Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine in Healthy Infants

NCT ID: NCT01090453

Last Updated: 2018-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 480 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-17
• Study Completion Date: 2011-10-11

Brief 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.

Conditions

Tetanus; Hepatitis B; Haemophilus Influenzae Type b; Poliomyelitis; Acellular Pertussis; Diphtheria; Neisseria Meningitidis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

GSK2202083A Group

Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.

Group Type: EXPERIMENTAL

GSK2202083A vaccine

Intervention Type: BIOLOGICAL

3 doses given at 2, 4 and 12 months of age

Prevenar 13®

Intervention Type: BIOLOGICAL

3 co-administered doses

Rotarix™

Intervention Type: BIOLOGICAL

Oral, two doses

Infanrix hexa Group

Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.

Group Type: ACTIVE_COMPARATOR

Prevenar 13®

Intervention Type: BIOLOGICAL

3 co-administered doses

Infanrix hexa™

Intervention Type: BIOLOGICAL

3 doses given at 2, 4 and 12 months of age

Menjugate®

Intervention Type: BIOLOGICAL

3 co-administered doses

Rotarix™

Intervention Type: BIOLOGICAL

Oral, two doses

Interventions

GSK2202083A vaccine

3 doses given at 2, 4 and 12 months of age

Intervention Type: BIOLOGICAL

Prevenar 13®

3 co-administered doses

Intervention Type: BIOLOGICAL

Infanrix hexa™

3 doses given at 2, 4 and 12 months of age

Intervention Type: BIOLOGICAL

Menjugate®

3 co-administered doses

Intervention Type: BIOLOGICAL

Rotarix™

Oral, two doses

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
• Major congenital defects or serious chronic illness.

• Current febrile illness or other moderate to severe illness within 24 hours of study vaccine administration.
• Current gastrointestinal infection.

• Minimum Eligible Age: 8 Weeks
• Maximum Eligible Age: 12 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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

GSK Investigational Site

Nice, , France

GSK Investigational Site

Trélazé, , France

GSK Investigational Site

Bad Saulgau, Baden-Wurttemberg, Germany

GSK Investigational Site

Kehl, Baden-Wurttemberg, Germany

GSK Investigational Site

Schwäbisch Hall, Baden-Wurttemberg, Germany

GSK Investigational Site

Stuttgart, Baden-Wurttemberg, Germany

GSK Investigational Site

Tuttlingen, Baden-Wurttemberg, Germany

GSK Investigational Site

Berchtesgaden, Bavaria, Germany

GSK Investigational Site

Bindlach, Bavaria, Germany

GSK Investigational Site

Munich, Bavaria, Germany

GSK Investigational Site

Nördlingen, Bavaria, Germany

GSK Investigational Site

Eschwege, Hesse, Germany

GSK Investigational Site

Wolfenbüttel, Lower Saxony, Germany

GSK Investigational Site

Detmold, North Rhine-Westphalia, Germany

GSK Investigational Site

Heiligenhaus, North Rhine-Westphalia, Germany

GSK Investigational Site

Kleve-Materborn, North Rhine-Westphalia, Germany

GSK Investigational Site

Löhne, North Rhine-Westphalia, Germany

GSK Investigational Site

Porta Westfalica, North Rhine-Westphalia, Germany

GSK Investigational Site

Solingen, North Rhine-Westphalia, Germany

GSK Investigational Site

Willich, North Rhine-Westphalia, Germany

GSK Investigational Site

Frankenthal, Rhineland-Palatinate, Germany

GSK Investigational Site

Mainz, Rhineland-Palatinate, Germany

GSK Investigational Site

Trier, Rhineland-Palatinate, Germany

GSK Investigational Site

Worms, Rhineland-Palatinate, Germany

Countries

Canada; France; Germany

Study Documents

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

113615

Identifier Type: -

Identifier Source: org_study_id