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Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine in Healthy Infants | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine in Healthy Infants

Feasibility Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine in Healthy Infants at 2, 4 and 12 Months of Age

NCT01090453•GlaxoSmithKline

Summary

This study will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083 vaccine co-administered with Prevenar 13® at 2, 4 and 12 months of age and with Rotarix™ at 2 and 4 months of age.

Eligibility

Age

0 - 0 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol.
•A male or female infant between, and including, 8 and 12 weeks at the time of the first vaccination.
•Born after a gestation period of 36 to 42 weeks inclusive.
•Written informed consent obtained from the parent(s), Legally Acceptable Representative(s) 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.
•Child in care.
•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 the end of the study with the exception of inactivated influenza vaccines. The administration of diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, Haemophilus influenzae type b, pneumococcal, rotavirus and/or MenC vaccines is not allowed at any time during the study period but other vaccines are 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 diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, Hib, pneumococcal, rotavirus and/or MenC vaccination or disease, including Hepatitis B virus vaccination at birth.
•History of seizures or progressive neurological disease.
•Subjects with history of intussusception or uncorrected congenital malformation of the gastrointestinal tract that would predispose for intussusception.
•Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
+4 more criteria

Locations (34)

GSK Investigational Site

Vancouver, British Columbia, Canada

GSK Investigational Site

Winnipeg, Manitoba, Canada

GSK Investigational Site

Hamilton, Ontario, Canada

GSK Investigational Site

Aix-en-Provence, France

GSK Investigational Site

Dax, France

GSK Investigational Site

Draguignan, France

GSK Investigational Site

Essey-lès-Nancy, France

GSK Investigational Site

Floirac, France

GSK Investigational Site

Le Havre, France

GSK Investigational Site

Lingolsheim, France

Key Dates

Start Date

May 17, 2010

Primary Completion Date

October 11, 2011

Completion Date

October 11, 2011

Last Updated

August 20, 2018

Enrollment

480

ACTUAL participants

Conditions

TetanusHepatitis BHaemophilus Influenzae Type bPoliomyelitisAcellular PertussisDiphtheriaNeisseria Meningitidis

Interventions

GSK2202083A vaccine

BIOLOGICAL

Prevenar 13®

BIOLOGICAL

Infanrix hexa™

BIOLOGICAL

Menjugate®

BIOLOGICAL

Rotarix™

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: August 20, 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.

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Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine in Healthy Infants

Inclusion Criteria

Exclusion Criteria

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