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

March 18, 2010
August 29, 2013
May 2010
October 2011   (final data collection date for primary outcome measure)
Immunogenicity with respect to components of the study vaccines. [ Time Frame: One month after the second vaccine dose. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01090453 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Haemophilus Influenzae Type b
  • Poliomyelitis
  • Hepatitis B
  • Serogroup C Meningococcal Diseases
  • Diphtheria
  • Pertussis
  • Pneumococcal Diseases
  • Tetanus
  • Biological: GSK2202083A vaccine
    Intramuscular, three doses
  • Biological: Prevenar 13®
    Intramuscular, three doses
  • Biological: Infanrix hexa™
    Intramuscular, three doses
  • Biological: Menjugate®
    Intramuscular, three doses
  • Biological: Rotarix™
    Oral, two doses
  • 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.
    Interventions:
    • Biological: GSK2202083A vaccine
    • Biological: Prevenar 13®
    • Biological: Rotarix™
  • 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.
    Interventions:
    • Biological: Prevenar 13®
    • Biological: Infanrix hexa™
    • Biological: Menjugate®
    • Biological: Rotarix™
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
480
October 2011
October 2011   (final data collection date for primary outcome measure)

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.
Both
8 Weeks to 12 Weeks
Yes
Contact information is only displayed when the study is recruiting subjects
Canada,   France,   Germany
 
NCT01090453
113615
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP