NCT00695669 is a Phase 2 clinical trial of Influenza A (H5N1) Virus Monovalent Vaccine in Influenza, sponsored by GlaxoSmithKline.

Who is sponsoring NCT00695669?

NCT00695669 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT00695669?

Interventions in NCT00695669: Influenza A (H5N1) Virus Monovalent Vaccine.

Is NCT00695669 still recruiting?

NCT00695669 is currently completed. Last updated 31 July 2018.

Are results published for NCT00695669?

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

Last reviewed 2018-07-31 · How we verify

NCT00695669

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

A Trial to Test the Response to Different Vaccination Regimens With an H5N1 Vaccine With AS03 in Adults Aged 18-64

Completed Phase 2 Results posted Last updated 31 July 2018

What this trial tests

Phase 2 trial testing Influenza A (H5N1) Virus Monovalent Vaccine in Influenza in 312 participants. Completed in 8 January 2009.

Timeline

5 June 2008

Primary endpoint
13 August 2008

8 January 2009

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	312
Start date	5 June 2008
Primary completion	13 August 2008
Estimated completion	8 January 2009
Sites	3 locations across Canada

Drugs / interventions tested

Influenza A (H5N1) Virus Monovalent Vaccine — full drug profile →

Conditions studied

Influenza — all drugs for Influenza →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 18 to 64, 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.

Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. Primary · At Day 14 post Dose 2

A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination (Day 0) reciprocal hemagglutination inhibition (HI) titer less than (\<) 1:10 and a post-vaccination (at Day 14 post Dose 2) reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal HI titer ≥ 1:10 and at least a four-fold increase in post-vaccination (at Day 14 post Dose 2) titer.

Group	Value	95% CI
Influenza A (H5N1) 1 Group	63
Influenza A (H5N1) 2 Group	64
Influenza A (H5N1) 3 Group	53
Influenza A (H5N1) 4 Group	54

Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. Primary · At Day 0 and at Day 14 post Dose 2

Titers are presented as geometric mean titers (GMTs). The Confidence Interval for this outcome was 98.75%.

H5N1 at Day 0

Group	Value	95% CI
Influenza A (H5N1) 1 Group	5.4	4.7 – 6.1
Influenza A (H5N1) 2 Group	5.3	4.7 – 6.0
Influenza A (H5N1) 3 Group	5.5	4.8 – 6.3
Influenza A (H5N1) 4 Group	5.8	4.8 – 7.0

H5N1 at Day 14 post Dose 2

Group	Value	95% CI
Influenza A (H5N1) 1 Group	640.0	413.7 – 990.0
Influenza A (H5N1) 2 Group	345.0	221.2 – 538.1
Influenza A (H5N1) 3 Group	77.7	49.9 – 121.0
Influenza A (H5N1) 4 Group	67.4	42.5 – 107.0

Number of Seroprotected Subjects Against 3 Strains the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. Primary · At Day 0 and at Day 14 post Dose 2

A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40.

H5N1 at Day 0

Group	Value	95% CI
Influenza A (H5N1) 1 Group	2
Influenza A (H5N1) 2 Group	1
Influenza A (H5N1) 3 Group	2
Influenza A (H5N1) 4 Group	3

H5N1 at Day 14 post Dose 2

Group	Value	95% CI
Influenza A (H5N1) 1 Group	63
Influenza A (H5N1) 2 Group	64
Influenza A (H5N1) 3 Group	55
Influenza A (H5N1) 4 Group	56

Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. Secondary · At Days 0, 21, 28, 35, 42 and 182.

Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 1 Group.

H5N1 at Day 0 [N=65]

Group	Value	95% CI
Influenza A (H5N1) 1 Group	5.4	4.9 – 5.9

H5N1 at Day 21 [N=64]

Group	Value	95% CI
Influenza A (H5N1) 1 Group	40.2	27.9 – 58.1

H5N1 at Day 28 [N=65]

Group	Value	95% CI
Influenza A (H5N1) 1 Group	150.9	101.1 – 225.1

H5N1 at Day 35 [N=65]

Group	Value	95% CI
Influenza A (H5N1) 1 Group	640.0	455.9 – 898.4

H5N1 at Day 42 [N=62]

Group	Value	95% CI
Influenza A (H5N1) 1 Group	523.3	366.0 – 748.3

H5N1 at Day 182 [N=65]

Group	Value	95% CI
Influenza A (H5N1) 1 Group	51.1	37.0 – 70.6

Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. Secondary · At Days 0, 14, 21, 28, 35, 42 and 182.

Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 2 Group.

H5N1 at Day 0 [N=69]

Group	Value	95% CI
Influenza A (H5N1) 2 Group	5.3	4.9 – 27.5

H5N1 at Day 14 [N=68]

Group	Value	95% CI
Influenza A (H5N1) 2 Group	26.8	18.8 – 38.0

H5N1 at Day 21 [N=69]

Group	Value	95% CI
Influenza A (H5N1) 2 Group	99.8	67.0 – 148.8

H5N1 at Day 28 [N=69]

Group	Value	95% CI
Influenza A (H5N1) 2 Group	345.0	244.2 – 487.5

H5N1 at Day 35 [N=69]

Group	Value	95% CI
Influenza A (H5N1) 2 Group	305.9	220.8 – 423.7

H5N1 at Day 42 [N=68]

Group	Value	95% CI
Influenza A (H5N1) 2 Group	262.3	192.9 – 356.8

H5N1 at Day 182 [N=68]

Group	Value	95% CI
Influenza A (H5N1) 2 Group	36.5	27.5 – 48.4

Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. Secondary · At Days 0, 7, 14, 21, 28, 42 and 182.

Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 3 Group.

H5N1 at Day 0 [N=74]

Group	Value	95% CI
Influenza A (H5N1) 3 Group	5.5	4.9 – 6.1

H5N1 at Day 7 [N=74]

Group	Value	95% CI
Influenza A (H5N1) 3 Group	7.6	6.1 – 9.4

H5N1 at Day 14 [N=73]

Group	Value	95% CI
Influenza A (H5N1) 3 Group	45.1	32.0 – 63.5

H5N1 at Day 21 [N=74]

Group	Value	95% CI
Influenza A (H5N1) 3 Group	77.7	55.1 – 109.7

H5N1 at Day 28 [N=72]

Group	Value	95% CI
Influenza A (H5N1) 3 Group	99.8	70.9 – 140.6

H5N1 at Day 42 [N=73]

Group	Value	95% CI
Influenza A (H5N1) 3 Group	81.1	58.7 – 112.0

H5N1 at Day 182 [N=71]

Group	Value	95% CI
Influenza A (H5N1) 3 Group	21.3	16.2 – 28.1

Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. Secondary · At Days 0, 7, 14, 21, 42 and 182.

Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 4 Group.

H5N1 at Day 0 [N=75]

Group	Value	95% CI
Influenza A (H5N1) 4 Group	5.8	5.0 – 6.7

H5N1 at Day 7 [N=74]

Group	Value	95% CI
Influenza A (H5N1) 4 Group	10.8	8.0 – 14.6

H5N1 at Day 14 [N=75]

Group	Value	95% CI
Influenza A (H5N1) 4 Group	67.4	47.1 – 96.6

H5N1 at Day 21 [N=74]

Group	Value	95% CI
Influenza A (H5N1) 4 Group	76.3	52.6 – 110.8

H5N1 at Day 42 [N=74]

Group	Value	95% CI
Influenza A (H5N1) 4 Group	78.9	55.8 – 111.5

H5N1 at Day 182 [N=73]

Group	Value	95% CI
Influenza A (H5N1) 4 Group	28.2	21.0 – 37.8

Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. Secondary · At Days 0, 21, 28, 35, 42 and 182.

Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 1 Group.

VIET at Day 0 [N=65]

Group	Value	95% CI
Influenza A (H5N1) 1 Group	5.3	4.9 – 5.8

VIET at Day 21 [N=64]

Group	Value	95% CI
Influenza A (H5N1) 1 Group	9.7	7.3 – 12.9

VIET at Day 28 [N=65]

Group	Value	95% CI
Influenza A (H5N1) 1 Group	20.7	15.0 – 28.6

VIET at Day 35 [N=65]

Group	Value	95% CI
Influenza A (H5N1) 1 Group	61.6	44.4 – 85.6

VIET at Day 42 [N=62]

Group	Value	95% CI
Influenza A (H5N1) 1 Group	48.6	34.7 – 68.1

TURK at Day 0 [N=65]

Group	Value	95% CI
Influenza A (H5N1) 1 Group	7.6	6.0 – 9.7

TURK at Day 21 [N=64]

Group	Value	95% CI
Influenza A (H5N1) 1 Group	22.5	16.5 – 30.8

TURK at Day 28 [N=65]

Group	Value	95% CI
Influenza A (H5N1) 1 Group	46.4	32.0 – 67.4

Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 2 Group.

VIET at Day 0 [N=69]

Group	Value	95% CI
Influenza A (H5N1) 2 Group	5.4	5.0 – 5.9

VIET at Day 14 [N=68]

Group	Value	95% CI
Influenza A (H5N1) 2 Group	9.2	7.2 – 11.7

VIET at Day 21 [N=69]

Group	Value	95% CI
Influenza A (H5N1) 2 Group	15.1	11.2 – 20.3

VIET at Day 28 [N=69]

Group	Value	95% CI
Influenza A (H5N1) 2 Group	29.9	21.8 – 40.9

VIET at Day 35 [N=69]

Group	Value	95% CI
Influenza A (H5N1) 2 Group	26.5	19.9 – 35.2

VIET at Day 42 [N=68]

Group	Value	95% CI
Influenza A (H5N1) 2 Group	23.2	17.4 – 30.9

TURK at Day 0 [N=69]

Group	Value	95% CI
Influenza A (H5N1) 2 Group	7.1	5.7 – 8.9

TURK at Day 14 [N=68]

Group	Value	95% CI
Influenza A (H5N1) 2 Group	17.0	12.0 – 24.0

Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 3 Group.

VIET at Day 0 [N=74]

Group	Value	95% CI
Influenza A (H5N1) 3 Group	5.3	4.9 – 5.8

VIET at Day 7 [N=74]

Group	Value	95% CI
Influenza A (H5N1) 3 Group	6.4	5.6 – 7.4

VIET at Day 14 [N=73]

Group	Value	95% CI
Influenza A (H5N1) 3 Group	13.7	10.4 – 17.9

VIET at Day 21 [N=74]

Group	Value	95% CI
Influenza A (H5N1) 3 Group	16.1	12.2 – 21.2

VIET at Day 28 [N=72]

Group	Value	95% CI
Influenza A (H5N1) 3 Group	15.3	11.6 – 20.1

VIET at Day 42 [N=73]

Group	Value	95% CI
Influenza A (H5N1) 3 Group	13.4	10.5 – 17.1

TURK at Day 0 [N=74]

Group	Value	95% CI
Influenza A (H5N1) 3 Group	7.2	5.9 – 8.9

TURK at Day 7 [N=74]

Group	Value	95% CI
Influenza A (H5N1) 3 Group	8.7	6.8 – 11.2

Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 4 Group.

VIET at Day 0 [N=75]

Group	Value	95% CI
Influenza A (H5N1) 4 Group	5.8	5.1 – 6.6

VIET at Day 7 [N=74]

Group	Value	95% CI
Influenza A (H5N1) 4 Group	7.9	6.4 – 9.8

VIET at Day 14 [N=75]

Group	Value	95% CI
Influenza A (H5N1) 4 Group	16.3	12.1 – 21.9

VIET at Day 21 [N=74]

Group	Value	95% CI
Influenza A (H5N1) 4 Group	16.2	12.1 – 21.6

VIET at Day 42 [N=74]

Group	Value	95% CI
Influenza A (H5N1) 4 Group	16.0	12.3 – 20.6

TURK at Day 0 [N=75]

Group	Value	95% CI
Influenza A (H5N1) 4 Group	7.7	6.2 – 9.4

TURK at Day 7 [N=74]

Group	Value	95% CI
Influenza A (H5N1) 4 Group	11.8	8.7 – 16.0

TURK at Day 14 [N=75]

Group	Value	95% CI
Influenza A (H5N1) 4 Group	28.9	20.5 – 40.8

Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1), Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease. Secondary · At Day 42

A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination (Day 0) reciprocal HI titer \< 1:10 and a post-vaccination (at Day 14 post Dose 2) reciprocal titer ≥ 1:40 or a pre-vaccination reciprocal HI titer ≥ 1:10 and at least a four-fold increase in post-vaccination (at Day 14 post Dose 2) titer.

H5N1

Group	Value	95% CI
Influenza A (H5N1) 1 Group	59
Influenza A (H5N1) 2 Group	63
Influenza A (H5N1) 3 Group	57
Influenza A (H5N1) 4 Group	55

VIET

Group	Value	95% CI
Influenza A (H5N1) 1 Group	41
Influenza A (H5N1) 2 Group	35
Influenza A (H5N1) 3 Group	16
Influenza A (H5N1) 4 Group	19

TURK

Group	Value	95% CI
Influenza A (H5N1) 1 Group	52
Influenza A (H5N1) 2 Group	51
Influenza A (H5N1) 3 Group	41
Influenza A (H5N1) 4 Group	39

Adverse events — posted to ClinicalTrials.gov

Time frame: Solicited local and general symptoms: Within the 7-day period after primary vaccination. Unsolicited AEs: Within the 51-day period after primary vaccination. SAEs: from Day 0 to Day 182.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Influenza A (H5N1) 1 Group

Serious: 1/78 (1%)

Deaths: —

Influenza A (H5N1) 2 Group

Serious: 0/78 (0%)

Deaths: —

Influenza A (H5N1) 3 Group

Serious: 3/78 (4%)

Deaths: —

Influenza A (H5N1) 4 Group

Serious: 1/78 (1%)

Deaths: —

Serious adverse events (8 terms)

Reaction	System	Influenza A (H5N1) 1 Group	Influenza A (H5N1) 2 Group	Influenza A (H5N1) 3 Group	Influenza A (H5N1) 4 Group
Cardiac failure congestive	Cardiac disorders	—	—	—	—
Cellulitis	Infections and infestations	—	—	—	—
Diabetes mellitus	Metabolism and nutrition disorders	—	—	—	—
Injury	Injury, poisoning and procedural complications	—	—	—	—
Irritable bowel syndrome	Gastrointestinal disorders	—	—	—	—
Myocardial infarction	Cardiac disorders	—	—	—	—
Phlebitis	Vascular disorders	—	—	—	—
Syncope	Nervous system disorders	—	—	—	—

Other adverse events (17 terms — click to expand)

Reaction	System	Influenza A (H5N1) 1 Group	Influenza A (H5N1) 2 Group	Influenza A (H5N1) 3 Group	Influenza A (H5N1) 4 Group
Pain	General disorders	—	—	—	—
Muscle aches	General disorders	—	—	—	—
Fatigue	General disorders	—	—	—	—
Headache	General disorders	—	—	—	—
Joint pain	General disorders	—	—	—	—
Sweating	General disorders	—	—	—	—
Shivering	General disorders	—	—	—	—
Swelling	General disorders	—	—	—	—
Redness	General disorders	—	—	—	—
Lymphadenopathy	Blood and lymphatic system disorders	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Fever	General disorders	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—
Injection site warmth	General disorders	—	—	—	—
Oedema peripheral	General disorders	—	—	—	—

Most-reported serious reactions: Cardiac failure congestive, Cellulitis, Diabetes mellitus, Injury, Irritable bowel syndrome, Myocardial infarction, Phlebitis, Syncope.

Data from ClinicalTrials.gov NCT00695669 adverse events section.

Sponsor's own description

The purpose of the study is to characterize the immunogenicity \& safety of 2 doses of GSK's avian flu vaccine GSK 1557484A given according to different regimens to adults aged 18 to 64 years

Publications & conference data

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

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
Rapid immunization against H5N1: a randomized trial evaluating homologous and cross-reactive immune responses to AS03(A)-adjuvanted vaccination in adults.
Lasko B, Reich D, Madan A, Roman F, et al · · 2011 · cited 19× · PMID 21791660 · DOI 10.1093/infdis/jir328

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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 NCT00695669 (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: 31 July 2018

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/NCT00695669.

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

NCT00695669

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (8 terms)

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for Influenza

Other GlaxoSmithKline trials

Verify against primary sources