Status:
COMPLETED
Immunogenicity and Safety Study of GSK Biologicals' GSK2202083A Vaccine in Healthy Infants at 2, 3 and 4 Months of Age
Lead Sponsor:
GlaxoSmithKline
Conditions:
Tetanus
Diphtheria
Eligibility:
All Genders
8-12 years
Phase:
PHASE2
Brief Summary
This study will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083A vaccine co-administered with GSK Biologicals' 10-valent pneumococcal conjugate (GSK1024850A) vaccine given as a t...
Detailed Description
In accordance with the local recommended immunisation schedule, all subjects will receive 2 doses of GSK Biologicals' Human Rotavirus Vaccine (Rotarix) at 2 and 3 months of age.
Eligibility Criteria
Inclusion
- A male or female infant between, and including, 8 and 12 weeks of age at the time of the first vaccination.
- Born after a gestation period of 36 to 42 weeks inclusive.
- Subjects should have received one dose of hepatitis B vaccination at birth as per local recommendations.
- Subjects who the investigator believes that their parent(s)/LAR can and will comply with the requirements of the protocol.
- Written informed consent obtained from the parent/LAR of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
Exclusion
- Use of any investigational or non-registered product other than the study vaccines 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 any vaccine since birth, with exception of HBV and Bacillus Calmette-Guérin, or planned administration during the study period.
- 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, polio, Hib, pneumococcal and/or MenC disease.
- History of seizures or progressive neurological disease.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
- 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.
Key Trial Info
Start Date :
August 13 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 27 2010
Estimated Enrollment :
421 Patients enrolled
Trial Details
Trial ID
NCT00970307
Start Date
August 13 2009
End Date
January 27 2010
Last Update
January 3 2020
Active Locations (9)
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1
GSK Investigational Site
Bydgoszcz, Poland, 85-021
2
GSK Investigational Site
Dębica, Poland, 39-200
3
GSK Investigational Site
Krakow, Poland, 31-503
4
GSK Investigational Site
Krakow, Poland