Clinical Study in Children, 6 Months to 3 Years of Age, to Assess Two Dose Levels of an Experimental Flu Vaccine, Using a Licensed Influenza Virus Vaccine, Vaxigrip® as the Control

NCT00778895 | Completed Phase 2 Results

• 1 other identifier: 111635
• Study Type: interventional
• Target: 390
• Locations: 1 country
• Sites: 18

Brief Summary

Children younger than 5 years of age are at high risk for severe influenza disease (flu) and hospitalization due to flu. Scientists are in the process of re-evaluating the dosing initially based on whole virus vaccines to improve their efficacy in infants. In this study, we will compare two different dose levels of GSK1557482A flu vaccine. Another already approved flu vaccine made by a different company will be used as a control.

Conditions

Influenza

Keywords

Flu; Safety; Immunogenicity; Flu vaccine; Influenza; Virus

Outcome Measures

Primary Outcomes (7)

• Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination

  Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported regardless of intensity grade. Grade 3 pain = Cried when limb was moved/spontaneously painful. Grade 3 redness and swelling were defined as redness/swelling above 50 millimeters (mm). This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.

  During the 4-day follow-up period (Days 0-3) after any vaccination

• Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination

  Symptoms assessed were drowsiness, irritability, loss of appetite and fever. Any was defined as occurrence of any general symptom regardless of their intensity grade or relationship to vaccination. Any fever = Axillary temperature ≥ 38.0 degrees Celsius (°C). Grade 3 fever = Axillary temperature ≥ 39.0°C. For other symptoms, grade 3 was defined as an adverse event which prevented normal everyday activities. Related = A general symptom assessed by the investigator as causally related to vaccination. This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.

  During the 4-day follow-up period (Days 0-3) after any vaccination

• Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) After Vaccination

  Unsolicited AEs covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = Occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 = Occurrence of any unsolicited AE that prevented normal, everyday activities. Related = Occurrence of an unsolicited AE assessed by the investigator to be causally related to study vaccination. This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.

  During the 28-day follow-up period (Days 0-27) after vaccination

• Number of Subjects With Any, Grade 3 and Related Medically-attended Adverse Events (MAEs) After Vaccination

  MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination. Analysis of intensity and relationship to vaccination of MAEs was not performed. This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.

  During the 28-day post-vaccination period

• Number of Subjects With Any, Grade 3 and Related Medically-attended Adverse Events (MAEs) After Vaccination

  MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination. Analysis of intensity and relationship to vaccination of MAEs was not performed. This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.

  During the 6-month safety follow up after vaccination

• Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination

  SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE(s) = Occurrence of any SAE(s) regardless of intensity grade or relation to vaccination. Related SAE(s) = Occurrence of any SAE(s) assessed by the investigator as causally related to vaccination. This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.

  During the 28-day post-vaccination period

• Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination

  SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE(s) = Occurrence of any SAE(s) regardless of intensity grade or relation to vaccination. Related SAE(s) = Occurrence of any SAE(s) assessed by the investigator as causally related to vaccination. This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.

  During the 6-month safety follow up after vaccination

Secondary Outcomes (11)

• Titers for Serum Hemagglutination Inhibition (HI) Antibodies

  At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]

• Number of Subjects Seroconverted to HI Antibodies

  At Day 28 (for primed subjects) and at Day 56 (for unprimed subjects) [POST]

• Number of Subjects Seroprotected Against HI Antibodies

  At Day 0 [PRE] and at Day 28 (for primed subjects) and at Day 56 (for unprimed subjects) [POST]

• Seroconversion Factor for HI Antibodies

  At Day 28 (for primed subjects) and at Day 56 (for unprimed subjects) [POST]

• Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination

  During the 4-day follow-up period (Days 0-3) after any vaccination

Study Arms (3)

Fluviral F1 Group

EXPERIMENTAL

Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.

Biological: GSK Biologicals' influenza vaccine GSK1557482A

Fluviral F2 Group

EXPERIMENTAL

Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.

Biological: GSK Biologicals' influenza vaccine GSK1557482A

Vaxigrip Group

ACTIVE COMPARATOR

Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.

Biological: Vaxigrip

Interventions

GSK Biologicals' influenza vaccine GSK1557482A BIOLOGICAL

one IM injection at Day 0 for primed subjects (defined as subjects who had a prior 2-dose priming influenza immunization) or two IM injections at Day 0 and approximately Day 28 for un-primed subjects (defined as subjects who have not previously received a complete 2-dose priming influenza immunization).

Also known as: Fluviral

Fluviral F1 Group; Fluviral F2 Group

Vaxigrip BIOLOGICAL

one IM injection at Day 0 for primed subjects (defined as subjects who had a prior 2-dose priming influenza immunization) or two IM injections at Day 0 and approximately Day 28 for un-primed subjects (defined as subjects who have not previously received a complete 2-dose priming influenza immunization).

Vaxigrip Group

Eligibility Criteria

• Age: 6 Months - 36 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• A male or female child 6 months to \< 3 years of age at the time of the vaccination, regardless of previous administration of influenza vaccine in a previous season;
• Subjects must be in good health established by medical history and physical examination before entering into the study;
• Subjects having a parent/guardian who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study;
• Written informed consent obtained from the subject's parent/guardian.
• Parents/guardian access to a consistent means of telephone contact, land line or mobile

You may not qualify if:

• History of hypersensitivity to any vaccine;
• History of allergy to or reactions likely to be exacerbated by, any component of the vaccine including egg, chicken protein, formaldehyde, or sodium deoxycholate;
• History of any congenital, acquired, or iatrogenic immunodeficiency state (current or potential) including HIV infection, disorders of the lymphoid system or bone marrow, or chronic administration (defined as more than 14 consecutive days) of immunosuppressant or other immune-modifying drugs within 3 months prior to the administration of the study vaccine.
• Acute disease at the time of enrolment.
• History of Guillain Barré syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine;
• Any significant disorder of blood coagulation or treatment with vitamin K antagonists; or any known disorder of hemostasis;
• Receipt of any immunoglobulins and/or any blood products within three months of study enrollment or planned administration of any of these products during the study period.
• Receipt of a non-study related influenza vaccine outside of this study and during the current (2008-09) influenza immunization campaign.
• Any use of analgesics/antipyretics 12 hours before receipt of vaccine.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (18)

GSK Investigational Site

Calgary, Alberta, T3B 6A8, Canada

Location

GSK Investigational Site

Langley, British Columbia, V3A 4H9, Canada

Location

GSK Investigational Site

Winnipeg, Manitoba, R3E 3P4, Canada

Location

GSK Investigational Site

Mount Pearl, Newfoundland and Labrador, A1N 5B6, Canada

Location

GSK Investigational Site

Halifax, Nova Scotia, B3K 6R8, Canada

Location

GSK Investigational Site

Greater Sudbury, Ontario, P3E 1H5, Canada

Location

GSK Investigational Site

Hamilton, Ontario, L8L 5G8, Canada

Location

GSK Investigational Site

London, Ontario, N6A 5R9, Canada

Location

GSK Investigational Site

London, Ontario, N6H 4P2, Canada

Location

GSK Investigational Site

Mississauga, Ontario, L5A 3V4, Canada

Location

GSK Investigational Site

Newmarket, Ontario, L3Y 5G8, Canada

Location

GSK Investigational Site

Sarnia, Ontario, N7T 4X3, Canada

Location

GSK Investigational Site

Toronto, Ontario, M5G 1N8, Canada

Location

GSK Investigational Site

Charlottetown, Prince Edward Island, C1A 5N4, Canada

Location

GSK Investigational Site

Montreal, Quebec, H3T 1C5, Canada

Location

GSK Investigational Site

Québec, Quebec, G1V 4M6, Canada

Location

GSK Investigational Site

Ste-Foy, Quebec, G1X 3V7, Canada

Location

GSK Investigational Site

Trois-Rivières, Quebec, G8T 7A1, Canada

Location

Related Publications (1)

• Langley JM, Vanderkooi OG, Garfield HA, Hebert J, Chandrasekaran V, Jain VK, Fries L. Immunogenicity and Safety of 2 Dose Levels of a Thimerosal-Free Trivalent Seasonal Influenza Vaccine in Children Aged 6-35 Months: A Randomized, Controlled Trial. J Pediatric Infect Dis Soc. 2012 Mar;1(1):55-63. doi: 10.1093/jpids/pis012. Epub 2012 Mar 1.

  PMID: 23687572 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; Virus Diseases

Interventions

Influenza Vaccines; vaxigrip

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2008
• First Posted: October 24, 2008
• Study Start: November 10, 2008
• Primary Completion: August 19, 2009
• Study Completion: August 19, 2009
• Last Updated: August 17, 2018
• Results First Posted: July 9, 2013

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share

Locations

CA (18)