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Feasibility Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine in Healthy Infants at 3, 5 and 11 Months of Age.

Primary Purpose

Tetanus, Poliomyelitis, Neisseria Meningitidis

Status
Terminated
Phase
Phase 2
Locations
Slovakia
Study Type
Interventional
Intervention
GSK2202083A vaccine
Infanrix hexa
Menjugate
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Tetanus focused on measuring Combined vaccine, Primary vaccination

Eligibility Criteria

8 Weeks - 16 Weeks (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • A male or female infant between, and including, 8 and 16 weeks at the time of the first vaccination.
  • Born after a gestation period of 36 to 42 weeks inclusive.
  • Subjects who the investigator believes that their parents/ guardians can and will comply with the requirements of the protocol.
  • 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 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.
  • 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 study Visit 3, or from 30 days before to 30 days after study Visit 4, with the exception of influenza and human rotavirus vaccines. The administration of other vaccines, including conjugated pneumococcal vaccine, is 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 or intercurrent diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, Hib and/or MenC vaccination or disease, including HBV vaccination at birth.
  • History of seizures or progressive neurological disease.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • History of allergic disease or reactions 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 axillary temperature >= 38.5 ºC or other moderate to severe illness within 24 hours of study vaccine administration

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

GSK2202083A GROUP

INFANRIX + MENJUGATE GROUP

Arm Description

Subjects in this group were to receive three doses of GSK2202083A vaccine at 3, 5 and 11 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.

Subjects in this group were to receive three doses of Infanrix™ hexa vaccine at 3, 5 and 11 months of age, and two doses of Menjugate® vaccine at 3 and 5 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.

Outcomes

Primary Outcome Measures

Anti-PRP Antibody Concentrations ≥ 0.15 mg/mL
As the study was terminated, no blood samples were taken. Hence no immunogenicity analyses were done.

Secondary Outcome Measures

Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms
The solicited local symptoms assessed were pain, redness and swelling. Any = any solicited local symptom irrespective of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site. Subjects from Control Group did not receive the second study vaccination dose due to study termination.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
The solicited general symptoms assessed were drowsiness, irritability, loss of appetite and temperature. Any = any general symptom irrespective of intensity grade and relationship to vaccination. Grade 3 Irritability = crying that could not be comforted/prevented normal activity. Grade 3 Drowsiness = drowsiness that prevented normal activity. Grade 3 Loss of Appetite = did not eat at all. Related = symptoms assessed by the investigator as causally related to vaccination. Subjects from Control Group did not receive the second study vaccination dose due to study termination.
Number of Subjects With Unsolicited Adverse Events AE(s)
An unsolicited AE covers 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 and 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. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Full Information

First Posted
March 26, 2009
Last Updated
April 27, 2018
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00871741
Brief Title
Feasibility Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine in Healthy Infants at 3, 5 and 11 Months of Age.
Official Title
Feasibility Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine in Healthy Infants at 3, 5 and 11 Months of Age.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Terminated
Why Stopped
Study stopped due to non-approval of IEC to proposed change in locations. Study discontinuation not due to safety/efficacy reasons related to the vaccine.
Study Start Date
April 1, 2009 (undefined)
Primary Completion Date
June 25, 2009 (Actual)
Study Completion Date
June 25, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

Brief Summary
This study will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083A vaccine given as a three-dose vaccination course at 3, 5 and 11 months of age.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tetanus, Poliomyelitis, Neisseria Meningitidis, Haemophilus Influenzae Type b, Diphtheria, Acellular Pertussis, Hepatitis B
Keywords
Combined vaccine, Primary vaccination

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GSK2202083A GROUP
Arm Type
Experimental
Arm Description
Subjects in this group were to receive three doses of GSK2202083A vaccine at 3, 5 and 11 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.
Arm Title
INFANRIX + MENJUGATE GROUP
Arm Type
Active Comparator
Arm Description
Subjects in this group were to receive three doses of Infanrix™ hexa vaccine at 3, 5 and 11 months of age, and two doses of Menjugate® vaccine at 3 and 5 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.
Intervention Type
Biological
Intervention Name(s)
GSK2202083A vaccine
Intervention Description
Intramuscular, three doses
Intervention Type
Biological
Intervention Name(s)
Infanrix hexa
Intervention Description
Intramuscular, three doses
Intervention Type
Biological
Intervention Name(s)
Menjugate
Intervention Description
Intramuscular, two doses
Primary Outcome Measure Information:
Title
Anti-PRP Antibody Concentrations ≥ 0.15 mg/mL
Description
As the study was terminated, no blood samples were taken. Hence no immunogenicity analyses were done.
Time Frame
At Month 3
Secondary Outcome Measure Information:
Title
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms
Description
The solicited local symptoms assessed were pain, redness and swelling. Any = any solicited local symptom irrespective of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site. Subjects from Control Group did not receive the second study vaccination dose due to study termination.
Time Frame
During the 8-day (Days 0-7) post-vaccination period following each dose and across doses
Title
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Description
The solicited general symptoms assessed were drowsiness, irritability, loss of appetite and temperature. Any = any general symptom irrespective of intensity grade and relationship to vaccination. Grade 3 Irritability = crying that could not be comforted/prevented normal activity. Grade 3 Drowsiness = drowsiness that prevented normal activity. Grade 3 Loss of Appetite = did not eat at all. Related = symptoms assessed by the investigator as causally related to vaccination. Subjects from Control Group did not receive the second study vaccination dose due to study termination.
Time Frame
During the 8-day (Days 0-7) post-vaccination period following each dose and across doses
Title
Number of Subjects With Unsolicited Adverse Events AE(s)
Description
An unsolicited AE covers 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 and 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. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Time Frame
During the 31-day (Days 0-30) post-vaccination period
Title
Number of Subjects With Serious Adverse Events (SAEs)
Description
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time Frame
During the entire study period (from Month 0 to Month 9)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Weeks
Maximum Age & Unit of Time
16 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: A male or female infant between, and including, 8 and 16 weeks at the time of the first vaccination. Born after a gestation period of 36 to 42 weeks inclusive. Subjects who the investigator believes that their parents/ guardians can and will comply with the requirements of the protocol. 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 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. 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 study Visit 3, or from 30 days before to 30 days after study Visit 4, with the exception of influenza and human rotavirus vaccines. The administration of other vaccines, including conjugated pneumococcal vaccine, is 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 or intercurrent diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, Hib and/or MenC vaccination or disease, including HBV vaccination at birth. History of seizures or progressive neurological disease. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. History of allergic disease or reactions 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 axillary temperature >= 38.5 ºC or other moderate to severe illness within 24 hours of study vaccine administration
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Bratislava
ZIP/Postal Code
841 08
Country
Slovakia
Facility Name
GSK Investigational Site
City
Bratislava
ZIP/Postal Code
851 05
Country
Slovakia
Facility Name
GSK Investigational Site
City
Dolny Kubin
ZIP/Postal Code
026 01
Country
Slovakia
Facility Name
GSK Investigational Site
City
Dunajska Streda
ZIP/Postal Code
929 01
Country
Slovakia
Facility Name
GSK Investigational Site
City
Nove Zamky
ZIP/Postal Code
940 01
Country
Slovakia
Facility Name
GSK Investigational Site
City
Ruzomberok
ZIP/Postal Code
034 01
Country
Slovakia
Facility Name
GSK Investigational Site
City
Sturovo
ZIP/Postal Code
943 01
Country
Slovakia
Facility Name
GSK Investigational Site
City
Trnava
ZIP/Postal Code
917 01
Country
Slovakia

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
111761
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
111761
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
111761
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
111761
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
111761
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
111761
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Annotated Case Report Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
111761
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

Feasibility Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine in Healthy Infants at 3, 5 and 11 Months of Age.

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