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NCT00449670

Assess Consistency of Immunogenicity of GlaxoSmithKline Biologicals' Pandemic Influenza Vaccine (GSK1562902A) in Adults

Completed Phase 3 Results posted Last updated 9 April 2020
What this trial tests

Phase 3 trial testing H5N1 adjuvanted split virus vaccine (A/Vietnam/1194/2004 strain) in Influenza in 1,206 participants. Completed in 10 June 2008.

Timeline
24 March 2007
Primary endpoint
12 July 2007
10 June 2008

Quick facts

Lead sponsorGlaxoSmithKline
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposeprevention
Enrollment1,206
Start date24 March 2007
Primary completion12 July 2007
Estimated completion10 June 2008
Sites6 locations across Hong Kong, Singapore, Thailand, Taiwan

Drugs / interventions tested

Conditions studied

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 18 to 60, any sex, with Influenza or Influenza Vaccines. 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 2 Strains of Influenza Disease Primary · Before vaccination (Day 0)

Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:10.

A/Vietnam/1194/2004
GroupValue95% CI
H5N1 Adjuvanted Group - Lot 15.65.3 – 5.9
H5N1 Adjuvanted Group - Lot 25.55.2 – 5.8
H5N1 Adjuvanted Group - Lot 35.65.2 – 5.9
H5N1 Adjuvanted Group - Lot 45.45.2 – 5.7
H5N1 Un-adjuvanted Group5.65.3 – 5.9
A/Indonesia/5/2005
GroupValue95% CI
H5N1 Adjuvanted Group - Lot 15.15 – 5.2
H5N1 Adjuvanted Group - Lot 255 – 5.1
H5N1 Adjuvanted Group - Lot 355 – 5.1
H5N1 Adjuvanted Group - Lot 45.15 – 5.1
H5N1 Un-adjuvanted Group5.05.0 – 5.1
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease Primary · Within 21 days following 2-dose primary vaccination (at Day 42)

Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:10.

A/Vietnam/1194/2004
GroupValue95% CI
H5N1 Adjuvanted Group - Lot 1192.7164.2 – 226.2
H5N1 Adjuvanted Group - Lot 2235.2203.1 – 272.5
H5N1 Adjuvanted Group - Lot 3225.6193.5 – 263
H5N1 Adjuvanted Group - Lot 4226.3194 – 264
H5N1 Un-adjuvanted Group7.56.7 – 8.3
A/Indonesia/5/2005
GroupValue95% CI
H5N1 Adjuvanted Group - Lot 124.320.4 – 29
H5N1 Adjuvanted Group - Lot 227.923.4 – 33.3
H5N1 Adjuvanted Group - Lot 325.521.2 – 30.7
H5N1 Adjuvanted Group - Lot 422.418.6 – 27
H5N1 Un-adjuvanted Group5.25.0 – 5.4
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease Secondary · Within 21 days following the first primary vaccination dose (Day 21)

Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:10.

A/Vietnam/1194/2004
GroupValue95% CI
H5N1 Adjuvanted Group - Lot 121.818.1 – 26.2
H5N1 Adjuvanted Group - Lot 225.120.7 – 30.5
H5N1 Adjuvanted Group - Lot 32419.6 – 29.3
H5N1 Adjuvanted Group - Lot 420.517 – 24.6
H5N1 Un-adjuvanted Group6.76.0 – 7.4
A/Indonesia/5/2005
GroupValue95% CI
H5N1 Adjuvanted Group - Lot 16.35.7 – 6.8
H5N1 Adjuvanted Group - Lot 25.95.6 – 6.3
H5N1 Adjuvanted Group - Lot 35.95.5 – 6.4
H5N1 Adjuvanted Group - Lot 45.15 – 5.1
H5N1 Un-adjuvanted Group5.25.0 – 5.3
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease Secondary · Before booster vaccination at Month 6 (M6) and following booster vaccination at Month 6+21 days (M6+21D) and at Month 6+42 days (M6+42D)

Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:10.

A/Vietnam/1194/2004, M6
GroupValue95% CI
H5N1 Adjuvanted Group19.116.5 – 22.2
H5N1 Un-adjuvanted Group5.85.4 – 6.2
A/Vietnam/1194/2004, M6+21D
GroupValue95% CI
H5N1 Adjuvanted Group397.4342.5 – 461.0
H5N1 Un-adjuvanted Group30.124.9 – 36.3
A/Vietnam/1194/2004, M6+42D
GroupValue95% CI
H5N1 Un-adjuvanted Group76.364.1 – 90.8
A/Indonesia/5/2005, M6
GroupValue95% CI
H5N1 Adjuvanted Group6.46 – 6.9
H5N1 Un-adjuvanted Group5.15 – 5.1
A/Indonesia/5/2005, M6+21D
GroupValue95% CI
H5N1 Adjuvanted Group321.3274.3 – 376.2
H5N1 Un-adjuvanted Group24.820.5 – 30.0
A/Indonesia/5/2005, M6+42D
GroupValue95% CI
H5N1 Un-adjuvanted Group96.380.6 – 115.1
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease Secondary · Before booster vaccination at Month 6 (M6) and following booster vaccination at Month 6+21 days (M6+21D) and at Month 6+42 days (M6+42D) and at Month 12 (M12)

Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:10.

A/Vietnam/1194/2004, M6
GroupValue95% CI
H5N1 Adjuvanted Group19.416.6 – 22.5
H5N1 Un-adjuvanted Group5.85.4 – 6.2
A/Vietnam/1194/2004, M6+21D
GroupValue95% CI
H5N1 Adjuvanted Group395.3339.8 – 459.7
H5N1 Un-adjuvanted Group31.025.6 – 37.5
A/Vietnam/1194/2004, M6+42D
GroupValue95% CI
H5N1 Un-adjuvanted Group7865.5 – 92.9
A/Vietnam/1194/2004, M12
GroupValue95% CI
H5N1 Adjuvanted Group76.162.5 – 92.7
H5N1 Un-adjuvanted Group14.312.2 – 16.8
A/Indonesia/5/2005, M6
GroupValue95% CI
H5N1 Adjuvanted Group6.56 – 6.9
H5N1 Un-adjuvanted Group5.15 – 5.1
A/Indonesia/5/2005, M6+21D
GroupValue95% CI
H5N1 Adjuvanted Group319.1271.7 – 374.7
H5N1 Un-adjuvanted Group25.521 – 30.9
A/Indonesia/5/2005, M6+42D
GroupValue95% CI
H5N1 Un-adjuvanted Group98.582.3 – 117.9
A/Indonesia/5/2005, M12
GroupValue95% CI
H5N1 Adjuvanted Group46.938.3 – 57.4
H5N1 Un-adjuvanted Group14.612.5 – 17.1
Titers for Serum Neutralizing (SN) Antibodies Against 2 Strains of Influenza Disease Secondary · Before vaccination at Day 0 (D0) and within 21 days following 2-dose primary vaccination at Day 42 (D42)

Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:28.

A/Vietnam/1194/2004, D0
GroupValue95% CI
H5N1 Adjuvanted Group - Lot 117.815.4 – 20.5
H5N1 Adjuvanted Group - Lot 217.815.7 – 20.2
H5N1 Adjuvanted Group - Lot 31815.7 – 20.8
H5N1 Adjuvanted Group - Lot 416.615.3 – 18.1
H5N1 Un-adjuvanted Group17.715.4 – 20.4
A/Vietnam/1194/2004, D42
GroupValue95% CI
H5N1 Adjuvanted Group - Lot 1274.4232.7 – 323.5
H5N1 Adjuvanted Group - Lot 2330.6281.4 – 388.4
H5N1 Adjuvanted Group - Lot 3283.1234.2 – 342.3
H5N1 Adjuvanted Group - Lot 4350.4293.9 – 417.8
H5N1 Un-adjuvanted Group29.023.4 – 35.9
A/Indonesia/5/2005, D0
GroupValue95% CI
H5N1 Adjuvanted Group - Lot 114.614 – 15.3
H5N1 Adjuvanted Group - Lot 214.814 – 15.7
H5N1 Adjuvanted Group - Lot 315.313.7 – 17.2
H5N1 Adjuvanted Group - Lot 414.713.9 – 15.5
H5N1 Un-adjuvanted Group15.614.4 – 16.7
A/Indonesia/5/2005, D42
GroupValue95% CI
H5N1 Adjuvanted Group - Lot 174.361.9 – 89.3
H5N1 Adjuvanted Group - Lot 2100.086 – 116.5
H5N1 Adjuvanted Group - Lot 380.466.7 – 96.9
H5N1 Adjuvanted Group - Lot 482.169.8 – 96.5
H5N1 Un-adjuvanted Group16.214.8 – 17.8
Titers for Serum Neutralization (SN) Antibodies Against 2 Strains of Influenza Disease Secondary · Before booster vaccination at Month 6 (M6) and following booster vaccination at Month 6+21 days (M6+21D) and at Month 6+42 days (M6+42D)

Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:10.

A/Vietnam/1194/2004, M6
GroupValue95% CI
H5N1 Adjuvanted Group170.5154.6 – 188.0
H5N1 Un-adjuvanted Group29.423 – 37.6
A/Vietnam/1194/2004, M6+21D
GroupValue95% CI
H5N1 Adjuvanted Group1660.11435.9 – 1919.4
H5N1 Un-adjuvanted Group248.1187 – 329
A/Vietnam/1194/2004, M6+42D
GroupValue95% CI
H5N1 Un-adjuvanted Group447.1331.9 – 602.1
A/Indonesia/5/2005, M6
GroupValue95% CI
H5N1 Adjuvanted Group183.6167 – 201.8
H5N1 Un-adjuvanted Group30.322.8 – 40.1
A/Indonesia/5/2005, M6+21D
GroupValue95% CI
H5N1 Adjuvanted Group2917.52490.8 – 3417.3
H5N1 Un-adjuvanted Group451.9357.5 – 571.3
A/Indonesia/5/2005, M6+42D
GroupValue95% CI
H5N1 Un-adjuvanted Group1075.8834.7 – 1386.6
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease in Adults Who Had Not Received the Booster Dose at Month 6 Secondary · At Day 0, at Day 21, at Day 42, at Month 6 and at Month 12

Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:10.

A/Vietnam/1194/2004, D0
GroupValue95% CI
H5N1 Adjuvanted Group5.65.4 – 5.7
A/Vietnam/1194/2004, D21
GroupValue95% CI
H5N1 Adjuvanted Group23.320.8 – 26.1
A/Vietnam/1194/2004, D42
GroupValue95% CI
H5N1 Adjuvanted Group215.7197.4 – 235.7
A/Vietnam/1194/2004, M6
GroupValue95% CI
H5N1 Adjuvanted Group18.517 – 20.3
A/Vietnam/1194/2004, M12
GroupValue95% CI
H5N1 Adjuvanted Group11.410.4 – 12.5
A/Indonesia/5/2005, D0
GroupValue95% CI
H5N1 Adjuvanted Group5.15 – 5.1
A/Indonesia/5/2005, D21
GroupValue95% CI
H5N1 Adjuvanted Group6.15.8 – 6.3
A/Indonesia/5/2005, D42
GroupValue95% CI
H5N1 Adjuvanted Group24.822.3 – 27.5
Titers for Serum Neutralization (SN) Antibodies Against 2 Strains of Influenza Disease in Adults Who Had Not Received the Booster Dose at Month 6 Secondary · At Month 12

Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:10.

A/Vietnam/1194/2004
GroupValue95% CI
H5N1 Adjuvanted Group215.5191.4 – 242.7
A/Indonesia/5/2005
GroupValue95% CI
H5N1 Adjuvanted Group57.950.5 – 66.4
Number of Seroconverted Subjects for HI Antibodies Against 2 Strains of Influenza Disease Secondary · At Day 21 (D21) and at Day 42 (D42)

Seroconversion was defined as: for initially seronegative subjects, antibody titer greater than or equal to ≥ 1:40 after vaccination; and for initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).

A/Vietnam/1194/2004, D21
GroupValue95% CI
H5N1 Adjuvanted Group - Lot 197
H5N1 Adjuvanted Group - Lot 2103
H5N1 Adjuvanted Group - Lot 397
H5N1 Adjuvanted Group - Lot 496
H5N1 Un-adjuvanted Group8
A/Vietnam/1194/2004, D42
GroupValue95% CI
H5N1 Adjuvanted Group - Lot 1213
H5N1 Adjuvanted Group - Lot 2220
H5N1 Adjuvanted Group - Lot 3214
H5N1 Adjuvanted Group - Lot 4219
H5N1 Un-adjuvanted Group13
A/Indonesia/5/2005, D21
GroupValue95% CI
H5N1 Adjuvanted Group - Lot 19
H5N1 Adjuvanted Group - Lot 24
H5N1 Adjuvanted Group - Lot 35
H5N1 Adjuvanted Group - Lot 46
H5N1 Un-adjuvanted Group0
A/Indonesia/5/2005, D42
GroupValue95% CI
H5N1 Adjuvanted Group - Lot 1108
H5N1 Adjuvanted Group - Lot 2128
H5N1 Adjuvanted Group - Lot 3118
H5N1 Adjuvanted Group - Lot 4110
H5N1 Un-adjuvanted Group1
Number of Seroconverted Subjects for HI Antibodies Against 2 Strains of Influenza Disease Secondary · Before booster vaccination at Month 6 (M6) and following booster vaccination at Month 6+21 days (M6+21D) and at Month 6+42 days (M6+42D)

Seroconversion was defined as: for initially seronegative subjects, antibody titer greater than or equal to ≥ 1:40 after vaccination; and for initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).

A/Vietnam/1194/2004, M6
GroupValue95% CI
H5N1 Adjuvanted Group96
H5N1 Un-adjuvanted Group2
A/Vietnam/1194/2004, M6+21D
GroupValue95% CI
H5N1 Adjuvanted Group244
H5N1 Un-adjuvanted Group110
A/Vietnam/1194/2004, M6+42D
GroupValue95% CI
H5N1 Adjuvanted Group0
H5N1 Un-adjuvanted Group174
A/Indonesia/5/2005, M6
GroupValue95% CI
H5N1 Adjuvanted Group9
H5N1 Un-adjuvanted Group0
A/Indonesia/5/2005, M6+21D
GroupValue95% CI
H5N1 Adjuvanted Group241
H5N1 Un-adjuvanted Group105
A/Indonesia/5/2005, M6+42D
GroupValue95% CI
H5N1 Adjuvanted Group0
H5N1 Un-adjuvanted Group188
Number of Seroconverted Subjects for HI Antibodies Against 2 Strains of Influenza Disease for Adults Who Received the Booster Dose at Month 6 - Booster Phase Secondary · Following booster vaccination at Month 6 +21 days (M6+21D) and Month 6 +42 days (M6+42D)

Seroconversion was defined as: for initially seronegative subjects, antibody titer greater than or equal to ≥ 1:40 after vaccination; and for initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).

A/Vietnam/1194/2004, M6+21D
GroupValue95% CI
H5N1 Adjuvanted Group233
H5N1 Un-adjuvanted Group112
A/Vietnam/1194/2004, M6+42D
GroupValue95% CI
H5N1 Adjuvanted Group0
H5N1 Un-adjuvanted Group173
A/Indonesia/5/2005, M6+21D
GroupValue95% CI
H5N1 Adjuvanted Group241
H5N1 Un-adjuvanted Group106
A/Indonesia/5/2005, M6+42D
GroupValue95% CI
H5N1 Adjuvanted Group0
H5N1 Un-adjuvanted Group189

Adverse events — posted to ClinicalTrials.gov

Time frame: Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs up to 21 days (Day 0-20) after the first vaccination and 30 days (Day 0-29) after the second vaccination, SAEs during the entire study period (Day 0 - Month 12).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

H5N1 Adjuvanted Group
Serious: 25/961 (3%)
Deaths: 1/961
H5N1 Un-adjuvanted Group
Serious: 5/245 (2%)
Deaths: 0/245

Serious adverse events (35 terms)

ReactionSystemH5N1 Adjuvanted GroupH5N1 Un-adjuvanted Group
Ligament ruptureInjury, poisoning and procedural complications——
AppendicitisInfections and infestations——
Skin lacerationInjury, poisoning and procedural complications——
Uterine leiomyomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)——
ContusionInjury, poisoning and procedural complications——
Normochromic normocytic anaemiaBlood and lymphatic system disorders——
Abdominal painGastrointestinal disorders——
Anorectal disorderGastrointestinal disorders——
GastritisGastrointestinal disorders——
HaemorrhoidsGastrointestinal disorders——
Accidental deathGeneral disorders——
PyrexiaGeneral disorders——
Pyelonephritis acuteInfections and infestations——
Urinary tract infectionInfections and infestations——
Head injuryInjury, poisoning and procedural complications——
Meniscus lesionInjury, poisoning and procedural complications——
Radius fractureInjury, poisoning and procedural complications——
HypoalbuminaemiaMetabolism and nutrition disorders——
Benign ovarian tumourNeoplasms benign, malignant and unspecified (incl cysts and polyps)——
HeadacheNervous system disorders——
Adjustment disorderPsychiatric disorders——
AnxietyPsychiatric disorders——
Cervical polypReproductive system and breast disorders——
EndometriosisReproductive system and breast disorders——
Vaginal haemorrhageReproductive system and breast disorders——
Other adverse events (12 terms — click to expand)

ReactionSystemH5N1 Adjuvanted GroupH5N1 Un-adjuvanted Group
Injection site painGeneral disorders——
MyalgiaMusculoskeletal and connective tissue disorders——
FatigueGeneral disorders——
HeadacheNervous system disorders——
Injection site swellingGeneral disorders——
Injection site erythemaGeneral disorders——
IndurationGeneral disorders——
ArthralgiaMusculoskeletal and connective tissue disorders——
PyrexiaGeneral disorders——
HyperhidrosisSkin and subcutaneous tissue disorders——
ChillsGeneral disorders——
EcchymosisSkin and subcutaneous tissue disorders——

Most-reported serious reactions: Ligament rupture, Appendicitis, Skin laceration, Uterine leiomyoma, Contusion, Normochromic normocytic anaemia, Abdominal pain, Anorectal disorder.

Data from ClinicalTrials.gov NCT00449670 adverse events section.

Sponsor's own description

The present study is designed to assess the lot-to-lot consistency of the immunogenicity of a GlaxoSmithKline Biologicals' pandemic influenza candidate vaccine (GSK1562902A) in adults aged between 18 and 60 years.

Publications & conference data

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

  1. 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
  2. Long-term booster schedules with AS03A-adjuvanted heterologous H5N1 vaccines induces rapid and broad immune responses in Asian adults.
    Gillard P, Chu DW, Hwang SJ, Yang PC, et al · · 2014 · cited 19× · PMID 24628789 · DOI 10.1186/1471-2334-14-142
  3. Immunogenicity and safety of an AS03(A)-adjuvanted H5N1 influenza vaccine in a Taiwanese population.
    Hwang SJ, Chang SC, Yu CJ, Chan YJ, et al · · 2011 · cited 7× · PMID 22248833 · DOI 10.1016/j.jfma.2011.11.009
  4. Cross-clade immunogenicity and antigen-sparing with an AS03(A)-adjuvanted prepandemic influenza vaccine in a Thai population.
    Thongcharoen P, Auewarakul P, Hutagalung Y, Ong G, et al · · 2011 · cited 2× · PMID 21863672

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