Study to Evaluate the Immunogenicity and Safety of an Investigational Pandemic Influenza Vaccine in Children

NCT01323946 | Completed Phase 2 Results

• 2 other identifiers: 1098252011-004734-33
• Study Type: interventional
• Target: 113
• Locations: 2 countries
• Sites: 6

Brief Summary

The objective of the study is to evaluate the immunogenicity and safety of prime-boost vaccination schedule of GSK Biologicals' investigational vaccine GSK1562902A.

Conditions

Influenza

Keywords

H5N1; influenza infection; Influenza vaccine GSK1562902A

Outcome Measures

Primary Outcomes (3)

• Number of Seroconverted Subjects in Terms of H5N1 Hemagglutination Inhibition (HI) Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain

  A seroconverted subject is defined as a subject that had either a pre-vaccination (Day 0) 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 on Day 192.

  At Day 192

• Mean Geometric Change in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/01/2005 H5N1 Virus Strain

  Mean Geometric Change is defined as the geometric mean of the within-subject ratios of the post vaccination (Day 192) reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer (i.e. post-vaccination divided by pre-vaccination titer).

  At Day 192

• Number of Seroprotected Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/01/2005 H5N1 Virus Strain

  A seroprotected subject is defined as a subject with a serum H5N1 HI antibody titer ≥1:40.

  At Day 192

Secondary Outcomes (26)

• Hemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/05/2005 H5N1 Virus Strain

  At Day 0, Day 42, Day 182, Day 192 and Day 364

• Hemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/01/2005 H5N1 Virus Strain

  At Day 0, Day 182, Day 192 and Day 364

• Number of Seropositive Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005

  At Day 0, Day 42, Day 182, Day 192 and Day 364

• Number of Seropositive Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain

  At Day 0, Day 182, Day 192 and Day 364

• Number of Seroconverted Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain

  At Day 42, Day 182, Day 192 and Day 364

Study Arms (3)

GSK1562902A 6 to 12 M Group

EXPERIMENTAL

Subjects between 6 and 12 months of age (6 to 12 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.

Biological: GSK Biologicals' investigational vaccine GSK1562902A

GSK1562902A 12 to 24 M Group

EXPERIMENTAL

Subjects between 12 and 24 months of age (12 to 24 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.

Biological: GSK Biologicals' investigational vaccine GSK1562902A

GSK1562902A 24 to 36 M Group

EXPERIMENTAL

Subjects between 24 and 36 months of age (24 to 36 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.

Biological: GSK Biologicals' investigational vaccine GSK1562902A

Interventions

GSK Biologicals' investigational vaccine GSK1562902A BIOLOGICAL

Three intramuscular injections

GSK1562902A 12 to 24 M Group; GSK1562902A 24 to 36 M Group; GSK1562902A 6 to 12 M Group

Eligibility Criteria

• Age: 6 Months - 35 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Subjects who the investigator believes that parents/Legally Acceptable Representatives (LARs) can and will comply with the requirements of the protocol.
• Children, male or female between, and including, 6 and 35 months of age at the time of first study vaccination.
• Written informed consent obtained from the parent(s)/LAR(s) of the subject.
• Healthy children as established by medical history and clinical examination before entering the study.
• Parent/LAR access to a consistent means of telephone contact, land line or mobile, but NOT a pay phone or other multiple-user device.
• Subjects who are likely to reside in the vicinity of the study centre for the duration of the study. In studies using the home-based model for vaccination and follow-up, subjects who are likely to remain in the vicinity of the area where they were recruited.

You may not qualify if:

• Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
• Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
• Planned administration of any vaccine 30 days prior and 21 days after any study vaccine administration.
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines such as egg protein or thiomersal.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
• History of any neurological disorders or seizures.
• Acute disease at the time of enrolment.
• Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory tests.
• Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned administration during the study period.
• Any condition which, in the opinion of the investigator, renders the subject unfit for participation in the study.
• Child in care.
• Previous vaccination at any time with an H5N1 vaccine.
• Medical history of physician-confirmed infection with a H5N1 virus.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (6)

GSK Investigational Site

Garran, Australian Capital Territory, 2606, Australia

Location

GSK Investigational Site

Westmead, New South Wales, 2145, Australia

Location

GSK Investigational Site

North Adelaide, South Australia, 5006, Australia

Location

GSK Investigational Site

Carlton, Victoria, 3053, Australia

Location

GSK Investigational Site

Singapore, 119074, Singapore

Location

GSK Investigational Site

Singapore, 228510, Singapore

Location

Related Publications (1)

• Nolan T, Izurieta P, Lee BW, Chan PC, Marshall H, Booy R, Drame M, Vaughn DW. Heterologous prime-boost vaccination using an AS03B-adjuvanted influenza A(H5N1) vaccine in infants and children<3 years of age. J Infect Dis. 2014 Dec 1;210(11):1800-10. doi: 10.1093/infdis/jiu359. Epub 2014 Jun 27.

  PMID: 24973461 BACKGROUND

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects were to be stratified into three age strata (6 to 11 months, 12 to 23 months and 24 to 35 months) in the ratio of 2:1:1.

Study Record Dates

• First Submitted: March 24, 2011
• First Posted: March 28, 2011
• Study Start: April 18, 2011
• Primary Completion: June 22, 2012
• Study Completion: November 2, 2012
• Last Updated: May 7, 2019
• Results First Posted: February 4, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will share

Locations

AU (4); SG (2)