Clinical Trial Results:
A Phase 3b, Open-Label Study to Evaluate the Safety and Immunogenicity of Nimenrix® in Healthy Infants, Given at 3 and 12 Months of Age
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Summary
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EudraCT number |
2020-005059-19 |
Trial protocol |
FI PL |
Global end of trial date |
09 Sep 2022
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Results information
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Results version number |
v1 |
This version publication date |
05 Mar 2023
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First version publication date |
05 Mar 2023
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Other versions |
v2 |
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 |
C0921062
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT04819113 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Pfizer Inc.
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Sponsor organisation address |
235 E 42nd Street, New York, United States, NY 10017
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Public contact |
Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
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Scientific contact |
Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.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? |
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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 |
10 Jan 2023
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
09 Sep 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 |
Safety: To describe the safety of 2 doses of Nimenrix when administered in healthy infants at 3 and 12 months of age.
Immunogenicity: To describe the immune response for Neisseria meningitidis serogroups A, C, W-135, and Y induced by 2 doses of Nimenrix administered at 3 and 12 months of age.
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Protection of trial subjects |
The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Council for Harmonisation (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
09 Apr 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 |
Finland: 95
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Country: Number of subjects enrolled |
Poland: 26
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Country: Number of subjects enrolled |
Spain: 24
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Worldwide total number of subjects |
145
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EEA total number of subjects |
145
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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) |
145
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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 |
- | ||||||||||
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Pre-assignment
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Screening details |
Total of 153 subjects were screened, of which 4 were screen failures.149 subjects were enrolled and randomised in study of which 2 subjects did not receive any vaccination. 147 subjects received vaccination of which 2 subjects received at least 1 dose of vaccination but had no available safety information; hence, excluded from safety population. | ||||||||||
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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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Nimenrix | ||||||||||
Arm description |
Subjects aged 3 months were administered a single dose of 0.5 millilitre (mL) Nimenrix (Vaccination 1) intramuscularly into the left thigh muscle on Day 1. Subjects received the second dose of Nimenrix (Vaccination 2) at 12 months of age. | ||||||||||
Arm type |
Experimental | ||||||||||
Investigational medicinal product name |
Nimenrix
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Powder and solvent for solution for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Subjects received 0.5 mL of Nimenrix intramuscularly into the left thigh muscle at Visits 1 and 3.
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Baseline characteristics reporting groups
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Reporting group title |
Nimenrix
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Reporting group description |
Subjects aged 3 months were administered a single dose of 0.5 millilitre (mL) Nimenrix (Vaccination 1) intramuscularly into the left thigh muscle on Day 1. Subjects received the second dose of Nimenrix (Vaccination 2) at 12 months of age. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Nimenrix
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Reporting group description |
Subjects aged 3 months were administered a single dose of 0.5 millilitre (mL) Nimenrix (Vaccination 1) intramuscularly into the left thigh muscle on Day 1. Subjects received the second dose of Nimenrix (Vaccination 2) at 12 months of age. | ||
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End point title |
Percentage of Subjects With Local Reactions Within 7 Days After Vaccination 2 [1] | ||||||||||||||||||||||||||
End point description |
Local reactions included pain at injection site, redness and swelling and were recorded by the subject’s parents/legal guardians in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm) and graded as mild: greater than (>)0.0 to 2.0 cm; moderate: >2.0 to 7.0 cm; and severe: >7.0 cm. Pain at injection site was graded as mild: hurts if gently touched; moderate: hurts if gently touched with crying; severe: limited limb movement. Exact 2-sided confidence interval (CI) was based on the Clopper and Pearson method. Safety population included all enrolled subjects who received at least 1 dose of investigational product (IP) and had safety data reported after vaccination. Here, ‘Number of Subjects Analysed’ (N)=subjects evaluable for this endpoint.
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End point type |
Primary
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End point timeframe |
Within 7 days after Vaccination 2
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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: Only descriptive summary statistics was planned for the analysis of this endpoint. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||
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End point title |
Percentage of Subjects With Systemic Events Within 7 Days After Vaccination 2 [2] | ||||||||||||||||||||||||||||||||||
End point description |
Systemic events included fever, decreased appetite, increased sleep and irritability were recorded in e-diary. Fever was defined as temperature greater than or equal to (>=) 38.0 degrees (deg) Celsius (C), categorised as >=38.0 to 38.4 deg C, >38.4 to 38.9 deg C,>38.9 to 40.0 deg C and >40.0 deg C; decreased appetite graded as mild: decreased interest in eating, moderate: decreased oral intake and severe: refusal to feed; increased sleep graded as mild: increased or prolonged sleeping bouts, moderate: slightly subdued, interfered with daily activity and severe: disabling, not interested in usual daily activity; irritability graded as mild: easily consolable, moderate: required increased attention and severe: inconsolable, crying could not be comforted. Exact 2-sided CI was based on Clopper and Pearson method. Safety population: all enrolled subjects who received at least 1 dose of IP and had safety data reported after vaccination. N=subjects evaluable for this endpoint.
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End point type |
Primary
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End point timeframe |
Within 7 days after Vaccination 2
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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: Only descriptive summary statistics was planned for the analysis of this endpoint. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||
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End point title |
Percentage of Subjects With Serious Adverse Events (SAEs) Within 30 Days After Vaccination 2 [3] | ||||||||
End point description |
An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalisation or prolongation of existing hospitalisation; was life-threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. Exact 2-sided CI was based on the Clopper and Pearson method. Dose 2 safety population included subjects who received the first and second doses of investigational product at Visit 1 and Visit 3 and for whom safety information was available from Visit 3.
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End point type |
Primary
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End point timeframe |
Within 30 days after Vaccination 2
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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: Only descriptive summary statistics was planned for the analysis of this endpoint. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Percentage of Subjects With Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 30 Days After Vaccination 2 [4] | ||||||||
End point description |
An NDCMC was defined as a significant disease or medical condition, not previously identified, that is expected to be persistent or was otherwise long-lasting in its effects. Exact 2-sided CI was based on the Clopper and Pearson method. Dose 2 safety population included subjects who received the first and second doses of investigational product at Visit 1 and Visit 3 and for whom safety information was available from Visit 3.
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End point type |
Primary
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End point timeframe |
Within 30 days after Vaccination 2
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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: Only descriptive summary statistics was planned for the analysis of this endpoint. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Percentage of Subjects With Adverse Events (AEs) Within 30 Days After Vaccination 2 [5] | ||||||||
End point description |
An AE was any untoward medical occurrence in a subject, temporally associated with the use of investigational product, whether or not considered related to the investigational product. Exact 2-sided CI was based on the Clopper and Pearson method. Dose 2 safety population included subjects who received the first and second doses of investigational product at Visit 1 and Visit 3 and for whom safety information was available from Visit 3.
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End point type |
Primary
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End point timeframe |
Within 30 days after Vaccination 2
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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: Only descriptive summary statistics was planned for the analysis of this endpoint. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Percentage of Subjects With Use of Antipyretic Medication Within 7 Days After Vaccination 2 [6] | ||||||||
End point description |
The use of antipyretic medication was recorded by the subject’s parents/legal guardians in an e-diary for 7 days after vaccination. Exact 2-sided CI was based on the Clopper and Pearson method. Safety population included all enrolled subjects who received at least 1 dose of investigational product and had safety data reported after vaccination. Here, ‘Number of Subjects Analysed’= subjects evaluable for this endpoint.
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End point type |
Primary
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End point timeframe |
Within 7 days after Vaccination 2
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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: Only descriptive summary statistics was planned for the analysis of this endpoint. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Percentage of Subjects With Immediate AE Within 30 Minutes After Vaccination 2 [7] | ||||||||
End point description |
Immediate AEs were defined as AEs occurring within the first 30 minutes after administration of the investigational product. Exact 2-sided CI was based on the Clopper and Pearson method. Dose 2 safety population included subjects who received the first and second doses of investigational product at Visit 1 and Visit 3 and for whom safety information was available from Visit 3.
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End point type |
Primary
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End point timeframe |
Within 30 minutes after Vaccination 2
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| 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: Only descriptive summary statistics was planned for the analysis of this endpoint. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Percentage of Subjects Achieving Serum Bactericidal Assay Using Rabbit Complement (rSBA) Titers >=1:8 for Each Serogroup, Neisseria Meningitidis Group A (MenA), MenC, MenW-135 and MenY at Baseline: Post Dose 2 Evaluable Immunogenicity Population [8] | ||||||||
End point description |
Percentage of subjects achieving rSBA titer >=1:8 for each serogroup MenA, MenC, MenW-135 and MenY at baseline in subjects who received vaccinations 1 and 2 were reported in this endpoint. Exact 2-sided CI using the Clopper and Pearson method was presented. Post dose 2 (PD2) evaluable immunogenicity population: subjects enrolled and eligible through 1 month after dose 2 of vaccination; received vaccine at visit (V) 1 and V3; blood drawn for assay testing within time frames at month 0 (V1; before dose 1) and at 1 month after dose 2 (V4; 1 month after dose 2: window 28-42 days); had at least 1 valid, determinate MenA, MenC, MenW-135, and MenY assay result at V4, received no prohibited vaccines/treatment and had no protocol deviations through V4. Here, ‘Number of Subjects Analysed’=subjects evaluable for this endpoint.
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End point type |
Primary
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End point timeframe |
At baseline
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| 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: Only descriptive summary statistics was planned for the analysis of this endpoint. |
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| Notes [9] - Data for this endpoint was not summarised due to delay in serology from the external laboratory. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Percentage of Subjects Achieving rSBA Titers >= 1:8 for Each Serogroup MenA, MenC, MenW-135 and MenY at 1 Month After Vaccination 1: Post Dose 2 Evaluable Immunogenicity Population [10] | ||||||||
End point description |
Percentage of subjects achieving rSBA titer >=1:8 for each serogroup MenA, MenC, MenW-135 and MenY at 1 month after Vaccination 1 in subjects who received Vaccination 1 and 2 were reported in this endpoint. Exact 2-sided CI using the Clopper and Pearson method was presented. PD2 evaluable immunogenicity population: subjects enrolled and eligible through 1 month after dose 2 of vaccination; received vaccine at V1 and V3; blood drawn for assay testing within time frames at month 0 (V1; before dose 1) and at 1 month after dose 2 (V4; 1 month after dose 2: window 28-42 days); had at least 1 valid, determinate MenA, MenC, MenW-135 and MenY assay result at V4, received no prohibited vaccines/treatment and had no protocol deviations through V4. Here, ‘Number of Subjects Analysed’=subjects evaluable for this endpoint.
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End point type |
Primary
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End point timeframe |
1 Month after Vaccination 1
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| 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: Only descriptive summary statistics was planned for the analysis of this endpoint. |
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| Notes [11] - Data for this endpoint was not summarised due to delay in serology from the external laboratory. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Percentage of Subjects Achieving rSBA Titers >= 1:8 for Each Serogroup MenA, MenC, MenW-135 and MenY at Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population [12] | ||||||||
End point description |
Percentage of subjects achieving rSBA titer >=1:8 for each serogroup MenA, MenC, MenW-135 and MenY at Vaccination 2 in subjects who received Vaccination 1 and 2 were reported in this endpoint. Exact 2-sided CI using the Clopper and Pearson method was presented. PD2 evaluable immunogenicity population: subjects enrolled and eligible through 1 month after dose 2 of vaccination; received vaccine at V1 and V3; blood drawn for assay testing within time frames at month 0 (V1; before dose 1) and at 1 month after dose 2 (V4; 1 month after dose 2: window 28-42 days); had at least 1 valid, determinate MenA, MenC, MenW-135 and MenY assay result at V4, received no prohibited vaccines/treatment and had no protocol deviations through V4. Here, ‘Number of Subjects Analysed’=subjects evaluable for this endpoint.
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End point type |
Primary
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End point timeframe |
At Vaccination 2
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| 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: Only descriptive summary statistics was planned for the analysis of this endpoint. |
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| Notes [13] - Data for this endpoint was not summarised due to delay in serology from the external laboratory. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Percentage of Subjects Achieving rSBA Titers >= 1:8 for Each Serogroup MenA, MenC, MenW-135 and MenY at 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population [14] | ||||||||
End point description |
Percentage of subjects achieving rSBA titer >=1:8 for each serogroup MenA, MenC, MenW-135 and MenY at 1 month after Vaccination 2 in subjects who received Vaccination 1 and 2 were reported in this endpoint. Exact 2-sided CI using the Clopper and Pearson method was presented. PD2 evaluable immunogenicity population: subjects enrolled and eligible through 1 month after dose 2 of vaccination; received vaccine at V1 and V3; blood drawn for assay testing within time frames at month 0 (V1; before dose 1) and at 1 month after dose 2 (V4; 1 month after dose 2: window 28-42 days); had at least 1 valid, determinate MenA, MenC, MenW-135 and MenY assay result at V4, received no prohibited vaccines/treatment and had no protocol deviations through V4. Here, ‘Number of Subjects Analysed’=subjects evaluable for this endpoint.
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End point type |
Primary
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End point timeframe |
1 Month After Vaccination 2
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| Notes [14] - 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: Only descriptive summary statistics was planned for the analysis of this endpoint. |
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| Notes [15] - Data for this endpoint was not summarised due to delay in serology from the external laboratory. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Geometric Mean Titers (GMTs) of rSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at Baseline: Post Dose 2 Evaluable Immunogenicity Population [16] | ||||||||
End point description |
GMTs of rSBA titer for each of MenA, MenC, MenW-135 and MenY serogroups at baseline in subjects who received Vaccination 1 and 2 were reported in this endpoint. PD2 evaluable immunogenicity population: subjects enrolled and eligible through 1 month after dose 2 of vaccination; received vaccine at V1 and V3; blood drawn for assay testing within time frames at month 0 (V1; before dose 1) and at 1 month after dose 2 (V4; 1 month after dose 2: window 28-42 days); had at least 1 valid, determinate MenA, MenC, MenW-135 and MenY assay result at V4, received no prohibited vaccines/treatment and had no protocol deviations through V4. Here, ‘Number of Subjects Analysed’=subjects evaluable for this endpoint.
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End point type |
Primary
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End point timeframe |
At baseline
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| Notes [16] - 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: Only descriptive summary statistics was planned for the analysis of this endpoint. |
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| Notes [17] - Data for this endpoint was not summarised due to delay in serology from the external laboratory. |
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| No statistical analyses for this end point | |||||||||
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End point title |
GMTs of rSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at 1 Month After Vaccination 1: Post Dose 2 Evaluable Immunogenicity Population [18] | ||||||||
End point description |
GMTs of rSBA titer for each of MenA, MenC, MenW-135 and MenY serogroups 1 month after Vaccination 1 in subjects who received Vaccination 1 and 2 were reported in this endpoint. PD2 evaluable immunogenicity population: subjects enrolled and eligible through 1 month after dose 2 of vaccination; received vaccine at V1 and V3; blood drawn for assay testing within time frames at month 0 (V1; before dose 1) and at 1 month after dose 2 (V4; 1 month after dose 2: window 28-42 days); had at least 1 valid, determinate MenA, MenC, MenW-135 and MenY assay result at V4, received no prohibited vaccines/treatment and had no protocol deviations through V4. Here, ‘Number of Subjects Analysed’=subjects evaluable for this endpoint.
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End point type |
Primary
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End point timeframe |
1 month after Vaccination 1
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| Notes [18] - 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: Only descriptive summary statistics was planned for the analysis of this endpoint. |
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| Notes [19] - Data for this endpoint was not summarised due to delay in serology from the external laboratory. |
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| No statistical analyses for this end point | |||||||||
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End point title |
GMTs of rSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population [20] | ||||||||
End point description |
GMTs of rSBA titer for each of MenA, MenC, MenW-135 and MenY serogroups at Vaccination 2 in subjects who received Vaccination 1 and 2 were reported in this endpoint. PD2 evaluable immunogenicity population: subjects enrolled and eligible through 1 month after dose 2 of vaccination; received vaccine at V1 and V3; blood drawn for assay testing within time frames at month 0 (V1; before dose 1) and at 1 month after dose 2 (V4; 1 month after dose 2: window 28-42 days); had at least 1 valid, determinate MenA, MenC, MenW-135 and MenY assay result at V4, received no prohibited vaccines/treatment and had no protocol deviations through V4. Here, ‘Number of Subjects Analysed’=subjects evaluable for this endpoint.
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End point type |
Primary
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End point timeframe |
At Vaccination 2
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| Notes [20] - 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: Only descriptive summary statistics was planned for the analysis of this endpoint. |
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| Notes [21] - Data for this endpoint was not summarised due to delay in serology from the external laboratory. |
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| No statistical analyses for this end point | |||||||||
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End point title |
GMTs of rSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population [22] | ||||||||
End point description |
GMTs of rSBA titer for each of MenA, MenC, MenW-135 and MenY serogroups at 1 month after Vaccination 2 in subjects who received Vaccination 1 and 2 were reported in this endpoint. PD2 evaluable immunogenicity population: subjects enrolled and eligible through 1 month after dose 2 of vaccination; received vaccine at V1 and V3; blood drawn for assay testing within time frames at month 0 (V1; before dose 1) and at 1 month after dose 2 (V4; 1 month after dose 2: window 28-42 days); had at least 1 valid, determinate MenA, MenC, MenW-135 and MenY assay result at V4, received no prohibited vaccines/treatment and had no protocol deviations through V4. Here, ‘Number of Subjects Analysed’=subjects evaluable for this endpoint.
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End point type |
Primary
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End point timeframe |
1 month after Vaccination 2
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| Notes [22] - 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: Only descriptive summary statistics was planned for the analysis of this endpoint. |
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| Notes [23] - Data for this endpoint was not summarised due to delay in serology from the external laboratory. |
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||||||||||||||||||||
End point title |
Percentage of Subjects With Local Reactions Within 7 Days After Vaccination 1 | ||||||||||||||||||||||||||
End point description |
Local reactions included pain at injection site, redness and swelling and were recorded by the subject’s parents/legal guardians in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm) and graded as mild: >0.0 to 2.0 cm; moderate: >2.0 to 7.0 cm; and severe: >7.0 cm. Pain at injection site was graded as mild: hurts if gently touched; moderate: hurts if gently touched with crying; severe: limited limb movement. Exact 2-sided CI was based on the Clopper and Pearson method. Safety population included all enrolled subjects who received at least 1 dose of investigational product and had safety data reported after vaccination.
|
||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||
End point timeframe |
Within 7 days after Vaccination 1
|
||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||
End point title |
Percentage of Subjects With Systemic Events Within 7 Days After Vaccination 1 | ||||||||||||||||||||||||||||||||||
End point description |
Systemic events included fever, decreased appetite, increased sleep and irritability were recorded in e-diary. Fever was defined as temperature >=38.0 deg C, categorised as >=38.0 to 38.4 deg C, >38.4 to 38.9 deg C,>38.9 to 40.0 deg C and >40.0 deg C; decreased appetite graded as mild: decreased interest in eating, moderate: decreased oral intake and severe: refusal to feed; increased sleep graded as mild: increased or prolonged sleeping bouts, moderate: slightly subdued, interfered with daily activity and severe: disabling, not interested in usual daily activity; irritability graded as mild: easily consolable, moderate: required increased attention and severe: inconsolable, crying could not be comforted. Exact 2-sided CI was based on Clopper and Pearson method. Safety population included all enrolled subjects who received at least 1 dose of IP and had safety data reported after vaccination.
|
||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||
End point timeframe |
Within 7 days after Vaccination 1
|
||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||
|
|||||||||
End point title |
Percentage of Subjects With Use of Antipyretic Medication Within 7 Days After Vaccination 1 | ||||||||
End point description |
The use of antipyretic medication was recorded by the subject’s parents/legal guardians in an e-diary for 7 days after vaccination. Exact 2-sided CI was based on the Clopper and Pearson method. Safety population included all enrolled subjects who received at least 1 dose of investigational product and had safety data reported after vaccination.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Within 7 days after Vaccination 1
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Percentage of Subjects With AEs Within 30 Days After Vaccination 1 | ||||||||
End point description |
An AE was any untoward medical occurrence in a subject, temporally associated with the use of investigational product, whether or not considered related to the investigational product. Exact 2-sided CI was based on the Clopper and Pearson method. Dose 1 safety population included subjects who received the first dose of investigational product at Visit 1 and for whom safety information was available from Visit 1 to prior to Visit 3.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Within 30 days after Vaccination 1
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||||||||||||||
End point title |
Percentage of Subjects With SAEs and NDCMCs: Within 30 Days After Vaccination 1, From 1 Month After Vaccination 1 to 9 Months After Vaccination 1, From Vaccination 1 to 9 Months After Vaccination 1 | ||||||||||||||||||||
End point description |
An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalisation or prolongation of existing hospitalisation; was life-threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. An NDCMC was defined as a significant disease or medical condition, not previously identified, that is expected to be persistent or was otherwise long-lasting in its effects. Exact 2-sided CI was based on the Clopper and Pearson method. Dose 1 safety population included subjects who received the first dose of investigational product at Visit 1 and for whom safety information was available from Visit 1 to prior to Visit 3.
|
||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||
End point timeframe |
Within 30 days after Vaccination 1, from 1 month (M) after Vaccination 1 to 9 months after Vaccination 1 and from Vaccination 1 to 9 months after Vaccination (Vacc.) 1
|
||||||||||||||||||||
|
|||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||
|
|||||||||
End point title |
Percentage of Subjects With Immediate AE Within 30 Minutes After Vaccination 1 | ||||||||
End point description |
Immediate AEs were defined as AEs occurring within the first 30 minutes after administration of the investigational product. Exact 2-sided CI was based on the Clopper and Pearson method. Dose 1 safety population included subjects who received the first dose of investigational product at Visit 1 and for whom safety information was available from Visit 1 to prior to Visit 3.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Within 30 minutes after Vaccination 1
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Percentage of Subjects Achieving rSBA Titers >= 1:8 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline and 1 Month After Vaccination 1: Post Dose 1 Evaluable Immunogenicity Population | ||||||||
End point description |
Percentage of subjects achieving rSBA titer >=1:8 for each serogroup MenA, MenC, MenW-135 and MenY at baseline and 1 month after Vaccination 1 in subjects who received Vaccination 1 were reported in this endpoint. Exact 2-sided CI using the Clopper and Pearson method was presented. Post dose 1 (PD1) evaluable immunogenicity population: subjects enrolled and eligible through V2; received vaccine at V1; blood drawn for assay testing within time frames at month 0 (V1; before dose 1) and month 1 (V2; 1 month after dose 1: window 28-42 days); had at least 1 valid, determinate MenA, MenC, MenW-135 and MenY assay result at V2, received no prohibited vaccines/treatment and had no protocol deviations through V2. Here, ‘Number of Subjects Analysed’=subjects evaluable for this endpoint.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
At baseline and 1 month after Vaccination 1
|
||||||||
|
|||||||||
| Notes [24] - Data for this endpoint was not summarised due to delay in serology from the external laboratory. |
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Percentage of Subjects Achieving rSBA Titers >= 1:128 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline and 1 Month After Vaccination 1: Post Dose 1 Evaluable Immunogenicity Population | ||||||||
End point description |
Percentage of subjects achieving rSBA titer >= 1:128 for each serogroup MenA, MenC, MenW-135 and MenY at baseline and 1 month after Vaccination 1 in subjects who received Vaccination 1 were reported in this endpoint. Exact 2-sided CI using the Clopper and Pearson method was presented. PD1 evaluable immunogenicity population: subjects enrolled and eligible through V2; received vaccine at V1; blood drawn for assay testing within time frames at month 0 (V1; before dose 1) and month 1 (V2; 1 month after dose 1: window 28-42 days); had at least 1 valid, determinate MenA, MenC, MenW-135 and MenY assay result at V2, received no prohibited vaccines/treatment and had no protocol deviations through V2. Here, ‘Number of Subjects Analysed’=subjects evaluable for this endpoint.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
At baseline and 1 month after Vaccination 1
|
||||||||
|
|||||||||
| Notes [25] - Data for this endpoint was not summarised due to delay in serology from the external laboratory. |
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
GMTs of rSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at Baseline and 1 Month After Vaccination 1: Post Dose 1 Evaluable Immunogenicity Population | ||||||||
End point description |
GMTs of rSBA titer for each of MenA, MenC, MenW-135 and MenY serogroups at baseline and 1 month after Vaccination 1 in subjects who received Vaccination 1 were reported in this endpoint. PD1 evaluable immunogenicity population: subjects enrolled and eligible through V2; received vaccine at V1; blood drawn for assay testing within time frames at month 0 (V1; before dose 1) and month 1 (V2; 1 month after dose 1: window 28-42 days); had at least 1 valid, determinate MenA, MenC, MenW-135 and MenY assay result at V2, received no prohibited vaccines/treatment and had no protocol deviations through V2. Here, ‘Number of Subjects Analysed’=subjects evaluable for this endpoint.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
At baseline and 1 month after Vaccination 1
|
||||||||
|
|||||||||
| Notes [26] - Data for this endpoint was not summarised due to delay in serology from the external laboratory. |
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Percentage of Subjects Achieving hSBA Titers >= 1:8 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | ||||||||
End point description |
Percentage of subjects achieving hSBA titers >= 1:8 for each serogroup MenA, MenC, MenW-135 and MenY at baseline, 1 month after Vaccination 1, at Vaccination 2 and 1 month after Vaccination 2 in subjects who received Vaccination 1 and 2 were reported in this endpoint. Exact 2-sided CI using the Clopper and Pearson method was presented. PD2 evaluable immunogenicity population: subjects enrolled and eligible through 1 month after dose 2 of vaccination; received vaccine at V1 and V3; blood drawn for assay testing within time frames at month 0 (V1; before dose 1) and at 1 month after dose 2 (V4; 1 month after dose 2: window 28-42 days); had at least 1 valid, determinate MenA, MenC, MenW-135 and MenY assay result at V4, received no prohibited vaccines/treatment and had no protocol deviations through V4. Here, ‘Number of Subjects Analysed’=subjects evaluable for this endpoint.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
At baseline, 1 month after Vaccination 1, at Vaccination 2 and 1 month after Vaccination 2
|
||||||||
|
|||||||||
| Notes [27] - Data for this endpoint was not summarised due to delay in serology from the external laboratory. |
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Percentage of Subjects Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titers >= 1:4 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline and 1 Month After Vaccination 1: Post Dose 1 Evaluable Immunogenicity Population | ||||||||
End point description |
Percentage of subjects achieving hSBA titers >= 1:4 for each serogroup MenA, MenC, MenW-135 and MenY at baseline and 1 month after Vaccination 1 in subjects who received Vaccination 1 were reported in this endpoint. Exact 2-sided CI using the Clopper and Pearson method was presented. PD1 evaluable immunogenicity population: subjects enrolled and eligible through V2; received vaccine at V1; blood drawn for assay testing within time frames at month 0 (V1; before dose 1) and month 1 (V2; 1 month after dose 1: window 28-42 days); had at least 1 valid, determinate MenA, MenC, MenW-135 and MenY assay result at V2, received no prohibited vaccines/treatment and had no protocol deviations through V2. Here, ‘Number of Subjects Analysed’=subjects evaluable for this endpoint.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
At baseline and 1 month after Vaccination 1
|
||||||||
|
|||||||||
| Notes [28] - Data for this endpoint was not summarised due to delay in serology from the external laboratory. |
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Percentage of Subjects Achieving hSBA Titers >= 1:8 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline and 1 Month After Vaccination 1: Post Dose 1 Evaluable Immunogenicity Population | ||||||||
End point description |
Percentage of subjects achieving hSBA titers >= 1:8 for each serogroup MenA, MenC, MenW-135 and MenY at baseline and 1 month after Vaccination 1 in subjects who received Vaccination 1 were reported in this endpoint. Exact 2-sided CI using the Clopper and Pearson method was presented. PD1 evaluable immunogenicity population: subjects enrolled and eligible through V2; received vaccine at V1; blood drawn for assay testing within time frames at month 0 (V1; before dose 1) and month 1 (V2; 1 month after dose 1: window 28-42 days); had at least 1 valid, determinate MenA, MenC, MenW-135 and MenY assay result at V2, received no prohibited vaccines/treatment and had no protocol deviations through V2. Here, ‘Number of Subjects Analysed’=subjects evaluable for this endpoint.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
At baseline and 1 month after Vaccination 1
|
||||||||
|
|||||||||
| Notes [29] - Data for this endpoint was not summarised due to delay in serology from the external laboratory. |
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
GMTs of hSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at Baseline and 1 Month After Vaccination 1: Post Dose 1 Evaluable Immunogenicity Population | ||||||||
End point description |
GMTs of hSBA titer for each of MenA, MenC, MenW-135 and MenY serogroups at baseline and 1 month after Vaccination 1 in subjects who received Vaccination 1 were reported in this endpoint. PD1 evaluable immunogenicity population: subjects enrolled and eligible through V2; received vaccine at V1; blood drawn for assay testing within time frames at month 0 (V1; before dose 1) and month 1 (V2; 1 month after dose 1: window 28-42 days); had at least 1 valid, determinate MenA, MenC, MenW-135 and MenY assay result at V2, received no prohibited vaccines/treatment and had no protocol deviations through V2. Here, ‘Number of Subjects Analysed’=subjects evaluable for this endpoint.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
At baseline and 1 month after Vaccination 1
|
||||||||
|
|||||||||
| Notes [30] - Data for this endpoint was not summarised due to delay in serology from the external laboratory. |
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Percentage of Subjects Achieving hSBA Titers >= 1:4 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | ||||||||
End point description |
Percentage of subjects achieving hSBA titers >= 1:4 for each serogroup MenA, MenC, MenW-135 and MenY at baseline, 1 month after Vaccination 1, at Vaccination 2 and 1 month after Vaccination 2 in subjects who received Vaccination 1 and 2 were reported in this endpoint. Exact 2-sided CI using the Clopper and Pearson method was presented. PD2 evaluable immunogenicity population: subjects enrolled and eligible through 1 month after dose 2 of vaccination; received vaccine at V1 and V3; blood drawn for assay testing within time frames at month 0 (V1; before dose 1) and at 1 month after dose 2 (V4; 1 month after dose 2: window 28-42 days); had at least 1 valid, determinate MenA, MenC, MenW-135 and MenY assay result at V4, received no prohibited vaccines/treatment and had no protocol deviations through V4. Here, ‘Number of Subjects Analysed’ = subjects evaluable for this endpoint.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
At baseline, 1 month after Vaccination 1, at Vaccination 2 and 1 month after Vaccination 2
|
||||||||
|
|||||||||
| Notes [31] - Data for this endpoint was not summarised due to delay in serology from the external laboratory. |
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
GMTs of hSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | ||||||||
End point description |
GMTs of hSBA titer for each of MenA, MenC, MenW-135 and MenY serogroups at baseline, 1 month after Vaccination 1, at Vaccination 2 and 1 month after Vaccination 2 in subjects who received Vaccination 1 and 2 were reported in this endpoint. PD2 evaluable immunogenicity population: subjects enrolled and eligible through 1 month after dose 2 of vaccination; received vaccine at V1 and V3; blood drawn for assay testing within time frames at month 0 (V1; before dose 1) and at 1 month after dose 2 (V4; 1 month after dose 2: window 28-42 days); had at least 1 valid, determinate MenA, MenC, MenW-135 and MenY assay result at V4, received no prohibited vaccines/treatment and had no protocol deviations through V4. Here, ‘Number of Subjects Analysed’=subjects evaluable for this endpoint.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
At baseline, 1 month after Vaccination 1, at Vaccination 2 and 1 month after Vaccination 2
|
||||||||
|
|||||||||
| Notes [32] - Data for this endpoint was not summarised due to delay in serology from the external laboratory. |
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Percentage of Subjects Achieving rSBA Titers >= 1:128 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | ||||||||
End point description |
Percentage of subjects achieving rSBA Titers >= 1:128 for each serogroup MenA, MenC, MenW-135 and MenY at baseline, 1 month after Vaccination 1, at Vaccination 2 and 1 month after Vaccination 2 in subjects who received Vaccination 1 and 2 were reported in this endpoint. Exact 2-sided CI using the Clopper and Pearson method was presented. PD2 evaluable immunogenicity population: subjects enrolled and eligible through 1 month after dose 2 of vaccination; received vaccine at V1 and V3; blood drawn for assay testing within time frames at month 0 (V1; before dose 1) and at 1 month after dose 2 (V4; 1 month after dose 2: window 28-42 days); had at least 1 valid, determinate MenA, MenC, MenW-135 and MenY assay result at V4, received no prohibited vaccines/treatment and had no protocol deviations through V4. Here, ‘Number of Subjects Analysed’=subjects evaluable for this endpoint.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
At baseline, 1 month after Vaccination 1, at Vaccination 2 and 1 month after Vaccination 2
|
||||||||
|
|||||||||
| Notes [33] - Data for this endpoint was not summarised due to delay in serology from the external laboratory. |
|||||||||
| No statistical analyses for this end point | |||||||||
|
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|
Adverse events information
|
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Timeframe for reporting adverse events |
Systematic assessment(SA): local reactions/systemic events recorded within 7 days after Vaccination (V) 1 and 2; Non-SA: SAEs: Day 1 up to 42 days after V 2; other AEs: from Day 1 up to 42 days after V 1 and from Day of V 2 up to 42 days after V 2
|
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Adverse event reporting additional description |
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorised as serious in one subject and as non-serious in another, or a subject may have experienced both a serious and non-serious event. Safety population was evaluated.
|
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Dictionary used for adverse event reporting
|
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
25.0
|
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Reporting groups
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Reporting group title |
Nimenrix
|
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Reporting group description |
Subjects aged 3 months were administered a single dose of 0.5 mL Nimenrix (Vaccination 1) intramuscularly into the left thigh muscle on Day 1. Subjects received the second dose of Nimenrix (Vaccination 2) at 12 months of age. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 1% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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|
|||
Substantial protocol amendments (globally) |
|||
| Were there any global substantial amendments to the protocol? No | |||
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. | |||
| Data for the serology endpoints were not summarised due to delay in serology from the external laboratory. | |||
