A Laboratory Evaluation of the Humoral Immune Response in Adults and Children to the H1 Hemagglutinin (HA) Stalk Domain and Other Influenza A Virus Protein Epitopes, After Administration of GlaxoSmithKline (GSK) Biologicals' Pandemic Influenza Vaccines
Status
Completed
Conditions
Immunologic Tests
Treatments
Other: Serum samples
Details and patient eligibility
About
The purpose of this exploratory, retrospective laboratory study is to assess the humoral immune response to H1 hemagglutinin stalk domain and other influenza A virus protein epitopes following administration, in adults and children, of GSK Biologicals' adjuvanted and unadjuvanted pandemic influenza vaccines, using archived serum samples from previously completed clinical trials.
Enrollment
414 patients
Sex
All
Ages
6 months to 64 years old
Volunteers
Accepts Healthy Volunteers
Inclusion criteria
Not applicable since no subjects will be actively enrolled in this study; only the sera samples of the subjects who were a part of previously conducted primary trials will be used for testing. However, the archived serum samples of only those subjects who satisfy the following criteria will be included in this study:
- Subjects who received two doses of influenza vaccine 21 days apart and were included in the ATP cohort for immunogenicity and Persistence cohort (depending on the study) in the primary studies listed.
- Subjects who had agreed that their blood samples could be used for further research while giving informed consent for any of the primary studies listed.
- Subjects who have sufficient residual sample volume (i.e., ≥0.5 mL) of serum at all time points.
- Subjects with vaccine homologous neutralizing antibody result available at Day 0 and at 21 (25 samples available per group in Study H9N2-001)
Exclusion criteria
- Not applicable since no subjects will be actively enrolled in this study; only the serum samples of the subjects who were a part of previously conducted trials will be used for testing.
Trial design
414 participants in 13 patient groups
H1N1_AS Group
Description:
Subjects 19-40 years of age (in H1N1 cohort of primary completed study Q-PAN H1N1-019 (113536) (A/California/07/2009)) who were administered adjuvanted (AS03A) pandemic vaccine with 3.75 µg HA (hemagglutinin) at Days 0 and 21 and TIV at Day 42.
Treatment:
Other: Serum samples
H1N1_NAS Group
Description:
Subjects 19-40 years of age (in H1N1 cohort of primary completed study -Q-PAN H1N1-019 (113536) (A/California/07/2009)) who were administered unadjuvanted pandemic vaccine with 15 µg HA (hemagglutinin) at Days 0 and 21 and TIV at Day 42
Treatment:
Other: Serum samples
H5N1_AS Group
Description:
Subjects 18-49 years of age (in H5N1 cohort of primary completed study CC-PAN H5N1-001 (114371)(A/Indonesia/5/2005 RG)) who were administered adjuvanted (AS03A) pandemic vaccine with 3.75 µg HA (hemagglutinin) at Days 0 and 21
Treatment:
Other: Serum samples
H5N1_NAS Group
Description:
Subjects 18-49 years of age (in H5N1 cohort of primary completed study CC-PAN H5N1-001 (114371)(A/Indonesia/5/2005 RG)) who were administered unadjuvanted pandemic vaccine with 15 µg HA (hemagglutinin) at Days 0 and 21.
Treatment:
Other: Serum samples
H9N2_AS Group
Description:
Subjects 18-64 years of age (in H9N2 cohort of primary completed study Q-PAN H9N2-001 (116358) (A/chicken/Hong Kong/G9/1997 NIBRG-91)) who were administered adjuvanted (AS03A) pandemic vaccine with 3.75 µg HA (hemagglutinin) at Days 0 and 21 and saline placebo at Day 182.
Treatment:
Other: Serum samples
H9N2_NAS Group
Description:
Subjects 18-64 years of age (in H9N2 cohort of primary completed studyQ-PAN H9N2-001 (116358)(A/chicken/Hong Kong/G9/1997 NIBRG-91)) who were administered unadjuvanted pandemic vaccine with 15 µg HA (hemagglutinin) at Days 0 and 21 and with saline placebo at Day 182.
Treatment:
Other: Serum samples
DQIV_NAS Group
Description:
Subjects 18-≤39 years of age (in D-QIV cohort of primary completed study FLU D-QIV-015 (201251) (A/Christchurch/16/2010 (H1N1)pdm09, A/Texas/50/2012 (H3N2), B/Massachusetts/02/2012, B/Brisbane/60/2008)) who were administered 15 µg HA (no AS) of each of 4 strains (total 60 µg HA) at Day 0.
Treatment:
Other: Serum samples
QPAN_C Group
Description:
Subjects 18-40 years of age (in Q-PAN cohort of primary completed study Q-PAN-005 (110624)) who were administered 3.8 µg A/Indonesia/5/05 (H5N1) with AS03A on Day 0; phosphate buffer saline (PBS) preserved with 20 ppm thimerosal on Day 182; 3.8 µg A/turkey/Turkey/1/05 (H5N1) with AS03A on Day 549.
Treatment:
Other: Serum samples
QPAN5_G Group
Description:
Subjects 18-40 years of age (in Q-PAN cohort of primary completed study Q-PAN-005 (110624)) who were administered PBS preserved with 20 ppm thimerosal on Day 0; 3.8 µg A/turkey/Turkey/1/05 (H5N1) with AS03A on Days 182 and 549.
Treatment:
Other: Serum samples
H5N1_VT Group
Description:
Subjects 18-60 years of age (in H5N1 cohort of primary completed study H5N1-012 (107495) A/Vietnam/1194/2004-like or A/Indonesia/05/2005-like) who received two administrations of the adjuvanted (AS03A) pandemic influenza vaccine (3.8 µg) containing the Vietnam (VT) strain at Day 0 and Month 12.
Treatment:
Other: Serum samples
H5N1_IN Group
Description:
Subjects 18-60 years of age (in H5N1 cohort of primary completed studyH5N1-012 (107495) A/Vietnam/1194/2004-like or A/Indonesia/05/2005-like) who received one administration(3.8 µg) of the adjuvanted (AS03A) pandemic influenza vaccine containing the Vietnam (VT) strain at Day 0 and one administration(3.8 µg) of the adjuvanted (AS03A) pandemic vaccine containing the Indonesia (IN) strain at Month 12.
Treatment:
Other: Serum samples
H5N1_PAS Group
Description:
Subjects 6-35 months of age (in H5N1 cohort of primary completed study Q-PAN H5N1-AS03-021 (114464)(A/Indonesia/5/2005 RG)) who were administered adjuvanted (AS03B) pandemic vaccine with 1.9 µg HA (hemagglutinin) at Days 0 and 21.
Treatment:
Other: Serum samples
H5N1_PCN Group
Description:
Subjects 6-35 months of age (in H5N1 cohort of primary completed study Q-PAN H5N1-AS03-021 (114464)(A/Indonesia/5/2005 RG)) who were administered placebo at Days 0 and 21.
Treatment:
Other: Serum samples
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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