NCT00985790 is a Phase 2 clinical trial of Influenza vaccine GSK2321138A in Influenza, sponsored by GlaxoSmithKline.

Who is sponsoring NCT00985790?

NCT00985790 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT00985790?

Interventions in NCT00985790: Influenza vaccine GSK2321138A, Fluarix™.

Is NCT00985790 still recruiting?

NCT00985790 is currently completed. Last updated 21 September 2018.

Are results published for NCT00985790?

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

Last reviewed 2018-09-21 · How we verify

NCT00985790

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

Immunogenicity and Safety Study of a GlaxoSmithKline Biologicals' Candidate Influenza Vaccine in Healthy Children

Completed Phase 2 Results posted Last updated 21 September 2018

What this trial tests

Phase 2 trial testing Influenza vaccine GSK2321138A in Influenza in 599 participants. Completed in 21 May 2010.

Timeline

8 October 2009

Primary endpoint
21 May 2010

21 May 2010

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	599
Start date	8 October 2009
Primary completion	21 May 2010
Estimated completion	21 May 2010
Sites	2 locations across Mexico

Drugs / interventions tested

Influenza vaccine GSK2321138A — full drug profile →
Fluarix™ — full drug profile →

Conditions studied

Influenza — all drugs for Influenza →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 18 Months to 47 Months, 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 Hemagglutination Inhibition (HI) Antibodies Against the 3 Fluarix Vaccine Strains. Primary · At Day 0 [PRE] and at 28 days post last vaccination (Day 28 or Day 56) [POST]

Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. The 3 influenza strains assessed were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2) and Flu B/Brisbane/60/08 Victoria (VICT).The POST results were the primary outcome variables.

H1N1, PRE

Group	Value	95% CI
GSK2321138A Group	22.2	17.2 – 28.7
Fluarix Group	21.6	16.7 – 28.0

H1N1, POST

Group	Value	95% CI
GSK2321138A Group	173.8	141.4 – 213.5
Fluarix Group	176.9	143.3 – 218.5

H3N2, PRE

Group	Value	95% CI
GSK2321138A Group	18.6	14.9 – 23.2
Fluarix Group	20.8	16.5 – 26.2

H3N2, POST

Group	Value	95% CI
GSK2321138A Group	120.7	101.2 – 143.9
Fluarix Group	130.4	108.0 – 157.5

VICT, PRE

Group	Value	95% CI
GSK2321138A Group	8.7	7.3 – 10.2
Fluarix Group	9.0	7.7 – 10.6

VICT, POST

Group	Value	95% CI
GSK2321138A Group	61.9	48.7 – 78.6
Fluarix Group	66.6	52.4 – 84.7

Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. Secondary · At Days 0 and 28.

Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. The 4 influenza strains assessed were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the primed groups.

H1N1. Day 0

Group	Value	95% CI
GSK2321138A-Primed Group	40.3	27.0 – 60.2
Fluarix-Primed Group	36.5	24.3 – 54.9

H1N1. Day 28

Group	Value	95% CI
GSK2321138A-Primed Group	117.0	83.2 – 164.5
Fluarix-Primed Group	124.4	89.8 – 172.4

H3N2, Day 0

Group	Value	95% CI
GSK2321138A-Primed Group	22.8	16.7 – 31.2
Fluarix-Primed Group	21.7	16.0 – 29.5

H3N2, Day 28

Group	Value	95% CI
GSK2321138A-Primed Group	85.2	64.8 – 112.0
Fluarix-Primed Group	83.0	63.6 – 108.2

VICT, Day 0

Group	Value	95% CI
GSK2321138A-Primed Group	8.9	7.2 – 11.0
Fluarix-Primed Group	9.7	7.7 – 12.4

VICT, Day 28

Group	Value	95% CI
GSK2321138A-Primed Group	38.7	26.2 – 57.1
Fluarix-Primed Group	44.0	29.6 – 65.2

YAMA, Day 0

Group	Value	95% CI
GSK2321138A-Primed Group	29.3	23.0 – 37.4
Fluarix-Primed Group	37.7	29.8 – 47.8

YAMA, Day 28

Group	Value	95% CI
GSK2321138A-Primed Group	243.6	198.1 – 299.6
Fluarix-Primed Group	127.2	106.1 – 152.3

Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. Secondary · At Days 0, 28 and Day 56

H1N1, Day 0

Group	Value	95% CI
GSK2321138A-Unprimed Group	14.7	11.8 – 18.4
Fluarix-Unprimed Group	12.8	10.5 – 15.7

H1N1, Day 28

Group	Value	95% CI
GSK2321138A-Unprimed Group	173.1	113.1 – 264.8
Fluarix-Unprimed Group	161.6	103.9 – 251.4

H1N1, Day 56

Group	Value	95% CI
GSK2321138A-Unprimed Group	253.1	203.4 – 314.8
Fluarix-Unprimed Group	249.0	192.5 – 321.9

H3N2, Day 0

Group	Value	95% CI
GSK2321138A-Unprimed Group	17.7	14.1 – 22.1
Fluarix-Unprimed Group	17.9	14.1 – 22.6

H3N2, Day 28

Group	Value	95% CI
GSK2321138A-Unprimed Group	99.3	64.8 – 152.2
Fluarix-Unprimed Group	84.2	54.1 – 131.2

H3N2, Day 56

Group	Value	95% CI
GSK2321138A-Unprimed Group	168.1	136.6 – 206.7
Fluarix-Unprimed Group	202.1	158.6 – 257.5

VICT, Day 0

Group	Value	95% CI
GSK2321138A-Unprimed Group	7.8	6.7 – 9.2
Fluarix-Unprimed Group	8.7	7.5 – 10.3

VICT, Day 28

Group	Value	95% CI
GSK2321138A-Unprimed Group	26.5	17.7 – 39.7
Fluarix-Unprimed Group	34.6	22.4 – 53.6

Number of Seropositive Subjects Against 4 Strains of Influenza Disease. Secondary · At Days 0 and 28

A seropositive subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:10. The 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the primed groups.

H1N1, Day 0

Group	Value	95% CI
GSK2321138A-Primed Group	58
Fluarix-Primed Group	54

H1N1, Day 28

Group	Value	95% CI
GSK2321138A-Primed Group	83
Fluarix-Primed Group	87

H3N2, Day 0

Group	Value	95% CI
GSK2321138A-Primed Group	60
Fluarix-Primed Group	59

H3N2, Day 28

Group	Value	95% CI
GSK2321138A-Primed Group	88
Fluarix-Primed Group	87

VICT, Day 0

Group	Value	95% CI
GSK2321138A-Primed Group	26
Fluarix-Primed Group	28

VICT, Day 28

Group	Value	95% CI
GSK2321138A-Primed Group	62
Fluarix-Primed Group	66

YAMA, Day 0

Group	Value	95% CI
GSK2321138A-Primed Group	73
Fluarix-Primed Group	80

YAMA, Day 28

Group	Value	95% CI
GSK2321138A-Primed Group	93
Fluarix-Primed Group	94

Number of Seropositive Subjects Against 4 Strains of Influenza Disease. Secondary · At Days 0, 28 and 56

H1N1, Day 0

Group	Value	95% CI
GSK2321138A-Unprimed Group	75
Fluarix-Unprimed Group	71

H1N1, Day 28

Group	Value	95% CI
GSK2321138A-Unprimed Group	83
Fluarix-Unprimed Group	84

H1N1, Day 56

Group	Value	95% CI
GSK2321138A-Unprimed Group	99
Fluarix-Unprimed Group	96

H3N2, Day 0

Group	Value	95% CI
GSK2321138A-Unprimed Group	85
Fluarix-Unprimed Group	82

H3N2, Day 28

Group	Value	95% CI
GSK2321138A-Unprimed Group	74
Fluarix-Unprimed Group	78

H3N2, Day 56

Group	Value	95% CI
GSK2321138A-Unprimed Group	99
Fluarix-Unprimed Group	98

VICT, Day 0

Group	Value	95% CI
GSK2321138A-Unprimed Group	30
Fluarix-Unprimed Group	42

VICT, Day 28

Group	Value	95% CI
GSK2321138A-Unprimed Group	51
Fluarix-Unprimed Group	61

Number of Seroconverted Subjects Against 4 Strains of Influenza Disease. Secondary · At Day 28

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 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the primed groups.

H1N1, Day 28

Group	Value	95% CI
GSK2321138A-Primed Group	30
Fluarix-Primed Group	39

H3N2, Day 28

Group	Value	95% CI
GSK2321138A-Primed Group	48
Fluarix-Primed Group	46

VICT, Day 28

Group	Value	95% CI
GSK2321138A-Primed Group	46
Fluarix-Primed Group	42

YAMA, Day 28

Group	Value	95% CI
GSK2321138A-Primed Group	82
Fluarix-Primed Group	40

Number of Seroconverted Subjects Against 4 Strains of Influenza Disease. Secondary · At Days 28 and 56

H1N1, Day 28

Group	Value	95% CI
GSK2321138A-Unprimed Group	63
Fluarix-Unprimed Group	74

H1N1, Day 56

Group	Value	95% CI
GSK2321138A-Unprimed Group	81
Fluarix-Unprimed Group	89

H3N2, Day 28

Group	Value	95% CI
GSK2321138A-Unprimed Group	55
Fluarix-Unprimed Group	54

H3N2, Day 56

Group	Value	95% CI
GSK2321138A-Unprimed Group	79
Fluarix-Unprimed Group	75

VICT, Day 28

Group	Value	95% CI
GSK2321138A-Unprimed Group	34
Fluarix-Unprimed Group	40

VICT, Day 56

Group	Value	95% CI
GSK2321138A-Unprimed Group	77
Fluarix-Unprimed Group	85

YAMA, Day 28

Group	Value	95% CI
GSK2321138A-Unprimed Group	59
Fluarix-Unprimed Group	40

YAMA, Day 56

Group	Value	95% CI
GSK2321138A-Unprimed Group	90
Fluarix-Unprimed Group	42

Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. Secondary · At Day 28

The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the primed groups.

H1N1, Day 28

Group	Value	95% CI
GSK2321138A-Primed Group	2.9	2.3 – 3.6
Fluarix-Primed Group	3.4	2.7 – 4.2

H3N2, Day 28

Group	Value	95% CI
GSK2321138A-Primed Group	3.7	3.1 – 4.5
Fluarix-Primed Group	3.8	3.1 – 4.7

VICT, Day 28

Group	Value	95% CI
GSK2321138A-Primed Group	4.4	3.3 – 5.8
Fluarix-Primed Group	4.5	3.4 – 6.0

YAMA, Day 28

Group	Value	95% CI
GSK2321138A-Primed Group	8.3	6.8 – 10.1
Fluarix-Primed Group	3.4	2.8 – 4.0

Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. Secondary · At Days 28 and 56

H1N1, Day 28

Group	Value	95% CI
GSK2321138A-Unprimed Group	9.9	7.0 – 14.1
Fluarix-Unprimed Group	12.7	9.1 – 17.7

H1N1, Day 56

Group	Value	95% CI
GSK2321138A-Unprimed Group	19.8	15.4 – 25.6
Fluarix-Unprimed Group	19.2	15.2 – 24.2

H3N2, Day 28

Group	Value	95% CI
GSK2321138A-Unprimed Group	4.9	3.7 – 6.3
Fluarix-Unprimed Group	5.1	3.9 – 6.7

H3N2, Day 56

Group	Value	95% CI
GSK2321138A-Unprimed Group	11.1	9.0 – 13.7
Fluarix-Unprimed Group	10.3	8.3 – 12.9

VICT, Day 28

Group	Value	95% CI
GSK2321138A-Unprimed Group	3.6	2.7 – 5.0
Fluarix-Unprimed Group	3.8	2.9 – 5.0

VICT, Day 56

Group	Value	95% CI
GSK2321138A-Unprimed Group	11.3	9.4 – 13.6
Fluarix-Unprimed Group	12.1	9.8 – 14.8

YAMA, Day 28

Group	Value	95% CI
GSK2321138A-Unprimed Group	9.9	6.9 – 14.0
Fluarix-Unprimed Group	3.4	2.5 – 4.5

YAMA, Day 56

Group	Value	95% CI
GSK2321138A-Unprimed Group	35.1	27.6 – 44.6
Fluarix-Unprimed Group	3.7	2.9 – 4.8

Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. Secondary · At Days 0 and 28

A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the primed groups.

H1N1, Day 0

Group	Value	95% CI
GSK2321138A-Primed Group	48
Fluarix-Primed Group	45

H1N1, Day 28

Group	Value	95% CI
GSK2321138A-Primed Group	73
Fluarix-Primed Group	78

H3N2, Day 0

Group	Value	95% CI
GSK2321138A-Primed Group	39
Fluarix-Primed Group	36

H3N2, Day 28

Group	Value	95% CI
GSK2321138A-Primed Group	75
Fluarix-Primed Group	80

VICT, Day 0

Group	Value	95% CI
GSK2321138A-Primed Group	16
Fluarix-Primed Group	20

VICT, Day 28

Group	Value	95% CI
GSK2321138A-Primed Group	50
Fluarix-Primed Group	52

YAMA, Day 0

Group	Value	95% CI
GSK2321138A-Primed Group	56
Fluarix-Primed Group	62

YAMA, Day 28

Group	Value	95% CI
GSK2321138A-Primed Group	91
Fluarix-Primed Group	90

Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. Secondary · At Days 0, 28 and 56

H1N1, Day 0

Group	Value	95% CI
GSK2321138A-Unprimed Group	58
Fluarix-Unprimed Group	54

H1N1, Day 28

Group	Value	95% CI
GSK2321138A-Unprimed Group	76
Fluarix-Unprimed Group	78

H1N1, Day 56

Group	Value	95% CI
GSK2321138A-Unprimed Group	95
Fluarix-Unprimed Group	94

H3N2, Day 0

Group	Value	95% CI
GSK2321138A-Unprimed Group	74
Fluarix-Unprimed Group	70

H3N2, Day 28

Group	Value	95% CI
GSK2321138A-Unprimed Group	64
Fluarix-Unprimed Group	61

H3N2, Day 56

Group	Value	95% CI
GSK2321138A-Unprimed Group	96
Fluarix-Unprimed Group	94

VICT, Day 0

Group	Value	95% CI
GSK2321138A-Unprimed Group	25
Fluarix-Unprimed Group	35

VICT, Day 28

Group	Value	95% CI
GSK2321138A-Unprimed Group	36
Fluarix-Unprimed Group	41

Number of Subjects With Any and Grade 3 Solicited Local Symptoms. Secondary · During the 7-day follow-up period (Days 0 to 6) after any vaccination

Assessed solicited local symptoms were pain, redness and swelling at the injection site. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.

Any Pain

Group	Value	95% CI
GSK2321138A Group	125
Fluarix Group	116

Grade 3 Pain

Group	Value	95% CI
GSK2321138A Group	4
Fluarix Group	1

Any Redness

Group	Value	95% CI
GSK2321138A Group	31
Fluarix Group	34

Redness >50 mm

Group	Value	95% CI
GSK2321138A Group	0
Fluarix Group	0

Any Swelling

Group	Value	95% CI
GSK2321138A Group	27
Fluarix Group	24

Swelling >50 mm

Group	Value	95% CI
GSK2321138A Group	0
Fluarix Group	0

Adverse events — posted to ClinicalTrials.gov

Time frame: SAE(s): during the entire study period (Day 0 - Day 180); Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination; Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

GSK2321138A Group

Serious: 0/298 (0%)

Deaths: —

Fluarix Group

Serious: 2/301 (1%)

Deaths: —

Serious adverse events (2 terms)

Reaction	System	GSK2321138A Group	Fluarix Group
Bronchopneumonia	Infections and infestations	—	—
Urticaria	Skin and subcutaneous tissue disorders	—	—

Other adverse events (9 terms — click to expand)

Reaction	System	GSK2321138A Group	Fluarix Group
Pain	General disorders	—	—
Irritability	General disorders	—	—
Loss of appetite	General disorders	—	—
Temperature	General disorders	—	—
Nasopharyngitis	Infections and infestations	—	—
Drowsiness	General disorders	—	—
Redness	General disorders	—	—
Swelling	General disorders	—	—
Pharyngitis	Infections and infestations	—	—

Most-reported serious reactions: Bronchopneumonia, Urticaria.

Data from ClinicalTrials.gov NCT00985790 adverse events section.

Sponsor's own description

The purpose of the present study is to assess the immunogenicity and safety of vaccine GSK2321138A in children.

Publications & conference data

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

Immunogenicity and safety of inactivated quadrivalent and trivalent influenza vaccines in children 18-47 months of age.
Rodriguez Weber MA, Claeys C, Aranza Doniz C, Feng Y, et al · · 2014 · cited 17× · PMID 25386965 · DOI 10.1097/inf.0000000000000463

Verify or expand the search:

Other trials of Influenza vaccine GSK2321138A

Trials testing the same drug.

NCT01204671 — Safety and Immunogenicity Study of GSK Biologicals' Seasonal Influenza Candidate Vaccine (GSK2321138A) · Phase 3 · completed
NCT01196988 — Immunogenicity and Safety Study of GSK Biologicals' Influenza Vaccine When Administered in Children · Phase 3 · completed

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 NCT00985790 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 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: 21 September 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/NCT00985790.

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

NCT00985790

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 (2 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of Influenza vaccine GSK2321138A

Other recruiting trials for Influenza

Other GlaxoSmithKline trials

Verify against primary sources