Safety and Immunogenicity Study of GSK Biologicals' Pandemic Influenza Candidate Vaccine (GSK2340272A) in Children Aged 3 to 17 Years
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Influenza
- Sponsor
- GlaxoSmithKline
- Enrollment
- 245
- Locations
- 1
- Primary Endpoint
- Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against the Flu A/California/7/2009 (H1N1) Vaccine Strain
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
The objective of this study is to evaluate the immunogenicity and safety of GSK Biologicals' investigational vaccine GSK2340272A in children aged between 3 and 17 years.
Detailed Description
This Protocol Posting has been updated following Protocol amendment 1, October 2009. The impacted section are the study design section, the outcomes measures section and the intervention section.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 17 years at the time of the first study vaccination.
- •Written informed consent obtained from the subject parent(s) or LAR(s) of the subject. Assent obtained from the subject when applicable.
- •Healthy children as established by medical history and clinical examination when 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.
Exclusion Criteria
- •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.
- •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.
- •Previous administration of any H1N1 A/California-like vaccine.
- •Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned during the study.
- •If the subject is female and if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for two months after completion of the vaccination series.
Outcomes
Primary Outcomes
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against the Flu A/California/7/2009 (H1N1) Vaccine Strain
Time Frame: At Day 0, Day 21 and Day 42
Antibody titers were expressed as Geometric mean titers (GMTs).
Number of Seroconverted Subjects for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain
Time Frame: At Day 42
A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titre less than (\<) 1:10 and a post-vaccination titre greater than or equal to (≥) 1:40 or a pre-vaccination titre ≥ 1:10 and at least a 4-fold increase in post-vaccination titre. The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the point estimate for SCR was greater than (\>) 40% in children aged 3 to 17 years.
Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain
Time Frame: At Day 42
A seroprotected subject was defined as a vaccinated subject with a serum HI titre greater than or equal to (≥) 1:40, that usually is accepted as indicating protection. The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the post-vaccination time point estimate for SPR the point estimate for SPR was greater than (\>) 70% in children aged 3 to 17 years.
HI Antibody Geometric Mean Fold Rise (GMFR) Against the Flu A/California/7/2009 (H1N1) Virus Strain
Time Frame: At Day 42
GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The CHMP criterion was fulfilled if the point estimate for GMFR was greater than (\>) 2.5 in children aged 3 to 17 years
Secondary Outcomes
- Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against the Flu A/California/7/2009 (H1N1) Vaccine Strain(At Month 12)
- Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)(During the entire study period (Day 0 to Month 12))
- Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)(At Day 0, Day 21, Day 42 and Month 6 (M6))
- Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms(During the 7-day (Days 0-6) post-vaccination period)
- Number of Subjects Reporting Any Adverse Events of Specific Interest (AESI)/Potential Immune-mediated Diseases (pIMDs)(During the entire study period (Day 0 to Month 12))
- Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs).(Within the 84-day after the first vaccination or from 63-day follow-up period after the second vaccination)
- Number of Seroconverted Subjects for Neutralising Antibodies Against the Flu A/Netherlands/602/2009 (H1N1) Virus Strain(At Month 6)
- Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms(During the 7-day (Days 0-6) post-vaccination period)
- Number of Subjects Reporting Any Medically Attended Adverse Events (MAEs)(During the entire study period (Day 0 to Month 12))
- Number of Seroconverted Subjects for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain(At Month 6)
- Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain(At Month 12)
- HI Antibody Geometric Mean Fold Rise (GMFR) Against the Flu A/California/7/2009 (H1N1) Virus Strain(At Month 6)
- Humoral Immune Response in Terms of Neutralising Antibodies Against the Flu A/Netherlands/602/2009 (H1N1) Vaccine Strain(At Month 12)