Safety, Immunogenicity Study of GSK Biologicals' Pandemic Influenza Candidate Vaccine (H1N1) (GSK2340272A)
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00971321
First received: August 27, 2009
Last updated: June 30, 2011
Last verified: June 2011
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Influenza A Virus, H1N1 Subtype Influenza Infection |
Biological: Pandemic influenza vaccine GSK2340272A |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Safety and Immunogenicity Study of GSK Biologicals' Pandemic Influenza Candidate Vaccine (GSK2340272A) in Children Aged 6 to 35 Months |
Resource links provided by NLM:
MedlinePlus related topics:
Flu
Drug Information available for:
Influenza Vaccines
U.S. FDA Resources
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- Humoral immune response in terms of H1N1 haemagglutination inhibition (HI) antibodies [ Time Frame: At Day 0 ] [ Designated as safety issue: No ]
- Humoral immune response in terms of H1N1 haemagglutination inhibition (HI) antibodies [ Time Frame: At Day 42 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Humoral immune response in terms of HI antibodies [ Time Frame: Day 0, 21, 42, and at Month 11-12 ] [ Designated as safety issue: No ]
- Humoral immune response in terms of neutralizing antibodies (in all subjects aged 6 to 11 months and a subset of subjects randomly selected using GSK SBIR) [ Time Frame: Day 0, 21, 42, Month 6, and at Month 11-12 ] [ Designated as safety issue: No ]
- Occurrence of local and general symptoms [ Time Frame: During a 7-day (day 0-6) follow-up period after each vaccination ] [ Designated as safety issue: No ]
- Occurrence of unsolicited symptoms [ Time Frame: During a 21-day (day 0-20) follow-up period after the first vaccination, and during a 62-day follow-up period after the second vaccination ] [ Designated as safety issue: No ]
- Occurrence of adverse events of specific interest / potential immune-mediated disorders, of serious adverse events, and of medically attended events [ Time Frame: From the beginning up to the study end (day 0 - month 12) ] [ Designated as safety issue: No ]
- Safety evaluation in terms of biochemical parameters [ Time Frame: Day 0, 21 and 42 ] [ Designated as safety issue: No ]
| Enrollment: | 157 |
| Study Start Date: | September 2009 |
| Study Completion Date: | November 2010 |
| Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group A
Subjects in this group will receive investigational vaccine regimen according to a protocol specified schedule different from Group B
|
Biological: Pandemic influenza vaccine GSK2340272A
Two primary intramuscular (IM) injections
|
|
Experimental: Group B
Subjects in this group will receive investigational vaccine regimen according to a protocol specified schedule different from Group A
|
Biological: Pandemic influenza vaccine GSK2340272A
Two primary intramuscular (IM) injections
|
Eligibility| Ages Eligible for Study: | 6 Months to 35 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00971321
Locations
| Spain | |
| GSK Investigational Site | |
| Bilbao, Spain, 48013 | |
| GSK Investigational Site | |
| Burgos, Spain, 09005 | |
| GSK Investigational Site | |
| Madrid, Spain, 28046 | |
| GSK Investigational Site | |
| Móstoles/Madrid, Spain, 28935 | |
| GSK Investigational Site | |
| Sevilla, Spain, 41013 | |
Sponsors and Collaborators
GlaxoSmithKline
Investigators
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure |
| ClinicalTrials.gov Identifier: | NCT00971321 History of Changes |
| Other Study ID Numbers: | 113462 |
| Study First Received: | August 27, 2009 |
| Last Updated: | June 30, 2011 |
| Health Authority: | Spain: Agencia Española del Medicamento y Productos Sanitarios |
Keywords provided by GlaxoSmithKline:
|
influenza infection GSK Bio's influenza vaccine GSK2340272A |
Additional relevant MeSH terms:
|
Influenza, Human Orthomyxoviridae Infections RNA Virus Infections |
Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 16, 2013