 | EudraCT Number |
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The purpose of this study is to assess the reactogenicity, safety and immune response of various formulations of the RSV mRNA investigational vaccine administered in healthy participants 18-45 years of age.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RSV_Group A | Experimental |
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| RSV_Group B | Experimental |
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| RSV_Group C | Experimental |
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| RSV_Group D | Experimental |
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| RSV_Group E | Experimental |
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| RSV_Group F | Experimental |
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| Placebo Group | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Investigational RSV vaccine 1 | Biological | Investigational RSV vaccine 1 administered intramuscularly on Day 1 and Day 30. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of participants reporting solicited administration site events within 7 days post-Dose 1 | From Day 1 to Day 7 | |
| Number of participants reporting solicited administration site events within 7 days post-Dose 2 | From Day 30 to Day 36 | |
| Number of participants reporting solicited systemic events within 7 days post-Dose 1 | From Day 1 to Day 7 | |
| Number of participants reporting solicited systemic events within 7 days post-Dose 2 | From Day 30 to Day 36 | |
| Number of participants reporting unsolicited adverse events (AEs) within 29 days post-Dose 1 | From Day 1 to Day 29 | |
| Number of participants reporting unsolicited AEs within 29 days post-Dose 2 | From Day 30 to Day 58 | |
| Number of participants reporting serious adverse events (SAEs) | From Day 1 (Dose 1) up to Month 7 (6 months post-Dose 2) | |
| Number of participants reporting medically attended adverse events (MAAEs) | From Day 1 (Dose 1) up to Month 7 (6 months post-Dose 2) | |
| Number of participants reporting adverse event of special interest (AESI) | From Day 1 (Dose 1) up to Month 7 (6 months post-Dose 2) | |
| Measure | Description | Time Frame |
|---|---|---|
| RSV- A neutralizing titers expressed as Geometric mean titers (GMTs) | At Day 1 (pre-Dose 1), Day 8 and Day 30 (post-Dose 1), Day 37, Day 59, Month 7 and Month 13 (post-Dose 2) | |
| RSV- B neutralizing titers expressed as GMTs | At Day 1 (pre-Dose 1), Day 8 and Day 30 (post-Dose 1), Day 37, Day 59, Month 7 and Month 13 (post-Dose 2) |
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Inclusion Criteria:
Participants, who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the eDiary, return for follow-up visits).
Written informed consent obtained from the participant prior to performance of any study-specific procedure.
Healthy participants as established by medical history, clinical examination and laboratory assessment at screening.
Male or female between and including 18 and 45 years of age at the time of enrollment into the study.
Body mass index more than or equal to (>=) 18 kg/m^2 and less than (<) 40 kg/m^2.
Female participants of non-childbearing potential may be enrolled in the study.
Female participants of childbearing potential may be enrolled in the study if the participant:
Exclusion Criteria:
Medical conditions
Prior/Concomitant therapy
Prior/Concurrent clinical study experience
• Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention (drug/invasive medical device).
Other exclusion criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Rolling Hills Estates | California | 90274 | United States | ||
| GSK Investigational Site |
GSK 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 terminated asset(s) 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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Data will be collected in an observer-blind manner
| Investigational RSV vaccine 2 | Biological | Investigational RSV vaccine 2 administered intramuscularly on Day 1 and Day 30. |
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| Investigational RSV vaccine 3 | Biological | Investigational RSV vaccine 3 administered intramuscularly on Day 1 and Day 30. |
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| Investigational RSV vaccine 4 | Biological | Investigational RSV vaccine 4 administered intramuscularly on Day 1 and Day 30. |
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| Investigational RSV vaccine 5 | Biological | Investigational RSV vaccine 5 administered intramuscularly on Day 1 and Day 30. |
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| Investigational RSV vaccine 6 | Biological | Investigational RSV vaccine 6 administered intramuscularly on Day 1. |
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| Placebo | Drug | Placebo administered intramuscularly on Day 1 and Day 30 and for RSV_Group F placebo administered only on Day 30. |
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| Number of participants reporting fatal SAEs |
| From Day 1 (Dose 1) up to Month 13 (study end) |
| Number of participants reporting related SAEs | From Day 1 (Dose 1) up to Month 13 (study end) |
| Number of participants reporting related AESIs | From Day 1 (Dose 1) up to Month 13 (study end) |
| Number of participants with clinically significant hematological and biochemical abnormalities at pre-Dose 1 | At Day 1 |
| Number of participants with clinically significant hematological and biochemical abnormalities post-Dose 1 | At Day 8 |
| Number of participants with clinically significant hematological and biochemical abnormalities post-Dose 1 | At Day 30 |
| Number of participants with clinically significant hematological and biochemical abnormalities post-Dose 2 | At Day 37 |
| Geometric mean fold increase in serum neutralizing titers against RSV-A from baseline | Day 8 and Day 30 (post-Dose 1), Day 37, Day 59, Month 7 and Month 13 (post-Dose 2) compared with baseline (Day 1, pre-Dose 1) |
| Geometric mean fold increase in serum neutralizing titers against RSV-B from baseline | Day 8 and Day 30 (post-Dose 1), Day 37, Day 59, Month 7 and Month 13 (post-Dose 2) compared with baseline (Day 1, pre-Dose 1) |
| Number of participants with seroresponse in terms of neutralizing titer against RSV-A | Seroresponse is defined as at least a 4-fold increase compared to pre-dosing titer. | Day 8 and Day 30 (post-Dose 1), Day 37, Day 59, Month 7 and Month 13 (post-Dose 2) compared with baseline (Day 1, pre-Dose 1) |
| Number of participants with seroresponse in terms of neutralizing titer against RSV-B | Seroresponse is defined as at least a 4-fold increase compared to pre-dosing titer. | Day 8 and Day 30 (post-Dose 1), Day 37, Day 59, Month 7 and Month 13 (post-Dose 2) compared with baseline (Day 1, pre-Dose 1) |
| Atlanta |
| Georgia |
| 30281 |
| United States |
| GSK Investigational Site | Lenexa | Kansas | 66219 | United States |
| GSK Investigational Site | Omaha | Nebraska | 68134 | United States |
| GSK Investigational Site | Rochester | New York | 14609 | United States |
| GSK Investigational Site | Camberwell | Victoria | 3124 | Australia |
| GSK Investigational Site | Madrid | 28006 | Spain |
| GSK Investigational Site | Madrid | 28046 | Spain |
| GSK Investigational Site | Madrid | 28222 | Spain |
| ID | Term |
|---|---|
| D018357 | Respiratory Syncytial Virus Infections |
| ID | Term |
|---|---|
| D018186 | Pneumovirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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