Safety and Efficacy of H1N1 Vaccines in Children Aged 6 Months to Less Than 10 Years of Age

NCT01051661 | Completed Phase 3 Results

• 1 other identifier: 114000
• Study Type: interventional
• Target: 6,154
• Locations: 7 countries
• Sites: 16

Brief Summary

The purpose of this study is to characterize the safety and efficacy of GSK Biologicals' H1N1 flu candidate vaccines GSK2340274A and GSK2340273A in children 6 months to less than 10 years of age.

Conditions

Influenza

Keywords

Influenza; H1N1; Pandemic

Outcome Measures

Primary Outcomes (1)

• Number of Subjects Reporting at Least One A/California Influenza Event

  The influenza virus presence was confirmed by quantitative reverse transcription polymerase chain reaction assay (RT-qPCR).

  From 14 days after first vaccination until study conclusion on Day 385

Secondary Outcomes (38)

• Number of Subjects Reporting at Least One A/California Influenza Event

  From 42 days after first vaccination until study conclusion on Day 385

• Number of Subjects Reporting at Least One A/California Influenza Event

  From Day 0 until study conclusion on Day 385

• Number of Subjects Reporting at Least One Culture Confirmed A/California Influenza Event

  From 14 days after first vaccination until study conclusion on Day 385

• Number of Subjects Reporting at Least One Culture Confirmed A/California Influenza Event

  From 42 days after first vaccination until study conclusion on Day 385

• Number of Subjects Reporting at Least One Culture Confirmed A/California Influenza Event

  From Day 0 until study conclusion on Day 385

Study Arms (6)

Arepanrix 2D 6M-3Y Group

EXPERIMENTAL

Subjects, male and female, aged 6 months (M) to 3 years (Y), received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.

Biological: GSK Biologicals' investigational vaccine GSK2340274A (alternative formulations)

Arepanrix 2D 3Y-10Y Group

EXPERIMENTAL

Subjects, male and female, aged 3 years (Y) to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).

Biological: GSK Biologicals' investigational vaccine GSK2340274A (alternative formulations)

Arepanrix 1D 6M-3Y Group

EXPERIMENTAL

Subjects, male and female, aged 6 months (M) to 3 years (Y), received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.

Biological: GSK Biologicals' investigational vaccine GSK2340274A (alternative formulations); Biological: Placebo

Arepanrix 1D 3Y-10Y Group

EXPERIMENTAL

Subjects, male and female, aged 3 years (Y) to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).

Biological: GSK Biologicals' investigational vaccine GSK2340274A (alternative formulations); Biological: Placebo

GSK2340273A 6M-3Y Group

EXPERIMENTAL

Subjects, male and female, aged 6 months (M) to 3 years (Y), received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.

Biological: GSK Biologicals' investigational vaccine GSK2340273A (alternative formulations)

GSK2340273A 3Y-10Y Group

EXPERIMENTAL

Subjects, male and female, aged 3 years (Y) to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).

Biological: GSK Biologicals' investigational vaccine GSK2340273A (alternative formulations)

Interventions

GSK Biologicals' investigational vaccine GSK2340274A (alternative formulations) BIOLOGICAL

Intramuscular injection, one or two doses

Also known as: Arepanrix

Arepanrix 1D 3Y-10Y Group; Arepanrix 1D 6M-3Y Group; Arepanrix 2D 3Y-10Y Group; Arepanrix 2D 6M-3Y Group

GSK Biologicals' investigational vaccine GSK2340273A (alternative formulations) BIOLOGICAL

Intramuscular injection, two doses

GSK2340273A 3Y-10Y Group; GSK2340273A 6M-3Y Group

Placebo BIOLOGICAL

Intramuscular injection, one dose

Arepanrix 1D 3Y-10Y Group; Arepanrix 1D 6M-3Y Group

Eligibility Criteria

• Age: 6 Months - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Written informed consent obtained from the subject's parent(s)/legally acceptable representative(s) (LAR(s)); written informed assent obtained from the subject if appropriate pre local requirements).
• Stable health status as defined by absence of a health event satisfying the definition of a SAE, or a change in an ongoing drug therapy due to therapeutic failure or symptoms of drug toxicity, within 1 month prior to enrolment.
• Parent(s)/LAR(s) available and accessible for active surveillance contacts.
• Parent(s)/LAR(s) and (if age-appropriate, subjects) who, in the investigator's opinion, can and will comply with the requirements of the protocol as documented by signature on the informed consent document.
• Female subjects of non-childbearing potential (pre-menarche) may be enrolled in the study.

You may not qualify if:

• Previous vaccination with an A/California/7/2009 (H1N1)v-like virus vaccine.
• Medical history of physician-confirmed infection with an A/California/7/2009 (H1N1)v-like virus.
• Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, even if stable, are deemed by the investigator to render the potential subject or parent(s)/LAR(s) unable/unlikely to provide accurate safety reports.
• Presence of a temperature ≥ 38.0ºC (≥ 100.4ºF) by any route or method, or acute symptoms greater than "mild" severity on the scheduled date of first vaccination. NOTE: The subject may be vaccinated at a later date, provided symptoms have resolved, vaccination occurs within the window specified by the protocol, and all other eligibility criteria continue to be satisfied.
• Diagnosed with cancer, or treatment for cancer, within 3 years.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
• Receipt of systemic glucocorticoids within 1 month prior to study enrollment (first dose of study vaccine), or any other cytotoxic or immunosuppressive drug within 6 months of study enrollment. Topical, intra-articular or inhaled glucocorticoids are allowed.
• Receipt of any immunoglobulins and/or any blood products within 6 months of study enrollment or planned administration of any of these products during the study period.
• 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.
• An acute evolving neurological disorder or history of Guillain-Barré syndrome within 6 weeks of receipt of seasonal influenza vaccine.
• Administration of any licensed live attenuated vaccine within 4 weeks before the first vaccination or of any licensed inactivated vaccine within 2 weeks before the first vaccination.
• Planned administration of any vaccine not foreseen by the study protocol between Day 0 and Day 42. Routine childhood vaccinations are exempted if they cannot be delayed, but they must not be administered on the same day as the H1N1 vaccine candidate.
• Planned use of a pandemic monovalent A/California/7/2009 (H1N1)v-like virus vaccine other than the study vaccines during the study period.
• Planned administration of seasonal trivalent influenza vaccine during the 4 month period following Day 0.
• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days before the first dose of study vaccine, or planned use during the study period.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (17)

GSK Investigational Site

Kippa-Ring, Queensland, 4021, Australia

Location

GSK Investigational Site

Carlton, Victoria, 3053, Australia

Location

GSK Investigational Site

Florianópolis, Santa Catarina, 88025 300, Brazil

Location

GSK Investigational Site

São Paulo, 04038 001, Brazil

Location

GSK Investigational Site

São Paulo, Brazil

Location

GSK Investigational Site

Cali, Colombia

Location

GSK Investigational Site

San José, Costa Rica

Location

GSK Investigational Site

Cuernavaca, Morelos, Mexico

Location

GSK Investigational Site

Durango, 3400, Mexico

Location

GSK Investigational Site

Mexico City, 04530, Mexico

Location

GSK Investigational Site

Monterrey, Mexico

Location

GSK Investigational Site

City of Muntinlupa, 1781, Philippines

Location

GSK Investigational Site

Dasmariñas, Cavite, 4114, Philippines

Location

GSK Investigational Site

Sampaloc, Manila, 1008, Philippines

Location

GSK Investigational Site

Singapore, 768826, Singapore

Location

GSK Investigational Site

Bangkok, 10400, Thailand

Location

GSK Investigational Site

Khon Kaen, 40002, Thailand

Location

Related Publications (2)

• Nolan T, Roy-Ghanta S, Montellano M, Weckx L, Ulloa-Gutierrez R, Lazcano-Ponce E, Kerdpanich A, Safadi MA, Cruz-Valdez A, Litao S, Lim FS, de Los Santos AM, Weber MA, Tinoco JC, Mezerville MH, Faingezicht I, Kosuwon P, Lopez P, Borja-Tabora C, Li P, Durviaux S, Fries L, Dubin G, Breuer T, Innis BL, Vaughn DW. Relative efficacy of AS03-adjuvanted pandemic influenza A(H1N1) vaccine in children: results of a controlled, randomized efficacy trial. J Infect Dis. 2014 Aug 15;210(4):545-57. doi: 10.1093/infdis/jiu173. Epub 2014 Mar 20.

  PMID: 24652494 BACKGROUND

• Taylor S, Lopez P, Weckx L, Borja-Tabora C, Ulloa-Gutierrez R, Lazcano-Ponce E, Kerdpanich A, Angel Rodriguez Weber M, Mascarenas de Los Santos A, Tinoco JC, Safadi MA, Lim FS, Hernandez-de Mezerville M, Faingezicht I, Cruz-Valdez A, Feng Y, Li P, Durviaux S, Haars G, Roy-Ghanta S, Vaughn DW, Nolan T. Respiratory viruses and influenza-like illness: Epidemiology and outcomes in children aged 6 months to 10 years in a multi-country population sample. J Infect. 2017 Jan;74(1):29-41. doi: 10.1016/j.jinf.2016.09.003. Epub 2016 Sep 22.

  PMID: 27667752 DERIVED

Related Links

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

MeSH Terms

Conditions

Influenza, Human

Interventions

arepanrix

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

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, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2010
• First Posted: January 18, 2010
• Study Start: February 12, 2010
• Primary Completion: August 31, 2011
• Study Completion: September 9, 2011
• Last Updated: February 26, 2021
• Results First Posted: May 13, 2020

Record last verified: 2021-02

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

BR (3); PH (3); CO (1); SG (1); AU (2); TH (2); ME (4)