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Feasibility Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine in Healthy Infants at 3, 5 and 11 Months of Age. | Clinical Trials | Clareo Health

TERMINATEDPHASE2

Feasibility Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine in Healthy Infants at 3, 5 and 11 Months of Age.

NCT00871741•GlaxoSmithKline

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

0 - 0 years

Sex

ALL

Healthy Volunteers

Yes

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.
+1 more criteria

Locations (8)

GSK Investigational Site

Bratislava, Slovakia

GSK Investigational Site

Bratislava, Slovakia

GSK Investigational Site

Dolný Kubín, Slovakia

GSK Investigational Site

Dunajská Streda, Slovakia

GSK Investigational Site

Nové Zámky, Slovakia

GSK Investigational Site

Ružomberok, Slovakia

GSK Investigational Site

Štúrovo, Slovakia

GSK Investigational Site

Trnava, Slovakia

Key Dates

Start Date

April 1, 2009

Primary Completion Date

June 25, 2009

Completion Date

June 25, 2009

Last Updated

June 6, 2018

Enrollment

ACTUAL participants

Conditions

TetanusPoliomyelitisNeisseria MeningitidisHaemophilus Influenzae Type bDiphtheriaAcellular PertussisHepatitis B

Interventions

GSK2202083A vaccine

BIOLOGICAL

Infanrix hexa

BIOLOGICAL

Menjugate

BIOLOGICAL

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 6, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Feasibility Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine in Healthy Infants at 3, 5 and 11 Months of Age.

Inclusion Criteria

Exclusion Criteria

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