Evaluate Safety & Immunogenicity of a Pandemic Influenza Vaccine (GSK1562902A) in Children

NCT ID: NCT00502593

Last Updated: 2018-10-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 138 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-23
• Study Completion Date: 2009-12-04

Brief Summary

The present study is designed to evaluate in children (aged between 3 and 9 years) the immunogenicity and safety of different antigen doses of the candidate vaccine (GSK1562902A) administered following a two-administration schedule (21 days apart). Subjects in the control group will receive Fluarix. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Detailed Description

This 107066 study is a participating study to the broader NCT00502593 study, which included 2 other studies, the 108498 and 108500 studies. The NCT00502593 study had a staggered design (subjects from each group being enrolled sequentially into 2 age strata, '6-9 years' 1st, and '3-5 years' next) and was run in 3 phases, phases A (Study 107066), B (Study 108498) and C (Study 108500). In each phase, the decision to vaccinate subjects aged 3-5 years and to administer a 2nd injection to subjects aged 6-9 years was made based on safety data collected on Days 0-6 after the 1st injection for the subjects aged 6-9 years. Decision to start Phase B was made on complete safety data including those collected on Day 28 of Phase A (7 days after the 2nd injection) for each age group. A similar approach was to be used to start Phase C. As safety data in Phase A did not raise any safety concerns, Phases B and C were run in parallel.

Conditions

Influenza

Study Design

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

Study Groups

GSK1562902A-A Lot 1 3-5Y Group

Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.

Group Type: EXPERIMENTAL

Pandemic Influenza Vaccine (GSK1562902A)

Intervention Type: BIOLOGICAL

2 doses, intramuscular injection on Days 0 and 21, 3 different formulations are tested.

Fluarix-A 3-5Y Group

Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.

Group Type: ACTIVE_COMPARATOR

Fluarix™

Intervention Type: BIOLOGICAL

2 doses, intramuscular injection on Days 0 and 21.

GSK1562902A-A Lot 1 6-9Y Group

Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.

Group Type: EXPERIMENTAL

Pandemic Influenza Vaccine (GSK1562902A)

Intervention Type: BIOLOGICAL

2 doses, intramuscular injection on Days 0 and 21, 3 different formulations are tested.

Fluarix-A 6-9Y Group

Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.

Group Type: ACTIVE_COMPARATOR

Fluarix™

Intervention Type: BIOLOGICAL

2 doses, intramuscular injection on Days 0 and 21.

GSK1562902A-B Lot 2 3-5Y Group

Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.

Group Type: EXPERIMENTAL

Pandemic Influenza Vaccine (GSK1562902A)

Intervention Type: BIOLOGICAL

2 doses, intramuscular injection on Days 0 and 21, 3 different formulations are tested.

Fluarix-B 3-5Y Group

Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.

Group Type: ACTIVE_COMPARATOR

Fluarix™

Intervention Type: BIOLOGICAL

2 doses, intramuscular injection on Days 0 and 21.

GSK1562902A-B Lot 2 6-9Y Group

Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.

Group Type: EXPERIMENTAL

Pandemic Influenza Vaccine (GSK1562902A)

Intervention Type: BIOLOGICAL

2 doses, intramuscular injection on Days 0 and 21, 3 different formulations are tested.

Fluarix-B 6-9Y Group

Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.

Group Type: ACTIVE_COMPARATOR

Fluarix™

Intervention Type: BIOLOGICAL

2 doses, intramuscular injection on Days 0 and 21.

GSK1562902A-C Lot 3 3-5Y Group

Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.

Group Type: EXPERIMENTAL

Pandemic Influenza Vaccine (GSK1562902A)

Intervention Type: BIOLOGICAL

2 doses, intramuscular injection on Days 0 and 21, 3 different formulations are tested.

Fluarix-C 3-5Y Group

Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.

Group Type: ACTIVE_COMPARATOR

Fluarix™

Intervention Type: BIOLOGICAL

2 doses, intramuscular injection on Days 0 and 21.

GSK1562902A-C Lot 3 6-9Y Group

Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.

Group Type: EXPERIMENTAL

Pandemic Influenza Vaccine (GSK1562902A)

Intervention Type: BIOLOGICAL

2 doses, intramuscular injection on Days 0 and 21, 3 different formulations are tested.

Fluarix-C 6-9Y Group

Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.

Group Type: ACTIVE_COMPARATOR

Fluarix™

Intervention Type: BIOLOGICAL

2 doses, intramuscular injection on Days 0 and 21.

Interventions

Pandemic Influenza Vaccine (GSK1562902A)

2 doses, intramuscular injection on Days 0 and 21, 3 different formulations are tested.

Intervention Type: BIOLOGICAL

Fluarix™

2 doses, intramuscular injection on Days 0 and 21.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Children who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
• Children aged between and including 3 and 9 years of age at the time of first vaccination.
• Written informed consent obtained from the parent(s) or guardian of the subject.
• Healthy children as established by medical history and clinical examination before entering the study.
• Subjects who are likely to reside in the vicinity of the study center for the duration of the study.

Exclusion Criteria

• Use of any investigational or non-registered product (drug or vaccine) other than the investigational vaccine within 30 days prior to the enrolment in this study, or planned use during the study period.
• Administration of licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. Planned administration of a vaccine not foreseen by the study protocol up to 30 days after the second vaccination, with the exception of routine childhood inoculations which cannot be delayed, but which must not be administered on the same day as the investigational vaccine candidate.
• Administration of the interpandemic influenza vaccine 21 days prior to Day 0 or up to Day 51.
• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the enrolment in this study.
• Any chronic drug therapy to be continued during the study period, with the exception of inhalative treatment for seasonal allergies or asthma.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
• Acute or chronic clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination.
• History of hypersensitivity to vaccines.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccines used in this study.
• History of any neurological disorders or seizures.
• Acute disease at the time of enrolment.
• 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 condition which, in the opinion of the investigator, renders the subject unfit for participation in the study

• 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

Blanes (Girona), , Spain

GSK Investigational Site

L'Eliana, Valencia, , Spain

GSK Investigational Site

Paiporta, Valencia, , Spain

GSK Investigational Site

Quart de Poblet, Valencia, , Spain

GSK Investigational Site

Valencia, , Spain

GSK Investigational Site

Valencia, , Spain

GSK Investigational Site

Valencia, , Spain

Countries

Spain

References

Diez-Domingo J, Baldo JM, Planelles-Catarino MV, Garces-Sanchez M, Ubeda I, Jubert-Rosich A, Mares J, Garcia-Corbeira P, Moris P, Teko M, Vanden Abeele C, Gillard P. Phase II, randomized, open, controlled study of AS03-adjuvanted H5N1 pre-pandemic influenza vaccine in children aged 3 to 9 years: follow-up of safety and immunogenicity persistence at 24 months post-vaccination. Influenza Other Respir Viruses. 2015 Mar;9(2):68-77. doi: 10.1111/irv.12295. Epub 2015 Feb 5.

Reference Type: DERIVED

PMID: 25652873 (View on PubMed)

Diez-Domingo J, Garces-Sanchez M, Baldo JM, Planelles MV, Ubeda I, JuBert A, Mares J, Moris P, Garcia-Corbeira P, Drame M, Gillard P. Immunogenicity and Safety of H5N1 A/Vietnam/1194/2004 (Clade 1) AS03-adjuvanted prepandemic candidate influenza vaccines in children aged 3 to 9 years: a phase ii, randomized, open, controlled study. Pediatr Infect Dis J. 2010 Jun;29(6):e35-46. doi: 10.1097/INF.0b013e3181daf921.

Reference Type: DERIVED

PMID: 20375709 (View on PubMed)

Study Documents

Document Type: Clinical Study Report

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. The results of this study are summarised with studies 108498 (second cohort study) and 108500 (third cohort study) on 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: 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

Document Type: Annotated Case Report Form

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

View Document

Related Links

https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

108498

Identifier Type: OTHER

Identifier Source: secondary_id

108500

Identifier Type: OTHER

Identifier Source: secondary_id

107066

Identifier Type: -

Identifier Source: org_study_id