Who is sponsoring NCT00506350?

NCT00506350 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT00506350?

Interventions in NCT00506350: Pandemic influenza candidate vaccine (GSK1562902A) - 1 dose, Pandemic influenza candidate vaccine (GSK1562902A) - 2 doses.

Is NCT00506350 still recruiting?

NCT00506350 is currently completed. Last updated 4 October 2017.

Are results published for NCT00506350?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2017-10-04 · How we verify

NCT00506350

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Evaluate Reactogenicity & Immunogenicity of an Influenza Pandemic Candidate Vaccine (GSK1562902A) in Primed Adults

Completed Phase 2 Results posted Last updated 4 October 2017

What this trial tests

Phase 2 trial testing Pandemic influenza candidate vaccine (GSK1562902A) - 1 dose in Influenza in 350 participants. Completed in 12 October 2009.

Timeline

1 August 2007

Primary endpoint
12 October 2009

12 October 2009

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	350
Start date	1 August 2007
Primary completion	12 October 2009
Estimated completion	12 October 2009
Sites	1 location across Belgium

Drugs / interventions tested

Pandemic influenza candidate vaccine (GSK1562902A) - 1 dose — full drug profile →
Pandemic influenza candidate vaccine (GSK1562902A) - 2 doses — full drug profile →

Conditions studied

Influenza — all drugs for Influenza →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 19 to 61, 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.

Titers for Serum H5N1 Haemagglutinin Inhibition (HI) Antibodies Against the A/Indonesia/05/2005 Strain Primary · At Day 0

Titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was A/Indonesia/05/2005.

Group	Value	95% CI
GSK1562902A AD F1 Primed Group	5.1	4.9 – 5.3
GSK1562902A AD F2 Primed Group	5.6	4.8 – 6.5
GSK1562902A AD F3 Primed Group	5.3	4.9 – 5.8
GSK1562902A AD Approved F Primed Group	5.2	4.8 – 5.5

Titers for Serum H5N1 Haemagglutinin Inhibition (HI) Antibodies Against the A/Indonesia/05/2005 Strain Primary · At Day 21

Titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was A/Indonesia/05/2005.

Group	Value	95% CI
GSK1562902A AD F1 Primed Group	406.8	225.9 – 732.7
GSK1562902A AD F2 Primed Group	429.5	281.2 – 655.9
GSK1562902A AD F3 Primed Group	208.4	126.3 – 343.9
GSK1562902A AD Approved F Primed Group	347.9	213.6 – 566.8

Number of Seroconverted Subjects for H5N1 HI Antibodies Against the A/Indonesia/05/2005 Strain Primary · At Day 21

Seroconversion rate for HI antibody response was defined as the percentage of vaccines who have 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 4-fold increase in post-vaccination titer.

Group	Value	95% CI
GSK1562902A AD F1 Primed Group	36
GSK1562902A AD F2 Primed Group	33
GSK1562902A AD F3 Primed Group	34
GSK1562902A AD Approved F Primed Group	31

Seroconversion Factor (SCF) for H5N1 HI Antibodies Against the A/Indonesia/05/2005 Strain Primary · At Day 21

Seroconversion factor (SCF) was defined as the fold increase in H5N1 HI antibody GMTs post-vaccination compared to Day 0. The flu strain assessed was A/Indonesia/05/2005.

Group	Value	95% CI
GSK1562902A AD F1 Primed Group	79.9	44.5 – 143.6
GSK1562902A AD F2 Primed Group	76.5	50.7 – 115.6
GSK1562902A AD F3 Primed Group	39.1	24.2 – 63.1
GSK1562902A AD Approved F Primed Group	76.9	51.5 – 115.0

Number of Seroprotected Subjects for H5N1 HI Antibodies Against the A/Indonesia/05/2005 Strain Primary · At Day 0

A seroprotected subject was defined as a vaccinated subject with a serum HI titer equal to or above (≥) 1:40. The flu strain assessed was A/Indonesia/05/2005.

Group	Value	95% CI
GSK1562902A AD F1 Primed Group	0
GSK1562902A AD F2 Primed Group	1
GSK1562902A AD F3 Primed Group	0
GSK1562902A AD Approved F Primed Group	0

Number of Seroprotected Subjects for H5N1 HI Antibodies Against the A/Indonesia/05/2005 Strain Primary · At Day 21

A seroprotected subject was defined as a vaccinated subject with a serum HI titer equal to or above (≥) 1:40. The flu strain assessed was A/Indonesia/05/2005.

Group	Value	95% CI
GSK1562902A AD F1 Primed Group	36
GSK1562902A AD F2 Primed Group	33
GSK1562902A AD F3 Primed Group	34
GSK1562902A AD Approved F Primed Group	31

Number of Subjects With Any and Grade 3 Solicited Local Symptoms Primary · During the 7-day (Days 0-6) post-vaccination period following each dose and across doses

Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 ecchymosis/induration/redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. No subject from GSK1562902A AD F1 Primed Group has received Dose 2.

Any Ecchymosis, Dose 1

Group	Value	95% CI
GSK1562902A Non-AD F1 Primed Group	0
GSK1562902A Non-AD F2 Primed Group	0
GSK1562902A Non-AD F3 Primed Group	0
GSK1562902A Non-AD F4 Primed Group	0
Control Group	0
GSK1562902A AD F1 Primed Group	0
GSK1562902A AD F2 Primed Group	0
GSK1562902A AD F3 Primed Group	0
GSK1562902A AD Approved F Primed Group	0

Grade 3 Ecchymosis, Dose 1

Group	Value	95% CI
GSK1562902A Non-AD F1 Primed Group	0
GSK1562902A Non-AD F2 Primed Group	0
GSK1562902A Non-AD F3 Primed Group	0
GSK1562902A Non-AD F4 Primed Group	0
Control Group	0
GSK1562902A AD F1 Primed Group	0
GSK1562902A AD F2 Primed Group	0
GSK1562902A AD F3 Primed Group	0
GSK1562902A AD Approved F Primed Group	0

Any Induration, Dose 1

Group	Value	95% CI
GSK1562902A Non-AD F1 Primed Group	5
GSK1562902A Non-AD F2 Primed Group	1
GSK1562902A Non-AD F3 Primed Group	3
GSK1562902A Non-AD F4 Primed Group	2
Control Group	2
GSK1562902A AD F1 Primed Group	2
GSK1562902A AD F2 Primed Group	3
GSK1562902A AD F3 Primed Group	3
GSK1562902A AD Approved F Primed Group	4

Grade 3 Induration, Dose 1

Group	Value	95% CI
GSK1562902A Non-AD F1 Primed Group	0
GSK1562902A Non-AD F2 Primed Group	0
GSK1562902A Non-AD F3 Primed Group	0
GSK1562902A Non-AD F4 Primed Group	0
Control Group	0
GSK1562902A AD F1 Primed Group	0
GSK1562902A AD F2 Primed Group	0
GSK1562902A AD F3 Primed Group	0
GSK1562902A AD Approved F Primed Group	0

Any Pain, Dose 1

Group	Value	95% CI
GSK1562902A Non-AD F1 Primed Group	33
GSK1562902A Non-AD F2 Primed Group	35
GSK1562902A Non-AD F3 Primed Group	32
GSK1562902A Non-AD F4 Primed Group	34
Control Group	45
GSK1562902A AD F1 Primed Group	38
GSK1562902A AD F2 Primed Group	34
GSK1562902A AD F3 Primed Group	39
GSK1562902A AD Approved F Primed Group	31

Grade 3 Pain, Dose 1

Group	Value	95% CI
GSK1562902A Non-AD F1 Primed Group	2
GSK1562902A Non-AD F2 Primed Group	0
GSK1562902A Non-AD F3 Primed Group	0
GSK1562902A Non-AD F4 Primed Group	2
Control Group	1
GSK1562902A AD F1 Primed Group	1
GSK1562902A AD F2 Primed Group	1
GSK1562902A AD F3 Primed Group	1
GSK1562902A AD Approved F Primed Group	0

Any Redness, Dose 1

Group	Value	95% CI
GSK1562902A Non-AD F1 Primed Group	0
GSK1562902A Non-AD F2 Primed Group	1
GSK1562902A Non-AD F3 Primed Group	0
GSK1562902A Non-AD F4 Primed Group	0
Control Group	1
GSK1562902A AD F1 Primed Group	1
GSK1562902A AD F2 Primed Group	3
GSK1562902A AD F3 Primed Group	1
GSK1562902A AD Approved F Primed Group	1

Grade 3 Redness, Dose 1

Group	Value	95% CI
GSK1562902A Non-AD F1 Primed Group	0
GSK1562902A Non-AD F2 Primed Group	0
GSK1562902A Non-AD F3 Primed Group	0
GSK1562902A Non-AD F4 Primed Group	0
Control Group	0
GSK1562902A AD F1 Primed Group	0
GSK1562902A AD F2 Primed Group	0
GSK1562902A AD F3 Primed Group	0
GSK1562902A AD Approved F Primed Group	0

Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Primary · During the 7-day (Days 0-6) post-vaccination period following each dose and across doses

Assessed solicited general symptoms were arthralgia, fatigue, headache, myalgia, shivering, sweating and fever \[defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as causally related to the study vaccination. No subject from GSK1562902A AD F1 Primed Group has received Dose 2.

Any Arthralgia, Dose 1

Group	Value	95% CI
GSK1562902A Non-AD F1 Primed Group	5
GSK1562902A Non-AD F2 Primed Group	7
GSK1562902A Non-AD F3 Primed Group	2
GSK1562902A Non-AD F4 Primed Group	5
Control Group	9
GSK1562902A AD F1 Primed Group	6
GSK1562902A AD F2 Primed Group	5
GSK1562902A AD F3 Primed Group	5
GSK1562902A AD Approved F Primed Group	5

Grade 3 Arthralgia, Dose 1

Group	Value	95% CI
GSK1562902A Non-AD F1 Primed Group	1
GSK1562902A Non-AD F2 Primed Group	0
GSK1562902A Non-AD F3 Primed Group	0
GSK1562902A Non-AD F4 Primed Group	1
Control Group	2
GSK1562902A AD F1 Primed Group	0
GSK1562902A AD F2 Primed Group	0
GSK1562902A AD F3 Primed Group	0
GSK1562902A AD Approved F Primed Group	0

Related Arthralgia, Dose 1

Group	Value	95% CI
GSK1562902A Non-AD F1 Primed Group	4
GSK1562902A Non-AD F2 Primed Group	5
GSK1562902A Non-AD F3 Primed Group	2
GSK1562902A Non-AD F4 Primed Group	5
Control Group	7
GSK1562902A AD F1 Primed Group	5
GSK1562902A AD F2 Primed Group	5
GSK1562902A AD F3 Primed Group	5
GSK1562902A AD Approved F Primed Group	4

Any Fatigue, Dose 1

Group	Value	95% CI
GSK1562902A Non-AD F1 Primed Group	12
GSK1562902A Non-AD F2 Primed Group	15
GSK1562902A Non-AD F3 Primed Group	15
GSK1562902A Non-AD F4 Primed Group	15
Control Group	24
GSK1562902A AD F1 Primed Group	15
GSK1562902A AD F2 Primed Group	10
GSK1562902A AD F3 Primed Group	18
GSK1562902A AD Approved F Primed Group	13

Grade 3 Fatigue, Dose 1

Group	Value	95% CI
GSK1562902A Non-AD F1 Primed Group	1
GSK1562902A Non-AD F2 Primed Group	0
GSK1562902A Non-AD F3 Primed Group	0
GSK1562902A Non-AD F4 Primed Group	0
Control Group	2
GSK1562902A AD F1 Primed Group	1
GSK1562902A AD F2 Primed Group	0
GSK1562902A AD F3 Primed Group	1
GSK1562902A AD Approved F Primed Group	0

Related Fatigue, Dose 1

Group	Value	95% CI
GSK1562902A Non-AD F1 Primed Group	10
GSK1562902A Non-AD F2 Primed Group	12
GSK1562902A Non-AD F3 Primed Group	15
GSK1562902A Non-AD F4 Primed Group	13
Control Group	22
GSK1562902A AD F1 Primed Group	15
GSK1562902A AD F2 Primed Group	9
GSK1562902A AD F3 Primed Group	17
GSK1562902A AD Approved F Primed Group	12

Any Fever, Dose 1

Group	Value	95% CI
GSK1562902A Non-AD F1 Primed Group	0
GSK1562902A Non-AD F2 Primed Group	0
GSK1562902A Non-AD F3 Primed Group	0
GSK1562902A Non-AD F4 Primed Group	0
Control Group	0
GSK1562902A AD F1 Primed Group	0
GSK1562902A AD F2 Primed Group	0
GSK1562902A AD F3 Primed Group	0
GSK1562902A AD Approved F Primed Group	0

Grade 3 Fever, Dose 1

Group	Value	95% CI
GSK1562902A Non-AD F1 Primed Group	0
GSK1562902A Non-AD F2 Primed Group	0
GSK1562902A Non-AD F3 Primed Group	0
GSK1562902A Non-AD F4 Primed Group	0
Control Group	0
GSK1562902A AD F1 Primed Group	0
GSK1562902A AD F2 Primed Group	0
GSK1562902A AD F3 Primed Group	0
GSK1562902A AD Approved F Primed Group	0

Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Primary · During the 21-day (Days 0-20) follow-up period after the first vaccination and 30-day (Days 0-29) follow-up period after the second vaccination

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 investiga

Any AE(s)

Group	Value	95% CI
GSK1562902A Non-AD F1 Primed Group	22
GSK1562902A Non-AD F2 Primed Group	24
GSK1562902A Non-AD F3 Primed Group	21
GSK1562902A Non-AD F4 Primed Group	26
Control Group	33

Grade 3 AE(s)

Group	Value	95% CI
GSK1562902A Non-AD F1 Primed Group	2
GSK1562902A Non-AD F2 Primed Group	4
GSK1562902A Non-AD F3 Primed Group	1
GSK1562902A Non-AD F4 Primed Group	3
Control Group	6

Related AE(s)

Group	Value	95% CI
GSK1562902A Non-AD F1 Primed Group	4
GSK1562902A Non-AD F2 Primed Group	1
GSK1562902A Non-AD F3 Primed Group	4
GSK1562902A Non-AD F4 Primed Group	1
Control Group	8

Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Primary · During the 30-day (Days 0-29) follow-up period after the first vaccination

Any AE(s)

Group	Value	95% CI
GSK1562902A AD F1 Primed Group	13
GSK1562902A AD F2 Primed Group	17
GSK1562902A AD F3 Primed Group	17
GSK1562902A AD Approved F Primed Group	17

Grade 3 AE(s)

Group	Value	95% CI
GSK1562902A AD F1 Primed Group	3
GSK1562902A AD F2 Primed Group	2
GSK1562902A AD F3 Primed Group	5
GSK1562902A AD Approved F Primed Group	2

Related AE(s)

Group	Value	95% CI
GSK1562902A AD F1 Primed Group	5
GSK1562902A AD F2 Primed Group	4
GSK1562902A AD F3 Primed Group	4
GSK1562902A AD Approved F Primed Group	4

Number of Subjects With Serious Adverse Events (SAEs) Primary · During the entire study period (From Day 0 up to Month 24)

SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Day 0 - Month 6

Group	Value	95% CI
GSK1562902A Non-AD F1 Primed Group	1
GSK1562902A Non-AD F2 Primed Group	1
GSK1562902A Non-AD F3 Primed Group	1
GSK1562902A Non-AD F4 Primed Group	0
Control Group	3
GSK1562902A AD F1 Primed Group	1
GSK1562902A AD F2 Primed Group	0
GSK1562902A AD F3 Primed Group	1
GSK1562902A AD Approved F Primed Group	0

Month 6 - Month 12

Group	Value	95% CI
GSK1562902A Non-AD F1 Primed Group	2
GSK1562902A Non-AD F2 Primed Group	1
GSK1562902A Non-AD F3 Primed Group	0
GSK1562902A Non-AD F4 Primed Group	0
Control Group	0
GSK1562902A AD F1 Primed Group	0
GSK1562902A AD F2 Primed Group	0
GSK1562902A AD F3 Primed Group	1
GSK1562902A AD Approved F Primed Group	0

Month 12 - Month 18

Group	Value	95% CI
GSK1562902A Non-AD F1 Primed Group	1
GSK1562902A Non-AD F2 Primed Group	1
GSK1562902A Non-AD F3 Primed Group	0
GSK1562902A Non-AD F4 Primed Group	0
Control Group	0
GSK1562902A AD F1 Primed Group	0
GSK1562902A AD F2 Primed Group	0
GSK1562902A AD F3 Primed Group	1
GSK1562902A AD Approved F Primed Group	2

Month 18 - Month 24

Group	Value	95% CI
GSK1562902A Non-AD F1 Primed Group	1
GSK1562902A Non-AD F2 Primed Group	1
GSK1562902A Non-AD F3 Primed Group	1
GSK1562902A Non-AD F4 Primed Group	0
Control Group	0
GSK1562902A AD F1 Primed Group	1
GSK1562902A AD F2 Primed Group	0
GSK1562902A AD F3 Primed Group	1
GSK1562902A AD Approved F Primed Group	2

Titers for Serum Neutralizing HI Antibodies Against A/Indonesia/05/2005 Strain Secondary · At Days 0, 21 (post-vaccination one) and 42 (post-vaccination two)

Titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:28. The flu strain assessed was A/Indonesia/05/2005. No subject from GSK1562902A AD F1 Primed Group has received a second vaccination.

A/Indonesia/05/2005, Day 0

Group	Value	95% CI
GSK1562902A Non-AD F1 Primed Group	47.0	34.2 – 64.6
GSK1562902A AD F1 Primed Group	157.8	130.3 – 191.2
Control Group	19.9	15.7 – 25.2

A/Indonesia/05/2005, Day 21

Group	Value	95% CI
GSK1562902A Non-AD F1 Primed Group	692.4	476.7 – 1005.7
Control Group	307.3	262.5 – 359.8

A/Indonesia/05/2005, Day 42

Group	Value	95% CI
GSK1562902A Non-AD F1 Primed Group	933.1	653.7 – 1331.9
GSK1562902A AD F1 Primed Group	3708.9	2458.6 – 5594.9
Control Group	1606.4	1282.7 – 2011.8

Adverse events — posted to ClinicalTrials.gov

Time frame: Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events (AEs): during the 21-day (Days 0-20) or 30-day (Days 0-29) post-vaccination 1 period and the 30-day (Days 0-29) post-vaccination 2 period; Serious adverse events (SAEs): during the whole study period (from Day 0 up to Month 24).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

GSK1562902A Non-AD F1 Primed Group

Serious: 4/36 (11%)

Deaths: 0/36

GSK1562902A Non-AD F2 Primed Group

Serious: 3/40 (8%)

Deaths: 0/40

GSK1562902A Non-AD F3 Primed Group

Serious: 2/37 (5%)

Deaths: 0/37

GSK1562902A Non-AD F4 Primed Group

Serious: 0/36 (0%)

Deaths: 0/36

Control Group

Serious: 4/50 (8%)

Deaths: 0/50

GSK1562902A AD F1 Primed Group

Serious: 2/40 (5%)

Deaths: 0/40

GSK1562902A AD F2 Primed Group

Serious: 1/35 (3%)

Deaths: 0/35

GSK1562902A AD F3 Primed Group

Serious: 4/41 (10%)

Deaths: 1/41

GSK1562902A AD Approved F Primed Group

Serious: 3/35 (9%)

Deaths: 1/35

Serious adverse events (27 terms)

Reaction	System	GSK1562902A Non-AD F1 Prim…	GSK1562902A Non-AD F2 Prim…	GSK1562902A Non-AD F3 Prim…	GSK1562902A Non-AD F4 Prim…	Control Group	GSK1562902A AD F1 Primed G…	GSK1562902A AD F2 Primed G…	GSK1562902A AD F3 Primed G…	GSK1562902A AD Approved F …
Osteoarthritis	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—
Arrhythmia	Cardiac disorders	—	—	—	—	—	—	—	—	—
Atrial fibrillation	Cardiac disorders	—	—	—	—	—	—	—	—	—
Pericarditis	Cardiac disorders	—	—	—	—	—	—	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Intestinal obstruction	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Chest pain	General disorders	—	—	—	—	—	—	—	—	—
Ill-defined disorder	General disorders	—	—	—	—	—	—	—	—	—
Abscess	Infections and infestations	—	—	—	—	—	—	—	—	—
Appendicitis	Infections and infestations	—	—	—	—	—	—	—	—	—
Gastroenteritis	Infections and infestations	—	—	—	—	—	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—	—	—	—	—	—
Jaw fracture	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—
Multiple injuries	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—
Tibia fracture	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—
Tooth fracture	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—
Traumatic fracture	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—
Wrist fracture	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—
Foot deformity	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—
Spinal column stenosis	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—
High grade b-cell lymphoma burkitt-like lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—	—	—
Pre-eclampsia	Pregnancy, puerperium and perinatal conditions	—	—	—	—	—	—	—	—	—
Major depression	Psychiatric disorders	—	—	—	—	—	—	—	—	—
Nephrolithiasis	Renal and urinary disorders	—	—	—	—	—	—	—	—	—

Other adverse events (30 terms — click to expand)

Reaction	System	GSK1562902A Non-AD F1 Prim…	GSK1562902A Non-AD F2 Prim…	GSK1562902A Non-AD F3 Prim…	GSK1562902A Non-AD F4 Prim…	Control Group	GSK1562902A AD F1 Primed G…	GSK1562902A AD F2 Primed G…	GSK1562902A AD F3 Primed G…	GSK1562902A AD Approved F …
Pain	General disorders	—	—	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—	—	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—
Chills	General disorders	—	—	—	—	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—
Hyperhidrosis	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—	—	—	—	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—
Induration	General disorders	—	—	—	—	—	—	—	—	—
Rhinitis	Infections and infestations	—	—	—	—	—	—	—	—	—
Swelling	General disorders	—	—	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Erythema	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—
Injection site pruritus	General disorders	—	—	—	—	—	—	—	—	—
Injection site reaction	General disorders	—	—	—	—	—	—	—	—	—
Productive cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Insomnia	Psychiatric disorders	—	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Oral herpes	Infections and infestations	—	—	—	—	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—
Influenza like illness	General disorders	—	—	—	—	—	—	—	—	—
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—
Neck pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—
Pharyngitis	Infections and infestations	—	—	—	—	—	—	—	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—

Most-reported serious reactions: Osteoarthritis, Arrhythmia, Atrial fibrillation, Pericarditis, Abdominal pain upper, Intestinal obstruction, Chest pain, Ill-defined disorder.

Data from ClinicalTrials.gov NCT00506350 adverse events section.

Sponsor's own description

The present study is designed to evaluate the reactogenicity and immunogenicity of one or two booster administrations of an influenza pandemic candidate vaccine (GSK1562902A) in adults aged between 19 and 61 years, previously vaccinated with 2 doses of a pandemic candidate vaccine. Fifty new subjects who did not participate in a primary study (106750, NCT00309634) will be recruited. This protocol posting deals with objectives \& outcome measures of the booster phase. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT00309634)

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Priming with AS03 A-adjuvanted H5N1 influenza vaccine improves the kinetics, magnitude and durability of the immune response after a heterologous booster vaccination: an open non-randomised extension of a double-blind randomised primary study.
Leroux-Roels I, Roman F, Forgus S, Maes C, et al · · 2010 · cited 104× · PMID 19835828 · DOI 10.1016/j.vaccine.2009.10.017
Safety of AS03-adjuvanted inactivated split virion A(H1N1)pdm09 and H5N1 influenza virus vaccines administered to adults: pooled analysis of 28 clinical trials.
Vaughn DW, Seifert H, Hepburn A, Dewe W, et al · · 2014 · cited 24× · PMID 25483467 · DOI 10.4161/21645515.2014.972149

Verify or expand the search:

Other recruiting trials for Influenza

Currently open trials in the same condition.

NCT07215858 — BPL-1357 Against H1N1 Influenza Virus Challenge · Phase 2 · recruiting
NCT07496450 — A Study of mRNA-1018-H5 Pandemic Influenza Vaccine in Healthy Adults · Phase 3 · recruiting
NCT07302256 — A Clinical Trial of Influenza Virus Split Vaccine for Individuals Aged 60 Years and Above · Phase 1 · recruiting
NCT07431840 — Immune Defense Protein Impact On Respiratory Immune Outcomes · NA · recruiting
NCT07485855 — Influenza Vaccination Strategy for Patients With Hematologic Malignancy · Phase 3 · recruiting

Other GlaxoSmithKline trials

Trials by the same sponsor.

NCT07569081 — A Study Evaluating the Efficacy and Safety of Momelotinib in Participants With Vacuoles, E1-enzyme, X-linked, Autoinflam · Phase 2, PHASE3 · not yet recruiting
NCT07406347 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Infants Receiving 3-dose · Phase 1 · not yet recruiting
NCT07286266 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Platinum-resistant Ovarian Cancer (BEH · Phase 3 · not yet recruiting
NCT07286331 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Recurrent Endometrial Cancer (BEHOLD-E · Phase 3 · not yet recruiting
NCT07406334 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Toddlers 12 to 15 Months · Phase 1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00506350 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 4 October 2017

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00506350.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing