An Efficacy Study of GlaxoSmithKline (GSK) Biologicals' Candidate Influenza Vaccine GSK2321138A in Children

NCT ID: NCT01439360

Last Updated: 2018-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 12046 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-01
• Study Completion Date: 2014-12-31

Brief Summary

The purpose of this study is to evaluate the efficacy, immunogenicity and safety of GSK Biologicals' influenza candidate vaccine GSK2321138A when compared to non-influenza vaccine comparators in children 6 to 35 months of age. Recruitment will encompass at least 4 independent cohorts: a first cohort in the Northern Hemisphere (2011-2012), a second cohort in subtropical countries (2012), third cohort in the Northern Hemisphere (2012-2013) and a fourth cohort and additional independent cohorts possibly in NH countries (end 2013) and subtropical countries (beginning 2014).

Conditions

Influenza

Study Design

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

Study Groups

D-QIV

Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).

Group Type: EXPERIMENTAL

Quadrivalent seasonal influenza vaccine(Flu D-QIV) GSK2321138A

Intervention Type: BIOLOGICAL

Intramuscular injection

Control

In function of their age and D-QIV-vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).

Group Type: ACTIVE_COMPARATOR

Havrix Junior

Intervention Type: BIOLOGICAL

Intramuscular injection administered to subjects aged 12 months or older

Prevenar 13

Intervention Type: BIOLOGICAL

Intramuscular injection administered to subjects less than 12 months of age

Varivax/ProVarivax

Intervention Type: BIOLOGICAL

Intramuscular injection administered to subjects more than 12 months of age

Varilrix

Intervention Type: BIOLOGICAL

Subcutaneous injection administered to subjects more than 12 months of age

Interventions

Quadrivalent seasonal influenza vaccine(Flu D-QIV) GSK2321138A

Intramuscular injection

Intervention Type: BIOLOGICAL

Havrix Junior

Intramuscular injection administered to subjects aged 12 months or older

Intervention Type: BIOLOGICAL

Prevenar 13

Intramuscular injection administered to subjects less than 12 months of age

Intervention Type: BIOLOGICAL

Varivax/ProVarivax

Intramuscular injection administered to subjects more than 12 months of age

Intervention Type: BIOLOGICAL

Varilrix

Subcutaneous injection administered to subjects more than 12 months of age

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Subjects who the investigator believes that their parents/Legally Acceptable Representative (LARs) can and will comply with the requirements of the protocol.
• A male or female between, and including, 6 and 35 months of age at the time of first vaccination; children are eligible regardless of history of influenza vaccination.
• 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

• Participation in a previous FLU-D-QIV-004 study (115345) cohort.
• Child in care.
• Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
• Prior receipt of any influenza vaccine within 6 months preceding the first dose of study vaccine, or planned use of such vaccines during the study period.
• Children with underlying illness who are at risk of complications of influenza and for whom yearly (seasonal) influenza vaccination is recommended in their respective country.
• Any confirmed or suspected immunosuppressive or immunodeficient condition (including HIV), based on medical history and physical examination.
• Chronic administration of immunosuppressants or other immune modifying drugs within six months prior to the first vaccine dose. 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.
• Any known or suspected allergy to any constituent of influenza vaccines, non-influenza vaccine comparators and latex; a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous vaccination.
• Any contraindication to intramuscular injection.
• Acute disease and/or fever at the time of enrolment.
• Any other condition which, in the opinion of the Investigator, prevents the subject from participating in the study.
• Additional criteria for children ≥ 12 months of age:

• Prior receipt of any licensed varicella vaccine* or any licensed hepatitis A vaccine or planned use of these vaccines during the study period. Other routine registered childhood vaccinations are permitted.

• For countries with varicella vaccine administered as 2-dose schedule, prior receipt of a single dose of a varicella vaccine is allowed if administered at least 2 weeks before the first study vaccination.
• Any history of hepatitis A or varicella diseases.
• Additional criteria for children 6 - 11 months of age in countries without universal mass vaccination recommendation for pneumococcal vaccine:

• Prior receipt of any pneumococcal conjugated vaccine or planned use of this vaccine during the study period. Other routine registered childhood vaccinations are permitted.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 35 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

Dhaka, , Bangladesh

GSK Investigational Site

Antwerp, , Belgium

GSK Investigational Site

Antwerp, , Belgium

GSK Investigational Site

Brussels, , Belgium

GSK Investigational Site

Mechelen, , Belgium

GSK Investigational Site

Namur, , Belgium

GSK Investigational Site

Roeselaere, , Belgium

GSK Investigational Site

Turnhout, , Belgium

GSK Investigational Site

Děčín, , Czechia

GSK Investigational Site

Humpolec, , Czechia

GSK Investigational Site

Jindřichův Hradec, , Czechia

GSK Investigational Site

Liberec, , 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

Santo Domingo, , Dominican Republic

GSK Investigational Site

Santo Domingo, Distrito Nacional, , Dominican Republic

GSK Investigational Site

San Pedro Sula, , Honduras

GSK Investigational Site

Tegucigalpa, , Honduras

GSK Investigational Site

Faridabad, , India

GSK Investigational Site

Pune, , India

GSK Investigational Site

Pune, , India

GSK Investigational Site

Beirut, , Lebanon

GSK Investigational Site

City of Muntinlupa, , Philippines

GSK Investigational Site

Manila, , Philippines

GSK Investigational Site

Manila, , Philippines

GSK Investigational Site

Metro Manila, , Philippines

GSK Investigational Site

Quezon City, , Philippines

GSK Investigational Site

Sampaloc, Manila, , Philippines

GSK Investigational Site

Bydgoszcz, , Poland

GSK Investigational Site

Bydgoszcz, , Poland

GSK Investigational Site

Bydgoszcz, , Poland

GSK Investigational Site

Dębica, , Poland

GSK Investigational Site

Gdansk, , Poland

GSK Investigational Site

Grudziądz, , Poland

GSK Investigational Site

Katowice, , Poland

GSK Investigational Site

Katowice, , Poland

GSK Investigational Site

Krakow, , Poland

GSK Investigational Site

Lodz, , Poland

GSK Investigational Site

Lublin, , Poland

GSK Investigational Site

Oborniki, , Poland

GSK Investigational Site

Poznan, , Poland

GSK Investigational Site

Poznan, , Poland

GSK Investigational Site

Siemianowice Śląskie, , Poland

GSK Investigational Site

Tarnów, , Poland

GSK Investigational Site

Torun, , Poland

GSK Investigational Site

Warsaw, , Poland

GSK Investigational Site

Wola, , Poland

GSK Investigational Site

Wroclaw, , Poland

GSK Investigational Site

Łęczna, , Poland

GSK Investigational Site

Antequera/Málaga, , Spain

GSK Investigational Site

Barcelona, , Spain

GSK Investigational Site

Barcelona, , Spain

GSK Investigational Site

Blanes (Girona), , Spain

GSK Investigational Site

Boadilla del Monte, , 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

Madrid, , Spain

GSK Investigational Site

Madrid, , Spain

GSK Investigational Site

Madrid, , Spain

GSK Investigational Site

Pozuelo de Alarcón/Madrid, , Spain

GSK Investigational Site

Quart de Poblet, Valencia, , Spain

GSK Investigational Site

Santiago de Compostela, , Spain

GSK Investigational Site

Seville, , Spain

GSK Investigational Site

Seville, , Spain

GSK Investigational Site

Torrelodones (Madrid), , Spain

GSK Investigational Site

Valencia, , Spain

GSK Investigational Site

Valencia, , Spain

GSK Investigational Site

Valencia, , Spain

GSK Investigational Site

Valencia, , Spain

GSK Investigational Site

Vic/ Barcelona, , Spain

GSK Investigational Site

Xativa/Valencia, , Spain

GSK Investigational Site

Bangkok, , Thailand

GSK Investigational Site

Khon Kaen, , Thailand

GSK Investigational Site

Bursa, , Turkey (Türkiye)

GSK Investigational Site

Eskişehir, , Turkey (Türkiye)

GSK Investigational Site

Istanbul, , Turkey (Türkiye)

GSK Investigational Site

St Austell, Cornwall, United Kingdom

GSK Investigational Site

Southampton, Hampshire, United Kingdom

GSK Investigational Site

Axbridge, Somerset, United Kingdom

GSK Investigational Site

Bath, Somerset, United Kingdom

GSK Investigational Site

Yeovil, Somerset, United Kingdom

GSK Investigational Site

Atherstone, Warwickshire, United Kingdom

GSK Investigational Site

Coventry, Warwickshire, United Kingdom

GSK Investigational Site

Belfast, , United Kingdom

GSK Investigational Site

Bolton, Nr Manchester, , United Kingdom

GSK Investigational Site

Bristol, , United Kingdom

GSK Investigational Site

Co Antrim, , United Kingdom

GSK Investigational Site

Crumpsall, Manchester, , United Kingdom

GSK Investigational Site

Exeter, , United Kingdom

GSK Investigational Site

Gloucester, , United Kingdom

GSK Investigational Site

London, , United Kingdom

GSK Investigational Site

Manchester, , United Kingdom

GSK Investigational Site

Nottingham, , United Kingdom

GSK Investigational Site

Oxford, , United Kingdom

GSK Investigational Site

Taunton, Somerset, , United Kingdom

GSK Investigational Site

Westminster Bridge Road, , United Kingdom

Countries

Bangladesh; Belgium; Czechia; Dominican Republic; Honduras; India; Lebanon; Philippines; Poland; Spain; Thailand; Turkey (Türkiye); United Kingdom

References

Danier J, Callegaro A, Soni J, Carmona A, Kosalaraska P, Rivera L, Friel D, Pu W, Vantomme V, Dbaibo G, Innis BL, Schuind A, Zaman K, Wilson J. Association Between Hemagglutination Inhibition Antibody Titers and Protection Against Reverse-Transcription Polymerase Chain Reaction-Confirmed Influenza Illness in Children 6-35 Months of Age: Statistical Evaluation of a Correlate of Protection. Open Forum Infect Dis. 2021 Sep 25;9(2):ofab477. doi: 10.1093/ofid/ofab477. eCollection 2022 Feb.

Reference Type: DERIVED

PMID: 35083365 (View on PubMed)

Dbaibo G, Amanullah A, Claeys C, Izu A, Jain VK, Kosalaraksa P, Rivera L, Soni J, Yanni E, Zaman K, Acosta B, Ariza M, Arroba Basanta ML, Bavdekar A, Carmona A, Cousin L, Danier J, Diaz A, Diez-Domingo J, Dinleyici EC, Faust SN, Garcia-Sicilia J, Gomez-Go GD, Gonzales MLA, Hacimustafaoglu M, Hughes SM, Jackowska T, Kant S, Lucero M, Mares Bermudez J, Martinon-Torres F, Montellano M, Prymula R, Puthanakit T, Ruzkova R, Sadowska-Krawczenko I, Szymanski H, Ulied A, Woo W, Schuind A, Innis BL; Flu4VEC Study Group. Quadrivalent Influenza Vaccine Prevents Illness and Reduces Healthcare Utilization Across Diverse Geographic Regions During Five Influenza Seasons: A Randomized Clinical Trial. Pediatr Infect Dis J. 2020 Jan;39(1):e1-e10. doi: 10.1097/INF.0000000000002504.

Reference Type: DERIVED

PMID: 31725115 (View on PubMed)

Danier J, Rivera L, Claeys C, Dbaibo G, Jain VK, Kosalaraksa P, Woo W, Yanni E, Zaman K, Acosta B, Amanullah A, Ariza M, Luisa Arroba Basanta M, Bavdekar A, Carmona A, Cousin L, Diaz A, Diez-Domingo J, Cagri Dinleyici E, Faust SN, Garcia-Sicilia J, Gomez-Go GD, Antionette Gonzales L, Hacimustafaoglu M, Hughes SM, Izu A, Jackowska T, Kant S, Lucero M, Mares Bermudez J, Martinon-Torres F, Montellano M, Prymula R, Puthanakit T, Ruzkova R, Sadowska-Krawczenko I, Soni J, Szymanski H, Ulied A, Schuind A, Innis BL; Flu4VEC Study Group. Clinical Presentation of Influenza in Children 6 to 35 Months of Age: Findings From a Randomized Clinical Trial of Inactivated Quadrivalent Influenza Vaccine. Pediatr Infect Dis J. 2019 Aug;38(8):866-872. doi: 10.1097/INF.0000000000002387.

Reference Type: DERIVED

PMID: 31306399 (View on PubMed)

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)

Related Links

https://clinicalstudydatarequest.com

IPD for this study will be made available via the Clinical Study Data Request site.

Other Identifiers

2011-000758-41

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

115345

Identifier Type: -

Identifier Source: org_study_id