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

August 27, 2009
December 8, 2011
August 2009
January 2010   (final data collection date for primary outcome measure)
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 of study vaccine antigens [ Time Frame: One month after the third vaccine dose ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00970307 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Immunogenicity of study vaccine antigens (on secondary readouts) [ Time Frame: One month after the third vaccine dose ] [ Designated as safety issue: No ]
  • Immunogenicity of study vaccine antigens [ Time Frame: Before the first 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 ]
Not Provided
Not Provided
 
Immunogenicity and Safety Study of GSK Biologicals' GSK2202083A Vaccine in Healthy Infants at 2, 3 and 4 Months of Age
Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine in Healthy Infants at 2, 3 and 4 Months of Age

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Poliomyelitis
  • Hepatitis B
  • Diphtheria
  • Haemophilus Influenzae Type b
  • Pertussis
  • Pneumococcal Diseases
  • Serogroup C Meningococcal
  • Rotavirus
  • Tetanus
  • Biological: GSK2202083A vaccine
    Intramuscular, three doses
  • Biological: 10-valent pneumococcal vaccine (GSK 1024850A)
    Intramuscular, three doses
  • Biological: Infanrix hexa™
    Intramuscular, three doses
  • Biological: Menjugate®
    Intramuscular, two doses
  • Experimental: Group A
    Interventions:
    • Biological: GSK2202083A vaccine
    • Biological: 10-valent pneumococcal vaccine (GSK 1024850A)
  • Active Comparator: Group B
    Interventions:
    • Biological: Infanrix hexa™
    • Biological: Menjugate®
  • Active Comparator: Group C
    Interventions:
    • Biological: 10-valent pneumococcal vaccine (GSK 1024850A)
    • Biological: Infanrix hexa™
Szenborn L, Czajka H, Brzostek J, Konior R, Caubet M, Ulianov L, Leyssen M. A randomized, controlled trial to assess the immunogenicity and safety of a heptavalent diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, hib and meningococcal serogroup C combination vaccine administered at 2, 3, 4 and 12-18 months of age. Pediatr Infect Dis J. 2013 Jul;32(7):777-85. doi: 10.1097/INF.0b013e31828d6b20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
421
January 2010
January 2010   (final data collection date for primary outcome measure)

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.

Both
8 Weeks to 12 Weeks
Yes
Contact information is only displayed when the study is recruiting subjects
Poland
 
NCT00970307
112157
Not Provided
Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
December 2011

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