Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Influenza Vaccine When Administered in Children Who Previously Participated in Study 115345

NCT ID: NCT01702454

Last Updated: 2018-09-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 470 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-06
• Study Completion Date: 2013-06-05

Brief Summary

The purpose of this study is to assess the safety and immunogenicity of GSK Biologicals' investigational vaccine GSK2321138A in children who previously participated in study 115345 (FLU D-QIV-004 PRI) (NCT01439360).

Conditions

Influenza

Study Design

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

Study Groups

Fluarix Quadrivalent Primed Group

Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.

Group Type: EXPERIMENTAL

Fluarix Quadrivalent

Intervention Type: BIOLOGICAL

1 or 2 doses administered intramuscularly (IM) in deltoid region depending on the priming status

Fluarix Quadrivalent Unprimed Group

Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.

Group Type: EXPERIMENTAL

Fluarix Quadrivalent

Intervention Type: BIOLOGICAL

1 or 2 doses administered intramuscularly (IM) in deltoid region depending on the priming status

Interventions

Fluarix Quadrivalent

1 or 2 doses administered intramuscularly (IM) in deltoid region depending on the priming status

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Subjects who the investigator believes that parent(s)/LAR(s) can and will comply with the requirements of the protocol.
• Children, male or female who received a 2-dose vaccination in the study 115345 (NCT01439360).
• Written informed consent obtained from the parent(s)/LAR(s) of the subject.
• Subjects in stable health as determined by medical history and clinical examination before entering into the study.

Exclusion Criteria

• Child in care.
• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
• Since the start of study 115345 (NCT01439360), receipt of any seasonal influenza vaccine other than the study vaccines of study 115345 or planned administration of any influenza vaccine other than the study vaccine during the study.
• Administration of any vaccine not foreseen by the study protocol within 4 weeks preceding the first dose of study vaccine or planned use until Visit 2.
• Laboratory confirmed influenza infection outside of the 115345 (NCT01439360) study.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to enrolment in the study or planned administration during the study period. Inhaled and topical steroids are allowed.
• Administration of immunoglobulins and/ or any blood products within 3 months preceding the first dose of study vaccine or planned administration during the study period.
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
• Any contraindication to intramuscular injection.
• Acute disease and/or fever at the time of enrollment:

• Fever is defined as temperature ≥ 37.5°C by any route.
• 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 other condition which, in the opinion of the Investigator, prevents the subject from participating in the study.

• Minimum Eligible Age: 17 Months
• Maximum Eligible Age: 48 Months
• 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

Děčín, , Czechia

GSK Investigational Site

Jindřichův Hradec, , Czechia

GSK Investigational Site

Lipník nad Bečvou, , Czechia

GSK Investigational Site

Náchod, , Czechia

GSK Investigational Site

Odolena Voda, , Czechia

GSK Investigational Site

Ostrava - Poruba, , Czechia

GSK Investigational Site

Pardubice, , Czechia

GSK Investigational Site

Prague, , Czechia

GSK Investigational Site

Tábor, , Czechia

GSK Investigational Site

Dębica, , Poland

GSK Investigational Site

Katowice, , Poland

GSK Investigational Site

Siemianowice Śląskie, , Poland

GSK Investigational Site

Antequera/Málaga, , Spain

GSK Investigational Site

Blanes (Girona), , Spain

GSK Investigational Site

Castellon, , Spain

GSK Investigational Site

Castellon, , Spain

GSK Investigational Site

Centelles (Barcelona), , Spain

GSK Investigational Site

Madrid, , Spain

GSK Investigational Site

Paiporta, Valencia, , Spain

GSK Investigational Site

Quart de Poblet, Valencia, , Spain

GSK Investigational Site

Santiago de Compostela, , Spain

GSK Investigational Site

Seville, , Spain

GSK Investigational Site

Valencia, , Spain

GSK Investigational Site

Valencia, , Spain

GSK Investigational Site

St Austell, Cornwall, United Kingdom

GSK Investigational Site

Coventry, Warwickshire, United Kingdom

GSK Investigational Site

Belfast, , United Kingdom

GSK Investigational Site

Bristol, , United Kingdom

GSK Investigational Site

Exeter, , United Kingdom

GSK Investigational Site

Gloucester, , United Kingdom

GSK Investigational Site

London, , United Kingdom

GSK Investigational Site

Oxford, , United Kingdom

GSK Investigational Site

Southampton, , United Kingdom

Countries

Czechia; Poland; Spain; United Kingdom

References

Claeys C, Chandrasekaran V, Garcia-Sicilia J, Prymula R, Diez-Domingo J, Brzostek J, Mares-Bermudez J, Martinon-Torres F, Pollard AJ, Ruzkova R, Carmona Martinez A, Ulied A, Miranda Valdivieso M, Faust SN, Snape MD, Friel D, Ollinger T, Soni J, Schuind A, Li P, Innis BL, Jain VK. Anamnestic Immune Response and Safety of an Inactivated Quadrivalent Influenza Vaccine in Primed Versus Vaccine-Naive Children. Pediatr Infect Dis J. 2019 Feb;38(2):203-210. doi: 10.1097/INF.0000000000002217.

Reference Type: DERIVED

PMID: 30325891 (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: Dataset Specification

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: Statistical Analysis Plan

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: 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

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

2012-001230-34

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

116023

Identifier Type: -

Identifier Source: org_study_id