Phase 2
N=157
Safety, Immunogenicity Study of GSK Biologicals' Pandemic Influenza Candidate Vaccine (H1N1) (GSK2340272A)
Influenza
Bottom Line
View on ClinicalTrials.gov: NCT00971321 ↗Enrolled (actual)
157
Serious AEs
5.1%
Results posted
Feb 2019
Primary outcome: Primary: Number of Seropositive Subjects for H1N1 Haemagglutination Inhibition (HI) Antibodies — 5; 6 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Pandemic influenza vaccine GSK2340272A (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Nov 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Seropositive Subjects for H1N1 Haemagglutination Inhibition (HI) Antibodies |
4; 4; 83; 37; 83; 37 | — |
| PRIMARY Number of Seropositive Subjects for H1N1 Haemagglutination Inhibition (HI) Antibodies |
4; 4; 83; 37; 83; 37 | — |
| PRIMARY Titers for H1N1 Haemagglutination Inhibition (HI) Antibodies |
5.8; 6.2; 234.0; 255.5; 1758.0; 1879.2 | — |
| PRIMARY Titers for H1N1 Haemagglutination Inhibition (HI) Antibodies |
5.8; 6.2; 234.0; 255.5; 1758.0; 1879.2 | — |
| PRIMARY Number of Seroconverted Subjects in Terms of H1N1 Haemagglutination Inhibition (HI) Antibodies |
97; 48 | — |
| PRIMARY Number of Seroprotected Subjects for H1N1 Haemagglutination Inhibition (HI) Antibodies |
3; 3; 83; 37; 83; 37 | — |
| PRIMARY Seroconversion Factor (SCF) for H1N1 Haemagglutination Inhibition (HI) Antibody Titers |
40.3; 41.2; 302.5; 302.8; 36.6; 38.6 | — |
| SECONDARY Number of Seropositive Subjects for H1N1 Haemagglutination Inhibition (HI) Antibodies |
4; 4; 83; 37; 83; 37 | — |
| SECONDARY Titers for H1N1 Haemagglutination Inhibition (HI) Antibodies |
5.8; 6.2; 234.0; 255.5; 1758.0; 1879.2 | — |
| SECONDARY Number of Seroconverted Subjects in Terms of H1N1 Haemagglutination Inhibition (HI) Antibody Titers |
82; 37; 83; 37; 81; 36 | — |
| SECONDARY Number of Seroprotected Subjects for H1N1 Haemagglutination Inhibition (HI) Antibodies |
3; 3; 83; 37; 83; 37 | — |
| SECONDARY Seroconversion Factor (SCF) for H1N1 Haemagglutination Inhibition (HI) Antibody Titers |
40.3; 41.2; 302.5; 302.8; 36.6; 38.6 | — |
| SECONDARY Titers for Serum Neutralising Antibodies |
5.6; 5.7; 36.9; 50.8; 1416.1; 1960.6 | — |
| SECONDARY Titers for Serum Neutralising Antibodies |
5.6; 5.7; 36.9; 50.8; 1416.1; 1960.6 | — |
| SECONDARY Number of Subjects With Vaccine Response for Serum Neutralising Antibodies |
14; 8; 24; 12; 19; 10 | — |
| SECONDARY Number of Subjects With Vaccine Response for Serum Neutralising Antibodies |
14; 8; 24; 12; 19; 10 | — |
| SECONDARY Number of Subjects With Any and Grade 3 Solicited Local Symptoms |
37; 31; 1; 0; 19; 17 | — |
| SECONDARY Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms |
24; 14; 0; 2; 17; 11 | — |
| SECONDARY Number of Subjects With Any Medically-attended Events (MAEs) |
92; 40; 94; 45 | — |
| SECONDARY Number of Subjects With Any Adverse Events of Specific Interest (AESIs)/ Potential Immune-mediated Disease (pIMDs) |
0; 0 | — |
| SECONDARY Number of Subjects With Normal/Abnormal Biochemical Levels |
3; 4; 0; 0; 101; 49 | — |
| SECONDARY Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) |
98; 47; 18; 8; 12; 8 | — |
| SECONDARY Number of Subjects With Serious Adverse Events (SAEs) |
2; 6 | — |
Summary
This trial is designed to assess the safety and immunogenicity of a prime-boost schedule of GSK Biologicals' investigational vaccine GSK2340272A in children aged between 6 and 35 months.
This protocol posting has been updated following protocol amendment 4, March 2010. The protocol posting sections impacted are number of subjects, primary and secondary endpoints and intervention.
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 6 and 35 months 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.
- 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.
- 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
- 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 condition which, in the opinion of the investigator, renders the subject unfit for participation in the study.
- Child in Care.
Data sourced from ClinicalTrials.gov (NCT00971321). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.