Immunogenicity and Safety Study of Fluarix™ Vaccine in Children Who Have Previously Been Vaccinated With Pandemrix™

NCT01196026 | Completed Phase 4 Results

• 1 other identifier: 114451
• Study Type: interventional
• Target: 162
• Locations: 2 countries
• Sites: 7

Brief Summary

This study is designed to assess the immunogenicity, reactogenicity and safety following vaccination with GSK Biologicals' Fluarix vaccine in children who have previously been vaccinated with two doses of Pandemrix at the age of 6 months-9 years.

Conditions

Influenza

Keywords

Influenza; H1N1; Fluarix; Pandemrix

Outcome Measures

Primary Outcomes (5)

• Haemagglutination Inhibition (HI) Antibody Titers Against H1N1 in All Subjects Receiving Fluarix Vaccine

  Antibody titers were expressed as Geometric mean titers (GMTs).

  Day 0 and 28

• Number of Subjects Seropositive for HI Antibodies Against H1N1 in All Subjects Receiving Fluarix Vaccine

  Seropositivity was defined as antibody titers greater than or equal to 1:10.

  Day 0-28

• Number of Subjects Seroprotected for HI Antibodies Against H1N1 in All Subjects Receiving Fluarix Vaccine

  A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection.

  Day 0-28

• Number of Subjects Seroconverted for HI Antibodies Against H1N1 in All Subjects Receiving Fluarix Vaccine

  A seroconverted subject was defined as a subject that had either a prevaccination (Day 0) titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer.

  Day 28

• Mean Geometric Increase (MGI) in HI Antibody Titers Against H1N1 in All Subjects Receiving Fluarix Vaccine

  MGI is defined as the geometric mean of the within-subject ratios of the post-vaccination (Day 28) reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer.

  Day 28

Secondary Outcomes (26)

• HI Antibody Titers Against All Fluarix Vaccine Strains

  Day 0 (for all groups) and Day 28 (for groups receiving Fluarix only)

• HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine

  Day 0 and Month 6

• Number of Subjects Seropositive for HI Antibodies Against All Fluarix Vaccine Strains

  Day 0 (for all groups) and Day 28 (for groups receiving Fluarix only)

• Number of Subjects Seropositive for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine

  Day 0 and Month 6

• Number of Subjects Seroconverted for HI Antibodies Against All Fluarix Vaccine Strains in All Subjects Receiving Fluarix Vaccine

  Day 28

Study Arms (6)

Fluarix 6-11 months Group

EXPERIMENTAL

Subjects previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine

Biological: Fluarix™

Fluarix 12-35 months Group

EXPERIMENTAL

Subjects previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine

Biological: Fluarix™

Fluarix 3-9 years Group

EXPERIMENTAL

Subjects previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine

Biological: Fluarix™

Havrix Junior 6-11 months Group

ACTIVE COMPARATOR

Subjects previously vaccinated with Pandemrix vaccine will receive two doses of Havrix Junior vaccine

Biological: Havrix™ Junior

Havrix Junior 12-35 months Group

ACTIVE COMPARATOR

Subjects previously vaccinated with Pandemrix vaccine will receive two doses of Havrix Junior vaccine

Biological: Havrix™ Junior

Havrix Junior 3-9 years Group

ACTIVE COMPARATOR

Subjects previously vaccinated with Pandemrix vaccine will receive two doses of Havrix Junior vaccine

Biological: Havrix™ Junior

Interventions

Fluarix™ BIOLOGICAL

One or two intramuscular injections

Fluarix 12-35 months Group; Fluarix 3-9 years Group; Fluarix 6-11 months Group

Havrix™ Junior BIOLOGICAL

Two intramuscular injections

Havrix Junior 12-35 months Group; Havrix Junior 3-9 years Group; Havrix Junior 6-11 months Group

Eligibility Criteria

• Age: 1 Year - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Subjects having previously been immunized with two 0.25 mL doses of Pandemrix, given at least 21 days apart, at the age of 6 months to 9 years inclusive at the time of first vaccination.
• Subjects having received the last dose of Pandemrix at least six months prior to study enrolment.
• Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) \[LAR(s)\] can and will comply with the requirements of the protocol.
• Written informed consent obtained from the parent(s)/LAR(s) of the subjects.
• Healthy subjects as established by medical history and clinical examination before entering into the study.
• Parent/LAR with access to a consistent means of telephone contact, land line or mobile, but NOT a pay phone or other multiple-user device.

You may not qualify if:

• Active participation in other clinical trials.
• Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period.
• Planned administration of any vaccine 30 days prior and 30 days after any study vaccine administration.
• Chronic administration of immunosuppressants or other immune-modifying drugs within three months prior to enrolment in this study or planned administration during the study period.
• Acute disease and/or fever at the time of enrolment.
• Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
• Acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination.
• Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned use during the study.
• 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.
• History of seizures or progressive neurological disease.
• Subjects having received an H1N1v pandemic vaccine other than Pandemrix or having received the 2010/2011 seasonal influenza vaccine.
• Child in care.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (7)

GSK Investigational Site

Rotterdam, 3011 EN, Netherlands

Location

GSK Investigational Site

Karlskrona, SE-371 41, Sweden

Location

GSK Investigational Site

Malmo, SE-205 02, Sweden

Location

GSK Investigational Site

Örebro, SE-702 11, Sweden

Location

GSK Investigational Site

Skellefteå, SE-931 86, Sweden

Location

GSK Investigational Site

Stockholm, SE-118 83, Sweden

Location

GSK Investigational Site

Umeå, SE-901 85, Sweden

Location

Related Publications (1)

• Vesikari T, Richardus JH, Berglund J, Korhonen T, Flodmark CE, Lindstrand A, Silfverdal SA, Bambure V, Caplanusi A, Dieussaert I, Roy-Ghanta S, Vaughn DW. Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine in Children 6 Months to 17 Years of Age, Previously Vaccinated with an AS03-Adjuvanted A(H1N1)Pdm09 Vaccine: Two Open-label, Randomized Trials. Pediatr Infect Dis J. 2015 Jul;34(7):774-82. doi: 10.1097/INF.0000000000000709.

  PMID: 26069949 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

fluarix

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 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2010
• First Posted: September 8, 2010
• Study Start: September 15, 2010
• Primary Completion: May 26, 2011
• Study Completion: May 26, 2011
• Last Updated: September 24, 2018
• Results First Posted: June 28, 2012

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will share

Locations

SE (6); NL (1)