Clinical Trial Results:
Immunogenicity and Safety of the Quadrivalent Inactivated Split-Virion Influenza Vaccine in Subjects 6 Months of age and Older in India
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Summary
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EudraCT number |
2022-001441-21 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
28 Jun 2022
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Results information
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Results version number |
v1(current) |
This version publication date |
14 Jan 2024
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First version publication date |
14 Jan 2024
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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 |
GQM00023
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
U1111-1254-0403 | ||
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Sponsors
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Sponsor organisation name |
Sanofi Pasteur
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Sponsor organisation address |
14 Espace Henry Vallée, Lyon, France, 69007
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Public contact |
Trial Transparency Team, Sanofi Pasteur, Contact-US@sanofi.com
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Scientific contact |
Trial Transparency Team, Sanofi Pasteur, Contact-US@sanofi.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 |
19 Sep 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 |
28 Jun 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 |
- To describe the immune response induced by quadrivalent influenza vaccine (QIV) in each age group.
- To describe the safety profile of QIV in each age group.
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Protection of trial subjects |
Vaccinations were performed by qualified and trained study personnel. Subjects with allergy to any of the vaccine components were not vaccinated. After vaccination, subjects were also kept under clinical observation for 30 minutes to ensure their safety. Appropriate medical equipment were also available on site in case of any immediate allergic reactions.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
07 Feb 2022
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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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 |
India: 401
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Worldwide total number of subjects |
401
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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) |
83
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Children (2-11 years) |
175
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Adolescents (12-17 years) |
43
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Adults (18-64 years) |
87
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From 65 to 84 years |
13
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85 years and over |
0
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Recruitment
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Recruitment details |
Study subjects were enrolled from 07 February 2022 to 30 May 2022 at 5 active sites in India. | |||||||||||||||||||||||||||||||||||
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Pre-assignment
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Screening details |
A total of 401 subjects were enrolled in the study. | |||||||||||||||||||||||||||||||||||
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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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Are arms mutually exclusive |
Yes
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Arm title
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Group 1: QIV: 6 to 35 months | |||||||||||||||||||||||||||||||||||
Arm description |
Subjects aged 6 to 35 months received an injection of 0.5 mililitres (mL) of QIV intramuscularly (IM) on Day 1. Previously vaccinated subjects (defined as subjects who had received at least 2 doses of seasonal influenza vaccine in prior influenza seasons) received only 1 dose of study vaccine after enrolling in the study (at Day 1). Previously unvaccinated subjects (defined as subjects who had not received at least 2 doses of seasonal influenza vaccine in prior influenza seasons) received 2 doses of study vaccine after enrolling in the study (first dose at Day 1 and second dose 28 days apart [at Day 29]). | |||||||||||||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Quadrivalent influenza vaccine (split-virion, inactivated)
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Suspension for injection in pre-filled syringe
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Routes of administration |
Intramuscular use
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Dosage and administration details |
0.5 mL, single IM on Day 1 for previously vaccinated subjects and 2 doses for previously unvaccinated subjects on Day 1 and 29.
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Arm title
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Group 2: QIV: 3 to 8 years | |||||||||||||||||||||||||||||||||||
Arm description |
Subjects aged 3 to 8 years received an injection of 0.5 mL of QIV IM on Day 1. Previously vaccinated subjects (defined as subjects who had received at least 2 doses of seasonal influenza vaccine in prior influenza seasons) received only 1 dose of study vaccine after enrolling in the study (at Day 1). Previously unvaccinated subjects (defined as subjects who had not received at least 2 doses of seasonal influenza vaccine in prior influenza seasons) received 2 doses of study vaccine after enrolling in the study (first dose at Day 1 and second dose 28 days apart [at Day 29]). | |||||||||||||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Quadrivalent influenza vaccine (split-virion, inactivated)
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Suspension for injection in pre-filled syringe
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Routes of administration |
Intramuscular use
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Dosage and administration details |
0.5 mL, single IM on Day 1 for previously vaccinated subjects and 2 doses for previously unvaccinated subjects on Day 1 and 29.
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Arm title
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Group 3: QIV: 9 to 17 years | |||||||||||||||||||||||||||||||||||
Arm description |
Subjects aged 9 to 17 years received an injection of 0.5 mL of QIV IM on Day 1. | |||||||||||||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Quadrivalent influenza vaccine (split-virion, inactivated)
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Suspension for injection in pre-filled syringe
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Routes of administration |
Intramuscular use
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Dosage and administration details |
0.5 mL, single IM injection on Day 1.
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Arm title
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Group 4: QIV: 18 years and older | |||||||||||||||||||||||||||||||||||
Arm description |
Subjects aged 18 years and older received an injection of 0.5 mL of QIV IM on Day 1. | |||||||||||||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Quadrivalent influenza vaccine (split-virion, inactivated)
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Suspension for injection in pre-filled syringe
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Routes of administration |
Intramuscular use
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Dosage and administration details |
0.5 mL, single IM injection on Day 1.
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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: Subjects who had received at least a dose of the study vaccine at specified timepoint. [2] - 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: Subjects who had received at least a dose of the study vaccine at specified timepoint. [3] - 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: Group 3 subjects did not receive second dose of vaccination at Day 29. [4] - 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: Group 4 subjects did not receive second dose of vaccination at Day 29. |
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Baseline characteristics reporting groups
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Reporting group title |
Group 1: QIV: 6 to 35 months
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Reporting group description |
Subjects aged 6 to 35 months received an injection of 0.5 mililitres (mL) of QIV intramuscularly (IM) on Day 1. Previously vaccinated subjects (defined as subjects who had received at least 2 doses of seasonal influenza vaccine in prior influenza seasons) received only 1 dose of study vaccine after enrolling in the study (at Day 1). Previously unvaccinated subjects (defined as subjects who had not received at least 2 doses of seasonal influenza vaccine in prior influenza seasons) received 2 doses of study vaccine after enrolling in the study (first dose at Day 1 and second dose 28 days apart [at Day 29]). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Group 2: QIV: 3 to 8 years
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Reporting group description |
Subjects aged 3 to 8 years received an injection of 0.5 mL of QIV IM on Day 1. Previously vaccinated subjects (defined as subjects who had received at least 2 doses of seasonal influenza vaccine in prior influenza seasons) received only 1 dose of study vaccine after enrolling in the study (at Day 1). Previously unvaccinated subjects (defined as subjects who had not received at least 2 doses of seasonal influenza vaccine in prior influenza seasons) received 2 doses of study vaccine after enrolling in the study (first dose at Day 1 and second dose 28 days apart [at Day 29]). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Group 3: QIV: 9 to 17 years
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Reporting group description |
Subjects aged 9 to 17 years received an injection of 0.5 mL of QIV IM on Day 1. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Group 4: QIV: 18 years and older
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Reporting group description |
Subjects aged 18 years and older received an injection of 0.5 mL of QIV IM on Day 1. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Group 1: QIV: 6 to 35 months
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Reporting group description |
Subjects aged 6 to 35 months received an injection of 0.5 mililitres (mL) of QIV intramuscularly (IM) on Day 1. Previously vaccinated subjects (defined as subjects who had received at least 2 doses of seasonal influenza vaccine in prior influenza seasons) received only 1 dose of study vaccine after enrolling in the study (at Day 1). Previously unvaccinated subjects (defined as subjects who had not received at least 2 doses of seasonal influenza vaccine in prior influenza seasons) received 2 doses of study vaccine after enrolling in the study (first dose at Day 1 and second dose 28 days apart [at Day 29]). | ||
Reporting group title |
Group 2: QIV: 3 to 8 years
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Reporting group description |
Subjects aged 3 to 8 years received an injection of 0.5 mL of QIV IM on Day 1. Previously vaccinated subjects (defined as subjects who had received at least 2 doses of seasonal influenza vaccine in prior influenza seasons) received only 1 dose of study vaccine after enrolling in the study (at Day 1). Previously unvaccinated subjects (defined as subjects who had not received at least 2 doses of seasonal influenza vaccine in prior influenza seasons) received 2 doses of study vaccine after enrolling in the study (first dose at Day 1 and second dose 28 days apart [at Day 29]). | ||
Reporting group title |
Group 3: QIV: 9 to 17 years
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Reporting group description |
Subjects aged 9 to 17 years received an injection of 0.5 mL of QIV IM on Day 1. | ||
Reporting group title |
Group 4: QIV: 18 years and older
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Reporting group description |
Subjects aged 18 years and older received an injection of 0.5 mL of QIV IM on Day 1. | ||
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End point title |
Geometric Mean Titers (GMTs) of Influenza Antibodies [1] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
GMTs of anti-influenza antibodies were measured using hemagglutination inhibition (HAI) assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Yamagata and B/Victoria lineage. Titers were expressed in terms of 1/dilution. Analysis was performed on full analysis set (FAS) population that included all subjects who received at least 1 dose of the study vaccine and had a post-vaccination blood sample. The data table excluded results from a trial clinical site with sample management issues.
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End point type |
Primary
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End point timeframe |
Day 1 (pre-vaccination), Day 29 (post-vaccination; for subjects with 1 vaccination) or Day 57 (post vaccination; for subjects with 2 vaccinations)
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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: As the endpoint was descriptive in nature, no statistical analysis was provided. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End point title |
Geometric Mean Titer Ratios (GMTRs) of Individual HAI Titer [2] | ||||||||||||||||||||||||||||||||||||||||
End point description |
GMTs of anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Yamagata and B/Victoria lineage. GMTRs were calculated as the ratio of GMTs post-vaccination (on Day 29 or Day 57) and pre-vaccination (on Day 0). Analysis was performed on FAS population. The data table excluded results from a trial clinical site with sample management issues.
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End point type |
Primary
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End point timeframe |
Day 1 (pre-vaccination), Day 29 (post-vaccination; for subjects with 1 vaccination) or Day 57 (post vaccination; for subjects with 2 vaccinations)
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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: As the endpoint was descriptive in nature, no statistical analysis was provided. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||
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End point title |
Percentage of Subjects With HAI Titer >= 10 (1/dilution) [3] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Yamagata and B/Victoria lineage. Percentage of subjects with HAI titers >=10 (1/dilution) is reported. Analysis was performed on FAS population. The data table excluded results from a trial clinical site with sample management issues.
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End point type |
Primary
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End point timeframe |
Day 1 (pre-vaccination), Day 29 (post-vaccination; for subjects with 1 vaccination) or Day 57 (post vaccination; for subjects with 2 vaccinations)
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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: As the endpoint was descriptive in nature, no statistical analysis was provided. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End point title |
Percentage of Subjects Achieving Seroconversion Against Antigens [4] | ||||||||||||||||||||||||||||||||||||||||
End point description |
Anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Yamagata and B/Victoria lineage. Seroconversion was defined as either a pre-vaccination HAI titer < 1:10 and a post-vaccination titer >= 1:40 or a pre-vaccination titer >= 1:10 and a >= four-fold increase in post-vaccination titer. Analysis was performed on FAS population. The data table excluded results from a trial clinical site with sample management issues.
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End point type |
Primary
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End point timeframe |
Day 29 (post-vaccination; for subjects with 1 vaccination) or Day 57 (post vaccination; for subjects with 2 vaccinations)
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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: As the endpoint was descriptive in nature, no statistical analysis was provided. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||
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End point title |
Percentage of Subjects With HAI Titer >= 40 (1/dilution) [5] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Yamagata and B/Victoria lineage. Percentage of subjects with HAI titers >=40 (1/dilution) is reported in the endpoint. Analysis was performed on FAS population. The data table excluded results from a trial clinical site with sample management issues.
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End point type |
Primary
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End point timeframe |
Day 1 (pre-vaccination), Day 29 (post-vaccination; for subjects with 1 vaccination) or Day 57 (post vaccination; for subjects with 2 vaccinations)
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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: As the endpoint was descriptive in nature, no statistical analysis was provided. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End point title |
Number of Subjects With Immediate Unsolicited Systemic Adverse Events (AEs) [6] | |||||||||||||||
End point description |
An AE was defined as any untoward medical occurrence in a subject who received study vaccine and does not necessarily had to have a causal relationship with treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of diagnosis and/or onset post-vaccination. All subjects were observed for 30 minutes after any vaccination, and any unsolicited AEs occurred during that time were recorded as immediate unsolicited AEs in the CRB. Analysis was performed on the safety analysis set (SafAS) that included subjects who had received at least one dose of the study vaccine.
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End point type |
Primary
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End point timeframe |
Within 30 minutes post-any vaccination
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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: As the endpoint was descriptive in nature, no statistical analysis was provided. |
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| No statistical analyses for this end point | ||||||||||||||||
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End point title |
Number of Subjects With Solicited Injection Site Reactions [7] | ||||||||||||||||||||||||||||||||||||||||
End point description |
A solicited reaction (SR) was an expected adverse reaction (AR) observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRB and considered as related to vaccination. An AR was all noxious and unintended responses to a medicinal product related to any dose. Solicited injection site reactions included pain/tenderness, erythema, swelling, induration and bruising. Analysis was performed on SafAS.
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End point type |
Primary
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End point timeframe |
Within 7 days post-any vaccination
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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: As the endpoint was descriptive in nature, no statistical analysis was provided. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||
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End point title |
Number of Subjects With Solicited Systemic Reactions [8] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
SR was an expected AR observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRB and considered as related to vaccination. An AR was all noxious and unintended responses to a medicinal product related to any dose. Solicited reaction were collected by different age group: fever, vomiting, crying abnormal, drowsiness, appetite lost, irritability were collected for infants and toddlers aged <=23 months and fever, headache, malaise, myalgia and shivering were collected for subjects aged >= 2 years. Analysis was performed on SafAS. Here, 'n' = subjects with available data for each specified category and "99999" is used as a space filler and denotes that no subjects were available for analysis for the specified category at the specified timepoint.
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End point type |
Primary
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End point timeframe |
Within 7 days post-any vaccination
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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: As the endpoint was descriptive in nature, no statistical analysis was provided. |
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| No statistical analyses for this end point | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End point title |
Number of Subjects With Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESIs) [9] | |||||||||||||||||||||||||
End point description |
An SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required initial or prolonged inpatient hospitalisation, resulted in persistent or significant disability/incapacity, congenital anomaly/birth defect or was a medically important event. An AESI was defined as one of scientific and medical concern specific to the Sponsor’s product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor was appropriate. Relatedness to study vaccine was based on investigator's discretion. Analysis was performed on SafAS.
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End point type |
Primary
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End point timeframe |
From Day 1 up to end of the study i.e., Day 29 (post-vaccination; for subjects with 1 vaccination) or Day 57 (post vaccination; for subjects with 2 vaccinations)
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| 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: As the endpoint was descriptive in nature, no statistical analysis was provided. |
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| No statistical analyses for this end point | ||||||||||||||||||||||||||
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End point title |
Number of Subjects With Unsolicited AEs [10] | |||||||||||||||
End point description |
An AE was defined as any untoward medical occurrence in a subject who received study vaccine and does not necessary had to have a causal relationship with treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRB in terms of diagnosis and/or onset window post-vaccination. Analysis was performed on SafAS.
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End point type |
Primary
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End point timeframe |
Within 28 days post-any vaccination
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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: As the endpoint was descriptive in nature, no statistical analysis was provided. |
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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 |
Unsolicited AEs: up to 28 days post-vaccination. Solicited reaction data: up to Day 7 post-vaccination. SAE: throughout study i.e., Day 29 (post-vaccination; for subjects with 1 vaccination) or Day 57 (post-vaccination; for subjects with 2 vaccinations)
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Adverse event reporting additional description |
Analysed on safety analysis set. Solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE that did not fulfill conditions prelisted (i.e., solicited) in CRB in terms of diagnosis & onset window post-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 |
25.0
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Reporting groups
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Reporting group title |
Group 1: QIV: 6 to 35 months
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Reporting group description |
Subjects aged 6 to 35 months received an injection of 0.5 mL of QIV IM on Day 1. Previously vaccinated subjects (defined as subjects who had received at least 2 doses of seasonal influenza vaccine in prior influenza seasons) received only 1 dose of study vaccine after enrolling in the study (at Day 1). Previously unvaccinated subjects (defined as subjects who had not received at least 2 doses of seasonal influenza vaccine in prior influenza seasons) received 2 doses of study vaccine after enrolling in the study (first dose at Day 1 and second dose 28 days apart [at Day 29]). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Group 4: QIV: 18 years and older
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Reporting group description |
Subjects aged 18 years and older received an injection of 0.5 mL of QIV IM on Day 1. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Group 3: QIV: 9 to 17 years
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Reporting group description |
Subjects aged 9 to 17 years received an injection of 0.5 mL of QIV IM on Day 1. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Group 2: QIV: 3 to 8 years
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Reporting group description |
Subjects aged 3 to 8 years received an injection of 0.5 mL of QIV IM on Day 1. Previously vaccinated subjects (defined as subjects who had received at least 2 doses of seasonal influenza vaccine in prior influenza seasons) received only 1 dose of study vaccine after enrolling in the study (at Day 1). Previously unvaccinated subjects (defined as subjects who had not received at least 2 doses of seasonal influenza vaccine in prior influenza seasons) received 2 doses of study vaccine after enrolling in the study (first dose at Day 1 and second dose 28 days apart [at Day 29]). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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? No | |||
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 | |||
