Safety and Immunogenicity of H1N1 Vaccines in Children Aged 6 Months to Less Than 9 Years of Age

NCT ID: NCT00976820

Last Updated: 2017-12-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 323 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-20
• Study Completion Date: 2011-03-21

Brief Summary

The purpose of this study is to characterize the safety and immune response of the H1N1 (swine) flu vaccines GSK2340274A and GSK2340273A in children 6 months to less than 9 years of age.

This Protocol Posting has been updated following the Protocol amendment 1 & 2, September and October 2009. The sections impacted are study design, objectives and analysis methods.

Detailed Description

Collaborators: United States Department of Health and Human Services, Office of Biomedical Advanced Research and Development Authority

Conditions

Influenza

Keywords

influenza infection; Influenza Vaccines; GSK Bio's influenza vaccine GSK2340273A; GSK Bio's influenza vaccine GSK2340274A

Study Design

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

Study Groups

Arepanrix/F1 Group

Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh \[for children under (\<) 12 months of age\]. The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).

Group Type: EXPERIMENTAL

GSK2340274A

Intervention Type: BIOLOGICAL

Two intramuscular injections

Arepanrix/F2 Group

Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).

Group Type: EXPERIMENTAL

GSK2340274A

Intervention Type: BIOLOGICAL

Two intramuscular injections

GSK2340273A/F1 Group

Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).

Group Type: EXPERIMENTAL

GSK2340273A

Intervention Type: BIOLOGICAL

Two intramuscular injections

GSK2340273A/F2 Group

Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).

Group Type: EXPERIMENTAL

GSK2340273A

Intervention Type: BIOLOGICAL

Two intramuscular injections

Interventions

GSK2340274A

Two intramuscular injections

Intervention Type: BIOLOGICAL

GSK2340273A

Two intramuscular injections

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Male or female children 6 months to less than 9 years of age at the time of the first vaccination.
• Written informed consent obtained from the subject's parent/ legally acceptable representative (LAR); written informed assent obtained from the subject if appropriate.
• Good general health as established by medical history and clinical examination before entering into the study.
• Safety laboratory test results within the parameters specified in the protocol.
• Parent/ LAR access to a consistent means of telephone contact, land line or mobile, but NOT a pay phone or other multiple-user device.
• Subjects who the investigator believes that their parent(s)/ LAR can and will comply with the requirements of the protocol.
• Female subjects of non-childbearing potential (pre-menarche) may be enrolled in the study.

Exclusion Criteria

• Previous vaccination with an H1N1v-like virus vaccine or a medical history of physician-confirmed infection with an H1N1v-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.
• 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
• Receipt of systemic glucocorticoids within 1 month prior to study enrollment, 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 3 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 vaccine within 4 weeks before the first dose of study vaccine, with the exception of seasonal influenza vaccine.
• Planned administration of any vaccine not foreseen by the study protocol between Day 0 and the Day 42 phlebotomy, including seasonal influenza vaccine. 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.
• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
• Any known or suspected allergy to any constituent of influenza vaccines a history of anaphylactic-type reaction to any constituent of influenza vaccines; or a history of severe adverse reaction to a previous influenza vaccine.
• Child in care.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 8 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

Conway, Arkansas, United States

GSK Investigational Site

Little Rock, Arkansas, United States

GSK Investigational Site

Sacramento, California, United States

GSK Investigational Site

San Francisco, California, United States

GSK Investigational Site

Arkansas City, Kansas, United States

GSK Investigational Site

Wichita, Kansas, United States

GSK Investigational Site

Bardstown, Kentucky, United States

GSK Investigational Site

Metairie, Louisiana, United States

GSK Investigational Site

Saint Paul, Minnesota, United States

GSK Investigational Site

Omaha, Nebraska, United States

GSK Investigational Site

Cleveland, Ohio, United States

GSK Investigational Site

Kingsport, Tennessee, United States

GSK Investigational Site

Austin, Texas, United States

GSK Investigational Site

Fort Worth, Texas, United States

GSK Investigational Site

San Angelo, Texas, United States

GSK Investigational Site

Orem, Utah, United States

GSK Investigational Site

South Jordan, Utah, United States

GSK Investigational Site

Coquitlam, British Columbia, Canada

GSK Investigational Site

Winnipeg, Manitoba, Canada

GSK Investigational Site

St. John's, Newfoundland and Labrador, Canada

GSK Investigational Site

Halifax, Nova Scotia, Canada

GSK Investigational Site

Brampton, Ontario, Canada

GSK Investigational Site

Greater Sudbury, Ontario, Canada

GSK Investigational Site

Hamilton, Ontario, Canada

GSK Investigational Site

Newmarket, Ontario, Canada

GSK Investigational Site

Toronto, Ontario, Canada

GSK Investigational Site

Toronto, Ontario, Canada

GSK Investigational Site

Montreal, Quebec, Canada

GSK Investigational Site

Québec, Quebec, Canada

GSK Investigational Site

Sherbrooke, Quebec, Canada

Countries

United States; Canada

References

Langley JM, Reich D, Aggarwal N, Connor D, Lebel MH, Gupta A, Garfield H, Li P, Madan A, Vaughn DW. Randomized, multicenter trial of a single dose of AS03-adjuvanted or unadjuvanted H1N1 2009 pandemic influenza vaccine in children 6 months to <9 years of age: safety and immunogenicity. Pediatr Infect Dis J. 2012 Aug;31(8):848-58. doi: 10.1097/INF.0b013e31825e6cd6.

Reference Type: DERIVED

PMID: 22801094 (View on PubMed)

Study Documents

Document Type: Clinical Study Report

View Document

Document Type: Individual Participant Data Set

View Document

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Dataset Specification

View Document

Document Type: Informed Consent Form

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

113482

Identifier Type: -

Identifier Source: org_study_id