NCT01153685

Immunogenicity & Safety Study of Fluviral® (2010 - 2011 Season) in Adults Aged 18 to 60 Years and Over 60 Years

Completed Phase 3 Results posted Last updated 8 June 2018

What this trial tests

Phase 3 trial testing Fluviral® in Influenza in 120 participants. Completed in 31 July 2010.

Timeline

9 July 2010

Primary endpoint
31 July 2010

31 July 2010

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	120
Start date	9 July 2010
Primary completion	31 July 2010
Estimated completion	31 July 2010
Sites	1 location across Canada

Drugs / interventions tested

• Fluviral®

Conditions studied

• Influenza — all drugs for Influenza →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

18 and older, any sex, with Influenza. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Geometric Mean Titers (GMTs) of Haemagglutination Inhibition (HI) Antibodies Against Fluviral Vaccine Strains. Primary · At Day 0 before vaccination

The Fluviral vaccine strains were A/California (H1N1), A/Victoria (H3N2) and B/Brisbane

A/California (H1N1)

Group	Value	95% CI
Fluviral A Group	39.2	24.0 – 63.8
Fluviral B Group	15.2	11.1 – 21.0

A/Victoria (H3N2)

Group	Value	95% CI
Fluviral A Group	14.1	10.1 – 19.8
Fluviral B Group	13.0	9.8 – 17.3

B/Brisbane

Group	Value	95% CI
Fluviral A Group	22.7	15.2 – 34.0
Fluviral B Group	28.0	21.5 – 36.5

Geometric Mean Titers (GMTs) of Haemagglutination Inhibition (HI) Antibodies Against Fluviral Vaccine Strains. Primary · At Day 21 after vaccination

The Fluviral vaccine strains were A/California (H1N1), A/Victoria (H3N2) and B/Brisbane

A/California (H1N1)

Group	Value	95% CI
Fluviral A Group	390.1	293.8 – 518.1
Fluviral B Group	142.1	105.1 – 192.0

A/Victoria (H3N2)

Group	Value	95% CI
Fluviral A Group	185.6	140.9 – 244.5
Fluviral B Group	183.7	139.6 – 241.8

B/Brisbane

Group	Value	95% CI
Fluviral A Group	260.6	184.6 – 368.0
Fluviral B Group	248.6	185.9 – 332.3

Number of Seroprotected Subjects for Antibodies Against Fluviral Vaccine Strains. Primary · At Day 0 before vaccination

A Seroprotected subject was defined as a subject with a serum haemagglutination inhibition (HI) antibody titer greater than or equal to 1:40.

A/California (H1N1)

Group	Value	95% CI
Fluviral A Group	29
Fluviral B Group	22

A/Victoria (H3N2)

Group	Value	95% CI
Fluviral A Group	15
Fluviral B Group	17

B/Brisbane

Group	Value	95% CI
Fluviral A Group	21
Fluviral B Group	35

Number of Seroprotected Subjects for Antibodies Against Fluviral Vaccine Strains. Primary · At Day 21 after vaccination

A Seroprotected subject was defined as a subject with a serum haemagglutination inhibition (HI) antibody titer greater than or equal to 1:40.

A/California (H1N1)

Group	Value	95% CI
Fluviral A Group	49
Fluviral B Group	62

A/Victoria (H3N2)

Group	Value	95% CI
Fluviral A Group	48
Fluviral B Group	65

B/Brisbane

Group	Value	95% CI
Fluviral A Group	47
Fluviral B Group	69

Number of Seroconverted Subjects for Antibodies Against Fluviral Vaccine Strains. Primary · At Day 21 after vaccination

A subject seroconverted for haemagglutination inhibition (HI) antibodies was defined as a subject with either a prevaccination (Day 0) HI antibody titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a prevaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer.

A/California (H1N1)

Group	Value	95% CI
Fluviral A Group	35
Fluviral B Group	50

A/Victoria (H3N2)

Group	Value	95% CI
Fluviral A Group	41
Fluviral B Group	57

B/Brisbane

Group	Value	95% CI
Fluviral A Group	33
Fluviral B Group	51

Seroconversion Factor for Antibodies Against Fluviral Vaccine Strains. Primary · At Day 21 after vaccination

Seroconversion Factor (SCF) is defined as the fold increase in serum HI antibody GMTs post-vaccination (Day 21) compared to prevaccination (Day 0).

A/California (H1N1)

Group	Value	95% CI
Fluviral A Group	10.0	6.3 – 15.7
Fluviral B Group	9.3	6.8 – 12.8

A/Victoria (H3N2)

Group	Value	95% CI
Fluviral A Group	13.1	9.3 – 18.5
Fluviral B Group	14.1	10.2 – 19.5

B/Brisbane

Group	Value	95% CI
Fluviral A Group	11.5	7.0 – 18.7
Fluviral B Group	8.9	6.3 – 12.4

Number of Subjects With Solicited Local and General Symptoms After Administration of Fluviral. Secondary · During a 4-days (Day 0-3) follow-up period after vaccination.

Solicited local symptoms assessed were pain, redness and swelling at the injection site. Solicited general symptoms assessed were bronchospasm, chills, cough, fatigue, headache, joint pain at other location, muscle aches, red eyes, sore throat, swelling of the face and temperature (defined as orally temperature equal or above 38.0 degrees Celcius)

Pain

Group	Value	95% CI
Fluviral A Group	41
Fluviral B Group	18

Redness

Group	Value	95% CI
Fluviral A Group	0
Fluviral B Group	0

Swelling

Group	Value	95% CI
Fluviral A Group	2
Fluviral B Group	1

Bronchospasm

Group	Value	95% CI
Fluviral A Group	0
Fluviral B Group	3

Chills

Group	Value	95% CI
Fluviral A Group	2
Fluviral B Group	0

Cough

Group	Value	95% CI
Fluviral A Group	2
Fluviral B Group	0

Fatigue

Group	Value	95% CI
Fluviral A Group	15
Fluviral B Group	7

Headache

Group	Value	95% CI
Fluviral A Group	13
Fluviral B Group	6

Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Secondary · Within the 21-day post-vaccination period

Unsolicited adverse events (AE) covers any AE reported in addition to those solicited during the clinical study and any solicited symptoms with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of any adverse event regardless of intensity grade or relationship to vaccination. Grade 3 = an unsolicited AE that prevented normal everyday activity. Related = event assessed by the investigator as causally related to the vaccination.

Any

Group	Value	95% CI
Fluviral A Group	16
Fluviral B Group	17

Grade 3

Group	Value	95% CI
Fluviral A Group	1
Fluviral B Group	0

Related

Group	Value	95% CI
Fluviral A Group	8
Fluviral B Group	3

Number of Subjects Reporting Unsolicited Adverse Events (AEs). Secondary · Within the 21-day post-vaccination period

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.

Headache

Group	Value	95% CI
Fluviral A Group	1
Fluviral B Group	3

Nausea

Group	Value	95% CI
Fluviral A Group	3
Fluviral B Group	1

Diarrhoea

Group	Value	95% CI
Fluviral A Group	3
Fluviral B Group	0

Dizziness

Group	Value	95% CI
Fluviral A Group	1
Fluviral B Group	2

Abdominal pain

Group	Value	95% CI
Fluviral A Group	2
Fluviral B Group	0

Cough

Group	Value	95% CI
Fluviral A Group	0
Fluviral B Group	2

Back pain

Group	Value	95% CI
Fluviral A Group	0
Fluviral B Group	1

Breast pain

Group	Value	95% CI
Fluviral A Group	0
Fluviral B Group	1

Number of Subjects With Serious Adverse Events (SAEs) Secondary · During the entire study period

SAEs assessed include medical occurences that results 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.

Group	Value	95% CI
Fluviral A Group	2
Fluviral B Group	0

Adverse events — posted to ClinicalTrials.gov

Time frame: Solicited symptoms: during a 4-day follow-up period after vaccination. Unsolicited symptoms: during 21 days following the vaccination (Day 0-21). Serious adverse events: during the entire study period (21 days). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Fluviral A Group

Serious: 2/50 (4%)

Deaths: —

Fluviral B Group

Serious: 0/70 (0%)

Deaths: —

Serious adverse events (2 terms)

Reaction	System	Fluviral A Group	Fluviral B Group
Crohn's disease	Gastrointestinal disorders	—	—
Renal colic	Renal and urinary disorders	—	—

Other adverse events (9 terms — click to expand)

Reaction	System	Fluviral A Group	Fluviral B Group
Pain	General disorders	—	—
Muscle aches	Musculoskeletal and connective tissue disorders	—	—
Fatigue	General disorders	—	—
Headache	Nervous system disorders	—	—
Sore throat	Infections and infestations	—	—
Joint pain at other location	General disorders	—	—
Red eyes	Eye disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Diarrhoea	Gastrointestinal disorders	—	—

Most-reported serious reactions: Crohn's disease, Renal colic.

Data from ClinicalTrials.gov NCT01153685 adverse events section.

Sponsor's own description

This study is designed to test the safety and immunogenicity of Fluviral® (2010 - 2011 Season) in adults aged 18 to 60 years and over 60 years.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A historically-controlled Phase III study in adults to characterize the acceptability of a process change for manufacturing inactivated quadrivalent influenza vaccine.
   Jain VK, Chandrasekaran V, Wang L, Li P, et al · · 2014 · cited 5× · PMID 24606983 · DOI 10.1186/1471-2334-14-133