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Study to Evaluate the Safety and Immunogenicity of a Pandemic Influenza Vaccine in Adults Aged 18 Years and Above

Primary Purpose

Influenza

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Adjuvanted pandemic influenza candidate vaccine
Fluarix
Placebo
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza focused on measuring Adjuvanted pandemic influenza candidate vaccine, Influenza

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Subjects who the investigator believes that they can and will comply with the requirements of the protocol. A male or female aged 18 years or above at the time of the first vaccination. Written informed consent obtained from the subject. Healthy subjects as established by medical history and clinical examination before entering into the study. If the subject is female, she must be of non-childbearing potential, for 30 days prior to first vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series. Exclusion Criteria: Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. Planned administration of a vaccine not foreseen by the study protocol up to 30 days after the second vaccination. Administration of interpandemic influenza vaccine between Day 0 and Day 51of the study. Those study participants belonging to risk groups eligible to receive the annual interpandemic influenza vaccine (in accordance with local regulations) can receive the annual vaccination after day 51 and before the end of the study on Day 180. Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the first administration of the study vaccine. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination History of chronic alcohol consumption and/or drug abuse. History of hypersensitivity to vaccines. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests. Major congenital defects or serious chronic disease including any medically significant chronic pulmonary, cardiovascular, renal, neurological, psychiatric or metabolic disorder, as determined by medical history and physical examination. (Subjects suffering from seasonal allergies or asthma under inhalative treatment can be included). Acute disease at the time of enrolment. Administration of immunoglobulins and/or any blood products within the 3 months preceding the first administration of the study vaccine or during the study. Lactating women Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days prior to the first vaccination, or planned use during the study period.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

GSK1562902A Group

Fluarix+Placebo Group

Arm Description

Male and female subjects aged 18 or over received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm. The group was further stratified by age for analyses.

Male and female subjects aged 18 or over received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm. The group was further stratified by age for analyses.

Outcomes

Primary Outcome Measures

Number of Subjects With Solicited Local Symptoms
Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling. Any = occurrence of symptom regardless of intensity grade. Grade 3 Pain = pain that prevented normal everyday activities Grade 3 ecchymosis/induration/redness/swelling = redness/swelling spreading beyond (>) 50 millimeters (mm) in diameter
Number of Subjects With Solicited General Symptoms (Dose 1)
Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], headache, myalgia, shivering, sweating. Any = occurrence of symptom regardless of intensity grade and relationship to vaccination. Grade 3 symptom = symptoms that prevented normal activity. Grade 3 Fever = fever higher than (>) 39.0 °C. Related = symptom considered by the investigator to be casually related with the study vaccination.
Number of Subjects With Solicited General Symptoms (Dose 2)
Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], headache, myalgia, shivering, sweating. Any = occurrence of symptom regardless of intensity grade and relationship to vaccination. Grade 3 symptom = symptoms that prevented normal activity. Grade 3 Fever = fever higher than (>) 39.0 °C. Related = symptom considered by the investigator to be casually related with the study vaccination.
Number of Subjects With Solicited General Symptoms (Across Doses)
Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], headache, myalgia, shivering, sweating. Any = occurrence of symptom regardless of intensity grade and relationship to vaccination. Grade 3 symptom = symptoms that prevented normal activity. Grade 3 Fever = fever higher than (>) 39.0 °C. Related = symptom considered by the investigator to be casually related with the study vaccination.
Number of Subjects With Unsolicited Adverse Events (AEs)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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 the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. Related symptoms were not available.
Number of Subjects With AEs
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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 the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. Related symptoms were not available.
Number of Subjects With Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Number of Subjects With New Onset Chronic Diseases (NOCDs)
NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.
Number of Subjects With Medically Significant Conditions (MSCs)
MSCs prompting emergency room or physician visits that were not related to common diseases or routine visits. Common diseases included upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.

Secondary Outcome Measures

Anti- Haemagglutinin Antibody (Anti-HA) Titers Against Avian Influenza A Subtype H5N1
Anti-HA antibody titers were expressed as Geometric Mean Tiyers (GMTs).
Number of Seroconverted Subjects Against H5N1
Seroconversion rate for Haemagglutinin antibody response was defined as the number of vaccinees who had either a pre-vaccination titer lower than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40 or a pre-vaccination titer ≥ 1:10 and at least a fourfold increase in post-vaccination titer. Seroconversion rate for Neutralising antibody response was defined as the percentage of vaccinees with a minimum 4-fold increase in titer at post-vaccination.
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against A/Vietnam Influenza Strain
Seroconversion factor was defined as the fold increase in serum HI GMTs post-vaccination compared to day 0.
Number of Seroprotected Subjects Against A/Vietnam Influenza Strain
Seroprotection rate was defined as the number of vaccinees with a serum HI titer ≥1:40 that usually is accepted as indicating protection.

Full Information

First Posted
April 26, 2006
Last Updated
May 28, 2018
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00319098
Brief Title
Study to Evaluate the Safety and Immunogenicity of a Pandemic Influenza Vaccine in Adults Aged 18 Years and Above
Official Title
A Phase III, Observer-blind, Randomised Study to Evaluate the Safety and Immunogenicity of One and Two Administrations of Pandemic Monovalent (H5N1) Influenza Vaccine (Adjuvanted Split Virus Formulation) in Adults Aged 18 Years and Older
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
May 1, 2006 (Actual)
Primary Completion Date
January 1, 2007 (Actual)
Study Completion Date
July 31, 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

Brief Summary
Today, the leading contender for the next pandemic of influenza is H5N1, a strain of avian virus. Prevention and control will depend on the rapid production and worldwide distribution of specific pandemic vaccines. Candidate 'pandemic-like' vaccines must be developed and tested in clinical trials to determine the most optimal formulation and the best vaccination schedule. This study is designed to test in healthy adults aged above 18 years the reactogenicity and immunogenicity of one and two administrations of a candidate pandemic H5N1 vaccine formulated from Split Virus.
Detailed Description
This study has 2 phases: The study ID 107064 corresponds to objectives & outcome measures evaluated from day 0 until day 51. The study ID 107217 corresponds to objectives & outcome measures evaluated at day 180. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Adjuvanted pandemic influenza candidate vaccine, Influenza

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
5075 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GSK1562902A Group
Arm Type
Experimental
Arm Description
Male and female subjects aged 18 or over received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm. The group was further stratified by age for analyses.
Arm Title
Fluarix+Placebo Group
Arm Type
Active Comparator
Arm Description
Male and female subjects aged 18 or over received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm. The group was further stratified by age for analyses.
Intervention Type
Biological
Intervention Name(s)
Adjuvanted pandemic influenza candidate vaccine
Intervention Description
2 doses, intramuscular injection
Intervention Type
Biological
Intervention Name(s)
Fluarix
Intervention Description
One intramuscular injection
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
One intramuscular injection
Primary Outcome Measure Information:
Title
Number of Subjects With Solicited Local Symptoms
Description
Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling. Any = occurrence of symptom regardless of intensity grade. Grade 3 Pain = pain that prevented normal everyday activities Grade 3 ecchymosis/induration/redness/swelling = redness/swelling spreading beyond (>) 50 millimeters (mm) in diameter
Time Frame
During a 7 day follow-up period after each dose of vaccine and overall.
Title
Number of Subjects With Solicited General Symptoms (Dose 1)
Description
Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], headache, myalgia, shivering, sweating. Any = occurrence of symptom regardless of intensity grade and relationship to vaccination. Grade 3 symptom = symptoms that prevented normal activity. Grade 3 Fever = fever higher than (>) 39.0 °C. Related = symptom considered by the investigator to be casually related with the study vaccination.
Time Frame
During the 7-day (Days 0-6) after Dose 1
Title
Number of Subjects With Solicited General Symptoms (Dose 2)
Description
Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], headache, myalgia, shivering, sweating. Any = occurrence of symptom regardless of intensity grade and relationship to vaccination. Grade 3 symptom = symptoms that prevented normal activity. Grade 3 Fever = fever higher than (>) 39.0 °C. Related = symptom considered by the investigator to be casually related with the study vaccination.
Time Frame
During the 7-day (Days 0-6) after Dose 2
Title
Number of Subjects With Solicited General Symptoms (Across Doses)
Description
Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], headache, myalgia, shivering, sweating. Any = occurrence of symptom regardless of intensity grade and relationship to vaccination. Grade 3 symptom = symptoms that prevented normal activity. Grade 3 Fever = fever higher than (>) 39.0 °C. Related = symptom considered by the investigator to be casually related with the study vaccination.
Time Frame
During the 7-day (Days 0-6) post vaccination across dosses
Title
Number of Subjects With Unsolicited Adverse Events (AEs)
Description
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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 the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. Related symptoms were not available.
Time Frame
During the 21st Day (Days 0-20) post Dose 1
Title
Number of Subjects With AEs
Description
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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 the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. Related symptoms were not available.
Time Frame
During the 30 Day (Days 0-29) post Dose 2
Title
Number of Subjects With Serious Adverse Events (SAEs)
Description
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time Frame
From Day 0 to Day 180
Title
Number of Subjects With New Onset Chronic Diseases (NOCDs)
Description
NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.
Time Frame
From Day 0 to Day 180
Title
Number of Subjects With Medically Significant Conditions (MSCs)
Description
MSCs prompting emergency room or physician visits that were not related to common diseases or routine visits. Common diseases included upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.
Time Frame
From Day 0 to Day 51
Secondary Outcome Measure Information:
Title
Anti- Haemagglutinin Antibody (Anti-HA) Titers Against Avian Influenza A Subtype H5N1
Description
Anti-HA antibody titers were expressed as Geometric Mean Tiyers (GMTs).
Time Frame
At Day 0 (PRE), 21 and 42
Title
Number of Seroconverted Subjects Against H5N1
Description
Seroconversion rate for Haemagglutinin antibody response was defined as the number of vaccinees who had either a pre-vaccination titer lower than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40 or a pre-vaccination titer ≥ 1:10 and at least a fourfold increase in post-vaccination titer. Seroconversion rate for Neutralising antibody response was defined as the percentage of vaccinees with a minimum 4-fold increase in titer at post-vaccination.
Time Frame
At Day 21 and Day 42
Title
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against A/Vietnam Influenza Strain
Description
Seroconversion factor was defined as the fold increase in serum HI GMTs post-vaccination compared to day 0.
Time Frame
At Day 21 and Day 42
Title
Number of Seroprotected Subjects Against A/Vietnam Influenza Strain
Description
Seroprotection rate was defined as the number of vaccinees with a serum HI titer ≥1:40 that usually is accepted as indicating protection.
Time Frame
At Day 0 (PRE), Day 21 and Day 42

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subjects who the investigator believes that they can and will comply with the requirements of the protocol. A male or female aged 18 years or above at the time of the first vaccination. Written informed consent obtained from the subject. Healthy subjects as established by medical history and clinical examination before entering into the study. If the subject is female, she must be of non-childbearing potential, for 30 days prior to first vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series. Exclusion Criteria: Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. Planned administration of a vaccine not foreseen by the study protocol up to 30 days after the second vaccination. Administration of interpandemic influenza vaccine between Day 0 and Day 51of the study. Those study participants belonging to risk groups eligible to receive the annual interpandemic influenza vaccine (in accordance with local regulations) can receive the annual vaccination after day 51 and before the end of the study on Day 180. Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the first administration of the study vaccine. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination History of chronic alcohol consumption and/or drug abuse. History of hypersensitivity to vaccines. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests. Major congenital defects or serious chronic disease including any medically significant chronic pulmonary, cardiovascular, renal, neurological, psychiatric or metabolic disorder, as determined by medical history and physical examination. (Subjects suffering from seasonal allergies or asthma under inhalative treatment can be included). Acute disease at the time of enrolment. Administration of immunoglobulins and/or any blood products within the 3 months preceding the first administration of the study vaccine or during the study. Lactating women Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days prior to the first vaccination, or planned use during the study period.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Tallinn
ZIP/Postal Code
10617
Country
Estonia
Facility Name
GSK Investigational Site
City
Tartu
ZIP/Postal Code
50417
Country
Estonia
Facility Name
GSK Investigational Site
City
Caen cedex 4
ZIP/Postal Code
14052
Country
France
Facility Name
GSK Investigational Site
City
Lagord
ZIP/Postal Code
17140
Country
France
Facility Name
GSK Investigational Site
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
GSK Investigational Site
City
Paris Cedex 18
ZIP/Postal Code
75877
Country
France
Facility Name
GSK Investigational Site
City
Poitiers
ZIP/Postal Code
86000
Country
France
Facility Name
GSK Investigational Site
City
Rouen
ZIP/Postal Code
76100
Country
France
Facility Name
GSK Investigational Site
City
Muenchen
State/Province
Bayern
ZIP/Postal Code
80799
Country
Germany
Facility Name
GSK Investigational Site
City
Muenchen
State/Province
Bayern
ZIP/Postal Code
81667
Country
Germany
Facility Name
GSK Investigational Site
City
Regensburg
State/Province
Bayern
ZIP/Postal Code
93053
Country
Germany
Facility Name
GSK Investigational Site
City
Wuerzburg
State/Province
Bayern
ZIP/Postal Code
97070
Country
Germany
Facility Name
GSK Investigational Site
City
Schwerin
State/Province
Mecklenburg-Vorpommern
ZIP/Postal Code
19055
Country
Germany
Facility Name
GSK Investigational Site
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30519
Country
Germany
Facility Name
GSK Investigational Site
City
Witten
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
58455
Country
Germany
Facility Name
GSK Investigational Site
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01067
Country
Germany
Facility Name
GSK Investigational Site
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04103
Country
Germany
Facility Name
GSK Investigational Site
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04229
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
10787
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
14057
Country
Germany
Facility Name
GSK Investigational Site
City
Hamburg
ZIP/Postal Code
20249
Country
Germany
Facility Name
GSK Investigational Site
City
Hamburg
ZIP/Postal Code
22143
Country
Germany
Facility Name
GSK Investigational Site
City
Rotterdam
ZIP/Postal Code
3011 EN
Country
Netherlands
Facility Name
GSK Investigational Site
City
Rotterdam
ZIP/Postal Code
3015 GE
Country
Netherlands
Facility Name
GSK Investigational Site
City
Ekaterinburg
ZIP/Postal Code
620028
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Ekaterinburg
ZIP/Postal Code
620078
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Kazan
ZIP/Postal Code
420015
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Novokuznetsk
ZIP/Postal Code
654063
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Saratov
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
GSK Investigational Site
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
GSK Investigational Site
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
GSK Investigational Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
GSK Investigational Site
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
GSK Investigational Site
City
Marid
ZIP/Postal Code
28040
Country
Spain
Facility Name
GSK Investigational Site
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Facility Name
GSK Investigational Site
City
Valencia
ZIP/Postal Code
46017
Country
Spain
Facility Name
GSK Investigational Site
City
Eskilstuna
ZIP/Postal Code
SE-631 88
Country
Sweden
Facility Name
GSK Investigational Site
City
Stockholm
ZIP/Postal Code
SE-141 86
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Citations:
PubMed Identifier
18407382
Citation
Rumke HC, Bayas JM, de Juanes JR, Caso C, Richardus JH, Campins M, Rombo L, Duval X, Romanenko V, Schwarz TF, Fassakhov R, Abad-Santos F, von Sonnenburg F, Drame M, Sanger R, Ballou WR. Safety and reactogenicity profile of an adjuvanted H5N1 pandemic candidate vaccine in adults within a phase III safety trial. Vaccine. 2008 May 2;26(19):2378-88. doi: 10.1016/j.vaccine.2008.02.068. Epub 2008 Mar 27.
Results Reference
derived
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
107064
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
107064
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
107064
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
107064
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
107064
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register. The results of this study 107064 are summarised with study 107217 on the GSK Clinical Study Register.
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
107064
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

Study to Evaluate the Safety and Immunogenicity of a Pandemic Influenza Vaccine in Adults Aged 18 Years and Above

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