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

Browse trials for

• Influenza, Human 2,214

Keywords

• Adjuvanted pandemic influenza candidate vaccine
• Influenza

Influenza, Human

2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.

This study's enrollment of 5,075 is above the median of 238 across 1,853 interventional studies indexed under Influenza, Human.

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Study arms

• Experimental
  GSK1562902A Group

  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.

  Biological: Adjuvanted pandemic influenza candidate vaccine

• Active comparator
  Fluarix+Placebo Group

  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.

  Biological: Fluarix · Biological: Placebo

Interventions

• BiologicalAdjuvanted pandemic influenza candidate vaccine

  2 doses, intramuscular injection

• BiologicalFluarix

  One intramuscular injection

• BiologicalPlacebo

  One intramuscular injection

Primary outcomes

1. 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

   Time frame: During a 7 day follow-up period after each dose of vaccine and overall.

2. 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.

   Time frame: During the 7-day (Days 0-6) after Dose 1

3. 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.

   Time frame: During the 7-day (Days 0-6) after Dose 2

4. 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.

   Time frame: During the 7-day (Days 0-6) post vaccination across dosses

5. 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.

   Time frame: During the 21st Day (Days 0-20) post Dose 1

6. 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.

   Time frame: During the 30 Day (Days 0-29) post Dose 2

7. 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.

   Time frame: From Day 0 to Day 180

8. Number of Subjects With New Onset Chronic Diseases (NOCDs)

   NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.

   Time frame: From Day 0 to Day 180

9. 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.

   Time frame: From Day 0 to Day 51

Secondary outcomes

1. Anti- Haemagglutinin Antibody (Anti-HA) Titers Against Avian Influenza A Subtype H5N1

   Anti-HA antibody titers were expressed as Geometric Mean Tiyers (GMTs).

   Time frame: At Day 0 (PRE), 21 and 42

2. 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.

   Time frame: At Day 21 and Day 42

3. 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.

   Time frame: At Day 21 and Day 42

4. 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.

   Time frame: At Day 0 (PRE), Day 21 and Day 42

Baseline characteristics

Publications

• 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. PubMed 18407382 ↗

Related links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. ↗

Individual participant data

Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.