Feasibility Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine in Healthy Infants at 3, 5 and 11 Months of Age.
This study has been terminated.
(Study stopped due to non-approval of IEC to proposed change in locations. Study discontinuation not due to safety/efficacy reasons related to the vaccine.)
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00871741
First received: March 26, 2009
Last updated: November 16, 2012
Last verified: November 2012
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Purpose
This study will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083A vaccine given as a three-dose vaccination course at 3, 5 and 11 months of age.
| Condition | Intervention | Phase |
|---|---|---|
|
Haemophilus Influenzae Type b Poliomyelitis Hepatitis B Serogroup C Meningococcal Diseases Diphtheria Pertussis Diphtheria-Tetanus-aPertussis-Hepatitis B-Poliomyelitis-Haemophilus Influenzae Type b-Neisseria Meningitidis Vaccines Tetanus |
Biological: GSK2202083A vaccine Biological: Infanrix hexa Biological: Menjugate |
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: | Feasibility Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine in Healthy Infants at 3, 5 and 11 Months of Age. |
Resource links provided by NLM:
MedlinePlus related topics:
Diphtheria
Flu
Hepatitis
Hepatitis A
Hepatitis B
Meningococcal Infections
Polio and Post-Polio Syndrome
Tetanus
Whooping Cough
U.S. FDA Resources
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- Immunogenicity of study vaccine antigens [ Time Frame: One month after the second vaccine dose ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Immunogenicity of study vaccine antigens [ Time Frame: One month after the second vaccine dose ] [ Designated as safety issue: No ]
- Immunogenicity of study vaccine antigens [ Time Frame: One month after the third vaccine dose ] [ Designated as safety issue: No ]
- Immunogenicity of study vaccine antigens [ Time Frame: Before the third vaccine dose ] [ Designated as safety issue: No ]
- Occurrence of solicited local/general symptoms [ Time Frame: During the 8-day follow-up period after each vaccination ] [ Designated as safety issue: No ]
- Occurrence of unsolicited symptoms [ Time Frame: During the 31-day follow-up period after each vaccination ] [ Designated as safety issue: No ]
- Occurrence of serious adverse events. [ Time Frame: From Dose 1 up to study end ] [ Designated as safety issue: No ]
| Enrollment: | 16 |
| Study Start Date: | April 2009 |
| Study Completion Date: | June 2009 |
| Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Combo Group |
Biological: GSK2202083A vaccine
Intramuscular, three doses
|
| Active Comparator: Control Group |
Biological: Infanrix hexa
Intramuscular, three doses
Biological: Menjugate
Intramuscular, two doses
|
Eligibility| Ages Eligible for Study: | 8 Weeks to 16 Weeks |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- A male or female infant between, and including, 8 and 16 weeks at the time of the first vaccination.
- Born after a gestation period of 36 to 42 weeks inclusive.
- Subjects who the investigator believes that their parents/ guardians can and will comply with the requirements of the protocol.
- Written informed consent obtained from the parent or guardian of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
Exclusion Criteria:
- Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- Administration of a vaccine not foreseen by the study protocol within 30 days prior to randomisation, or planned administration from randomisation to study Visit 3, or from 30 days before to 30 days after study Visit 4, with the exception of influenza and human rotavirus vaccines. The administration of other vaccines, including conjugated pneumococcal vaccine, is allowed during the period from one day after study Visit 3 to 31 days before study Visit 4.
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product
- Evidence of previous or intercurrent diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, Hib and/or MenC vaccination or disease, including HBV vaccination at birth.
- History of seizures or progressive neurological disease.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
- Major congenital defects or serious chronic illness.
The following condition is temporary or self-limiting, and a subject may be vaccinated once the condition has resolved if no other exclusion criteria is met:
• Current febrile illness or axillary temperature >= 38.5 ºC or other moderate to severe illness within 24 hours of study vaccine administration
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00871741
Locations
| Slovakia | |
| GSK Investigational Site | |
| Bratislava, Slovakia, 841 08 | |
| GSK Investigational Site | |
| Bratislava, Slovakia, 851 05 | |
| GSK Investigational Site | |
| Dolny Kubin, Slovakia, 026 01 | |
| GSK Investigational Site | |
| Dunajska Streda, Slovakia, 929 01 | |
| GSK Investigational Site | |
| Nove Zamky, Slovakia, 940 01 | |
Sponsors and Collaborators
GlaxoSmithKline
Investigators
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
No publications provided
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00871741 History of Changes |
| Other Study ID Numbers: | 111761 |
| Study First Received: | March 26, 2009 |
| Last Updated: | November 16, 2012 |
| Health Authority: | Slovakia: State Institute for Drug Control |
Keywords provided by GlaxoSmithKline:
|
Combined vaccine Primary vaccination |
Additional relevant MeSH terms:
|
Diphtheria Haemophilus Infections Hepatitis Hepatitis A Hepatitis B Influenza, Human Meningococcal Infections Whooping Cough Poliomyelitis Tetanus Tetany Corynebacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections |
Pasteurellaceae Infections Gram-Negative Bacterial Infections Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Hepadnaviridae Infections DNA Virus Infections Orthomyxoviridae Infections Respiratory Tract Infections Respiratory Tract Diseases Neisseriaceae Infections |
ClinicalTrials.gov processed this record on May 22, 2013