Clinical Trial Results:
A Phase 4, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, and Immunogenicity of Vaxelis™ in Healthy Children Previously Vaccinated With a 2-Dose Primary Infant Series of Either Vaxelis™ or Hexyon™
|
Summary
|
|
EudraCT number |
2021-004053-23 |
Trial protocol |
ES DE IT |
Global end of trial date |
17 Jan 2023
|
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
08 Jul 2023
|
First version publication date |
08 Jul 2023
|
Other versions |
|
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
|
|||
|
Trial identification
|
|||
Sponsor protocol code |
V419-016
|
||
|
Additional study identifiers
|
|||
ISRCTN number |
- | ||
US NCT number |
NCT05289271 | ||
WHO universal trial number (UTN) |
- | ||
|
Sponsors
|
|||
Sponsor organisation name |
Merck Sharp & Dohme LLC
|
||
Sponsor organisation address |
126 East Lincoln Avenue, Rahway, NJ, United States, P.O. Box 2000
|
||
Public contact |
Clinical Trials Disclosure, Merck Sharp & Dohme LLC, ClinicalTrialsDisclosure@merck.com
|
||
Scientific contact |
Clinical Trials Disclosure, Merck Sharp & Dohme LLC, ClinicalTrialsDisclosure@merck.com
|
||
|
Paediatric regulatory details
|
|||
Is trial part of an agreed paediatric investigation plan (PIP) |
No
|
||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
|
||
|
Results analysis stage
|
|||
Analysis stage |
Final
|
||
Date of interim/final analysis |
17 Jan 2023
|
||
Is this the analysis of the primary completion data? |
Yes
|
||
Primary completion date |
30 Aug 2022
|
||
Global end of trial reached? |
Yes
|
||
Global end of trial date |
17 Jan 2023
|
||
Was the trial ended prematurely? |
No
|
||
|
General information about the trial
|
|||
Main objective of the trial |
The primary objectives of this study were to evaluate the safety, tolerability, and immunogenicity of a booster dose of Vaxelis™ (V419) given at ~11 to 13 months of age in healthy participants who were previously vaccinated with a 2-dose primary infant series of either Vaxelis™ or Hexyon™
|
||
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.
|
||
Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
25 Mar 2022
|
||
Long term follow-up planned |
No
|
||
Independent data monitoring committee (IDMC) involvement? |
No
|
||
|
Population of trial subjects
|
|||
Number of subjects enrolled per country |
|||
Country: Number of subjects enrolled |
Germany: 53
|
||
Country: Number of subjects enrolled |
Spain: 104
|
||
Country: Number of subjects enrolled |
Italy: 11
|
||
Worldwide total number of subjects |
168
|
||
EEA total number of subjects |
168
|
||
Number of subjects enrolled per age group |
|||
In utero |
0
|
||
Preterm newborn - gestational age < 37 wk |
0
|
||
Newborns (0-27 days) |
0
|
||
Infants and toddlers (28 days-23 months) |
168
|
||
Children (2-11 years) |
0
|
||
Adolescents (12-17 years) |
0
|
||
Adults (18-64 years) |
0
|
||
From 65 to 84 years |
0
|
||
85 years and over |
0
|
||
|
|||||||||||||||||||
|
Recruitment
|
|||||||||||||||||||
Recruitment details |
- | ||||||||||||||||||
|
Pre-assignment
|
|||||||||||||||||||
Screening details |
Healthy participants approximately 11 to 13 months of age, (≥327 days to ≤396 days inclusive).were enrolled in this study. | ||||||||||||||||||
|
Period 1
|
|||||||||||||||||||
Period 1 title |
Overall Study (overall period)
|
||||||||||||||||||
Is this the baseline period? |
Yes | ||||||||||||||||||
Allocation method |
Non-randomised - controlled
|
||||||||||||||||||
Blinding used |
Not blinded | ||||||||||||||||||
|
Arms
|
|||||||||||||||||||
Are arms mutually exclusive |
Yes
|
||||||||||||||||||
|
Arm title
|
Group 1: V, V, V | ||||||||||||||||||
Arm description |
Participants who received a 2-dose regimen of Vaxelis™ as infants prior to enrollment received a Vaxelis™ booster at ~11 months of age. | ||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||
Investigational medicinal product name |
Vaxelis™
|
||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||
Other name |
V419
|
||||||||||||||||||
Pharmaceutical forms |
Suspension for injection in pre-filled syringe
|
||||||||||||||||||
Routes of administration |
Intramuscular use
|
||||||||||||||||||
Dosage and administration details |
0.5 mL sterile suspension in prefilled syringe for intramuscular administration.
|
||||||||||||||||||
|
Arm title
|
Group 2: H, H, V | ||||||||||||||||||
Arm description |
Participants who received a 2-dose regimen of Hexyon™ as infants prior to enrollment received a Vaxelis™ booster at ~11 months of age. | ||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||
Investigational medicinal product name |
Vaxelis™
|
||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||
Other name |
V419
|
||||||||||||||||||
Pharmaceutical forms |
Suspension for injection in pre-filled syringe
|
||||||||||||||||||
Routes of administration |
Intramuscular use
|
||||||||||||||||||
Dosage and administration details |
0.5 mL sterile suspension in prefilled syringe for intramuscular administration.
|
||||||||||||||||||
|
|||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Baseline characteristics reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Group 1: V, V, V
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Participants who received a 2-dose regimen of Vaxelis™ as infants prior to enrollment received a Vaxelis™ booster at ~11 months of age. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Group 2: H, H, V
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Participants who received a 2-dose regimen of Hexyon™ as infants prior to enrollment received a Vaxelis™ booster at ~11 months of age. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||
|
End points reporting groups
|
|||
Reporting group title |
Group 1: V, V, V
|
||
Reporting group description |
Participants who received a 2-dose regimen of Vaxelis™ as infants prior to enrollment received a Vaxelis™ booster at ~11 months of age. | ||
Reporting group title |
Group 2: H, H, V
|
||
Reporting group description |
Participants who received a 2-dose regimen of Hexyon™ as infants prior to enrollment received a Vaxelis™ booster at ~11 months of age. | ||
|
||||||||||||||||||||||
End point title |
Percentage of participants with a solicited injection-site adverse event (AE) [1] | |||||||||||||||||||||
End point description |
Solicited injection-site AEs are predefined local (at the injection/administration site) events for which the participant’s legally authorized representative was specifically questioned. Participant’s legally acceptable representative used a Vaccination Report Card (VRC) to report the following solicited injection-site AEs : swelling, redness (erythema), and pain/tenderness. 95% confidence intervals (CIs) were calculated based on the exact binomial method proposed by Clopper and Pearson. The population analyzed was all participants who received study vaccination.
|
|||||||||||||||||||||
End point type |
Primary
|
|||||||||||||||||||||
End point timeframe |
Up to 5 days postvaccination
|
|||||||||||||||||||||
| 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: Statistical comparisons between treatment groups were neither planned nor performed for this primary endpoint. |
||||||||||||||||||||||
|
||||||||||||||||||||||
| No statistical analyses for this end point | ||||||||||||||||||||||
|
|||||||||||||||||||||||||
End point title |
Percentage of participants with a solicited systemic AE [2] | ||||||||||||||||||||||||
End point description |
Solicited systemic AE are predefined systemic events for which the participant’s legally authorized representative was specifically questioned. Participant’s legally acceptable representative used a VRC to report the following solicited systemic AEs: vomiting, drowsiness (somnolence), loss of appetite, and irritability. 95% CIs were calculated based on the exact binomial method proposed by Clopper and Pearson. The population analyzed was all participants who received study vaccination.
|
||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
Up to 5 days postvaccination
|
||||||||||||||||||||||||
| 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: Statistical comparisons between treatment groups were neither planned nor performed for this primary endpoint. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||
|
|||||||||||||
End point title |
Percentage of participants with unsolicited AEs [3] | ||||||||||||
End point description |
An unsolicited AE is an AE that was not solicited using a VRC and that is communicated by a participant’s legally authorized representative who has signed the informed consent. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. 95% CIs were calculated based on the exact binomial method proposed by Clopper and Pearson. The population analyzed was all participants who received study vaccination.
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Up to 15 days postvaccination
|
||||||||||||
| 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: Statistical comparisons between treatment groups were neither planned nor performed for this primary endpoint. |
|||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
End point title |
Percentage of participants with a serious AE (SAE) [4] | ||||||||||||
End point description |
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an other important medical event. 95% CIs were calculated based on the exact binomial method proposed by Clopper and Pearson. The population analyzed was all participants who received study vaccination.
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Up to 40 days postvaccination
|
||||||||||||
| 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: Statistical comparisons between treatment groups were neither planned nor performed for this primary endpoint. |
|||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
End point title |
Percentage of participants with diphtheria toxoid antibodies ≥0.1 IU/mL [5] | ||||||||||||
End point description |
Human antibodies to diphtheria toxoid were quantified using the Meso Scale Discovery Electrochemiluminescence serological assay based on an established reference standard sample curve with the lower limit of quantitation (LLOQ) for diphtheria antibody of 0.005 IU/mL. The percentage of participants with diphtheria toxoid antibodies ≥0.1 international units per milliliter (IU/mL) one month after Vaxelis™ as the 3rd dose of a vaccination series is presented. The 95% CIs are based on the exact binomial method proposed by Clopper and Pearson. The population analyzed was all enrolled participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint.
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
30 days postvaccination (at ~12 months of age)
|
||||||||||||
| 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: Statistical comparisons between treatment groups were neither planned nor performed for this primary endpoint. |
|||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
End point title |
Percentage of participants with tetanus toxoid antibodies ≥0.1 IU/mL [6] | ||||||||||||
End point description |
Human antibodies to tetanus toxoid were quantified using the Meso Scale Discovery Electrochemiluminescence serological assay based on an established reference standard sample curve with a LLOQ for tetanus antibody of 0.01 IU/mL. The percentage of participants with tetanus toxoid antibodies ≥0.1 IU/mL one month after Vaxelis™ as the 3rd dose of a vaccination series is presented. The 95% CIs are based on the exact binomial method proposed by Clopper and Pearson. The population analyzed was all enrolled participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint.
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
30 days postvaccination (at ~12 months of age)
|
||||||||||||
| 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: Statistical comparisons between treatment groups were neither planned nor performed for this primary endpoint. |
|||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
End point title |
Percentage of participants with pertussis toxoid (PT) vaccine response [7] | ||||||||||||
End point description |
Human antibodies to pertussis toxoid were quantified using the Meso Scale Discovery Electrochemiluminescence serological assay based on an established reference standard sample curve with a LLOQ for pertussis antibody of 2.00 EU/mL. The percentage of participants meeting response criteria for PT is based on pre-vaccination level of PT is presented. The 95% CIs are based on the exact binomial method proposed by Clopper and Pearson. The population analyzed was all enrolled participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint.
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
30 days postvaccination (at ~12 months of age)
|
||||||||||||
| Notes [7] - 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: Statistical comparisons between treatment groups were neither planned nor performed for this primary endpoint. |
|||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
End point title |
Percentage of participants with filamentous hemagglutinin (FHA) vaccine response [8] | ||||||||||||
End point description |
Human antibodies to FHA were quantified using the Meso Scale Discovery Electrochemiluminescence serological assay based on an established reference standard sample curve with a LLOQ for FHA antibody of 2.00 EU/mL. The percentage of participants meeting response criteria for FHA response will be based on pre-vaccination level of FHA. The 95% CIs are based on the exact binomial method proposed by Clopper and Pearson. The population analyzed was all enrolled participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint.
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
30 days postvaccination (at ~12 months of age)
|
||||||||||||
| Notes [8] - 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: Statistical comparisons between treatment groups were neither planned nor performed for this primary endpoint. |
|||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
End point title |
Percentage of participants with Haemophilus influenzae type b polyribosylribitol phosphate (Hib-PRP) antibodies ≥1.0 µg/mL [9] | ||||||||||||
End point description |
Human antibodies to Hib-PRP were quantified using the Vacczyme™ Human Anti-Haemophilus influenzae Type b Enzyme Immunoassay Kit. Levels of anti-Hib IgG were quantified by interpolation from a standard curve that has been calibrated to the FDA lot 1983 reference serum. The percentage of participants with Hib-PRP antibodies ≥0.1 IU/mL one month after Vaxelis™ as the 3rd dose of a vaccination series is presented. The 95% CIs are based on the exact binomial method proposed by Clopper and Pearson. The population analyzed was all enrolled participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint.
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
30 days postvaccination (at ~12 months of age)
|
||||||||||||
| Notes [9] - 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: Statistical comparisons between treatment groups were neither planned nor performed for this primary endpoint. |
|||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
End point title |
Percentage of participants with hepatitis B surface antigen (HBsAg) antibodies ≥10 mIU/mL [10] | ||||||||||||
End point description |
Human antibodies to HBsAg were quantified using an Enhanced Chemiluminescence (ECi) assay, with the hepatitis B WHO International reference standard at 10 mIU/mL as a control in every assay, and the LLOQ of the assay is 5 mIU/mL. The percentage of participants with HBsAg antibodies ≥10 milli-international per liter (mIU/mL) one month after Vaxelis™ as the 3rd dose of a vaccination series is presented. The 95% CIs are based on the exact binomial method proposed by Clopper and Pearson. The population analyzed was all enrolled participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint.
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
30 days postvaccination (at ~12 months of age)
|
||||||||||||
| Notes [10] - 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: Statistical comparisons between treatment groups were neither planned nor performed for this primary endpoint. |
|||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
End point title |
Percentage of participants with poliovirus serotype 1 neutralizing antibodies (Nab) ≥1:8 dilution [11] | ||||||||||||
End point description |
Human antibodies to poliovirus serotype 1 were quantified with a neutralization assay by utilizing Vero cells and wild type poliovirus strain 1 as the challenge virus. The Karber method was used to determine the serum dilution that neutralized 50% of the challenge virus, with results expressed as titers (1:dilution), and the LLOQ was 1:4. dilution. The percentage of participants with poliovirus serotype 1 Nab ≥1:8 dilution one month after Vaxelis™ as the 3rd dose of a vaccination series is presented. The 95% CIs are based on the exact binomial method proposed by Clopper and Pearson. The population analyzed was all enrolled participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint.
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
30 days postvaccination (at ~12 months of age)
|
||||||||||||
| Notes [11] - 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: Statistical comparisons between treatment groups were neither planned nor performed for this primary endpoint. |
|||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
End point title |
Percentage of participants with poliovirus serotype 2 neutralizing antibodies (Nab) ≥1:8 dilution [12] | ||||||||||||
End point description |
Human antibodies to poliovirus serotype 2 were quantified with a neutralization assay by utilizing Vero cells and wild type poliovirus strain 2 as the challenge virus. The Karber method was used to determine the serum dilution that neutralized 50% of the challenge virus, with results expressed as titers (1:dilution), and the LLOQ was 1:4. dilution. The percentage of participants with poliovirus serotype 2 Nab ≥1:8 dilution one month after Vaxelis™ as the 3rd dose of a vaccination series is presented. The 95% CIs are based on the exact binomial method proposed by Clopper and Pearson. The population analyzed was all enrolled participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint.
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
30 days postvaccination (at ~12 months of age)
|
||||||||||||
| Notes [12] - 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: Statistical comparisons between treatment groups were neither planned nor performed for this primary endpoint. |
|||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
End point title |
Percentage of participants with poliovirus serotype 3 neutralizing antibodies (Nab) ≥1:8 dilution [13] | ||||||||||||
End point description |
Human antibodies to poliovirus serotype 3 were quantified with a neutralization assay by utilizing Vero cells and wild type poliovirus strain 3 as the challenge virus. The Karber method was used to determine the serum dilution that neutralized 50% of the challenge virus, with results expressed as titers (1:dilution), and the LLOQ was 1:4. dilution. The percentage of participants with poliovirus serotype 3 Nab ≥1:8 dilution one month after Vaxelis™ as the 3rd dose of a vaccination series is presented. The 95% CIs are based on the exact binomial method proposed by Clopper and Pearson. The population analyzed was all enrolled participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint.
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
30 days postvaccination (at ~12 months of age)
|
||||||||||||
| Notes [13] - 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: Statistical comparisons between treatment groups were neither planned nor performed for this primary endpoint. |
|||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
End point title |
Percentage of participants with pertactin (PRN) vaccine response | ||||||||||||
End point description |
Human antibodies to PRN were quantified using the Meso Scale Discovery Electrochemiluminescence serological assay based on an established reference standard sample curve with a LLOQ for PRN of 2.00 EU/mL.The percentage of participants meeting response criteria for PRN was based on pre-vaccination level of PRN. The 95% CIs are based on the exact binomial method proposed by Clopper and Pearson. The population analyzed was all enrolled participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
30 days postvaccination (at ~12 months of age)
|
||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
End point title |
Percentage of participants with fimbriae 2/3 (FIM 2/3) vaccine response | ||||||||||||
End point description |
Human antibodies to FIM 2/3 were quantified using the Meso Scale Discovery Electrochemiluminescence serological assay based on an established reference standard sample curve with a LLOQ for pertussis antibody of 2.00 EU/mL. The percentage of participants meeting response criteria for FIM 2/3 was based on pre-vaccination level of FIM 2/3. The 95% CIs are based on the exact binomial method proposed by Clopper and Pearson. The population analyzed was all enrolled participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
30 days postvaccination (at ~12 months of age)
|
||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Adverse events information
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
Adverse events (AEs): from vaccination up to 40 days post-vaccination; All-cause mortality (ACM): From allocation up to 40 days post-vaccination
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Adverse event reporting additional description |
AE population: All participants who received study vaccination. ACM population: all allocated participants.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Dictionary used for adverse event reporting
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
25.1
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Group 2: H, H, V
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Participants who received a 2-dose regimen of Hexyon™ as infants prior to enrollment received a Vaxelis™ booster at ~11 months of age. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Group 1: V, V, V
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Participants who received a 2-dose regimen of Vaxelis™ as infants prior to enrollment received a Vaxelis™ booster at ~11 months of age. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||
Substantial protocol amendments (globally) |
|||
| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
||
02 Aug 2022 |
Amendment 01: The sponsor Merck Sharp & Dohme Corp. underwent an entity name and address change to Merck Sharp & Dohme LLC, Rahway, NJ, USA. |
||
Interruptions (globally) |
|||
| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
