Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine Administered as a Booster Dose

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01171989
First received: July 27, 2010
Last updated: December 1, 2011
Last verified: December 2011
  Purpose

The current trial will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083A vaccine when administered as a booster dose following priming in the first year of life with the same vaccine.

This protocol posting deals with objectives & outcome measures of the booster phase. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00970307).


Condition Intervention Phase
Poliomyelitis
Haemophilus Influenzae Type b Disease
Hepatitis B
Serogroup C Meningococcal Diseases
Diphtheria
Pertussis
Tetanus
Biological: GSK2202083A vaccine
Biological: Infanrix hexa™
Biological: Menjugate™
Biological: NeisVac-C™
Biological: Synflorix™
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-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 Administered as a Booster Dose in 12-18 Months Old Healthy Children

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 antibody concentrations/titres [ Time Frame: One month after the booster dose (Month1) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Immunogenicity with respect to components of the study vaccine in terms of antibody concentrations/titres [ Time Frame: One month after the booster dose (Month 1) ] [ Designated as safety issue: No ]
  • Persistence of antibodies to the study vaccine antigens [ Time Frame: Before the booster dose (day 0) ] [ Designated as safety issue: No ]
  • Solicited local and general symptoms [ Time Frame: During the 8-day (Day 0-7) follow-up period following the booster dose ] [ Designated as safety issue: No ]
  • Unsolicited adverse events [ Time Frame: During the 31-day (Day 0-30) follow-up period following the booster dose ] [ Designated as safety issue: No ]
  • Serious adverse events [ Time Frame: After the booster dose of the study vaccine up to the study end (Month 1) ] [ Designated as safety issue: No ]

Enrollment: 391
Study Start Date: August 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Subjects will receive GSK2202083A vaccine at Visit 1 and Synflorix™ at Visit 2.
Biological: GSK2202083A vaccine
Intramuscular, one dose.
Biological: Synflorix™
Intramuscular, one dose.
Active Comparator: Group B
Subjects will receive Infanrix hexa™ co-administered with Menjugate™ at Visit 1.
Biological: Infanrix hexa™
Intramuscular, one dose.
Biological: Menjugate™
Intramuscular, one dose.
Active Comparator: Group C
Subjects will receive Infanrix hexa™ co-administered with NeisVac-C™ at Visit 1 and Synflorix™ at Visit 2.
Biological: Infanrix hexa™
Intramuscular, one dose.
Biological: NeisVac-C™
Intramuscular, one dose.
Biological: Synflorix™
Intramuscular, one dose.

  Eligibility

Ages Eligible for Study:   12 Months to 18 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who the investigator believes that parent(s)/ legally acceptable representative(s) can and will comply with the requirements of the protocol.
  • Subjects who have completed the full three-dose primary vaccination course according to their group allocation in the primary study DTPa-HBV-IPV=Hib-MenC-TT-002 (112157).
  • A male or female between, and including, 12 and 18 months of age at the time of booster vaccination.
  • 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:

  • Child in care.
  • Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the dose of study vaccine, or planned use during the study period.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the booster vaccination.
  • Planned administration/administration of immunoglobulins and/or any blood products within three months before the booster dose, or during the study period.
  • Planned administration/administration of any vaccine not foreseen by the study protocol during the period starting 30 days before and ending 30 days after the booster dose.
  • Participation in another clinical study since the primary study DTPa-HBV-IPV/Hib-MenC-TT-002 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 and MenC vaccination or disease since the conclusion visit of study DTPa-HBV-IPV/Hib-MenC-TT-002.
  • 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.
  • The following adverse event having occurred after previous administration of DTP vaccine:

    • Encephalopathy.
    • Temperature of >= 40.5°C (rectal temperature) within 48 hours of vaccination, not due to another identifiable cause.
    • Collapse or shock-like state within 48 hours of vaccination.
    • Persistent, inconsolable crying occurring within 48 hours of vaccination and lasting >= 3 hours.
    • Seizures with or without fever occurring within 3 days of vaccination.

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:

• Acute disease and/or fever at the time of enrolment.

  • Fever is defined as temperature ≥ 37.5°C on oral, axillary or tympanic setting, or ≥ 38.0°C on rectal setting.
  • Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
  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: NCT01171989

Locations
Poland
GSK Investigational Site
Bydgoszcz, Poland, 85-021
GSK Investigational Site
Debica, Poland, 39-200
GSK Investigational Site
Krakow, Poland, 31-422
GSK Investigational Site
Krakow, Poland, 31-503
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: NCT01171989     History of Changes
Other Study ID Numbers: 113978
Study First Received: July 27, 2010
Last Updated: December 1, 2011
Health Authority: Poland: Ministry of Health

Keywords provided by GlaxoSmithKline:
booster vaccination
combined vaccine

Additional relevant MeSH terms:
Hepatitis B
Poliomyelitis
Meningococcal Infections
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
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on October 16, 2014