Safety and Immune Response of Candidate H1N1 Influenza Vaccines GSK2340274A and GSK234072A in Children 3 to Less Than 10 Years Old

NCT01161160 | Completed Phase 2 Results

• 1 other identifier: 114495
• Study Type: interventional
• Target: 209
• Locations: 2 countries
• Sites: 2

Brief Summary

This study is designed to characterize the safety and immunogenicity of pandemic influenza (H1N1) candidate vaccines GSK2340274A and GSK234072A in children 3 to less than 10 years old.

Conditions

Influenza

Keywords

H1N1; Influenza; Pandemic; GSK Bio's influenza vaccines GSK2340274A and GSK234072A

Outcome Measures

Primary Outcomes (4)

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

  Seroconversion rate (SCR) was defined as the proportion of subjects who had either a pre-vaccination reciprocal HI titer below (\<) 10 and a post-vaccination reciprocal titre greater than or equal to (≥) 40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus. The Flu strain assessed was A/California/7/2009 (H1N1)v-like virus (Flu A/CAL/7/09), following the Committee for Medicinal Products for Human Use (CHMP) and the Center for Biologics Evaluation and Research (CBER) guidance. The CBER criterion was fulfilled if the lower 95% confidence interval (CI) for SCR was (\>) 40%. The CHMP criterion was fulfilled if the point estimate for SCR was \> 40%.

  At Day 21

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

  A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40, that usually is accepted as indicating protection. The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance. The CBER criterion was fulfilled if the lower limit of the 95% CI for seroprotection (SPR) was \> 70%. The CHMP criterion was fulfilled if the post-vaccination point estimate for SPR was \> 70%.

  At Day 0

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

  A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40, that usually is accepted as indicating protection. The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance. The CBER criterion was fulfilled if the lower limit of the 95% CI for seroprotection (SPR) was \> 70%. The CHMP criterion was fulfilled if the post-vaccination point estimate for SPR was \> 70%.

  At Day 21

• Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain

  GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance. The CHMP criterion was fulfilled if the point estimate for GMFR was \> 2.5.

  At Day 21

Secondary Outcomes (18)

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

  At Day 182

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

  At Day 0 and Day 182

• Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain

  At Day 182

• Number of Subjects With HI Antibody Titers Against Flu A/CAL/7/09 H1N1 Above the Cut-off Value

  At Day 21

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

  At Day 21

Study Arms (3)

AREPANRIX 1/2 GROUP

EXPERIMENTAL

Healthy male or female children aged 3 to less than (\<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.

Biological: GSK Biologicals' GSK2340274A (two different formulations)

PANDEMRIX 1/2 GROUP

EXPERIMENTAL

Healthy male or female children aged 3 to less than (\<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.

Biological: GSK Biologicals' - GSK2340272A

AREPANRIX GROUP

EXPERIMENTAL

Healthy male or female children aged 3 to less than (\<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.

Biological: GSK Biologicals' GSK2340274A (two different formulations)

Interventions

GSK Biologicals' GSK2340274A (two different formulations) BIOLOGICAL

Intramuscular injection

AREPANRIX 1/2 GROUP; AREPANRIX GROUP

GSK Biologicals' - GSK2340272A BIOLOGICAL

Intramuscular injection

PANDEMRIX 1/2 GROUP

Eligibility Criteria

• Age: 3 Years - 9 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.
• Subjects and/or parent(s)/LAR who the investigator believes can and will comply with the requirements of the protocol as documented by signature on the informed consent document (and, if appropriate, the informed assent document).

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 vaccination.
• 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 (day of study vaccination), 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.
• Administration of any licensed live-attenuated vaccine within 30 days before study vaccination or any licensed inactivated vaccine within 15 days before study vaccination.
• Planned administration of any A/California H1N1v-like vaccine other than the study vaccine between Day 0 and the Day 21 phlebotomy.
• Planned administration of any other vaccine not foreseen by the study protocol between Day 0 and Day 21. 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 study vaccination, 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.
• Child in care (A child who has been placed under the control or protection of an agency, organization, institution or entity by the courts).

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (2)

GSK Investigational Site

Sampaloc, Manila, 1008, Philippines

Location

GSK Investigational Site

Bangkok, 10400, Thailand

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 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2010
• First Posted: July 13, 2010
• Study Start: July 1, 2010
• Primary Completion: August 23, 2010
• Study Completion: January 31, 2011
• Last Updated: September 6, 2018
• Results First Posted: August 4, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share

Locations

PH (1); TH (1)