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

NCT ID: NCT01161160

Last Updated: 2018-09-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 209 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-01
• Study Completion Date: 2011-01-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

AREPANRIX 1/2 GROUP

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.

Group Type: EXPERIMENTAL

GSK Biologicals' GSK2340274A (two different formulations)

Intervention Type: BIOLOGICAL

Intramuscular injection

PANDEMRIX 1/2 GROUP

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.

Group Type: EXPERIMENTAL

GSK Biologicals' - GSK2340272A

Intervention Type: BIOLOGICAL

Intramuscular injection

AREPANRIX GROUP

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.

Group Type: EXPERIMENTAL

GSK Biologicals' GSK2340274A (two different formulations)

Intervention Type: BIOLOGICAL

Intramuscular injection

Interventions

GSK Biologicals' GSK2340274A (two different formulations)

Intramuscular injection

Intervention Type: BIOLOGICAL

GSK Biologicals' - GSK2340272A

Intramuscular injection

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Male or pre-menarchal female children 3 to < 10 years of age at the time of the study vaccination. "Less than 10 years of age" implies inclusion of children who have not reached their 10th birthday as of Day 0, the day of the study vaccine dose under this protocol.
• 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).

Exclusion Criteria

• 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).

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 9 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Sampaloc, Manila, , Philippines

GSK Investigational Site

Bangkok, , Thailand

Countries

Philippines; Thailand

References

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.

Reference Type: DERIVED

PMID: 24041010 (View on PubMed)

Study Documents

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

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Other Identifiers

114495

Identifier Type: -

Identifier Source: org_study_id