Study to Evaluate Immunological Equivalence Between Two Investigational Influenza Vaccines in Adults (H1N1)

NCT00979407 | Completed Phase 3 Results

• 1 other identifier: 113535
• Study Type: interventional
• Target: 336
• Locations: 2 countries
• Sites: 7

Brief Summary

The primary purpose of the study is to assess the equivalence of the immune response elicited by two GSK Biologicals' adjuvanted influenza investigational vaccines (GSK2340272A and GSK2340274A) in adults aged 18 to 60 years. The second purpose of the study is to evaluate the safety and reactogenicity of these two vaccines.

Conditions

Influenza

Keywords

influenza infection; GSK Biologicals' influenza vaccine GSK2340272A and GSK2340274A

Outcome Measures

Primary Outcomes (1)

• Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease

  Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/CAL/7/09. The reference seropositivity cut-off value was greater than or equal to (≥) 1:10.

  At Day 21

Secondary Outcomes (17)

• Number of Seroconverted (SCR) Subjects for HI Antibodies

  At Days 21 and 42

• Number of SCR Subjects for HI Antibodies

  At Days 182 and 364

• Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease

  At Days 0 and 42

• Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease

  At Days 182 and 364

• Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain

  At Days 0, 21 and 42

Study Arms (2)

GSK2340272A GROUP

EXPERIMENTAL

Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.

Biological: Influenza vaccine GSK2340272A

GSK2340274A GROUP

EXPERIMENTAL

Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340274A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.

Biological: Influenza vaccine GSK2340274A

Interventions

Influenza vaccine GSK2340272A BIOLOGICAL

Two intramuscular injections at Day 0 and Day 21

GSK2340272A GROUP

Influenza vaccine GSK2340274A BIOLOGICAL

Two intramuscular injections at Day 0 and Day 21

GSK2340274A GROUP

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female aged 18 to 60 years inclusive, at the time of the first vaccination.
• Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
• Written informed consent obtained from the subject.
• Satisfactory baseline medical assessment by history and physical examination.
• Access to a consistent means of telephone contact, which may be either in the home or at the workplace, land line or mobile, but NOT a pay phone or multiple-user device
• Females of non-childbearing potential may be enrolled in the study.
• Female of childbearing potential may be enrolled in the study, if she:
• has practiced adequate contraception for 30 days prior to vaccination, and
• has a negative pregnancy test on the day of vaccination, and
• has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.

You may not qualify if:

• Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period.
• Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, although stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
• Presence of an axillary temperature \>= 37.5°C (99.5°F), or acute symptoms greater than "mild" severity on the scheduled date of first vaccination. NOTE: The subject may be vaccinated at a later date, provided symptoms have resolved, vaccination occurs within the window specified by the protocol, and all other eligibility criteria continue to be satisfied.
• Clinically or virologically confirmed influenza infection within 6 months preceding the study start.
• Diagnosed with cancer, or treatment for cancer, within 3 years.
• Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus (HIV) infection.
• Clinically or virologically confirmed influenza infection within 6 months preceding the study start.
• Chronic administration of immunosuppressants or other immune modifying drugs within 6 months of study enrolment or planned administration during the study period.
• Receipt of any immunoglobulins and/or any blood products within 3 months of study enrolment or planned administration of any of these products during the study period.
• Any significant disorder of coagulation or treatment with warfarin derivatives or heparin.
• An acute evolving neurological disorder or history of Guillain-Barré syndrome.
• Administration of any vaccines within 30 days before vaccination.
• Any known or suspected allergy to any constituent of influenza vaccines; a history of anaphylactic-type reaction to any constituent of influenza vaccines; or a history of severe adverse reaction to a previous influenza vaccine.
• Pregnant or lactating female
• Female planning to become pregnant or planning to discontinue contraceptive precautions.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (7)

GSK Investigational Site

Caen, 14033, France

Location

GSK Investigational Site

Paris, 75679, France

Location

GSK Investigational Site

Paris, 75877, France

Location

GSK Investigational Site

Poitiers, 86000, France

Location

GSK Investigational Site

Regensburg, Bavaria, 93053, Germany

Location

GSK Investigational Site

Würzburg, Bavaria, 97070, Germany

Location

GSK Investigational Site

Schmiedeberg, Saxony, 01762, Germany

Location

Related Publications (1)

• Launay O, Duval X, Fitoussi S, Jilg W, Kerdpanich A, Montellano M, Schwarz TF, Watanveerade V, Wenzel JJ, Zalcman G, Bambure V, Li P, Caplanusi A, Madan A, Gillard P, Vaughn DW. Extended antigen sparing potential of AS03-adjuvanted pandemic H1N1 vaccines in children, and immunological equivalence of two formulations of AS03-adjuvanted H1N1 vaccines: results from two randomised trials. BMC Infect Dis. 2013 Sep 16;13:435. doi: 10.1186/1471-2334-13-435.

  PMID: 24041010 DERIVED

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 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2009
• First Posted: September 18, 2009
• Study Start: October 12, 2009
• Primary Completion: November 9, 2009
• Study Completion: November 4, 2010
• Last Updated: August 6, 2018
• Results First Posted: August 6, 2018

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will share

Locations

FR (4); DE (3)