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

NCT01439360 | Completed Phase 3 Results

• 2 other identifiers: 1153452011-000758-41
• Study Type: interventional
• Target: 12,046
• Locations: 13 countries
• Sites: 103

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

Keywords

Vaccine; Seasonal Flu; Efficacy; Children

Outcome Measures

Primary Outcomes (2)

• Number of Subjects With Moderate to Severe RT-PCR Confirmed Influenza.

  Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.

  During the surveillance period (approximately 6 to 8 months)

• Number of Subjects With RT-PCR Confirmed Influenza of Any Severity.

  Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.

  During the surveillance period (approximately 6 to 8 months)

Secondary Outcomes (20)

• Number of Subjects With First Occurrence of Lower Respiratory Illness (LRI) With RT-PCR Confirmed Influenza.

  At any time starting 7 days before the onset of LRI and ending 7 days after end of LRI during the surveillance period (approximately 6 to 8 months)

• Number of Subjects With First Occurrence of Culture-confirmed Moderate to Severe Influenza A and/or B Disease Due to Antigenically-matching Influenza Strains.

  During the surveillance period (approximately 6 to 8 months)

• Number of Subjects With First Occurrence of Culture-confirmed Influenza A and/or B Disease of Any Severity Due to Antigenically-matching Influenza Strains

  During the surveillance period (approximately 6 to 8 months)

• Number of Subjects With First Occurrence of Culture-confirmed Moderate to Severe Influenza A and/or B Disease Due to Any Seasonal Influenza Strain.

  During the surveillance period (approximately 6 to 8 months)

• Number of Subjects With First Occurrence of Culture-confirmed Influenza A and/or B Disease of Any Severity Due to Any Seasonal Influenza Strain.

  During the surveillance period (approximately 6 to 8 months)

Study Arms (2)

D-QIV

EXPERIMENTAL

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

Biological: Quadrivalent seasonal influenza vaccine(Flu D-QIV) GSK2321138A

Control

ACTIVE COMPARATOR

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 ®).

Biological: Havrix Junior; Biological: Prevenar 13; Biological: Varivax/ProVarivax; Biological: Varilrix

Interventions

Quadrivalent seasonal influenza vaccine(Flu D-QIV) GSK2321138A BIOLOGICAL

Intramuscular injection

D-QIV

Havrix Junior BIOLOGICAL

Intramuscular injection administered to subjects aged 12 months or older

Control

Prevenar 13 BIOLOGICAL

Intramuscular injection administered to subjects less than 12 months of age

Control

Varivax/ProVarivax BIOLOGICAL

Intramuscular injection administered to subjects more than 12 months of age

Control

Varilrix BIOLOGICAL

Subcutaneous injection administered to subjects more than 12 months of age

Control

Eligibility Criteria

• Age: 6 Months - 35 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (103)

GSK Investigational Site

Dhaka, 1000, Bangladesh

Location

GSK Investigational Site

Antwerp, 2018, Belgium

Location

GSK Investigational Site

Antwerp, 2020, Belgium

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GSK Investigational Site

Brussels, 1200, Belgium

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GSK Investigational Site

Mechelen, 2800, Belgium

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GSK Investigational Site

Namur, 5000, Belgium

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GSK Investigational Site

Roeselaere, 8800, Belgium

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GSK Investigational Site

Turnhout, 2300, Belgium

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GSK Investigational Site

Děčín, 405 01, Czechia

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GSK Investigational Site

Humpolec, 396 01, Czechia

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GSK Investigational Site

Jindřichův Hradec, 37701, Czechia

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GSK Investigational Site

Liberec, 46015, Czechia

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GSK Investigational Site

Lipník nad Bečvou, 75131, Czechia

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GSK Investigational Site

Náchod, 547 01, Czechia

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GSK Investigational Site

Odolena Voda, 25070, Czechia

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GSK Investigational Site

Ostrava - Poruba, 70800, Czechia

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GSK Investigational Site

Pardubice, 532 03, Czechia

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GSK Investigational Site

Prague, 1600, Czechia

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GSK Investigational Site

Tábor, 390 02, Czechia

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GSK Investigational Site

Santo Domingo, Dominican Republic

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GSK Investigational Site

Santo Domingo, Distrito Nacional, Dominican Republic

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GSK Investigational Site

San Pedro Sula, Honduras

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GSK Investigational Site

Tegucigalpa, Honduras

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GSK Investigational Site

Faridabad, 121004, India

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GSK Investigational Site

Pune, 411 011, India

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GSK Investigational Site

Pune, India

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GSK Investigational Site

Beirut, 1107-2020, Lebanon

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GSK Investigational Site

City of Muntinlupa, 1781, Philippines

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GSK Investigational Site

Manila, 1000, Philippines

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GSK Investigational Site

Manila, Philippines

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GSK Investigational Site

Metro Manila, 1000, Philippines

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GSK Investigational Site

Quezon City, 1113, Philippines

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GSK Investigational Site

Sampaloc, Manila, 1008, Philippines

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GSK Investigational Site

Bydgoszcz, 85-079, Poland

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GSK Investigational Site

Bydgoszcz, 85-168, Poland

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GSK Investigational Site

Bydgoszcz, 85-316, Poland

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GSK Investigational Site

Dębica, 39-200, Poland

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GSK Investigational Site

Gdansk, 84-462, Poland

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GSK Investigational Site

Grudziądz, 86-330, Poland

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GSK Investigational Site

Katowice, 40-018, Poland

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GSK Investigational Site

Katowice, 40-129, Poland

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GSK Investigational Site

Krakow, 31-223, Poland

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GSK Investigational Site

Lodz, 90-242, Poland

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GSK Investigational Site

Lublin, 20-044, Poland

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GSK Investigational Site

Oborniki, 55-120, Poland

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GSK Investigational Site

Poznan, 61-709, Poland

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GSK Investigational Site

Poznan, 62-064, Poland

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GSK Investigational Site

Siemianowice Śląskie, 41-103, Poland

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GSK Investigational Site

Tarnów, 33-100, Poland

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GSK Investigational Site

Torun, Poland

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GSK Investigational Site

Warsaw, 00-315, Poland

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GSK Investigational Site

Wola, 43-225, Poland

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GSK Investigational Site

Wroclaw, 52-312, Poland

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GSK Investigational Site

Łęczna, 21-010, Poland

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GSK Investigational Site

Antequera/Málaga, 29200, Spain

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GSK Investigational Site

Barcelona, 08025, Spain

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GSK Investigational Site

Barcelona, 08042, Spain

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GSK Investigational Site

Blanes (Girona), 17300, Spain

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GSK Investigational Site

Boadilla del Monte, 28660, Spain

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GSK Investigational Site

Castellon, 12004, Spain

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GSK Investigational Site

Castellon, 12530, Spain

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GSK Investigational Site

Centelles (Barcelona), 08540, Spain

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GSK Investigational Site

Madrid, 28034, Spain

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GSK Investigational Site

Madrid, 28035, Spain

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GSK Investigational Site

Madrid, 28046, Spain

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GSK Investigational Site

Madrid, 28700, Spain

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GSK Investigational Site

Pozuelo de Alarcón/Madrid, 28224, Spain

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GSK Investigational Site

Quart de Poblet, Valencia, 46930, Spain

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GSK Investigational Site

Santiago de Compostela, 15706, Spain

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GSK Investigational Site

Seville, 41014, Spain

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GSK Investigational Site

Seville, 41927, Spain

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GSK Investigational Site

Torrelodones (Madrid), 28250, Spain

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GSK Investigational Site

Valencia, 46011, Spain

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GSK Investigational Site

Valencia, 46024, Spain

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GSK Investigational Site

Valencia, 46200, Spain

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GSK Investigational Site

Valencia, 46702, Spain

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GSK Investigational Site

Vic/ Barcelona, 08500, Spain

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GSK Investigational Site

Xativa/Valencia, 46800, Spain

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GSK Investigational Site

Bangkok, 10330, Thailand

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GSK Investigational Site

Khon Kaen, 40002, Thailand

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GSK Investigational Site

Bursa, Turkey (Türkiye)

Location

GSK Investigational Site

Eskişehir, Turkey (Türkiye)

Location

GSK Investigational Site

Istanbul, 34890, Turkey (Türkiye)

Location

GSK Investigational Site

St Austell, Cornwall, PL26 7RL, United Kingdom

Location

GSK Investigational Site

Southampton, Hampshire, SO16 6YD, United Kingdom

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GSK Investigational Site

Axbridge, Somerset, BS26 2BJ, United Kingdom

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GSK Investigational Site

Bath, Somerset, BA1 3NG, United Kingdom

Location

GSK Investigational Site

Yeovil, Somerset, BA21 4AT, United Kingdom

Location

GSK Investigational Site

Atherstone, Warwickshire, CV9 1EU, United Kingdom

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GSK Investigational Site

Coventry, Warwickshire, CV6 4DD, United Kingdom

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GSK Investigational Site

Belfast, BT7 2EB, United Kingdom

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GSK Investigational Site

Bolton, Nr Manchester, BL3 6TL, United Kingdom

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GSK Investigational Site

Bristol, BS2 8AE, United Kingdom

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GSK Investigational Site

Co Antrim, BT41 3AE, United Kingdom

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GSK Investigational Site

Crumpsall, Manchester, M8 9JT, United Kingdom

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GSK Investigational Site

Exeter, EX2 5DW, United Kingdom

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GSK Investigational Site

Gloucester, GL1 3NN, United Kingdom

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GSK Investigational Site

London, SW17 0QT, United Kingdom

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GSK Investigational Site

Manchester, M13 9WL, United Kingdom

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GSK Investigational Site

Nottingham, NG7 2QW, United Kingdom

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GSK Investigational Site

Oxford, OX3 7LJ, United Kingdom

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GSK Investigational Site

Taunton, Somerset, TA1 5DA, United Kingdom

Location

GSK Investigational Site

Westminster Bridge Road, SE1 7EH, United Kingdom

Location

Related Publications (4)

• 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.

  PMID: 35083365 DERIVED

• 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.

  PMID: 31725115 DERIVED

• 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.

  PMID: 31306399 DERIVED

• 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.

  PMID: 30325891 DERIVED

Related Links

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

MeSH Terms

Conditions

Influenza, Human

Interventions

13-valent pneumococcal vaccine; Chickenpox Vaccine

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Herpesvirus Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2011
• First Posted: September 23, 2011
• Study Start: October 1, 2011
• Primary Completion: October 31, 2014
• Study Completion: December 31, 2014
• Last Updated: September 26, 2018
• Results First Posted: March 8, 2017

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Locations

DO (2); ES (24); PL (21); BA (1); LE (1); PH (6); CZ (11); TH (2); GB (20); IN (3); BE (7); TU (3); HO (2)