- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00696423
Immunogenicity and Safety of GSK Biologicals' Infanrix/Hib in Children
April 27, 2018 updated by: GlaxoSmithKline
Immunogenicity and Reactogenicity Study of GlaxoSmithKline Biologicals' Infanrix™/Hib Vaccine Administered as a Booster Dose to 18-24 Months Old Children
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 = NCT00412854).
This Phase IIIB study will compare GSK Biologicals' DTPa/Hib vaccine to separately administered DTPa and Hib vaccines in Chinese children 18 to 24 months of age, in terms of safety and immunogenicity.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
467
Phase
- Phase 3
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
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Mengshan, China
- GSK Investigational Site
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Wuzhou, China
- GSK Investigational Site
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Guangxi
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Liucheng County, Guangxi, China, 545200
- GSK Investigational Site
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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 year to 2 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
- Subjects should have completed the full three-dose primary vaccination course in study 104567.
- A male or female child between, and including, 18 and 24 months of age at the time of the booster vaccination.
- Written informed consent obtained from the parent or guardian 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 (drug or vaccine) other than the study vaccine(s) within 30 days preceding booster vaccination, or planned use during the study period.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the booster dose.
- Administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination, or planned administration during the study period, with the exception of measles or combined measles, mumps and rubella (MMR) vaccination.
- 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.
- Previous booster vaccination against diphtheria, tetanus, pertussis and/or Haemophilus influenzae type b diseases since the end of the primary study.
- History of diphtheria, tetanus, pertussis and/or Haemophilus influenzae type b diseases.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- A family history of congenital or hereditary immunodeficiency.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
- Major congenital defects or serious chronic illness.
- History of any progressive neurological disorders or seizures.
- Acute disease and/or fever at time of enrolment.
- Administration of immunoglobulins and/or any blood products within the three months preceding the booster dose or planned administration during the study period.
Occurrence of any of the following adverse events (AEs) after previous administration of a diphtheria-tetanus-pertussis (DTP) vaccine:
- Hypersensitivity reaction due to any component of the vaccine.
- Encephalopathy.
- Fever ≥ 40.0 °C (axillary temperature) within 48 hours of vaccination.
- 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.
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: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Infanrix/Hib Single Injection Group
Subjects received 1 dose of Infanrix™ extemporaneously mixed with Hiberix™.
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Intramuscular injection, one dose
Intramuscular injection, one dose
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Active Comparator: Infanrix + Hiberix Separate Injection Group
Subjects received two separate injections, one of Infanrix™ and one of Hiberix™.
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Intramuscular injection, one dose
Intramuscular injection, one dose
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anti-polyribosyl-ribitol-phosphate (PRP) Antibody Concentrations
Time Frame: One month after booster vaccination
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Geometric mean concentrations are given in microgram per milliliter (μg/mL).
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One month after booster vaccination
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Anti-diphtheria Toxoid Antibody Concentrations
Time Frame: One month after booster vaccination
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Geometric mean concentrations are given in international Unit per milliliter (IU/mL).
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One month after booster vaccination
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Anti-tetanus Toxoid Antibody Concentrations
Time Frame: One month after booster vaccination
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Geometric mean concentrations are given in IU/mL.
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One month after booster vaccination
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Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations
Time Frame: One month after booster vaccination
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Geometric mean concentrations are given in Enzyme-Linked Immuno Sorbent Assay (ELISA) unit per milliliter (EL.U/mL).
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One month after booster vaccination
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The Number of Subjects Seroprotected for Anti-PRP, Anti-diphtheria and Anti-tetanus Antibodies and Seropositive for Anti-PT, Anti-FHA and Anti-PRN Antibodies
Time Frame: One month after booster vaccination
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Assay cut-offs indicating seroprotection or seropositivity for the different antigens were the following: anti-PRP antibody concentrations ≥ 0.15 µg/mL, anti-diphtheria and anti-tetanus antibody concentrations ≥ 0.1 IU/mL, anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 20 EL.U/mL.
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One month after booster vaccination
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anti-PRP Antibody Concentrations
Time Frame: Before booster vaccination
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Geometric mean concentrations are given in μg/mL.
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Before booster vaccination
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Anti-diphtheria Toxoid Antibody Concentrations
Time Frame: Before booster vaccination
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Geometric mean concentrations are given in IU/mL.
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Before booster vaccination
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Anti-tetanus Toxoid Antibody Concentrations
Time Frame: Before booster vaccination
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Geometric mean concentrations are given in IU/mL.
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Before booster vaccination
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Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Time Frame: Before booster vaccination
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Geometric mean concentrations are given in EL.U/mL.
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Before booster vaccination
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The Number of Subjects Seroprotected for Anti-PRP, Anti-diphtheria and Anti-tetanus Antibodies and Seropositive for Anti-PT, Anti-FHA and Anti-PRN Antibodies
Time Frame: Before booster vaccination
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Assay cut-offs indicating seroprotection or seropositivity for the different antigens were the following: anti-PRP antibody concentrations ≥ 0.15 µg/mL, anti-diphtheria and anti-tetanus antibody concentrations ≥ 0.1 IU/mL, anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 20 EL.U/mL.
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Before booster vaccination
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Number of Subjects Reporting Solicited Local and General Symptoms
Time Frame: During the 4-day follow-up period after booster vaccination
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Solicited local symptoms assessed include pain, redness and swelling.
Solicited general symptoms assessed include drowsiness, fever, irritability, and loss of appetite.
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During the 4-day follow-up period after booster vaccination
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Number of Subjects Reporting Unsolicited Adverse Events (AE)
Time Frame: During the 31-day follow-up period after booster vaccination
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An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
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During the 31-day follow-up period after booster vaccination
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Number of Subjects Reporting Serious Adverse Events (SAE)
Time Frame: During the 31-day follow-up period after booster vaccination
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An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in isability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
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During the 31-day follow-up period after booster vaccination
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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
June 7, 2008
Primary Completion (Actual)
July 26, 2008
Study Completion (Actual)
July 26, 2008
Study Registration Dates
First Submitted
June 5, 2008
First Submitted That Met QC Criteria
June 10, 2008
First Posted (Estimate)
June 12, 2008
Study Record Updates
Last Update Posted (Actual)
June 6, 2018
Last Update Submitted That Met QC Criteria
April 27, 2018
Last Verified
October 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 111535
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD 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.
Study Data/Documents
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Study Protocol
Information identifier: 111535Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Statistical Analysis Plan
Information identifier: 111535Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Clinical Study Report
Information identifier: 111535Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Annotated Case Report Form
Information identifier: 111535Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Individual Participant Data Set
Information identifier: 111535Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Dataset Specification
Information identifier: 111535Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Informed Consent Form
Information identifier: 111535Information 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.
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