Safety and Immune Response Study of GSK Biologicals' Influenza Virus Vaccine 1388442A Compared With Fluarix

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• Influenza, Human 2,214

Keywords

• cell culture
• Safety
• Influenza
• Humans
• Adults
• Immunogenicity
• Influenza vaccine
• Vaccine

Influenza, Human

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

This study's enrollment of 200 is below 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
  GSK 1388442A Group

  Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

  Biological: Trivalent influenza vaccine GSK 138842A

• Active comparator
  Fluarix Group

  Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

  Biological: Fluarix

Interventions

• BiologicalTrivalent influenza vaccine GSK 138842A

  IM injection on Day 0

• BiologicalFluarix

  IM injection on Day 0

Primary outcomes

1. Number of Subjects With Solicited Local Symptoms.

   Solicited local symptoms were pain, redness and swelling at the injection site. Any = occurrence of a symptom regardless of intensity.

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

2. Number of Subjects With Solicited General Symptoms.

   Solicited general symptoms were arthralgia, fatigue, headache, muscle aches, shivering and temperature, assessed as oral temperature above or equal (≥) 38.0 degrees Celsius (°C). Any = occurrence of a symptom regardless of intensity or relationship to vaccination.

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

3. Number of Subjects With Medically Attended Adverse Events (MAEs).

   Medically-attended events (MAEs) refer to non-serious and serious events leading to an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits and hospitalization. Related MAE = MAE assessed by the investigator as related to the vaccination.

   Time frame: During the entire study period (Days 0-182)

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

   NOCDs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies.

   Time frame: During the entire study period (Days 0-182)

5. Number of Subjects With Unsolicited Adverse Events (AEs).

   Unsolicited AEs cover 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. Any unsolicited AE = any unsolicited AE regardless of intensity or relationship to vaccination.

   Time frame: During the 90-day (Days 0-89) post-vaccination period

6. Number of Subjects With Serious Adverse Events (SAEs).

   Serious adverse events (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 SAE = any SAE regardless of intensity or relationship to vaccination.

   Time frame: During the entire study period (Days 0-182)

7. Titers for Serum Hemagglutination Inhibition (HI) Antibodies for 3 Strains of Influenza Disease.

   Titers are presented as geometric mean titers (GMTs). The 3 influenza strains assessed were A/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2) and B/Malaysia/2506/2004 (MALAY.)

   Time frame: At Day 21

8. Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.

   A seroprotected subject was defined as a vaccinated subject with a serum HI antibody titer ≥ 1:40, a level of HI antibody that has been viewed as correlating with protection against influenza. The 3 influenza strains assessed were A/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2) and B/Malaysia/2506/2004 (MALAY.)

   Time frame: At Day 21

9. Number of Seroconverted Subjects Against 3 Strains of Influenza Disease.

   A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer \<1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 3 influenza strains assessed were A/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2) and B/Malaysia/2506/2004 (MALAY.)

   Time frame: At Day 21

10. Geometric Mean Fold-rise (GMFR) in 3 Strains of Influenza Disease.

    GMFR was defined as the geometric mean of the ratio of the post-vaccination inverse HI titer to the Day 0 inverse HI titer. The 3 influenza strains assessed were A/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2) and B/Malaysia/2506/2004 (MALAY.)

    Time frame: At Day 0 and Day 21

Baseline characteristics

Related links

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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.