Clinical Trial Results:
Immunogenicity and Safety of the Influenza Vaccine (Split Virion, Inactivated), Northern Hemisphere 2010-2011 Formulation (Intradermal Route)
Summary
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EudraCT number |
2009-017688-40 |
Trial protocol |
BE |
Global end of trial date |
24 Jun 2010
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Results information
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Results version number |
v1(current) |
This version publication date |
05 Feb 2016
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First version publication date |
29 Jan 2015
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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 |
GID34
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01138397 | ||
WHO universal trial number (UTN) |
U1111-1112-2795 | ||
Sponsors
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Sponsor organisation name |
Sanofi Pasteur SA
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Sponsor organisation address |
2, Avenue Pont Pasteur, Lyon cedex 07, France, F-69367
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Public contact |
Director, Clinical Development, Sanofi Pasteur SA, 33 4 37 37 58 50, Stephanie.pepin@sanofipasteur.com
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Scientific contact |
Director, Clinical Development, Sanofi Pasteur SA, 33 4 37 37 58 50, Stephanie.pepin@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 |
07 Jul 2010
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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 |
24 Jun 2010
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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 |
In each group:
1) To evaluate compliance, in terms of immunogenicity, of the corresponding strength of the ID influenza vaccine Northern Hemisphere (NH) 2010-2011 formulation with the requirements of the Committee for Proprietary Medicinal Products (CPMP) Note for Guidance (NfG) CPMP/BWP/214/96
2) To describe the safety of the corresponding strength of the ID influenza vaccine, NH 2010-2011 formulation
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Protection of trial subjects |
Only subjects who 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 was also available on site in case of any immediate allergic reactions.
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Background therapy |
Not applicable | ||
Evidence for comparator |
Not applicable | ||
Actual start date of recruitment |
02 Jun 2010
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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 |
Belgium: 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) |
78
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From 65 to 84 years |
52
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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 02 June 2010 to 03 June 2010 in 2 clinical centers in Belgium. | |||||||||||||||
Pre-assignment
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Screening details |
A total of 130 subjects who met all the inclusion criteria and none of the exclusion criteria were enrolled, 129 were 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; ID 9μg | |||||||||||||||
Arm description |
Adults aged 18 to 59 years who received the intradermal (ID) influenza vaccine 9μg Northern Hemisphere (NH) 2010-2011 formulation on Day 0. | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
Influenza vaccine (split-virion, inactivated) for intradermal route, NH 2010-2011
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Investigational medicinal product code |
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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 dose (9μg strength), intradermal (ID) in the region of the deltoid muscle, one dose on Day 0.
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Arm title
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60 years or older; ID 15μg | |||||||||||||||
Arm description |
Adults aged 60 years or older who received the intradermal (ID) influenza vaccine 15μg Northern Hemisphere (NH) 2010-2011 formulation on Day 0. | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
Influenza vaccine (split-virion, inactivated) for intradermal route, NH 2010-2011
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Investigational medicinal product code |
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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 dose (15μg strength), intradermal (ID) in the region of the deltoid muscle, one dose on Day 0.
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Baseline characteristics reporting groups
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Reporting group title |
18 to 59 years; ID 9μg
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Reporting group description |
Adults aged 18 to 59 years who received the intradermal (ID) influenza vaccine 9μg Northern Hemisphere (NH) 2010-2011 formulation on Day 0. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
60 years or older; ID 15μg
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Reporting group description |
Adults aged 60 years or older who received the intradermal (ID) influenza vaccine 15μg Northern Hemisphere (NH) 2010-2011 formulation on Day 0. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
18 to 59 years; ID 9μg
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Reporting group description |
Adults aged 18 to 59 years who received the intradermal (ID) influenza vaccine 9μg Northern Hemisphere (NH) 2010-2011 formulation on Day 0. | ||
Reporting group title |
60 years or older; ID 15μg
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Reporting group description |
Adults aged 60 years or older who received the intradermal (ID) influenza vaccine 15μg Northern Hemisphere (NH) 2010-2011 formulation on Day 0. |
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End point title |
Geometric Mean Titers (GMTs) of Influenza Antibodies Before and After Vaccination with Influenza Vaccine (Split Virion, Inactivated), Northern Hemisphere 2010-2011 Formulation Administered by Intradermal Route [1] | ||||||||||||||||||||||||||||||||||||
End point description |
Immunogenicity was evaluated using the hemagglutination inhibition (HAI) method.
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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 Antigens Before and After Vaccination with Influenza Vaccine (Split Virion, Inactivated), Northern Hemisphere 2010-2011 Formulation Administered by Intradermal Route [2] | ||||||||||||||||||||||||||||||||||||
End point description |
Immunogenicity was evaluated using the hemagglutination inhibition (HAI) method. Seroprotection was defined as a 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 |
Percentage of Subjects With Influenza Antibodies Titers < 10 1/dil Before and After Vaccination with Influenza Vaccine (Split Virion, Inactivated), Northern Hemisphere 2010-2011 Formulation Administered by Intradermal Route [3] | ||||||||||||||||||||||||||||||||||||
End point description |
Immunogenicity was evaluated using the hemagglutination inhibition (HAI) method.
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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 |
Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Before and After Vaccination with Influenza Vaccine (Split Virion, Inactivated), Northern Hemisphere 2010-2011 Formulation Administered by Intradermal Route [4] | ||||||||||||||||||||||||
End point description |
Immunogenicity was evaluated using the hemagglutination inhibition (HAI) method. Geometric mean of individual ratio was defined as the mean geometric increase between Day 0 and Day 21 as per the CPMP NfG.
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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 [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 Achieving Seroconversion or Significant increase Against Influenza Antigen Before and After Vaccination with Influenza Vaccine (Split Virion, Inactivated), Northern Hemisphere 2010-2011 Formulation Administered by Intradermal Route [5] | ||||||||||||||||||||||||
End point description |
Immunogenicity was evaluated using the hemagglutination inhibition (HAI) method. Seroconversion was defined as subjects with a titer <10 (1/dil) on Day 0: post-injection titer ≥40 (1/dil) on Day 21 or significant increase for subjects with a titer ≥10 (1/dil) on Day 0: ≥4-fold increase of post-injection titer on Day 21.
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End point type |
Primary
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End point timeframe |
Day 21 post-vaccination
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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: 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 Reactions Listed in the CPMP Note for Guidance Within 3 Days After Vaccination with Influenza Vaccine (Split Virion, Inactivated), Northern Hemisphere 2010-2011 Formulation Administered by Intradermal Route [6] | ||||||||||||||||||||||||||||||
End point description |
Solicited injection site reactions: Injection site induration ≥5 cm for at least 4 consecutive days and Injection site ecchymosis. Solicited systemic reactions: Pyrexia (recorded temperature >38°C) for at least 1 day, Malaise, and Shivering.
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End point type |
Primary
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End point timeframe |
Day 0 up to Day 3 post-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: 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 Reaction Within 3 Days After Vaccination with Influenza Vaccine (Split Virion, Inactivated), Northern Hemisphere 2010-2011 Formulation Administered by Intradermal Route [7] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Solicited injection site: Pain, Pruritus, Erythema, Swelling, Induration and Ecchymosis. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Shivering. Grade 3 Solicited Injection site reactions: Pain and Pruritus – Significant, prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis - >10 cm. Grade 3 Solicited systemic reactions: Fever - ≥39˚C; Headache, Malaise, Myalgia, and Shivering – Significant, prevents daily activity.
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End point type |
Primary
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End point timeframe |
Day 0 up to Day 3 post-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: 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 Reaction More than 3 Days After Vaccination with Influenza Vaccine (Split Virion, Inactivated), Northern Hemisphere 2010-2011 Formulation Administered by Intradermal Route [8] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Solicited injection site: Pain, Pruritus, Erythema, Swelling, Induration and Ecchymosis. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Shivering. Grade 3 Solicited Injection site reactions: Pain and Pruritus – Significant, prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis - >10 cm. Grade 3 Solicited systemic reactions: Fever - ≥39˚C; Headache, Malaise, Myalgia, and Shivering – Significant, prevents daily activity.
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End point type |
Primary
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End point timeframe |
>Day 3 post-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: 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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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 |
12.0
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Reporting groups
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Reporting group title |
18 to 59 years; ID 9μg
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Reporting group description |
Adults aged 18 to 59 years who received the intradermal (ID) influenza vaccine 9μg Northern Hemisphere (NH) 2010-2011 formulation on Day 0. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
60 years or older; ID 15μg
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Reporting group description |
Adults aged 60 years or older who received the intradermal (ID) influenza vaccine 15μg Northern Hemisphere (NH) 2010-2011 formulation on Day 0. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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 |