Study of GSK Biologicals' Pandemic Influenza (H1N1) Candidate Vaccine in Children Aged 10 to Less Than 18 Years

NCT01035749 | Completed Phase 2 Results

• 1 other identifier: 113883
• Study Type: interventional
• Target: 310
• Locations: 2 countries
• Sites: 9

Brief Summary

The purpose of this study is to show that vaccination with a single dose of GSK Biologicals' pandemic H1N1 vaccine results in an immune response that meets or exceeds European Medicines Agency (EMEA) Committee for Medicinal Products for Human Use (CHMP) guidance criteria for a pandemic influenza vaccine.

Conditions

Influenza

Keywords

pandemic influenza; Clinical trial; H1N1; children

Outcome Measures

Primary Outcomes (3)

• Number of Subjects Seroconverted for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain

  Seroconversion defined as: - For initially seronegative subjects, antibody titre ≥ 1:40 after vaccination - For initially seropositive subjects, antibody titre after vaccination ≥ 4 fold the pre-vaccination antibody titre

  At Day 21

• Number of Subjects Seroprotected for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain

  A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection.

  At Day 0 and Day 21

• HI Antibody Seroconversion Factors Against Flu A/CAL/7/09 H1N1 Strain

  Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0.

  At Day 21

Secondary Outcomes (25)

• HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain

  At Day 0 and Day 42

• HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain

  At Day 0 and Day 182

• HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain

  At Days 0, 182 and 189

• Number of Subjects Seroconverted for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain

  At Day 42

• HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain

  At Day 0 and Day 21

Study Arms (4)

AREPANRIX-ADJUVANTED F1 2D GROUP

EXPERIMENTAL

Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.

Biological: GSK Biologicals' Influenza investigational vaccine GSK2340274A; Biological: Placebo (saline)

AREPANRIX-ADJUVANTED F2 2D GROUP

EXPERIMENTAL

Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.

Biological: GSK Biologicals' Influenza investigational vaccine GSK2340274A; Biological: Placebo (saline)

AREPANRIX-ADJUVANTED F2 3D GROUP

EXPERIMENTAL

Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).

Biological: GSK Biologicals' Influenza investigational vaccine GSK2340274A

AREPANRIX-UNADJUVANTED F2 2D GROUP

EXPERIMENTAL

Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.

Biological: GSK Biologicals' Influenza investigational vaccine GSK2340273A; Biological: Placebo (saline)

Interventions

GSK Biologicals' Influenza investigational vaccine GSK2340274A BIOLOGICAL

One or two doses administered intramuscularly

AREPANRIX-ADJUVANTED F1 2D GROUP; AREPANRIX-ADJUVANTED F2 2D GROUP; AREPANRIX-ADJUVANTED F2 3D GROUP

GSK Biologicals' Influenza investigational vaccine GSK2340273A BIOLOGICAL

Two doses intramuscularly

AREPANRIX-UNADJUVANTED F2 2D GROUP

Placebo (saline) BIOLOGICAL

One dose intramuscularly

AREPANRIX-ADJUVANTED F1 2D GROUP; AREPANRIX-ADJUVANTED F2 2D GROUP; AREPANRIX-UNADJUVANTED F2 2D GROUP

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Written informed consent obtained from the subject's parent/legally acceptable representative (LAR); written informed assent obtained from the subject if appropriate.
• Good general health as established by medical history and clinical examination before entering into 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 the investigator believes that they and/or their parent(s)/LAR can and will comply with the requirements of the protocol.

You may not qualify if:

• Medical history of physician-confirmed infection with an A/California/7/2009 (H1N1)v-like virus.
• Previous vaccination at any time with an A/California/7/2009 (H1N1)v-like virus vaccine.
• Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, even if stable, are deemed by the investigator to render the potential subject or parent(s)/ LAR(s) unable/unlikely to provide accurate safety reports.
• Presence of a temperature \>= 38.0ºC by any route or method, 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.
• Diagnosed with cancer, or treatment for cancer, within 3 years.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
• Receipt of systemic glucocorticoids within 1 month prior to study enrollment (first dose of study vaccine), or any other cytotoxic or immunosuppressive drug within 6 months of study enrollment. Topical, intra-articular or inhaled glucocorticoids are allowed.
• Receipt of any immunoglobulins and/or any blood products within 6 months of study enrollment or planned administration of any of these products during the study period.
• Any significant disorder of coagulation or treatment with warfarin derivatives or heparin. Persons receiving individual doses of low molecular weight heparin are eligible if no such doses are given in the 24 hours before a study vaccination. Persons receiving prophylactic antiplatelet medications, e.g., low-dose acetylsalicylic acid, and without a clinically-apparent bleeding tendency, are eligible.
• An acute evolving neurological disorder or history of Guillain-Barré syndrome within 6 weeks of receipt of seasonal influenza vaccine.
• Administration of any licensed vaccine within 30 days before the first dose of study vaccine, with the exception of seasonal influenza vaccine (which may be given within 2 weeks before the first dose of study vaccine).
• Planned administration of any A/California H1N1v-like vaccine other than the study vaccine between Day 0 and the Day 189 phlebotomy.
• Planned administration of any other vaccine not foreseen by the study protocol between Day 0 and Day 42 after the first vaccine dose, including seasonal influenza vaccine. Routine childhood vaccinations are exempted if they cannot be delayed, but they must not be administered on the same day as the H1N1 vaccine candidate.
• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
• Any known or suspected allergy to any constituent of influenza vaccines; a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (9)

GSK Investigational Site

Tartu, 50106, Estonia

Location

GSK Investigational Site

Cífer, 919 43, Slovakia

Location

GSK Investigational Site

Dolný Kubín, 026 01, Slovakia

Location

GSK Investigational Site

Dunajská Streda, 929 01, Slovakia

Location

GSK Investigational Site

Nová Dubnica, 018 51, Slovakia

Location

GSK Investigational Site

Nové Mesto nad Váhom, 915 01, Slovakia

Location

GSK Investigational Site

Púchov, 020 01, Slovakia

Location

GSK Investigational Site

Ružomberok, 034 01, Slovakia

Location

GSK Investigational Site

Trenčín, 911 01, Slovakia

Location

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

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

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: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2009
• First Posted: December 21, 2009
• Study Start: February 1, 2010
• Primary Completion: September 27, 2010
• Study Completion: May 10, 2011
• Last Updated: August 17, 2018
• Results First Posted: January 25, 2017

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will share

Locations

SL (8); ES (1)