Safety and Immunogenocity Study of GSK Biologicals' Pandemic Influenza (H1N1) Candidate Vaccine in Japanese Children

NCT01001169 | Completed Phase 2 Results

• 1 other identifier: 113847
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to evaluate the immunogenicity and safety of GSK Biologicals' investigational influenza vaccine GSK2340274A following one dose and following a second dose, using the same dosage as has been used in the H5N1 development program in Japanese children aged 10-17 years and an alternative dose in children aged 6 months to 9 years.

Conditions

Influenza

Keywords

GSK Bio's influenza vaccine GSK2340274A; influenza infection

Outcome Measures

Primary Outcomes (5)

• Number of Subjects With Haemagglutination Inhibition (HI) Antibody Concentrations Above the Cut-off Value

  The cut-off values for the humoral immune response in terms of vaccine H1N1 HI antibodies were equal to or above (≥) 1:10. The Flu strain assessed was A/California/7/2009 (H1N1)v-like virus (Flu A/CAL/7/09), in subjects aged between 6 months to 9 years and 10 to 17 years, following the Committee for Medicinal Products for Human Use (CHMP) and the Center for Biologics Evaluation and Research (CBER) guidance.

  At Day 42

• Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease

  Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:10. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.

  At Day 42

• Number of Seroconverted Subjects for HI Antibodies

  Seroconversion (SCR) was defined as follows: For initially seronegative subjects, antibody titer ≥ 1:40 after vaccination; For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance. The CBER criterion was fulfilled if the lower 97.5% confidence interval for SCR was \> 40%. The CHMP criterion was fulfilled if the point estimate for SCR was \> 40%.

  At Day 42

• Number of Seroprotected Subjects for HI Antibodies

  A seroprotected subject was defined as a vaccinated subject with a serum hemagglutination inhibition (HI) titer equal to or above (≥) 1:40. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance. The CBER Criterion was fulfilled if the lower 97.5% confidence interval for seroprotection (SPR) was \> 70%. The CHMP Criterion was fulfilled if the post-vaccination point estimate for SPR was \> 70%.

  At Day 42

• Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease

  GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP guidance. The CHMP Criterion was fulfilled if the point estimate for GMFR was \> 2.5.

  At Day 42

Secondary Outcomes (33)

• Number of Subjects With HI Antibody Concentrations Above the Cut-off Value

  At Days 0 and 21

• Number of Subjects With HI Antibody Concentrations Above the Cut-off Value

  At Days 0 and 42

• Number of Subjects With HI Antibody Concentrations Above the Cut-off Value

  At Days 0 and 182

• Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease

  At Days 0 and 21

• Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease

  At Days 0 and 42

Study Arms (2)

GSK2340274A_F1 6M-9Y GROUP

EXPERIMENTAL

Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.

Biological: GSK Biologicals' Pandemic influenza (H1N1) candidate vaccine (GSK2340274A)

GSK2340274A_F2 10Y-17Y GROUP

EXPERIMENTAL

Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.

Biological: GSK Biologicals' Pandemic influenza (H1N1) candidate vaccine (GSK2340274A)

Interventions

GSK Biologicals' Pandemic influenza (H1N1) candidate vaccine (GSK2340274A) BIOLOGICAL

Two intramuscular injections

GSK2340274A_F1 6M-9Y GROUP; GSK2340274A_F2 10Y-17Y GROUP

Eligibility Criteria

• Age: 6 Months - 17 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.
• Japanese children, male or female, aged between 6 months and 17 years at the time of the first study vaccination.
• Written informed consent obtained from the subject's parent(s) or LAR(s) of the subject. Whenever possible, an assent should also be obtained from the subject.
• Healthy children as established by medical history and clinical examination when entering into the study (Particular attention must be exercised when dealing with patients with bronchial asthma).
• 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.
• Female subjects of childbearing potential may be enrolled in the study, if the subject: has practiced adequate contraception for 30 days prior to vaccination, and has a negative pregnancy test on the day of vaccination, and has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.

You may not qualify if:

• Use of any investigational or non-registered product (drug or vaccine) 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 from May 2009 to the day of enrolment.
• Previous administration of a novel \[H1N1\]v vaccine.
• Administration of any vaccines within 30 days before vaccination or planned administration within the first vaccination up to blood sampling at Day 42 and within 30 days prior to blood sampling at Day 182, with the exception of seasonal influenza vaccine.
• Administration of any seasonal influenza vaccine within 14 days before vaccination on Day 0, or planned administration within the first vaccination up to blood sampling at Day 42 and within 14 days prior to blood sampling at Day 182.
• Excessive underweight or excessive obesity. (Under or upper 2-fold standard deviation of weight distribution that are corresponding age group are used as reference).
• 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:
• Fever is defined as temperature \>= 37.5°C on oral, axillary or tympanic setting, or \>= 38.0°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.
• Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing required).
• 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 during the study.
• Any known or suspected allergy to any constituent of influenza vaccines; a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine.
• History of any neurological disorder including acute disseminated encephalomyelitis and Guillain-Barré syndrome, or convulsive seizures and epilepsy.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Tokyo, 157-8535, Japan

Location

Related Publications (2)

• Van Damme P, Kafeja F, Bambure V, Hanon E, Moris P, Roman F, Gillard P. Long-term persistence of humoral and cellular immune responses induced by an AS03A-adjuvanted H1N1 2009 influenza vaccine: an open-label, randomized study in adults aged 18-60 years and older. Hum Vaccin Immunother. 2013 Jul;9(7):1512-22. doi: 10.4161/hv.24504. Epub 2013 Apr 9.

  PMID: 23571166 DERIVED

• Saitoh A, Nagai A, Tenjinbaru K, Li P, Vaughn DW, Roman F, Kato T. Safety and persistence of immunological response 6 months after intramuscular vaccination with an AS03-adjuvanted H1N1 2009 influenza vaccine: an open-label, randomized trial in Japanese children aged 6 months to 17 years. Hum Vaccin Immunother. 2012 Jun;8(6):749-58. doi: 10.4161/hv.19684. Epub 2012 Apr 12.

  PMID: 22495117 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: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2009
• First Posted: October 23, 2009
• Study Start: October 1, 2009
• Primary Completion: May 17, 2010
• Study Completion: May 17, 2010
• Last Updated: August 17, 2018
• Results First Posted: May 2, 2017

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will share

Locations

JP (1)