Clinical Trial Results:
A phase I, open-label study to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals’ seasonal trivalent influenza vaccine adjuvanted with various doses of the AS03 (GSK2186877A), administered in healthy children aged 6 to 35 months.
Summary
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EudraCT number |
2010-018392-22 |
Trial protocol |
ES |
Global end of trial date |
13 Dec 2010
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Results information
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Results version number |
v3(current) |
This version publication date |
23 Jul 2022
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First version publication date |
01 Feb 2015
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Other versions |
v1 , v2 |
Version creation reason |
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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 |
114182
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01096056 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
GlaxoSmithKline Biologicals
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Sponsor organisation address |
Rue de l’Institut 89, Rixensart, Belgium, B-1330
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Public contact |
Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com
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Scientific contact |
Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.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 |
22 Feb 2011
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
13 Dec 2010
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Global end of trial reached? |
Yes
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Global end of trial date |
13 Dec 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 |
To evaluate the reactogenicity of seasonal trivalent influenza vaccine adjuvanted with various doses of the AS03 in terms of incidence of fever grade ≥2 (axillary temperature >38°C) reported during 7 days follow-up period after any vaccination.
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Protection of trial subjects |
As with all injectable vaccines, appropriate medical treatment was always readily available in case of anaphylactic reactions following the administration of the vaccine.
For this reason, the vaccinee remained under medical supervision for 30 minutes after vaccination.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
05 Apr 2010
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Long term follow-up planned |
Yes
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Long term follow-up rationale |
Efficacy | ||
Long term follow-up duration |
6 Months | ||
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 |
Spain: 40
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Worldwide total number of subjects |
40
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EEA total number of subjects |
40
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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) |
40
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
- | |||||||||||||||
Pre-assignment
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Screening details |
During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms. | |||||||||||||||
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 |
Non-randomised - controlled
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Blinding used |
Not blinded | |||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Influenza vaccine GSK2186877A formulation 1 Group | |||||||||||||||
Arm description |
- | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
Biological: Influenza vaccine GSK2186877A formulation 1
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Subjects received 2 doses of influenza vaccine GSK2186877A formulation 1 at Day 0 and Day 21 and 1 dose of Fluarix vaccine at Month 6.
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Investigational medicinal product name |
Biological: Fluarix
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Subjects received 2 doses of influenza vaccine GSK2186877A formulation 1 at Day 0 and Day 21 and 1 dose of Fluarix vaccine at Month 6.
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Arm title
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Influenza vaccine GSK2186877A formulation 2 Group | |||||||||||||||
Arm description |
- | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
Biological: Influenza vaccine GSK2186877A formulation 2
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Subjects received 1 dose of influenza vaccine GSK2186877A formulation 2 at Day 0 and 1 dose of Fluarix vaccine at Month 6.
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Investigational medicinal product name |
Biological: Fluarix
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Subjects received 1 dose of influenza vaccine GSK2186877A formulation 2 at Day 0 and 1 dose of Fluarix vaccine at Month 6.
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Baseline characteristics reporting groups
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Reporting group title |
Influenza vaccine GSK2186877A formulation 1 Group
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Influenza vaccine GSK2186877A formulation 2 Group
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Influenza vaccine GSK2186877A formulation 1 Group
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Reporting group description |
- | ||
Reporting group title |
Influenza vaccine GSK2186877A formulation 2 Group
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Reporting group description |
- |
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End point title |
Number of subjects reporting fever grade 2 or higher [1] | ||||||||||||
End point description |
Fever grade greater than or equal to 2 i.e. ≥2 was defined as axillary temperature >38 degree centigrade (°C).
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End point type |
Primary
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End point timeframe |
Within 7 days following any vaccination with New generation influenza vaccine GSK2186877A
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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: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed. |
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No statistical analyses for this end point |
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End point title |
Haemagglutination Inhibition (HI) antibody titers | ||||||||||||||||||||||||||||||
End point description |
Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains included Flu A/CAL/7/09 H1N1, Flu A/Uru/716/07 H3N2 and FluB/Bri/60/08 Victoria antigens.
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End point type |
Secondary
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End point timeframe |
At Day 0 and Day 42
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No statistical analyses for this end point |
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End point title |
The number of subjects seropositive to HI antibodies | |||||||||||||||||||||||||||
End point description |
A seropositive subject was defined as a subject with antibody titer greater than or equal to 1:10. The vaccine strains included Flu A/CAL/7/09 H1N1, Flu A/Uru/716/07 H3N2 and FluB/Bri/60/08 Victoria antigens.
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End point type |
Secondary
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End point timeframe |
At Day 0 and Day 42
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No statistical analyses for this end point |
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End point title |
The number of subjects seroprotected to HI antibodies | |||||||||||||||||||||||||||
End point description |
A seroprotected subject was defined as a subject with a serum HI titre greater than or equal to 1:40 that usually is accepted as indicating protection. The vaccine strains included Flu A/CAL/7/09 H1N1, Flu A/Uru/716/07 H3N2 and FluB/Bri/60/08 Victoria antigens.
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End point type |
Secondary
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End point timeframe |
At Day 0 and Day 42
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No statistical analyses for this end point |
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End point title |
The number of subjects seroconverted to HI antibodies | ||||||||||||||||||
End point description |
A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains included Flu A/CAL/7/09 H1N1, Flu A/Uru/716/07 H3N2 and FluB/Bri/60/08 Victoria antigens.
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End point type |
Secondary
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End point timeframe |
Day 42
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No statistical analyses for this end point |
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End point title |
HI antibody Geometric mean fold rise (GMFR) | |||||||||||||||||||||
End point description |
GMFR was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The vaccine strains included Flu A/CAL/7/09 H1N1, Flu A/Uru/716/07 H3N2 and FluB/Bri/60/08 Victoria antigens.
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End point type |
Secondary
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End point timeframe |
Day 42
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No statistical analyses for this end point |
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End point title |
Number of subjects reporting any and grade 3 solicited local Adverse Events (AEs) | |||||||||||||||||||||||||||
End point description |
Grade 3 redness and swelling was > 50 millimeter (mm) and grade 3 pain was subjects crying when limb was moved/spontaneously painful. Any was occurrence of any local symptom regardless of their intensity grade.
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End point type |
Secondary
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End point timeframe |
Within 7 days following any vaccination with New generation influenza vaccine GSK2186877A
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No statistical analyses for this end point |
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End point title |
Duration of solicited local AEs | ||||||||||||||||||||||||||||||
End point description |
Duration was defined as number of days with any grade of local symptoms following each dose of New generation influenza vaccine GSK2186877A. Dose 1 application of vaccine involved Influenza vaccine GSK2186877A formulation 1 Group and Influenza vaccine GSK2186877A formulation 2 Group while Dose 2 involved only Influenza vaccine GSK2186877A formulation 1 Group.
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End point type |
Secondary
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End point timeframe |
Within 7 days following any vaccination with New generation influenza vaccine GSK2186877A
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No statistical analyses for this end point |
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End point title |
Number of subjects reporting any, grade 3 and related solicited general AEs | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Any temperature was defined as axillary temperature ≥37.5°C, grade 3 temperature was axillary temperature >39.0°C. For other symptoms, any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination. Grade 3 drowsiness was defined as general symptom that prevented normal activity, grade 3 irritability was crying that cannot be comforted/prevented normal activity, grade 3 loss of appetite was not eating at all and grade 3 vomiting was defined as ≥3 episode of vomiting/day. Related was symptom assessed by the investigator as causally related to vaccination.
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End point type |
Secondary
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End point timeframe |
Within 7 days following any vaccination with New generation influenza vaccine GSK2186877A
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No statistical analyses for this end point |
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End point title |
Duration of solicited general AEs | ||||||||||||||||||||||||||||||||||||||||||
End point description |
Duration was defined as number of days with any grade of local symptoms following each dose of New generation influenza vaccine GSK2186877A. Dose 1 application of vaccine involved subjects in Influenza vaccine GSK2186877A formulation 1 Group and Influenza vaccine GSK2186877A formulation 2 Group while Dose 2 application of vaccine involved only subjects in the Influenza vaccine GSK2186877A formulation 1 Group.
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End point type |
Secondary
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End point timeframe |
Within 7 days following any vaccination with New generation influenza vaccine GSK2186877A
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No statistical analyses for this end point |
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End point title |
Number of subjects reporting any, grade 3 and related unsolicited AEs | ||||||||||||||||||
End point description |
Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was event that prevented normal activities and Related was defined as unsolicited AE assessed by the investigator to be causally related to the study vaccination.
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End point type |
Secondary
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End point timeframe |
Within 21 days after any vaccination with New generation influenza vaccine GSK2186877A
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No statistical analyses for this end point |
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End point title |
Number of subjects reporting any, grade 3 and related AEs with a medically attended visit (MAEs) | ||||||||||||||||||
End point description |
For each solicited and unsolicited AE the subject experienced, the subject was asked if they had received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination, grade 3 was defined as symptom that prevented normal activity and related was symptom assessed by the investigator as causally related to the study vaccination.
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End point type |
Secondary
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End point timeframe |
Day 0 up to Month 7
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No statistical analyses for this end point |
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End point title |
Number of subjects reporting any potential Immune-Mediated-Diseases (pIMDs) | ||||||||||||
End point description |
pIMDs are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.
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End point type |
Secondary
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End point timeframe |
Day 0 up to Month 7
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No statistical analyses for this end point |
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End point title |
Number of subjects reporting any and related serious adverse events (SAEs) | |||||||||||||||
End point description |
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was event assessed by the investigator as causally related to the study vaccination.
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End point type |
Secondary
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End point timeframe |
Day 0 up to Month 7
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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 |
Serious adverse events were assessed from day 0 up to month 7. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post vaccination period.
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
13.1
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Reporting groups
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Reporting group title |
Influenza vaccine GSK2186877A formulation 1 Group
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Reporting group description |
Subjects aged 6 to 35 months received 2 doses of new generation influenza vaccine GSK2186877A formulation 1 at Day 0 and Day 21 and 1 dose of Fluarix vaccine at Month 6. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Influenza vaccine GSK2186877A formulation 2 Group
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Reporting group description |
Subjects aged 6 to 35 months received 1 dose of new generation influenza vaccine GSK2186877A formulation 2 at Day 0 and 1 dose of Fluarix vaccine at Month 6. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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? Yes | |||
Date |
Amendment |
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16 Jun 2010 |
The reactogenicity data were collected in 20 subjects having received the first dose of GSK’s seasonal influenza vaccine 7.5 µg HA per strain + AS03C and they suggest a trend towards an increase of fever after the first dose compared to the data that were collected during the first study phase in the 7.5 µg HA per strain + AS03D group.
The observed incidence of any reported fever (≥37,5°; axillary measurement) after the first dose is 60% in TIV-AS03C group compared to 35% in the TIV-AS03D group. Importantly, the incidence of grade 3 temperature (axillary temperature ≥ 39.1°C) was low (5.0%-one children among the 20 recruited), and the majority of fever episodes were short (1 day) and did not require medical attention. The follow-up for the participants already enrolled will be continued according to the protocol including assessment of all safety, reactogenicity and immunogenicity end-points. However according to the recommendations of the internal Vaccine Safety Monitoring Board, any further vaccination was suspended (i.e. the administration of the second dose of TIV-AS03C and the further enrolment in the group TIV-AS03B).
Also the protocol was amended to proceed with an early analysis of the immunogenicty results of children who received 2 doses of the TIV-AS03D vaccine to evaluate the possible impact of high initial priming status which can contribute to the present findings and to evaluate how best to plan the further booster phase. |
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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 |