Immunogenicity and Safety Study of a GlaxoSmithKline Biologicals' Candidate Influenza Vaccine in Healthy Children

NCT00985790 | Completed Phase 2 Results

• 1 other identifier: 113237
• Study Type: interventional
• Target: 599
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of the present study is to assess the immunogenicity and safety of vaccine GSK2321138A in children.

Conditions

Influenza

Keywords

vaccine; Influenza

Outcome Measures

Primary Outcomes (1)

• Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the 3 Fluarix Vaccine Strains.

  Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. The 3 influenza strains assessed were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2) and Flu B/Brisbane/60/08 Victoria (VICT).The POST results were the primary outcome variables.

  At Day 0 [PRE] and at 28 days post last vaccination (Day 28 or Day 56) [POST]

Secondary Outcomes (15)

• Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.

  At Days 0 and 28.

• Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.

  At Days 0, 28 and Day 56

• Number of Seropositive Subjects Against 4 Strains of Influenza Disease.

  At Days 0 and 28

• Number of Seropositive Subjects Against 4 Strains of Influenza Disease.

  At Days 0, 28 and 56

• Number of Seroconverted Subjects Against 4 Strains of Influenza Disease.

  At Day 28

Study Arms (2)

GSK2321138A Group

EXPERIMENTAL

Subjects aged between 18 and 47 months received the GSK2321138A. "Primed" subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 - or the GSK2321138A-Primed Group) received 1 dose of GSK2321138A vaccine at Day 0. "Unprimed" subject (subjects who had not received any 2-dose priming influenza immunization in any previous year - or the the GSK2321138A-Unprimed Group) received 2 doses of GSK2321138A vaccine at Days 0 and 28. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.

Biological: Influenza vaccine GSK2321138A

Fluarix Group

ACTIVE COMPARATOR

Subjects aged between 18 and 47 months received the Fluarix™ vaccine. "Primed" subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 - or the Fluarix-Primed Group) received 1 dose of Fluarix™ vaccine at Day 0. "Unprimed" subject (subjects who had not received any 2-dose priming influenza immunization in any previous year - or the the Fluarix-Unprimed Group) received 2 doses of Fluarix™ vaccine at Days 0 and 28. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.

Biological: Fluarix™

Interventions

Influenza vaccine GSK2321138A BIOLOGICAL

Intramuscular injection

GSK2321138A Group

Fluarix™ BIOLOGICAL

Intramuscular injection

Fluarix Group

Eligibility Criteria

• Age: 18 Months - 47 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• For all subjects:
• Subjects who the investigator believes that they and/or their Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol.
• Written informed consent obtained from the subject/from the LAR(s).
• For unprimed subjects:
• A male or female child aged 18 to 47 months at the time of the first vaccination.
• Children who did not have influenza vaccine in a previous season.
• For primed subjects from study NCT00764790:
• Children who received Fluarix™ in the 111751 study NCT00764790.

You may not qualify if:

• Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
• History of hypersensitivity to any vaccine.
• History of allergy or reactions likely to be exacerbated by any component of the vaccine.
• Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before and ending 28 days after each dose of vaccine(s).
• Acute or chronic clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination.
• Acute disease at the time of enrolment.
• History of Guillain Barré syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine.
• Receipt of another seasonal influenza vaccine outside of this study, during current (2009-2010) flu season.
• Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
• Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccination Inhaled and topical steroids are allowed.
• Administration of immunoglobulins and/or blood products within the 3 month preceding the first dose of study vaccine or planned administration during the study period.
• Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (2)

GSK Investigational Site

Ecatepec de Morelos, State of Mexico, 55075, Mexico

Location

GSK Investigational Site

Mexico City, 04530, Mexico

Location

Related Publications (1)

• Rodriguez Weber MA, Claeys C, Aranza Doniz C, Feng Y, Innis BL, Jain VK, Peeters M. Immunogenicity and safety of inactivated quadrivalent and trivalent influenza vaccines in children 18-47 months of age. Pediatr Infect Dis J. 2014 Dec;33(12):1262-9. doi: 10.1097/INF.0000000000000463.

  PMID: 25386965 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 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2009
• First Posted: September 28, 2009
• Study Start: October 8, 2009
• Primary Completion: May 21, 2010
• Study Completion: May 21, 2010
• Last Updated: September 21, 2018
• Results First Posted: March 12, 2013

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will share

Locations

ME (2)