Safety and Immunogenocity Study of GSK Biologicals' Pandemic Influenza (H1N1) Candidate Vaccine in Japanese Children

NCT ID: NCT01001169

Last Updated: 2018-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-01
• Study Completion Date: 2010-05-17

Brief Summary

The objective of this study is to evaluate the immunogenicity and safety of GSK Biologicals' investigational influenza vaccine GSK2340274A following one dose and following a second dose, using the same dosage as has been used in the H5N1 development program in Japanese children aged 10-17 years and an alternative dose in children aged 6 months to 9 years.

Conditions

Influenza

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

GSK2340274A_F1 6M-9Y GROUP

Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.

Group Type: EXPERIMENTAL

GSK Biologicals' Pandemic influenza (H1N1) candidate vaccine (GSK2340274A)

Intervention Type: BIOLOGICAL

Two intramuscular injections

GSK2340274A_F2 10Y-17Y GROUP

Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.

Group Type: EXPERIMENTAL

GSK Biologicals' Pandemic influenza (H1N1) candidate vaccine (GSK2340274A)

Intervention Type: BIOLOGICAL

Two intramuscular injections

Interventions

GSK Biologicals' Pandemic influenza (H1N1) candidate vaccine (GSK2340274A)

Two intramuscular injections

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol.
• Japanese children, male or female, aged between 6 months and 17 years at the time of the first study vaccination.
• Written informed consent obtained from the subject's parent(s) or LAR(s) of the subject. Whenever possible, an assent should also be obtained from the subject.
• Healthy children as established by medical history and clinical examination when entering into the study (Particular attention must be exercised when dealing with patients with bronchial asthma).
• Parent/LAR with access to a consistent means of telephone contact, land line or mobile, but NOT a pay phone or other multiple-user device.
• Female subjects of childbearing potential may be enrolled in the study, if the subject: 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.

Exclusion Criteria

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period.
• Clinically or virologically confirmed influenza infection from May 2009 to the day of enrolment.
• Previous administration of a novel [H1N1]v vaccine.
• Administration of any vaccines within 30 days before vaccination or planned administration within the first vaccination up to blood sampling at Day 42 and within 30 days prior to blood sampling at Day 182, with the exception of seasonal influenza vaccine.
• Administration of any seasonal influenza vaccine within 14 days before vaccination on Day 0, or planned administration within the first vaccination up to blood sampling at Day 42 and within 14 days prior to blood sampling at Day 182.
• Excessive underweight or excessive obesity. (Under or upper 2-fold standard deviation of weight distribution that are corresponding age group are used as reference).
• Chronic administration of immunosuppressants or other immune-modifying drugs within three months prior to enrolment in this study or planned administration during the study period.
• Acute disease and/or fever at the time of enrolment:
• Fever is defined as temperature >= 37.5°C on oral, axillary or tympanic setting, or >= 38.0°C on rectal setting.
• Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator.
• Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing required).
• Acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination.
• Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned during the study.
• 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.
• History of any neurological disorder including acute disseminated encephalomyelitis and Guillain-Barré syndrome, or convulsive seizures and epilepsy.
• 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
• Any conditions which, in the opinion of the investigator, prevents the subject from participating to the study.
• Child in Care.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 17 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

Tokyo, , Japan

Countries

Japan

References

Van Damme P, Kafeja F, Bambure V, Hanon E, Moris P, Roman F, Gillard P. Long-term persistence of humoral and cellular immune responses induced by an AS03A-adjuvanted H1N1 2009 influenza vaccine: an open-label, randomized study in adults aged 18-60 years and older. Hum Vaccin Immunother. 2013 Jul;9(7):1512-22. doi: 10.4161/hv.24504. Epub 2013 Apr 9.

Reference Type: DERIVED

PMID: 23571166 (View on PubMed)

Saitoh A, Nagai A, Tenjinbaru K, Li P, Vaughn DW, Roman F, Kato T. Safety and persistence of immunological response 6 months after intramuscular vaccination with an AS03-adjuvanted H1N1 2009 influenza vaccine: an open-label, randomized trial in Japanese children aged 6 months to 17 years. Hum Vaccin Immunother. 2012 Jun;8(6):749-58. doi: 10.4161/hv.19684. Epub 2012 Apr 12.

Reference Type: DERIVED

PMID: 22495117 (View on PubMed)

Study Documents

Document Type: Study Protocol

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: 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: Clinical Study Report

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

View Document

Document Type: Annotated Case Report Form

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

View Document

Related Links

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Other Identifiers

113847

Identifier Type: -

Identifier Source: org_study_id