Study to Evaluate the Safety and Immunogenicity of GSK Biological Pandemic Candidate Influenza Vaccine (H1N1) in Children

NCT01014091 | Terminated Phase 3 Results

• 1 other identifier: 113810
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

Brief Summary

The objective of this study is to evaluate the safety and immunogenicity study of GSK Biologicals' pandemic influenza candidate vaccine (GSK2340272A) in children aged 3 to 9 years.

Conditions

Influenza

Keywords

influenza infection; GSK Bio's influenza vaccine GSK2340272A

Outcome Measures

Primary Outcomes (5)

• Haemagglutination Inhibition (HI) Antibody Titers Against Vaccine H1N1 Antigen

  Humoral immune response in terms of vaccine H1N1 haemagglutination inhibition (HI) antibodies against A/California/7/2009 (H1N1)v-like virus (Flu A/CAL/7/09) has been assessed. Antibody titers were presented as geometric mean titers (GMTs).

  At Day 42

• Number of Seropositive Subjects for HI Antibodies

  A seropositive subject was defined as a subject with a serum HI titer equal to or above (≥) 1:10. The flu strain assessed was Flu A/CAL/7/09.

  At Day 42

• Number of Seroconverted Subjects in Terms of HI Antibodies

  Seroconversion (SCR) was defined as: For initially seronegative subjects \[pre-vaccination titer below (\<) 1:10\], a post-vaccination titer ≥ 1:40. For initially seropositive subjects (pre-vaccination titer ≥ 1:10), at least a 4-fold increase in post-vaccination titer. The flu strain assessed was Flu A/CAL/7/09.

  At Day 42

• Number of Seroprotected Subjects for HI Antibodies

  A seroprotected subject was defined as a vaccinated subject with a serum HI titer ≥ 1:40, which is usually accepted as indicating protection. The flu strain assessed was Flu A/CAL/7/09.

  At Day 42

• Geometric Mean Fold Increase (GMFR) for Serum HI Antibody Titer

  GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09.

  At Day 42

Secondary Outcomes (12)

• Number of Seropositive Subjects for HI Antibodies

  At Day 0, Day 21 and Month 7

• HI Antibody Titers Against Vaccine H1N1 Antigen

  At Day 0, Day 21 and Month 7

• Number of Seroconverted Subjects in Terms of HI Antibodies

  At Day 21 and Month 7

• Number of Seroprotected Subjects for HI Antibodies

  At Day 0, Day 21 and Month 7

• Geometric Mean Fold Increase (GMFR) for Serum HI Antibody Titer

  At Day 21 and Month 7

Study Arms (6)

GSK2340272A F1 Y3-5 GROUP

EXPERIMENTAL

Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.

Biological: GSK pandemic vaccine GSK2340272A

GSK2340272A F1 Y6-9 GROUP

EXPERIMENTAL

Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.

Biological: GSK pandemic vaccine GSK2340272A

GSK2340272A F2 Y3-5 GROUP

EXPERIMENTAL

Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.

Biological: GSK pandemic vaccine GSK2340272A

GSK2340272A F2 Y6-9 GROUP

EXPERIMENTAL

Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.

Biological: GSK pandemic vaccine GSK2340272A

GSK2340272A F3 Y3-5 GROUP

EXPERIMENTAL

Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.

Biological: GSK pandemic vaccine GSK2340272A

GSK2340272A F3 Y6-9 GROUP

EXPERIMENTAL

Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.

Biological: GSK pandemic vaccine GSK2340272A

Interventions

GSK pandemic vaccine GSK2340272A BIOLOGICAL

2 intramuscular injections

GSK2340272A F1 Y3-5 GROUP; GSK2340272A F1 Y6-9 GROUP; GSK2340272A F2 Y3-5 GROUP; GSK2340272A F2 Y6-9 GROUP; GSK2340272A F3 Y3-5 GROUP; GSK2340272A F3 Y6-9 GROUP

Eligibility Criteria

• Age: 3 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol.
• Children, male or female, aged between 3 and 9 years at the time of first study vaccination.
• Written informed consent obtained from the parent(s) or LAR(s) of the subject.
• Healthy children, as established by medical history and clinical examination when entering the study.

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 the study vaccine or planned use during the study period.
• Clinically or virologically confirmed influenza infection within six months preceding the study start.
• Planned administration of any vaccine 30 days prior and 30 days after any study vaccine administration.
• Have received any seasonal flu vaccine since last year.
• Previous administration of any H1N1 A/California-like vaccine
• 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. For corticosteroids, this will mean prednisone \>= 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
• 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.
• History of hypersensitivity to vaccines.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
• History of any neurological disorders or seizures.
• Acute disease and/or fever at the time of enrolment:
• Fever is defined as temperature \>= 37.5°C on oral, axillary or tympanic setting, or \>= 38°C on rectal setting.
• Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator.
• Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned during the study.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (3)

GSK Investigational Site

Děčín, 405 01, Czechia

Location

GSK Investigational Site

Pardubice, 532 03, Czechia

Location

GSK Investigational Site

Prague, 1600, Czechia

Location

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 3
• 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: November 12, 2009
• First Posted: November 16, 2009
• Study Start: December 1, 2009
• Primary Completion: January 14, 2011
• Study Completion: January 14, 2011
• Last Updated: September 21, 2018
• Results First Posted: May 4, 2017

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will share

Locations

CZ (3)