Last updated: 07/17/2024 15:28:09
Study to evaluate the immunogenicity and safety of an investigational influenza vaccine (H1N1) in children
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Safety and immunogenicity study of GSK Biologicals’ pandemic influenza candidate vaccine (GSK2340272A) in children aged 3 to 17 years
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
Humoral immune response in terms of Haemagglutination Inhibition (HI) antibody titers against the Flu A/California/7/2009 (H1N1) vaccine strain
Timeframe: At Day 0, Day 21 and Day 42
Number of seroconverted subjects for HI antibodies against the Flu A/California/7/2009 (H1N1) virus strain
Timeframe: At Day 42
Number of subjects who were seroprotected for HI antibodies against the Flu A/California/7/2009 (H1N1) virus strain
Timeframe: At Day 42
HI antibody geometric mean fold rise (GMFR) against the Flu A/California/7/2009 (H1N1) virus strain
Timeframe: At Day 42
Secondary outcomes:
Humoral immune response in terms of Haemagglutination Inhibition (HI) antibody titers against the Flu A/California/7/2009 (H1N1) vaccine strain
Timeframe: At Month 6
Humoral immune response in terms of Haemagglutination Inhibition (HI) antibody titers against the Flu A/California/7/2009 (H1N1) vaccine strain
Timeframe: At Month 12
Number of seroconverted subjects for HI antibodies against the Flu A/California/7/2009 (H1N1) virus strain
Timeframe: At Month 6
Number of subjects who were seroprotected for HI antibodies against the Flu A/California/7/2009 (H1N1) virus strain
Timeframe: At Month 6
Number of subjects who were seroprotected for HI antibodies against the Flu A/California/7/2009 (H1N1) virus strain
Timeframe: At Month 12
HI antibody geometric mean fold rise (GMFR) against the Flu A/California/7/2009 (H1N1) virus strain
Timeframe: At Month 6
Humoral immune response in terms of neutralising antibodies against the Flu A/Netherlands/602/2009 (H1N1) vaccine strain
Timeframe: At Day 0, Day 21, Day 42 and Month 6
Humoral immune response in terms of neutralising antibodies against the Flu A/Netherlands/602/2009 (H1N1) vaccine strain
Timeframe: At Month 12
Number of seroconverted subjects for neutralising antibodies against the Flu A/Netherlands/602/2009 (H1N1) virus strain
Timeframe: At Day 21 and Day 42
Number of seroconverted subjects for neutralising antibodies against the Flu A/Netherlands/602/2009 (H1N1) virus strain
Timeframe: At Month 6
Number of subjects reporting Any and Grade 3 solicited local symptoms
Timeframe: During the 7-day (Days 0-6) post-vaccination period
Number of subjects reporting Any, Grade 3 and Related solicited general symptoms
Timeframe: During the 7-day (Days 0-6) post-vaccination period
Number of subjects reporting any Medically Attended Adverse Events (MAEs)
Timeframe: During the entire study period (Day 0 to Month 12)
Number of subjects reporting any Adverse Events of Specific Interest (AESI)/potential immune-mediated diseases (pIMDs)
Timeframe: During the entire study period (Day 0 to Month 12)
Number of subjects reporting any, grade 3 and related unsolicited adverse events (AEs).
Timeframe: Within the 84-day after the first vaccination or from 63-day follow-up period after the second vaccination
Number of subjects reporting any and related serious adverse events (SAEs)
Timeframe: 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)
Timeframe: At Day 0, Day 21, Day 42 and Month 6 (M6)
Interventions:
Biological/vaccine: GSK investigational vaccine GSK2340272A
Enrollment:
245
Observational study model:
Not applicable
Primary completion date:
2010-22-11
Time perspective:
Not applicable
Clinical publications:
Garcia-Sicilia J et al. (2011) Immunogenicity and safety of AS03-adjuvanted H1N1 pandemic vaccines in children and adolescents. Vaccine. 29(26):4353-4361.
Garcia-Sicilia J et al. (2015) Safety and persistence of the humoral and cellular immune responses induced by two doses of an AS03-adjuvanted A(H1N1)pdm09 pandemic influenza vaccine administered to infants, children and adolescents: two open, uncontrolled studies. Hum Vaccin Immunother. 11(10):2359-2369.
Medical condition
Influenza
Product
GSK2340272A
Collaborators
Not applicable
Study date(s)
September 2009 to November 2010
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
3 - 17 years
Accepts healthy volunteers
Yes
- 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.
- 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.
Inclusion and exclusion criteria
Inclusion criteria:
- 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.
Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol.
Exclusion criteria:
- 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.
- 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.
- Known use of an analgesic or antipyretic medication within 12 hours prior to first vaccination.
- Child in Care.
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.
Trial location(s)
Location
GSK Investigational Site
Frankenthal, Rheinland-Pfalz, Germany, 67227
Status
Study Complete
Location
GSK Investigational Site
Kehl, Baden-Wuerttemberg, Germany, 77694
Status
Study Complete
Location
GSK Investigational Site
Schwaebisch-Hall, Baden-Wuerttemberg, Germany, 74523
Status
Study Complete
Location
GSK Investigational Site
Stuttgart, Baden-Wuerttemberg, Germany, 70469
Status
Study Complete
Location
GSK Investigational Site
Worms, Rheinland-Pfalz, Germany, 67547
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2010-22-11
Actual study completion date
2010-22-11
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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