- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00970307
Immunogenicity and Safety Study of GSK Biologicals' GSK2202083A Vaccine in Healthy Infants at 2, 3 and 4 Months of Age
December 31, 2019 updated by: GlaxoSmithKline
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
421
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Bydgoszcz, Poland, 85-021
- GSK Investigational Site
-
Debica, Poland, 39-200
- GSK Investigational Site
-
Krakow, Poland
- 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
- GSK Investigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 month to 2 months (CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
Intramuscular, three doses
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.
|
Intramuscular, three doses
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.
|
Intramuscular, three doses
Intramuscular, three doses
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
At Month 3
|
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.
|
At Month 3
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
At Months 0 and 3
|
Antibody Titers Against rSBA-MenC
Time Frame: At Months 0 and 3
|
The seroprotection cut-off value of the assay was an antibody titer ≥ 1:8.
|
At Months 0 and 3
|
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 concentration ≥ 0.3 µg/mL.
|
At Month 3
|
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.
|
At Months 0 and 3
|
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 international units per milliliter (IU/mL).
|
At Month 3
|
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 IU/mL.
|
At Month 3
|
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).
|
At Month 3
|
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.
|
At Months 0 and 3
|
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.
|
At Month 3
|
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.
|
At Month 3
|
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.
|
At Month 3
|
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 antibody titers ≥ 1:8.
|
At Month 3
|
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.
|
At Month 3
|
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.
|
At Month 3
|
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.
|
At Month 3
|
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.
|
At Month 3
|
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.
|
At Month 3
|
Number of Subjects With Any Solicited Local Symptoms
Time Frame: During the 8-day (Days 0-7) 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.
|
During the 8-day (Days 0-7) post-vaccination period after any vaccination
|
Number of Subjects With Any Solicited General Symptoms
Time Frame: During the 8-day (Days 0-7) 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.
|
During the 8-day (Days 0-7) post-vaccination period after any vaccination
|
Number of Subjects With Unsolicited Adverse Events (AEs)
Time Frame: During the 31-day (Days 0-30) 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.
|
During the 31-day (Days 0-30) post-vaccination period after any vaccination
|
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.
|
During the entire study period (from Month 0 to Month 3)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
August 13, 2009
Primary Completion (ACTUAL)
January 27, 2010
Study Completion (ACTUAL)
January 27, 2010
Study Registration Dates
First Submitted
August 27, 2009
First Submitted That Met QC Criteria
September 1, 2009
First Posted (ESTIMATE)
September 2, 2009
Study Record Updates
Last Update Posted (ACTUAL)
January 3, 2020
Last Update Submitted That Met QC Criteria
December 31, 2019
Last Verified
December 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Metabolic Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Blood-Borne Infections
- Communicable Diseases
- Neurologic Manifestations
- Liver Diseases
- Neuromuscular Diseases
- Central Nervous System Infections
- Hepatitis, Viral, Human
- Hepadnaviridae Infections
- DNA Virus Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Gram-Positive Bacterial Infections
- Neuromuscular Manifestations
- Actinomycetales Infections
- Enterovirus Infections
- Picornaviridae Infections
- Spinal Cord Diseases
- Orthomyxoviridae Infections
- Clostridium Infections
- Hypocalcemia
- Calcium Metabolism Disorders
- Corynebacterium Infections
- Myelitis
- Hepatitis B
- Hepatitis
- Hepatitis A
- Influenza, Human
- Tetanus
- Diphtheria
- Tetany
- Poliomyelitis
- Physiological Effects of Drugs
- Immunologic Factors
- Vaccines
- Heptavalent Pneumococcal Conjugate Vaccine
Other Study ID Numbers
- 112157
- 2009-010431-41 (EUDRACT_NUMBER)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
IPD is available via the Clinical Study Data Request site (click on the link provided below)
IPD Sharing Time Frame
IPD is available via the Clinical Study Data Request site (click on the link provided below)
IPD Sharing Access Criteria
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place.
Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Study Data/Documents
-
Study Protocol
Information identifier: 112157Information comments: For additional information about this study please refer to the GSK Clinical Study Register
-
Annotated Case Report Form
Information identifier: 112157Information comments: For additional information about this study please refer to the GSK Clinical Study Register
-
Statistical Analysis Plan
Information identifier: 112157Information comments: For additional information about this study please refer to the GSK Clinical Study Register
-
Clinical Study Report
Information identifier: 112157Information comments: For additional information about this study please refer to the GSK Clinical Study Register
-
Individual Participant Data Set
Information identifier: 112157Information comments: For additional information about this study please refer to the GSK Clinical Study Register
-
Dataset Specification
Information identifier: 112157Information comments: For additional information about this study please refer to the GSK Clinical Study Register
-
Informed Consent Form
Information identifier: 112157Information comments: For additional information about this study please refer to the GSK Clinical Study Register
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hepatitis B
-
The Affiliated Nanjing Drum Tower Hospital of Nanjing...Gilead SciencesNot yet recruiting
-
Ain Shams UniversityCompleted
-
National Taiwan University HospitalChiayi Christian Hospital; E-DA Hospital; Taipei City Hospital; Taipei Tzu Chi... and other collaboratorsRecruitingChronic Hepatitis b | Hepatitis B ReactivationTaiwan
-
Mahidol UniversityUnknownChronic Hepatitis B, HBsAg, Hepatitis B VaccineThailand
-
Nanfang Hospital of Southern Medical UniversityRecruiting
-
IlDong Pharmaceutical Co LtdRecruitingChronic Hepatitis bKorea, Republic of
-
Antios Therapeutics, IncTerminatedChronic Hepatitis bUnited States
-
Xi'an Xintong Pharmaceutical Research Co.,Ltd.Unknown
-
Third Affiliated Hospital, Sun Yat-Sen UniversityRecruitingChronic Hepatitis b | Cirrhosis Due to Hepatitis BChina
-
Tongji HospitalChia Tai Tianqing Pharmaceutical Group Co., Ltd.UnknownChronic Hepatitis b
Clinical Trials on Infanrix hexa™
-
GlaxoSmithKlineCompletedInfections, Meningococcal | Meningococcal VaccinesEstonia, Germany, Spain
-
GlaxoSmithKlineWithdrawnInfections, Rotavirus
-
GlaxoSmithKlineCompletedStreptococcus Pneumoniae Vaccines | Infections, StreptococcalVietnam
-
GlaxoSmithKlineCompletedInfections, MeningococcalGermany, Austria, Greece
-
GlaxoSmithKlineCompletedHepatitis B | Tetanus | Diphtheria | Acellular Pertussis | Poliomyelitis | Haemophilus Influenzae Type bCanada
-
GlaxoSmithKlineCompletedHepatitis B | Tetanus | Diphtheria | Acellular Pertussis | Poliomyelitis | Haemophilus Influenzae Type b | Diphtheria-Tetanus-aPertussis-Hepatitis B-Poliomyelitis-Haemophilus Influenzae Type b-Neisseria MeniPoland
-
GlaxoSmithKlineCompletedHepatitis B | Tetanus | Diphtheria | Acellular Pertussis | Poliomyelitis | Haemophilus Influenzae Type b | Diphtheria-Tetanus-aPertussis-Hepatitis B-Poliomyelitis-Haemophilus Influenzae Type b VaccinesIndia
-
GlaxoSmithKlineCompletedHepatitis B | Tetanus | Diphtheria | Acellular Pertussis | Poliomyelitis | Haemophilus Influenzae Type b
-
GlaxoSmithKlineCompletedHepatitis B | Tetanus | Diphtheria | Acellular Pertussis | PoliomyelitisRussian Federation
-
GlaxoSmithKlineCompletedNeisseria Meningitidis | Haemophilus Influenzae Type bSpain