Immunogenicity and Safety Study of GSK Biologicals' GSK2202083A Vaccine in Healthy Infants at 2, 3 and 4 Months of Age

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00970307
First received: August 27, 2009
Last updated: December 8, 2011
Last verified: December 2011
  Purpose

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 three-dose primary vaccination course at 2, 3 and 4 months of age.


Condition Intervention Phase
Poliomyelitis
Hepatitis B
Diphtheria
Haemophilus Influenzae Type b
Pertussis
Pneumococcal Diseases
Serogroup C Meningococcal
Rotavirus
Tetanus
Biological: GSK2202083A vaccine
Biological: 10-valent pneumococcal vaccine (GSK 1024850A)
Biological: Infanrix hexa™
Biological: Menjugate®
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: Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine in Healthy Infants at 2, 3 and 4 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 vaccine in terms of number of seroprotected/seropositive subjects. [ Time Frame: One month after the third vaccine dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Immunogenicity with respect to components of the study vaccine in terms of number of seroprotected/seropositive subjects [ Time Frame: One month after the third vaccine dose ] [ Designated as safety issue: No ]
  • Immunogenicity with respect to components of the study vaccine in terms of antibody concentrations/titres [ Time Frame: Before the first vaccine dose (Day 0) and one month after the third vaccine dose ] [ Designated as safety issue: No ]
  • Occurrence of solicited local/general symptoms [ Time Frame: During the 8-day (day 0-7) follow-up period after each vaccination ] [ Designated as safety issue: No ]
  • Occurrence of unsolicited symptoms [ Time Frame: During the 31-day (Day 0-30) follow-up period after each vaccination ] [ Designated as safety issue: No ]
  • Occurrence of serious adverse events. [ Time Frame: From Dose 1 up to 1 month after Dose 3 ] [ Designated as safety issue: No ]
  • Immunogenicity with respect to components of the study vaccine in terms of vaccine response [ Time Frame: One month after the third vaccine dose ] [ Designated as safety issue: No ]

Enrollment: 421
Study Start Date: August 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A Biological: GSK2202083A vaccine
Intramuscular, three doses
Biological: 10-valent pneumococcal vaccine (GSK 1024850A)
Intramuscular, three doses
Active Comparator: Group B Biological: Infanrix hexa™
Intramuscular, three doses
Biological: Menjugate®
Intramuscular, two doses
Active Comparator: Group C Biological: 10-valent pneumococcal vaccine (GSK 1024850A)
Intramuscular, three doses
Biological: Infanrix hexa™
Intramuscular, three doses

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

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

Inclusion Criteria:

  • 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 Criteria:

  • 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.

  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: NCT00970307

Locations
Poland
GSK Investigational Site
Bydgoszcz, Poland, 85-021
GSK Investigational Site
Debica, Poland, 39-200
GSK Investigational Site
Krakow, Poland, 31-503
GSK Investigational Site
Krakow, Poland
GSK Investigational Site
Siemianowice Slaskie, Poland, 41-103
GSK Investigational Site
Tarnow, Poland, 33-100
GSK Investigational Site
Torun, Poland
GSK Investigational Site
Trzebnica, Poland, 55-100
GSK Investigational Site
Wroclaw, Poland, 50345
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00970307     History of Changes
Other Study ID Numbers: 112157
Study First Received: August 27, 2009
Last Updated: December 8, 2011
Health Authority: Poland: URZ.D REJESTRACJI PRODUKTÓW LECZNICZYCH, WYROBÓW MEDYCZNYCH I PRODUKTÓW BIOBÓJCZYCH,CEBK

Additional relevant MeSH terms:
Hepatitis B
Poliomyelitis
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Hepatitis
Liver Diseases
Digestive System Diseases
Myelitis
Central Nervous System Viral Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Neuromuscular Diseases

ClinicalTrials.gov processed this record on October 02, 2014