Clinical Trial Results:
Immunogenicity and Safety of the Trivalent Influenza Vaccine (Split-Virion, Inactivated), Northern Hemisphere 2013-2014 Formulation (Intradermal Route)
Summary
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EudraCT number |
2012-005243-25 |
Trial protocol |
FR |
Global end of trial date |
30 Jul 2013
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Results information
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Results version number |
v1(current) |
This version publication date |
10 Feb 2016
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First version publication date |
03 Dec 2014
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Other versions |
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 |
GID37
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
U1111-1127-7490 | ||
Sponsors
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Sponsor organisation name |
Sanofi Pasteur SA
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Sponsor organisation address |
1541, Avenue Marcel Mérieux, Marcy L’Etoile, France, 69280
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Public contact |
Medical Franchise Leader, Sanofi Pasteur SA, +33 (0)4 37 37 70 82 , eric.desauziers@sanofipasteur.com
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Scientific contact |
Medical Franchise Leader, Sanofi Pasteur SA, +33 (0)4 37 37 70 82 , eric.desauziers@sanofipasteur.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? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
14 Aug 2013
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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 |
30 Jul 2013
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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 evaluate the compliance, in terms of immunogenicity, of the ID influenza vaccine NH 2013-2014 formulation with the requirements of the Committee for Medicinal Products for Human Use (CHMP) Note for Guidance (NfG) CPMP/BWP/214/96 in both age groups
-To describe the safety of the ID influenza vaccine NH 2013-2014 formulation in both age groups
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Protection of trial subjects |
Only subjects that met all the study inclusion and none of the exclusion criteria were vaccinated in the study. 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 |
The new formulation of the trivalent ID influenza vaccine for the 2013-2014 season in the Northern Hemisphere was evaluated in compliance with the Committee for Medicinal Products for Human Use (CHMP) Note for Guidance (NfG) on harmonization of requirements for influenza vaccines CPMP/BWP/214/96. | ||
Evidence for comparator |
Not applicable | ||
Actual start date of recruitment |
03 Jul 2013
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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 |
France: 130
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Worldwide total number of subjects |
130
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EEA total number of subjects |
130
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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) |
0
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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) |
96
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From 65 to 84 years |
34
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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 03 July 2013 to 10 July 2013 in 2 clinic centers in France. | |||||||||
Pre-assignment
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Screening details |
A total of 130 subjects who met all inclusion criteria and none of the exclusion criteria were enrolled and vaccinated. | |||||||||
Period 1
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | |||||||||
Blinding implementation details |
Not applicable
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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18 to 59 years (9 µg) | |||||||||
Arm description |
Subjects aged 18 to 59 years who were vaccinated with one dose of the intradermal (ID) influenza vaccine 9 µg, Northern Hemisphere (NH) 2013-2014 formulation. | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
IDflu 9μg
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Investigational medicinal product code |
415
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Other name |
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Pharmaceutical forms |
Suspension for injection
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Routes of administration |
Intradermal use
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Dosage and administration details |
0.1 mL, intradermal into the deltoid muscle area, one dose on Day 0
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Arm title
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60 years or older (15 µg) | |||||||||
Arm description |
Subjects aged 60 years or older who were vaccinated with one dose of the intradermal (ID) influenza vaccine 15 µg, NH 2013-2014 formulation. | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
IDflu 15μg
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Investigational medicinal product code |
416
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Other name |
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Pharmaceutical forms |
Suspension for injection
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Routes of administration |
Intradermal use
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Dosage and administration details |
0.1 mL, intradermal into the deltoid muscle area, one dose on Day 0
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Baseline characteristics reporting groups
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Reporting group title |
18 to 59 years (9 µg)
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Reporting group description |
Subjects aged 18 to 59 years who were vaccinated with one dose of the intradermal (ID) influenza vaccine 9 µg, Northern Hemisphere (NH) 2013-2014 formulation. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
60 years or older (15 µg)
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Reporting group description |
Subjects aged 60 years or older who were vaccinated with one dose of the intradermal (ID) influenza vaccine 15 µg, NH 2013-2014 formulation. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
18 to 59 years (9 µg)
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Reporting group description |
Subjects aged 18 to 59 years who were vaccinated with one dose of the intradermal (ID) influenza vaccine 9 µg, Northern Hemisphere (NH) 2013-2014 formulation. | ||
Reporting group title |
60 years or older (15 µg)
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Reporting group description |
Subjects aged 60 years or older who were vaccinated with one dose of the intradermal (ID) influenza vaccine 15 µg, NH 2013-2014 formulation. |
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End point title |
Geometric Mean Titers (GMTs) of influenza Vaccine Antibodies Before and After Vaccination with Inactivated, Split-Virion Influenza Vaccine Administered by Intradermal Route [1] | ||||||||||||||||||||||||||||||
End point description |
Antibodies against influenza vaccine were evaluated using the hemagglutination inhibition technique.
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End point type |
Primary
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End point timeframe |
Day 0 (pre-vaccination) and Day 21 post-vaccination
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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: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome. |
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No statistical analyses for this end point |
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End point title |
Percentage of Subjects with Seroprotection Against Influenza Vaccine Antigens Before and After Vaccination with Inactivated, Split-Virion Influenza Vaccine Administered by Intradermal Route [2] | ||||||||||||||||||||||||||||||
End point description |
Antibodies against influenza vaccine were evaluated using the hemagglutination inhibition technique. Seroprotection was defined as titer ≥40 (1/dilution [1/dil]) on Day 0 and Day 21.
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End point type |
Primary
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End point timeframe |
Day 0 (pre-vaccination) and Day 21 post-vaccination
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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: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome. |
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No statistical analyses for this end point |
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End point title |
Summary of Geometric Mean Titer Ratios (GMTRs) of Influenza Vaccine Antibodies After Vaccination with Inactivated, Split-Virion Influenza Vaccine Administered by Intradermal Route [3] | |||||||||||||||||||||
End point description |
Antibodies against influenza vaccine were evaluated using the hemagglutination inhibition technique. Geometric mean titer ratio is the geometric mean of the individual post-vaccination/pre-vaccination titer of antibodies to the influenza vaccine.
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End point type |
Primary
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End point timeframe |
Day 0 (pre-vaccination) and Day 21 post-vaccination
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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: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome. |
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No statistical analyses for this end point |
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End point title |
Percentage of Subjects Achieving Seroconversion or Significant Increase in Influenza Vaccine Antibodies Following Vaccination with Inactivated, Split-Virion Influenza Vaccine Administered by Intradermal Route [4] | |||||||||||||||||||||
End point description |
Seroconversion was defined as percentage of subjects with a pre-vaccination titer < 10 (1/dil) to a post-vaccination titer >= 40 (1/dil) ; Significant increase was defined as the precentage of subjects with a pre-vaccination titer >= 10 (1/dil) and >= 4-fold increase of the titer.
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End point type |
Primary
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End point timeframe |
Day 21 post-vaccination
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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: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome. |
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No statistical analyses for this end point |
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End point title |
Percentage of Subjects Reporting Solicited Injection Site or Systemic Reactions Following Vaccination with Inactivated, Split-Virion Influenza Vaccine Administered by Intradermal Route | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Solicited Injection Site Reactions: Injection site Pain, Injection site Erythema, Injection site Swelling, Injection site Induration, Injection site Ecchymosis, and Injection site Pruritus. Solicited Systemic Reactions: Fever, Headache, Malaise, Myalgia, and Shivering. Grade 3 Solicited Injection Site Reactions: Injection site Pain and Pruritus, Significant, prevents daily activity; Injection site Erythema, Swelling, Induration, and Ecchymosis, >100 mm. Grade 3 Solicited Systemic Reactions: Fever, ≥39˚C, Headache, Malaise, Myalgia, and Shivering, Significant prevents daily activity.
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End point type |
Secondary
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End point timeframe |
Day 0 up to Day 7 post-vaccination
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No statistical analyses for this end point |
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End point title |
Summary of Solicited Reactions Listed in the CHMP Note for Guidance Within 3 days after Vaccination with Inactivated, Split-Virion Influenza Vaccine Administered by Intradermal Route | |||||||||||||||||||||||||||
End point description |
Solicited Injection Site Reactions: Injection site Pain, Injection site Erythema, Injection site Swelling, Injection site Induration, Injection site Ecchymosis, and Injection site Pruritus. Solicited Systemic Reactions: Fever, Headache, Malaise, Myalgia, and Shivering.
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End point type |
Secondary
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End point timeframe |
Day 0 up to Day 3 post-vaccination
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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 |
Adverse event data were collected from Day 0 (post-vaccination) up to Day 21 post-vaccination.
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Assessment type |
Non-systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
15.0
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Reporting groups
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Reporting group title |
18 to 59 years (9 µg)
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Reporting group description |
Subjects aged 18 to 59 years who were vaccinated with one dose of the intradermal (ID) influenza vaccine 9 µg, Northern Hemisphere (NH) 2013-2014 formulation. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
60 years or older (15 µg)
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Reporting group description |
Subjects aged 60 years or older who were vaccinated with one dose of the intradermal (ID) influenza vaccine 15 µg, Northern Hemisphere (NH) 2013-2014 formulation. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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 |