Clinical Trial Results:
A Phase 3, Single-Arm, Open-label Clinical Study to Evaluate the Safety and Immunogenicity of 4 doses of V114 Administered to Healthy Infants in South Korea.
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Summary
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EudraCT number |
2020-003181-39 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
07 Dec 2022
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Results information
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Results version number |
v1(current) |
This version publication date |
18 May 2023
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First version publication date |
18 May 2023
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
V114-036
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT04633226 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Merck Sharp & Dohme LLC
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Sponsor organisation address |
126 East Lincoln Avenue, P.O. Box 2000, Rahway, NJ, United States, 07065
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Public contact |
Clinical Trials Disclosure, Merck Sharp & Dohme LLC, ClinicalTrialsDisclosure@merck.com
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Scientific contact |
Clinical Trials Disclosure, Merck Sharp & Dohme LLC, ClinicalTrialsDisclosure@merck.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
04 Nov 2022
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
04 Nov 2022
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Global end of trial reached? |
Yes
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Global end of trial date |
07 Dec 2022
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The primary purpose of this phase 3, single-arm, open-label study is to evaluate the safety and immunogenicity of a 4-dose regimen of V114 administered to healthy infants in South Korea.
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Protection of trial subjects |
This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
10 Feb 2021
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Korea, Republic of: 58
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Worldwide total number of subjects |
58
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EEA total number of subjects |
0
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
58
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
This study enrolled healthy South Korean infants, approximately 2 months of age, from 42 days to 90 days inclusive. | ||||||||||||||||||||
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Pre-assignment
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Screening details |
58 infants (42 days to 90 days of age) were enrolled to receive V114. One participant was enrolled in error (participant had received previous administration of Prevenar 13™) and was discontinued from the study without receipt of V114. | ||||||||||||||||||||
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Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||||||||
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Arms
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Arm title
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V114 | ||||||||||||||||||||
Arm description |
Participants received 4 total doses of V114, administered at approximately 2, 4, 6, and 12 to 15 months of age. | ||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||
Investigational medicinal product name |
V114
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Investigational medicinal product code |
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Other name |
VAXNEUVANCE™, Pneumococcal 15-valent Conjugate Vaccine
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Pharmaceutical forms |
Suspension for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
15-valent pneumococcal conjugate vaccine (PCV) containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) present in Prevnar 13™ plus 2 additional serotypes (22F, 33F) in each 0.5 mL dose
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| Notes [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left. Justification: Participants could have been considered to complete the study without receipt of Vaccination 4 (~12 to 15 months of age). |
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Baseline characteristics reporting groups
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Reporting group title |
V114
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Reporting group description |
Participants received 4 total doses of V114, administered at approximately 2, 4, 6, and 12 to 15 months of age. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
V114
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Reporting group description |
Participants received 4 total doses of V114, administered at approximately 2, 4, 6, and 12 to 15 months of age. | ||
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End point title |
Percentage of participants with ≥1 solicited injection-site adverse events (AEs) [1] | ||||||||||||||||
End point description |
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following any of the doses of V114, the percentage of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs consist of redness/erythema, hard lump/induration, tenderness/pain, and swelling. All randomized participants who received at least 1 dose of study vaccination were analyzed.
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End point type |
Primary
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End point timeframe |
Up to 7 days after any vaccination, up to a total of ~ 13 months
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No statistical analyses were planned for this endpoint. |
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| No statistical analyses for this end point | |||||||||||||||||
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End point title |
Percentage of participants with ≥1 solicited systemic AE [2] | ||||||||||||||||
End point description |
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following any of the doses of V114, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs consist of appetite lost/decreased appetite, irritability, drowsiness/somnolence, and hives or welts/urticaria. All randomized participants who received at least 1 dose of study vaccination were analyzed.
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End point type |
Primary
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End point timeframe |
Up to 7 days after any vaccination, up to a total of ~ 13 months
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| Notes [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No statistical analyses were planned for this endpoint. |
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| No statistical analyses for this end point | |||||||||||||||||
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End point title |
Percentage of participants with ≥1 vaccine-related serious adverse events (SAEs) [3] | ||||||||
End point description |
A serious adverse event (SAE) is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. The percentage of participants with a vaccine-related SAE following any dose of V114 was reported. Vaccine-related SAEs were counted starting after vaccine dose 1 through completion of study. All randomized participants who received at least 1 dose of study vaccination were analyzed.
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End point type |
Primary
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End point timeframe |
Up to approximately 14.5 months
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| Notes [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No statistical analyses were planned for this endpoint. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Percentage of participants discontinuing study therapy due to AE(s) [4] | ||||||||
End point description |
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The percentage of participants who discontinued study treatment due to an AE is reported. The analysis population consisted of all participants who received at least 1 dose of study vaccination.
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End point type |
Primary
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End point timeframe |
Up to approximately 13 months
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| Notes [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No statistical analyses were planned for this endpoint. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Percentage of participants with anti-pneumococcal polysaccharides (PnPs) serotype-specific immunoglobulin G (IgG) ≥0.35 µg/mL [5] | ||||||||||||||||||||||||||||||||||||||
End point description |
The percentage of participants with IgG threshold values of ≥0.35 µg/mL for the 15 serotypes contained in V114 (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F) at 30 days postdose 3 is reported. The multiplex, pneumococcal electrochemiluminescence (PnECL) v2.0 assay was used to quantify IgG serotype-specific antibodies. All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity endpoint and who had sufficient data to perform the analyses were analyzed.
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End point type |
Primary
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End point timeframe |
30 days after vaccination 3 (Up to a total of ~5 months)
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| Notes [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No statistical analyses were planned for this endpoint. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||
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End point title |
Geometric mean concentrations (GMCs) of anti-PnPs serotype-specific IgG at 30 days postdose 3 [6] | ||||||||||||||||||||||||||||||||||||||
End point description |
The anti-PnPs serotype-specific IgG Geometric Mean Concentrations (GMCs) at 30 days postdose 3 for each serotype-specific were reported. The multiplex, ECL-based PnECL v2.0 assay was used. All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity endpoint and who had sufficient data to perform the analyses were analyzed.
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End point type |
Primary
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End point timeframe |
30 days after vaccination 3 (Up to a total of ~5 months)
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| Notes [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No statistical analyses were planned for this endpoint. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||
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End point title |
Geometric mean concentrations (GMCs) of anti-PnPs serotype-specific IgG at 30 days postdose 4 | ||||||||||||||||||||||||||||||||||||||
End point description |
The anti-PnPs serotype-specific IgG Geometric Mean Concentrations (GMCs) at 30 days postdose 4 for each serotype-specific were reported. The multiplex, ECL-based PnECL v2.0 assay was used. All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity endpoint and who had sufficient data to perform the analyses were analyzed.
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End point type |
Secondary
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End point timeframe |
30 days after vaccination 4 (Up to a total of ~14 months)
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
Up to ~14.5 months
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Adverse event reporting additional description |
The analysis population for Number of Deaths (all causes) included all randomized participants (N=58). The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
25.1
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Reporting groups
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Reporting group title |
V114
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Reporting group description |
Participants received 4 total doses of V114, administered at approximately 2, 4, 6, and 12 to 15 months of age. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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17 Dec 2021 |
Amendment 01: Primary reason for amendment was to reduce the number of participants in the study due to the enrollment challenges primarily related to the COVID-19 pandemic. |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
