Study to Evaluate Immunological Equivalence Between Two Investigational Influenza Vaccines in Adults (H1N1)

GlaxoSmithKline336 enrolled

Overview

The primary purpose of the study is to assess the equivalence of the immune response elicited by two GSK Biologicals' adjuvanted influenza investigational vaccines (GSK2340272A and GSK2340274A) in adults aged 18 to 60 years. The second purpose of the study is to evaluate the safety and reactogenicity of these two vaccines.

This Protocol Posting has been updated following Protocol Amendment 4, July 2010, leading to removal of one of the secondary outcome measures.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

336

Conditions

Influenza

Interventions

Influenza vaccine GSK2340272ABIOLOGICAL

Two intramuscular injections at Day 0 and Day 21

Influenza vaccine GSK2340274ABIOLOGICAL

Two intramuscular injections at Day 0 and Day 21

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female aged 18 to 60 years inclusive, at the time of the first vaccination. * Subjects who the investigator believes that they can and will comply with the requirements of the protocol. * Written informed consent obtained from the subject. * Satisfactory baseline medical assessment by history and physical examination. * Access to a consistent means of telephone contact, which may be either in the home or at the workplace, land line or mobile, but NOT a pay phone or multiple-user device * Females of non-childbearing potential may be enrolled in the study. * Female of childbearing potential may be enrolled in the study, if she: * has practiced adequate contraception for 30 days prior to vaccination, and * has a negative pregnancy test on the day of vaccination, and * has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series. Exclusion Criteria: * Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period. * Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, although stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports. * Presence of an axillary temperature \>= 37.5°C (99.5°F), or acute symptoms greater than "mild" severity on the scheduled date of first vaccination. NOTE: The subject may be vaccinated at a later date, provided symptoms have resolved, vaccination occurs within the window specified by the protocol, and all other eligibility criteria continue to be satisfied. * Clinically or virologically confirmed influenza infection within 6 months preceding the study start. * Diagnosed with cancer, or treatment for cancer, within 3 years. * Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus (HIV) infection. * Clinically or virologically confirmed influenza infection within 6 months preceding the study start. * Chronic administration of immunosuppressants or other immune modifying drugs within 6 months of study enrolment or planned administration during the study period. * Receipt of any immunoglobulins and/or any blood products within 3 months of study enrolment or planned administration of any of these products during the study period. * Any significant disorder of coagulation or treatment with warfarin derivatives or heparin. * An acute evolving neurological disorder or history of Guillain-Barré syndrome. * Administration of any vaccines within 30 days before vaccination. * Any known or suspected allergy to any constituent of influenza vaccines; a history of anaphylactic-type reaction to any constituent of influenza vaccines; or a history of severe adverse reaction to a previous influenza vaccine. * Pregnant or lactating female * Female planning to become pregnant or planning to discontinue contraceptive precautions. * Any conditions which, in the opinion of the investigator, prevents the subjects from participating in the study.

Locations (7)

GSK Investigational Site

Caen, France

GSK Investigational Site

Paris, France

GSK Investigational Site

Paris, France

GSK Investigational Site

Poitiers, France

Outcomes

Primary Outcomes

Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease

Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/CAL/7/09. The reference seropositivity cut-off value was greater than or equal to (≥) 1:10.

Time frame: At Day 21

Secondary Outcomes

Number of Seroconverted (SCR) Subjects for HI Antibodies

Seroconversion was defined as: For initially seronegative subjects \[antibody titer below (\<) 1:10 prior to vaccination\], antibody titer greater than or equal to (≥) 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09).

Time frame: At Days 21 and 42

Number of SCR Subjects for HI Antibodies

Seroconversion was defined as: For initially seronegative subjects \[antibody titer below (\<) 1:10 post to vaccination\], antibody titer greater than or equal to (≥) 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09).

Time frame: At Days 182 and 364

Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease

Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/CAL/7/09. The reference seropositivity cut-off value was ≥ 1:10.

Time frame: At Days 0 and 42

Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease

Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/CAL/7/09. The reference seropositivity cut-off value was ≥ 1:10.

Data from ClinicalTrials.gov

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GSK Investigational Site

Regensburg, Bavaria, Germany

GSK Investigational Site

Würzburg, Bavaria, Germany

GSK Investigational Site

Schmiedeberg, Saxony, Germany

Time frame: At Days 182 and 364

Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain

A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40, that usually is accepted as indicating protection.

Time frame: At Days 0, 21 and 42

Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain

A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40, that usually is accepted as indicating protection.

Time frame: At Days 182 and 364

Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease

GMFR was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09.

Time frame: At Days 21 and 42

Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease

GMFR was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09.

Time frame: At Days 182 and 364

Number of Subjects With Any and Grade 3 Solicited Local Symptoms

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.

Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses

Number of Days With Solicited Local Symptoms

The number of days with any solicited local symptoms reported during the solicited post-vaccination period.

Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses

Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms

Assessed solicited general symptoms were fatigue, headache, joint pain at other location, muscle aches, shivering, sweating and fever \[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptom = general symptom that prevented normal everyday activities as assessed by inability to attend/do work or school, or required intervention of a physician/healthcare provider. Grade 3 fever = temperature \> 39.0 °C and ≤ 40°C. Related = symptom assessed by the investigator as related to the vaccination.

Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses

Number of Days With Solicited General Symptoms

The number of days with any solicited general symptoms reported during the solicited post-vaccination period.

Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses

Number of Subjects With Potential Immune-mediated Diseases (pIMDs)

A pIMD was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.

Time frame: From Day 0 up to Day 42

Number of Subjects With pIMDs

A pIMD was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.

Time frame: During the entire study period (from Day 0 up to Day 364)

Number of Subjects With Any Adverse Event of Special Interest (AESIs)

An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.

Time frame: During the entire study period (from Day 0 up to Day 364)

Number of Subjects With Any, Grade 3 and Related 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.

Time frame: Within 21 days after the first vaccination (Days 0 - 20) and 63 days after the second vaccination (up to Day 84)

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: During the entire study period (from Day 0 up to Day 364)