Clinical Trial Results:
Immunogenicity and Safety of the Influenza Vaccine (Split Virion, Inactivated), Northern Hemisphere 2010-2011 Formulation (Intramuscular Route)
|
Summary
|
|
EudraCT number |
2009-017690-38 |
Trial protocol |
FR |
Global end of trial date |
27 May 2010
|
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
16 Feb 2016
|
First version publication date |
03 Dec 2014
|
Other versions |
|
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
|
|||
|
Trial identification
|
|||
Sponsor protocol code |
GRT90
|
||
|
Additional study identifiers
|
|||
ISRCTN number |
- | ||
US NCT number |
NCT01121822 | ||
WHO universal trial number (UTN) |
U1111-1112-8285 | ||
|
Sponsors
|
|||
Sponsor organisation name |
Sanofi Pasteur SA
|
||
Sponsor organisation address |
1541, Avenue Marcel Mérieux, Marcy L’Etoile, France, 69280
|
||
Public contact |
Director, Clinical Development, Sanofi Pasteur SA, 33 (0)4 37 37 53 50, diane.vandervliet@sanofipasteur.com
|
||
Scientific contact |
Director, Clinical Development, Sanofi Pasteur SA, 33 (0)4 37 37 53 50, diane.vandervliet@sanofipasteur.com
|
||
|
Paediatric regulatory details
|
|||
Is trial part of an agreed paediatric investigation plan (PIP) |
No
|
||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
|
Results analysis stage
|
|||
Analysis stage |
Final
|
||
Date of interim/final analysis |
21 Jun 2010
|
||
Is this the analysis of the primary completion data? |
No
|
||
Global end of trial reached? |
Yes
|
||
Global end of trial date |
27 May 2010
|
||
Was the trial ended prematurely? |
No
|
||
|
General information about the trial
|
|||
Main objective of the trial |
1) To evaluate the compliance, in terms of immunogenicity, of the influenza vaccine (split virion, inactivated) 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 in both age groups
2) To describe the safety of the influenza vaccine (split virion, inactivated) NH 2010-2011 formulation in both age groups
|
||
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 were also available on site in case of any immediate allergic reactions.
|
||
Background therapy |
Not applcable | ||
Evidence for comparator |
Not applicable | ||
Actual start date of recruitment |
05 May 2010
|
||
Long term follow-up planned |
No
|
||
Independent data monitoring committee (IDMC) involvement? |
No
|
||
|
Population of trial subjects
|
|||
Number of subjects enrolled per country |
|||
Country: Number of subjects enrolled |
France: 129
|
||
Worldwide total number of subjects |
129
|
||
EEA total number of subjects |
129
|
||
Number of subjects enrolled per age group |
|||
In utero |
0
|
||
Preterm newborn - gestational age < 37 wk |
0
|
||
Newborns (0-27 days) |
0
|
||
Infants and toddlers (28 days-23 months) |
0
|
||
Children (2-11 years) |
0
|
||
Adolescents (12-17 years) |
0
|
||
Adults (18-64 years) |
99
|
||
From 65 to 84 years |
30
|
||
85 years and over |
0
|
||
|
|||||||||||||||||||
|
Recruitment
|
|||||||||||||||||||
Recruitment details |
Study subjects were enrolled from 05 May 2010 to 27 May 2010 in 3 clinical centers in France. | ||||||||||||||||||
|
Pre-assignment
|
|||||||||||||||||||
Screening details |
A total of 129 subjects who met all inclusion criteria and none of the exclusion criteria were enrolled and vaccinated. | ||||||||||||||||||
|
Period 1
|
|||||||||||||||||||
Period 1 title |
Overall trial (overall period)
|
||||||||||||||||||
Is this the baseline period? |
Yes | ||||||||||||||||||
Allocation method |
Not applicable
|
||||||||||||||||||
Blinding used |
Not blinded | ||||||||||||||||||
Blinding implementation details |
Not applicable
|
||||||||||||||||||
|
Arms
|
|||||||||||||||||||
Are arms mutually exclusive |
Yes
|
||||||||||||||||||
|
Arm title
|
18 to 60 years | ||||||||||||||||||
Arm description |
Subjects aged 18 to 60 years who received one dose of inactivated, split-virion influenza vaccine, Northern Hemisphere 2010-2011 formulation on day 0. | ||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||
Investigational medicinal product name |
Influenza vaccine (split virion, inactivated)
|
||||||||||||||||||
Investigational medicinal product code |
314
|
||||||||||||||||||
Other name |
|||||||||||||||||||
Pharmaceutical forms |
Suspension for injection
|
||||||||||||||||||
Routes of administration |
Intramuscular use
|
||||||||||||||||||
Dosage and administration details |
0.5 mL, intramuscular into the deltoid muscle, one dose at Day 0.
|
||||||||||||||||||
|
Arm title
|
61 years or older | ||||||||||||||||||
Arm description |
Subjects aged 61 years or older who received one dose of inactivated, split-virion influenza vaccine, Northern Hemisphere 2010-2011 formulation on day 0. | ||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||
Investigational medicinal product name |
Influenza vaccine (split virion, inactivated)
|
||||||||||||||||||
Investigational medicinal product code |
314
|
||||||||||||||||||
Other name |
|||||||||||||||||||
Pharmaceutical forms |
Suspension for injection
|
||||||||||||||||||
Routes of administration |
Intramuscular use
|
||||||||||||||||||
Dosage and administration details |
0.5 mL, intramuscular into the deltoid muscle, one dose at Day 0.
|
||||||||||||||||||
|
|||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Baseline characteristics reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
18 to 60 years
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Subjects aged 18 to 60 years who received one dose of inactivated, split-virion influenza vaccine, Northern Hemisphere 2010-2011 formulation on day 0. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
61 years or older
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Subjects aged 61 years or older who received one dose of inactivated, split-virion influenza vaccine, Northern Hemisphere 2010-2011 formulation on day 0. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||
|
End points reporting groups
|
|||
Reporting group title |
18 to 60 years
|
||
Reporting group description |
Subjects aged 18 to 60 years who received one dose of inactivated, split-virion influenza vaccine, Northern Hemisphere 2010-2011 formulation on day 0. | ||
Reporting group title |
61 years or older
|
||
Reporting group description |
Subjects aged 61 years or older who received one dose of inactivated, split-virion influenza vaccine, Northern Hemisphere 2010-2011 formulation on day 0. | ||
|
|||||||||||||||||||||||||||||||||||||
End point title |
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies Before and After Vaccination with Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2010-2011 Formulation by the Intramuscular Route [1] | ||||||||||||||||||||||||||||||||||||
End point description |
Influenza vaccine antibodies were assessed using the hemagglutination inhibition technique.
|
||||||||||||||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||||||||||||||
End point timeframe |
Day 0 (pre-vaccination) and Day 21 post vaccination
|
||||||||||||||||||||||||||||||||||||
| 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. |
|||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||
End point title |
Geometric Mean Titers Ratios (GMTR) of Influenza Vaccine Antibodies After Vaccination with Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2010-2011 Formulation by the Intramuscular Route [2] | ||||||||||||||||||||||||
End point description |
Influenza vaccine antibodies were assessed 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 virus antigens.
|
||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
Day 0 (pre-vaccination) and Day 21 post vaccination
|
||||||||||||||||||||||||
| 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. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
End point title |
Percentage of Subjects Achieving a Titer of < 10 (1/dil) Against the Influenza Vaccine Antigens Before and After Vaccination with Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2010-2011 Formulation by the Intramuscular Route [3] | ||||||||||||||||||||||||||||||||||||
End point description |
Influenza vaccine antibodies were assessed using the hemagglutination inhibition technique.
|
||||||||||||||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||||||||||||||
End point timeframe |
Day 0 (pre-vaccination) and Day 21 post vaccination
|
||||||||||||||||||||||||||||||||||||
| 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. |
|||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
End point title |
Percentage of Subjects with Seroprotection Against the Influenza Vaccine Antigens Before and After Vaccination with Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2010-2011 Formulation by the Intramuscular Route [4] | ||||||||||||||||||||||||||||||||||||
End point description |
Influenza vaccine antibodies were assessed using the hemagglutination inhibition technique. Seroprotection was defined as titers ≥40 (1/dil) on Day 0 and Day 21.
|
||||||||||||||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||||||||||||||
End point timeframe |
Day 0 (pre-vaccination) and Day 21 post vaccination
|
||||||||||||||||||||||||||||||||||||
| 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. |
|||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||
End point title |
Percentage of Subjects with Seroconversion or Significant Increase Against the Influenza Vaccine Antigens Before and After Vaccination with Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2010-2011 Formulation by Intramuscular Route [5] | ||||||||||||||||||||||||
End point description |
Influenza vaccine antibodies were assessed using the hemagglutination inhibition technique. Seroconversion was defined as subjects with a titer <10 (1/dil) on Day 0 and a post-injection titer ≥40 (1/dil) on Day 21 or significant increase was defined as subjects with a titer ≥10 (1/dil) on Day 0 and a ≥4-fold increase from pre- to post-injection titer on Day 21.
|
||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
Day 21 post-vaccination
|
||||||||||||||||||||||||
| 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. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||
|
||||||||||||||||||||||||||||
End point title |
Percentage of Subjects with at Least One Reaction Corresponding to those Listed in the EMEA Note for Guidance Within 3 Days After Vaccination with Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2010-2011 Formulation (Intramuscular Route) [6] | |||||||||||||||||||||||||||
End point description |
Solicited injection site: Induration and Ecchymosis. Solicited systemic reactions: Pyrexia, Malaise, and Shivering.
|
|||||||||||||||||||||||||||
End point type |
Primary
|
|||||||||||||||||||||||||||
End point timeframe |
Day 0 up to Day 3 post-vaccination
|
|||||||||||||||||||||||||||
| 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. |
||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||
| No statistical analyses for this end point | ||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point title |
Percentage of Subjects Reporting Solicited Injection-site or Systemic Reactions within 3 Days After Vaccination with Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2010-2011 Formulation by the Intramuscular Route [7] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Solicited injection site: Pain, Erythema, Swelling, Induration and Ecchymosis. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Shivering. Grade 3 injection site: Pain – Significant, prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis – >10 cm. Grade 3 systemic reactions: Fever – ≥39.0°C; Headache, Malaise, Myalgia, and Shivering – Significant, prevents daily activity.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
Day 0 up to Day 3 post-vaccination
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point title |
Percentage of Subjects Reporting Solicited Injection-site or Systemic Reactions More than 3 Days After Vaccination with Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2010-2011 Formulation by the Intramuscular Route [8] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Solicited injection site: Pain, Erythema, Swelling, Induration and Ecchymosis. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Shivering. Grade 3 injection site: Pain – Significant, prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis – >10 cm. Grade 3 systemic reactions: Fever – ≥39.0°C; Headache, Malaise, Myalgia, and Shivering – Significant, prevents daily activity.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
>Day 3 post-vaccination
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||
End point title |
Percentage of Subjects Reporting a Solicited Injection-site or Systemic Reactions Within 7 Days After Vaccination with Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2010-2011 Formulation by the Intramuscular Route [9] | ||||||||||||||||||||||||||||||||||||||||||
End point description |
Solicited injection site: Pain, Erythema, Swelling, Induration and Ecchymosis. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Shivering.
|
||||||||||||||||||||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
Day 0 up to Day 7 post-vaccination
|
||||||||||||||||||||||||||||||||||||||||||
| 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: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome. |
|||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Adverse events information
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
Adverse event data were collected from Day 0 (post-vaccination) up to Day 21 post-vaccination.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Dictionary used for adverse event reporting
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
12.0
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
18 to 60 years
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Subjects aged 18 to 60 years who received one dose of inactivated, split-virion influenza vaccine, Northern Hemisphere 2010-2011 formulation on day 0. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
61 years or older
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Subjects aged 61 years or older who received one dose of inactivated, split-virion influenza vaccine, Northern Hemisphere 2010-2011 formulation on day 0. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||
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. | |||
| None reported | |||
