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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 (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00970307
First received: August 27, 2009
Last updated: March 3, 2017
Last verified: March 2017
  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
Tetanus
Diphtheria
Haemophilus Influenzae Type b
Poliomyelitis
Acellular Pertussis
Hepatitis B
Biological: GSK2202083A vaccine
Biological: 10-valent pneumococcal vaccine (GSK 1024850A)
Biological: Infanrix hexa™
Biological: Menjugate®
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
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:
  • Number of Seroprotected Subjects Against Polyribosyl-Ribitol-Phosphate (PRP) [ Time Frame: At Month 3 ]
    A seroprotected subject was defined as a subject with anti-PRP antibody concentrations greater than or equal to (≥) 0.15 micrograms per milliliter (µg/mL).

  • Number of Seroprotected Subjects Against Neisseria Meningitidis Serogroup C Using Baby Rabbit Complement (rSBA-MenC) [ Time Frame: At Month 3 ]
    A seroprotected subject was defined as a subject with rSBA-MenC titers greater than or equal to (≥) 1:8.


Secondary Outcome Measures:
  • Anti-PRP Antibody Concentrations [ Time Frame: At Months 0 and 3 ]
    Concentrations were expressed as geometric mean concentrations (GMCs) for the seroprotection cut-off value of ≥ 0.15 µg/mL.

  • Antibody Titers Against rSBA-MenC [ Time Frame: At Months 0 and 3 ]
    The seroprotection cut-off value was of ≥ 1:8.

  • Number of Seropositive Subjects for Anti-polysaccharide Neisseria Meningitidis Serogroup C (Anti-PSC) [ Time Frame: At Month 3 ]
    A seropositive subject was defined as a subject with anti-PSC antibody concentrations ≥ 0.3 µg/mL.

  • Anti-PSC Antibody Concentrations [ Time Frame: At Months 0 and 3 ]
    Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off value of ≥ 0.3 µg/mL.

  • Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) [ Time Frame: At Month 3 ]
    A seroprotected subject was defined as a subject with anti-D or anti-T antibody concentrations ≥ 0.1 IU/mL.

  • Anti-D and Anti-T Antibody Concentrations [ Time Frame: At Month 3 ]
    Concentrations were expressed as geometric mean concentrations (GMCs) for the seroprotection cut-off value of ≥ 0.1 international units per milliliter (IU/mL).

  • Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) [ Time Frame: At Month 3 ]
    A seropositive subject was defined as a subject with anti-PT, anti-FHA or anti-PRN concentrations ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).

  • Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations [ Time Frame: At Months 0 and 3 ]
    Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off value of ≥ 5 EL.U/mL.

  • Number of Subjects With a Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN [ Time Frame: At Month 3 ]
    A subject with a vaccine response was defined as either an initially seronegative subject with anti-PT, anti-FHA or anti-PRN concentrations ≥ 5 EL.U/mL or an initially seropositive subjects with antibody concentrations one month after the primary vaccination ≥ 1 fold the-pre vaccination antibody concentration.

  • Number of Seroprotected and Seropositive Subjects for Anti-hepatitis B Surface Antigen (Anti-HBs) [ Time Frame: At Month 3 ]
    A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL. A seropositive subject was defined as a subjects with anti-HBs antibody concentrations ≥ 3.3 mIU/mL. A decrease in the specificity of the anti-HB ELISA had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis.

  • Anti-HBs Antibody Concentrations [ Time Frame: At Month 3 ]
    Antibody concentrations were expressed as GMCs. The seroprotection cut-off used was of ≥ 10 mIU/mL. A decrease in the specificity of the anti-HB ELISA had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the CLIA approved by the FDA. The table shows updated results following partial or complete retesting/reanalysis.

  • Number of Seroprotected Subjects for Anti-poliovirus (Anti-polio) Types 1, 2 and 3 [ Time Frame: At Month 3 ]
    A seroprotected subject was defined as a subject with anti-polio type 1, 2 or 3 ≥ 1:8.

  • Anti-polio Types 1, 2 and 3 Antibody Titers [ Time Frame: At Month 3 ]
    Titers were expressed as geometric mean titers (GMTs) for the seroprotection cut-off value of ≥ 1:8.

  • Number of Seropositive Subjects for Anti-pneumococcal (Anti-pneumo) Serotypes [ Time Frame: At Month 3 ]
    A seropositive subject was defined as a subject with anti-pneumo concentrations ≥ 0.05 µg/mL. The anti-pneumo serotypes assessed were: 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.

  • Anti-pneumo Antibody Concentrations [ Time Frame: At Month 3 ]
    Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off value of ≥ 0.05 µg/mL.

  • Number of Seropositive Subjects for Anti-protein D (Anti-PD) [ Time Frame: At Month 3 ]
    A seropositive subject was defined as a subject with anti-PD concentrations ≥ 100 EL.U/mL.

  • Anti-PD Antibody Concentrations [ Time Frame: At Month 3 ]
    Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off value of ≥ 100 EL.U/mL.

  • Number of Subjects With Any Solicited Local Symptoms [ Time Frame: During the 8-day (Days 0 to 7) post-vaccination period after any vaccination ]
    Assessed solicited local symptoms were pain, redness and swelling. Any = incidence of a local symptom irrespective of intensity grade.

  • Number of Subjects With Any Solicited General Symptoms [ Time Frame: During the 8-day (Days 0 to 7) post-vaccination period after any vaccination ]
    Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever (defined as axillary temperature ≥ 37.5°C). Any= incidence of a general symptom irrespective of intensity grade and relationship to vaccination.

  • Number of Subjects With Unsolicited Adverse Events (AEs) [ Time Frame: During the 31-day (Days 0 to 30) post-vaccination period after any vaccination ]
    An unsolicited AE was any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.

  • Number of Subjects With Serious Adverse Events (SAEs) [ Time Frame: During the entire study period (from Month 0 to Month 3) ]
    SAEs were defined as medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.


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: GSK2202083A + SYNFLORIX GROUP
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
Biological: GSK2202083A vaccine
Intramuscular, three doses
Biological: 10-valent pneumococcal vaccine (GSK 1024850A)
Intramuscular, three doses
Active Comparator: INFANRIX HEXA + MENJUGATE GROUP
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
Biological: Infanrix hexa™
Intramuscular, three doses
Biological: Menjugate®
Intramuscular, two doses
Active Comparator: INFANRIX HEXA + SYNFLORIX GROUP
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
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   (Child)
Sexes Eligible for Study:   All
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

Additional Information:
Publications:
Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 112157
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: 112157
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 112157
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 112157
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 112157
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 112157
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 112157
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00970307     History of Changes
Other Study ID Numbers: 112157
Study First Received: August 27, 2009
Results First Received: March 3, 2017
Last Updated: March 3, 2017
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Additional relevant MeSH terms:
Hepatitis B
Poliomyelitis
Diphtheria
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Hepatitis
Liver Diseases
Digestive System Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Myelitis
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Neuromuscular Diseases
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 24, 2017