Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine in Healthy Infants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01090453
First received: March 18, 2010
Last updated: August 29, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Haemophilus Influenzae Type b
Poliomyelitis
Hepatitis B
Serogroup C Meningococcal Diseases
Diphtheria
Pertussis
Pneumococcal Diseases
Tetanus
Biological: GSK2202083A vaccine
Biological: Prevenar 13®
Biological: Infanrix hexa™
Biological: Menjugate®
Biological: Rotarix™
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 2, 4 and 12 Months of Age

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Immunogenicity with respect to components of the study vaccines. [ Time Frame: One month after the second vaccine dose. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Immunogenicity with respect to components of the study vaccines (on secondary readouts). [ Time Frame: One month after the second vaccine dose. ] [ Designated as safety issue: No ]
  • Immunogenicity with respect to components of the study vaccines. [ Time Frame: One month after the third vaccine dose. ] [ Designated as safety issue: No ]
  • Immunogenicity with respect to components of the study vaccines. [ Time Frame: Before the third vaccine dose. ] [ Designated as safety issue: No ]
  • Occurrence of solicited local and general symptoms. [ Time Frame: During the 8-day (Day 0- Day 7) follow-up period after each vaccination. ] [ Designated as safety issue: No ]
  • Occurrence of unsolicited adverse events [ Time Frame: During the 31-day (Day 0- Day 30) 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: 480
Study Start Date: May 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Combo Group
Subjects will receive GSK2202083A vaccine co-administered with Prevenar 13® at 2, 4 and 12 months of age and Rotarix™ at 2 and 4 months of age.
Biological: GSK2202083A vaccine
Intramuscular, three doses
Biological: Prevenar 13®
Intramuscular, three doses
Biological: Rotarix™
Oral, two doses
Active Comparator: Control Group
Subjects will receive Infanrix hexa™ co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age and Rotarix™ at 2 and 4 months of age.
Biological: Prevenar 13®
Intramuscular, three doses
Biological: Infanrix hexa™
Intramuscular, three doses
Biological: Menjugate®
Intramuscular, three doses
Biological: Rotarix™
Oral, two doses

  Eligibility

Ages Eligible for Study:   8 Weeks to 12 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

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 other moderate to severe illness within 24 hours of study vaccine administration.
  • Current gastrointestinal infection.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01090453

Locations
Canada, British Columbia
GSK Investigational Site
Vancouver, British Columbia, Canada, V5Z 4H4
Canada, Manitoba
GSK Investigational Site
Winnipeg, Manitoba, Canada, R3E 3P4
Canada, Ontario
GSK Investigational Site
Hamilton, Ontario, Canada, L8L 5G8
France
GSK Investigational Site
Aix en Provence, France, 13100
GSK Investigational Site
Dax, France, 40100
GSK Investigational Site
Draguignan, France, 83300
GSK Investigational Site
Essey les Nancy, France, 54270
GSK Investigational Site
Floirac, France, 33270
GSK Investigational Site
Le Havre, France, 76600
GSK Investigational Site
Lingolsheim, France, 67380
GSK Investigational Site
Nice, France, 06300
GSK Investigational Site
Trélazé, France, 49800
Germany
GSK Investigational Site
Bad Saulgau, Baden-Wuerttemberg, Germany, 88348
GSK Investigational Site
Kehl, Baden-Wuerttemberg, Germany, 77694
GSK Investigational Site
Schwaebisch-Hall, Baden-Wuerttemberg, Germany, 74523
GSK Investigational Site
Stuttgart, Baden-Wuerttemberg, Germany, 70469
GSK Investigational Site
Tuttlingen, Baden-Wuerttemberg, Germany, 78532
GSK Investigational Site
Berchtesgaden, Bayern, Germany, 83471
GSK Investigational Site
Bindlach, Bayern, Germany, 95463
GSK Investigational Site
Muenchen, Bayern, Germany, 81735
GSK Investigational Site
Noerdlingen, Bayern, Germany, 86720
GSK Investigational Site
Eschwege, Hessen, Germany, 37269
GSK Investigational Site
Wolfenbuettel, Niedersachsen, Germany, 38302
GSK Investigational Site
Detmold, Nordrhein-Westfalen, Germany, 32756
GSK Investigational Site
Heiligenhaus, Nordrhein-Westfalen, Germany, 42579
GSK Investigational Site
Kleve-Materborn, Nordrhein-Westfalen, Germany, 47533
GSK Investigational Site
Loehne, Nordrhein-Westfalen, Germany, 32584
GSK Investigational Site
Porta Westfalica, Nordrhein-Westfalen, Germany, 32457
GSK Investigational Site
Solingen, Nordrhein-Westfalen, Germany, 42719
GSK Investigational Site
Willich, Nordrhein-Westfalen, Germany, 47877
GSK Investigational Site
Frankenthal, Rheinland-Pfalz, Germany, 67227
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55131
GSK Investigational Site
Trier, Rheinland-Pfalz, Germany, 54290
GSK Investigational Site
Worms, Rheinland-Pfalz, Germany, 67547
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01090453     History of Changes
Other Study ID Numbers: 113615
Study First Received: March 18, 2010
Last Updated: August 29, 2013
Health Authority: Canada: Biologics and Genetic Therapies Directorate (BGTD)
France: Agence Française de Sécurité Sanitaire des Produits de Santé
Germany: Paul-Ehrlich-Institut

Additional relevant MeSH terms:
Diphtheria
Hepatitis
Hepatitis A
Hepatitis B
Influenza, Human
Meningococcal Infections
Whooping Cough
Poliomyelitis
Tetanus
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
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
Gram-Negative Bacterial Infections
Bordetella Infections
Infection
Myelitis

ClinicalTrials.gov processed this record on July 24, 2014