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

NCT00976820 | Completed Phase 2 Results

• 1 other identifier: 113482
• Study Type: interventional
• Target: 323
• Locations: 2 countries
• Sites: 30

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.

Conditions

Influenza

Keywords

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

Outcome Measures

Primary Outcomes (20)

• Number of Seroconverted Subjects Against Flu A/CAL/7/09 Influenza Strain - Preliminary Analysis

  A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal hemagglutination inhibition (HI) titer lower than (\<) 10 and a post-vaccination reciprocal HI titer higher than or equal to (≥) 40, or a pre-vaccination reciprocal hemagglutination inhibition (HI) titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.

  At Day 21

• Number of Seroconverted Subjects Against Flu A/CAL/7/09 Influenza Strain - First Analysis

  A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal HI titer \< 10 and a post-vaccination reciprocal titer higher than or equal to (≥) 40, or a pre-vaccination reciprocal hemagglutination inhibition (HI) titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.

  At Day 21

• Number of Seroconverted Subjects Against Flu A/CAL/7/09 Influenza Strain - Second Analysis

  A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal HI titer \< 10 and a post-vaccination reciprocal titer higher than or equal to (≥) 40, or a pre-vaccination reciprocal hemagglutination inhibition (HI) titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.

  At Day 21

• Number of Seroconverted Subjects Against Flu A/CAL/7/09 Influenza Strain - First Analysis

  A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal HI titer \< 10 and a post-vaccination reciprocal titer higher than or equal to (≥) 40, or a pre-vaccination reciprocal hemagglutination inhibition (HI) titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.

  At Day 42

• Number of Seroconverted Subjects Against Flu A/CAL/7/09 Influenza Strain - Second Analysis

  A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal HI titer \< 10 and a post-vaccination reciprocal titer higher than or equal to (≥) 40, or a pre-vaccination reciprocal hemagglutination inhibition (HI) titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.

  At Day 42

• Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain - Preliminary Analysis

  A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.

  At Day 0

• Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain - Preliminary Analysis

  A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.

  At Day 21

• Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain - First Analysis

  A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.

  At Day 0

• Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain - First Analysis

  A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.

  At Day 21

• Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain - Second Analysis

  A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.

  At Day 0

• Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain - Second Analysis

  A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.

  At Day 21

• Number of Seroprotected Subjects Against Flu A/CAL/7/09 Strain - First Analysis

  A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.

  At Day 0

• Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain - First Analysis

  A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.

  At Day 42

• Number of Seroprotected Subjects Against Flu A/CAL/7/09 Strain - Second Analysis

  A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.

  At Day 0

• Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain - Second Analysis

  A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.

  At Day 42

• Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Influenza Strain - Preliminary Analysis

  SCF was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.

  At Day 21

• Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Influenza Strain - First Analysis

  SCF was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.

  At Day 21

• Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Influenza Strain - Second Analysis

  SCF was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.

  At Day 21

• Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Influenza Strain - First Analysis

  SCF was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.

  At Day 42

• Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Influenza Strain - Second Analysis

  SCF was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.

  At Day 42

Secondary Outcomes (57)

• Number of Seropositive Subjects for HI Antibodies - Preliminary Analysis

  At Day 0 (PRE) and at Day 21

• Number of Seropositive Subjects for HI Antibodies - First Analysis

  At Day 0 (PRE) and at Day 21

• Number of Seropositive Subjects for HI Antibodies - Second Analysis

  At Day 0 (PRE) and at Day 21

• Number of Seropositive Subjects for HI Antibodies - First Analysis

  At Day 0 (PRE) and at Day 42

• Number of Seropositive Subjects for HI Antibodies - Second Analysis

  At Day 0 (PRE) and at Day 42

Study Arms (4)

Arepanrix/F1 Group

EXPERIMENTAL

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).

Biological: GSK2340274A

Arepanrix/F2 Group

EXPERIMENTAL

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).

Biological: GSK2340274A

GSK2340273A/F1 Group

EXPERIMENTAL

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).

Biological: GSK2340273A

GSK2340273A/F2 Group

EXPERIMENTAL

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).

Biological: GSK2340273A

Interventions

GSK2340274A BIOLOGICAL

Two intramuscular injections

Arepanrix/F1 Group; Arepanrix/F2 Group

GSK2340273A BIOLOGICAL

Two intramuscular injections

GSK2340273A/F1 Group; GSK2340273A/F2 Group

Eligibility Criteria

• Age: 6 Months - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (30)

GSK Investigational Site

Conway, Arkansas, 72034, United States

Location

GSK Investigational Site

Little Rock, Arkansas, 72202, United States

Location

GSK Investigational Site

Sacramento, California, 95816, United States

Location

GSK Investigational Site

San Francisco, California, 94102, United States

Location

GSK Investigational Site

Arkansas City, Kansas, 67005, United States

Location

GSK Investigational Site

Wichita, Kansas, 67205, United States

Location

GSK Investigational Site

Bardstown, Kentucky, 40004, United States

Location

GSK Investigational Site

Metairie, Louisiana, 70006, United States

Location

GSK Investigational Site

Saint Paul, Minnesota, 55108, United States

Location

GSK Investigational Site

Omaha, Nebraska, 68134, United States

Location

GSK Investigational Site

Cleveland, Ohio, 44121, United States

Location

GSK Investigational Site

Kingsport, Tennessee, 37660, United States

Location

GSK Investigational Site

Austin, Texas, 78705, United States

Location

GSK Investigational Site

Fort Worth, Texas, 76135, United States

Location

GSK Investigational Site

San Angelo, Texas, 76904, United States

Location

GSK Investigational Site

Orem, Utah, 84057, United States

Location

GSK Investigational Site

South Jordan, Utah, 84095, United States

Location

GSK Investigational Site

Coquitlam, British Columbia, V3K 3P4, Canada

Location

GSK Investigational Site

Winnipeg, Manitoba, R3A 1M3, Canada

Location

GSK Investigational Site

St. John's, Newfoundland and Labrador, A1A 3R5, Canada

Location

GSK Investigational Site

Halifax, Nova Scotia, B3K 6R8, Canada

Location

GSK Investigational Site

Brampton, Ontario, L6T 0G1, Canada

Location

GSK Investigational Site

Greater Sudbury, Ontario, P3E 1H5, Canada

Location

GSK Investigational Site

Hamilton, Ontario, L8L 5G8, Canada

Location

GSK Investigational Site

Newmarket, Ontario, L3Y 5G8, Canada

Location

GSK Investigational Site

Toronto, Ontario, M5G 1N8, Canada

Location

GSK Investigational Site

Toronto, Ontario, M9V 4B4, Canada

Location

GSK Investigational Site

Montreal, Quebec, H3T 1C5, Canada

Location

GSK Investigational Site

Québec, Quebec, G1V 4T3, Canada

Location

GSK Investigational Site

Sherbrooke, Quebec, J1H 1Z1, Canada

Location

Related Publications (1)

• 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.

  PMID: 22801094 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

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

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 2
• 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: September 11, 2009
• First Posted: September 14, 2009
• Study Start: October 20, 2009
• Primary Completion: March 21, 2011
• Study Completion: March 21, 2011
• Last Updated: December 12, 2017
• Results First Posted: December 12, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will share

Locations

CA (13); US (17)