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Booster Vaccination Study With a Pneumococcal Vaccine in Children Primed With the Same Vaccine

Primary Purpose

Infections, Streptococcal

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
GSK Biologicals' Synflorix™ (Pneumococcal vaccine GSK1024850A)
Wyeth-Lederle's Prevenar™
GSK Biologicals' Hiberix™
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Infections, Streptococcal focused on measuring Safety, Pneumococcal vaccine, Immunogenicity, Pneumococcal disease, Booster vaccination

Eligibility Criteria

12 Months - 18 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • A male or female between, and including, 12-18 months of age at the time of booster vaccination.
  • Subjects for whom the investigator believes that their parent(s)/ guardian(s) can and will comply with the requirements of the protocol.
  • Subjects who received three doses of pneumococcal conjugate vaccine in study NCT00680914.
  • Written informed consent obtained from the parent(s)/guardian(s) of the child/ward.
  • 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) within 30 days preceding the vaccination, or planned use 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 (pharmaceutical product or device).
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to vaccination.
  • Administration of immunoglobulins and/or any blood products within three months preceding the vaccination or planned administration during the study period.
  • Administration of any pneumococcal and/or Hib vaccine since the end of study NCT00680914.
  • Planned administration/administration of a vaccine not allowed by the study protocol during the period starting 1 month (30 days) before the administration of the booster dose of the study vaccines (Visit 1) and up to the follow-up visit (Visit 2) with the exception of vaccines included in the Korean routine immunization which can be given at least one week before the administration of the study vaccines or after study end.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • History of reactions or allergic disease likely to be exacerbated by any component of the study vaccines.
  • Known hypersensitivity to any component of the study vaccines including anaphylactic reactions following the administration of the study vaccines.
  • Major congenital defects or serious chronic illness.
  • History of any neurologic disorders or seizures.
  • Tympanic or axillary/ oral temperature >= 37.5°C or rectal temperature >= 38.0°C. A temperature greater than or equal to these cut-offs warrants deferral of the vaccination pending recovery of the subject.
  • Acute disease at the time of enrolment.

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
  • 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

Synflorix Group

Prevenar Group

Arm Description

Subjects previously primed (NCT00680914) with 3 doses of Synflorix and Hiberix in the first year of life receiving a booster dose of the same vaccines in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.

Subjects previously primed (NCT00680914) with 3 doses of Prevenar and Hiberix in the first year of life receiving a booster dose of Prevenar and Hiberix in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.

Outcomes

Primary Outcome Measures

Number of Subjects Reporting Grade 3 Adverse Events
Grade 3 adverse events are severe symptoms that prevent normal, everyday activities.

Secondary Outcome Measures

Number of Subjects Reporting Solicited Symptoms
Solicited local symptoms assessed include pain, redness and swelling at the injection site. Solicited general symptoms assessed include drowsiness, fever (equal to or above 37.5 degrees Celsius), irritability and loss of appetite.
Number of Subjects Reporting Unsolicited Adverse Events
An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study. Also any "solicited" symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event.
Number of Subjects Reporting Serious Adverse Events
Serious adverse events are medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Concentration of Antibodies Against Vaccine Pneumococcal Serotypes
Concentrations of antibodies are measured by 22F-inhibition enzyme-linked immunosorbent assay (ELISA) and are presented as geometric mean concentrations expressed as microgram per milliliter (ug/mL). Vaccine pneumococcal serotypes included serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes
Streptococcus pneumoniae opsonophagocytic activity was measured by a killing-assay using a HL 60 cell line. The results are presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. Vaccine pneumococcal serotypes included serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
Concentration of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A
Concentrations of antibodies are measured by 22F-inhibition ELISA and are presented as geometric mean concentrations expressed as microgram per milliliter.
Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A
Streptococcus pneumoniae opsonophagocytic activity was measured by a killing-assay using a HL 60 cell line. The results are presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions.
Concentration of Antibodies Against Protein D (PD)
Concentrations of antibodies are presented as geometric mean concentrations expressed as Enzyme-Linked Immuno-Sorbent Assay (ELISA) units per milliliter (EU/mL).
Concentration of Antibodies Against Polyribosyl-ribitol-phosphate (PRP)
Concentrations of antibodies are presented as geometric mean concentrations expressed as microgram per milliliter.

Full Information

First Posted
May 28, 2009
Last Updated
August 21, 2018
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00911144
Brief Title
Booster Vaccination Study With a Pneumococcal Vaccine in Children Primed With the Same Vaccine
Official Title
Booster Vaccination With Pneumococcal Vaccine GSK1024850A or Prevenar™ Co-administered With Hiberix™ in Children Primed With the Same Vaccines
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
June 11, 2009 (undefined)
Primary Completion Date
January 11, 2010 (Actual)
Study Completion Date
January 11, 2010 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to evaluate the reactogenicity, safety and immunogenicity of a booster (fourth) dose of pneumococcal vaccine GSK1024850A when co-administered with Hiberix at 12-18 months of age, in children primed with the same vaccines in primary study NCT00680914.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infections, Streptococcal
Keywords
Safety, Pneumococcal vaccine, Immunogenicity, Pneumococcal disease, Booster vaccination

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
450 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Synflorix Group
Arm Type
Experimental
Arm Description
Subjects previously primed (NCT00680914) with 3 doses of Synflorix and Hiberix in the first year of life receiving a booster dose of the same vaccines in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
Arm Title
Prevenar Group
Arm Type
Active Comparator
Arm Description
Subjects previously primed (NCT00680914) with 3 doses of Prevenar and Hiberix in the first year of life receiving a booster dose of Prevenar and Hiberix in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
Intervention Type
Biological
Intervention Name(s)
GSK Biologicals' Synflorix™ (Pneumococcal vaccine GSK1024850A)
Other Intervention Name(s)
Pneumococcal vaccine GSK1024850A
Intervention Description
Intramuscular injection, administered as a single dose
Intervention Type
Biological
Intervention Name(s)
Wyeth-Lederle's Prevenar™
Intervention Description
Intramuscular injection, administered as a single dose
Intervention Type
Biological
Intervention Name(s)
GSK Biologicals' Hiberix™
Other Intervention Name(s)
Hib
Intervention Description
Intramuscular injection, administered as a single dose
Primary Outcome Measure Information:
Title
Number of Subjects Reporting Grade 3 Adverse Events
Description
Grade 3 adverse events are severe symptoms that prevent normal, everyday activities.
Time Frame
Within 31 days (Day 0 - Day 30) after booster vaccination.
Secondary Outcome Measure Information:
Title
Number of Subjects Reporting Solicited Symptoms
Description
Solicited local symptoms assessed include pain, redness and swelling at the injection site. Solicited general symptoms assessed include drowsiness, fever (equal to or above 37.5 degrees Celsius), irritability and loss of appetite.
Time Frame
Within 4 days (Days 0 to 3) after booster vaccination
Title
Number of Subjects Reporting Unsolicited Adverse Events
Description
An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study. Also any "solicited" symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event.
Time Frame
Within 31 days (Days 0 to 30) after booster vaccination
Title
Number of Subjects Reporting Serious Adverse Events
Description
Serious adverse events are medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Time Frame
After booster vaccination up to study end (Month 0 to Month 1)
Title
Concentration of Antibodies Against Vaccine Pneumococcal Serotypes
Description
Concentrations of antibodies are measured by 22F-inhibition enzyme-linked immunosorbent assay (ELISA) and are presented as geometric mean concentrations expressed as microgram per milliliter (ug/mL). Vaccine pneumococcal serotypes included serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
Time Frame
One month after booster vaccination (Month 1)
Title
Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes
Description
Streptococcus pneumoniae opsonophagocytic activity was measured by a killing-assay using a HL 60 cell line. The results are presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. Vaccine pneumococcal serotypes included serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
Time Frame
One month after booster vaccination (Month 1)
Title
Concentration of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A
Description
Concentrations of antibodies are measured by 22F-inhibition ELISA and are presented as geometric mean concentrations expressed as microgram per milliliter.
Time Frame
One month after booster vaccination (Month 1)
Title
Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A
Description
Streptococcus pneumoniae opsonophagocytic activity was measured by a killing-assay using a HL 60 cell line. The results are presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions.
Time Frame
One month after booster vaccination (Month 1)
Title
Concentration of Antibodies Against Protein D (PD)
Description
Concentrations of antibodies are presented as geometric mean concentrations expressed as Enzyme-Linked Immuno-Sorbent Assay (ELISA) units per milliliter (EU/mL).
Time Frame
One month after booster vaccination (Month 1)
Title
Concentration of Antibodies Against Polyribosyl-ribitol-phosphate (PRP)
Description
Concentrations of antibodies are presented as geometric mean concentrations expressed as microgram per milliliter.
Time Frame
One month after booster vaccination (Month 1)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
18 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: A male or female between, and including, 12-18 months of age at the time of booster vaccination. Subjects for whom the investigator believes that their parent(s)/ guardian(s) can and will comply with the requirements of the protocol. Subjects who received three doses of pneumococcal conjugate vaccine in study NCT00680914. Written informed consent obtained from the parent(s)/guardian(s) of the child/ward. 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) within 30 days preceding the vaccination, or planned use 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 (pharmaceutical product or device). Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to vaccination. Administration of immunoglobulins and/or any blood products within three months preceding the vaccination or planned administration during the study period. Administration of any pneumococcal and/or Hib vaccine since the end of study NCT00680914. Planned administration/administration of a vaccine not allowed by the study protocol during the period starting 1 month (30 days) before the administration of the booster dose of the study vaccines (Visit 1) and up to the follow-up visit (Visit 2) with the exception of vaccines included in the Korean routine immunization which can be given at least one week before the administration of the study vaccines or after study end. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. History of reactions or allergic disease likely to be exacerbated by any component of the study vaccines. Known hypersensitivity to any component of the study vaccines including anaphylactic reactions following the administration of the study vaccines. Major congenital defects or serious chronic illness. History of any neurologic disorders or seizures. Tympanic or axillary/ oral temperature >= 37.5°C or rectal temperature >= 38.0°C. A temperature greater than or equal to these cut-offs warrants deferral of the vaccination pending recovery of the subject. Acute disease at the time of enrolment.
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
Ansan
ZIP/Postal Code
425-707
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Bucheon-Si, GyeongGi-do,
ZIP/Postal Code
420-767
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Daejeon
ZIP/Postal Code
301-723
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Gyeonggi-do
ZIP/Postal Code
411-706
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
GyeongSangNam-do
ZIP/Postal Code
641-560
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Iksan
ZIP/Postal Code
570-711
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Jeju City
ZIP/Postal Code
690-121
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Jeonju Jeonbuk
ZIP/Postal Code
561-712
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Pusan
ZIP/Postal Code
602-739
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
130-702
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
150-719
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
158-710
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Suwon City, Gyeonggi-do
ZIP/Postal Code
442-723
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Wonju-si Kangwon-do
ZIP/Postal Code
220-701
Country
Korea, Republic of

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.
Citations:
PubMed Identifier
21817957
Citation
Kim CH, Kim JS, Cha SH, Kim KN, Kim JD, Lee KY, Kim HM, Kim JH, Hyuk S, Hong JY, Park SE, Kim YK, Kim NH, Fanic A, Borys D, Ruiz-Guinazu J, Moreira M, Schuerman L, Kim KH. Response to primary and booster vaccination with 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine in Korean infants. Pediatr Infect Dis J. 2011 Dec;30(12):e235-43. doi: 10.1097/INF.0b013e31822a8541.
Results Reference
background
Citation
Kim CH et al. Immunogenicity and safety of 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in Korean children. Abstract presented at the Korean Society of Pediatric Infectious Diseases - 2011 Spring Conference. Seoul, South Korea, 7-11 June 2011.
Results Reference
background
Citation
Kim JS et al. Safety and reactogenicity of booster vaccination with 10-valent pneumococcal non-typeable Haemophilus influenzae protein d conjugate vaccine (PHiD-CV) in Korean children. Abstract presented at the 8th International Symposium on Antimicrobial Agents and Resistance (ISAAR). Seoul, Republic of Korea, 6-8 April 2011.
Results Reference
background
Citation
Kim KH et al. Immunogenicity of booster vaccination with 10-valent pneumococcal non-typeable Haemophilus influenzae protein d conjugate vaccine (PHiD-CV) in Korean children. Abstract presented at the 8th International Symposium on Antimicrobial Agents and Resistance (ISAAR). Seoul, Republic of Korea, 6-8 April 2011.
Results Reference
background
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
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
112933
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
112933
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
112933
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
112933
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
112933
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
112933
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
112933
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register

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Booster Vaccination Study With a Pneumococcal Vaccine in Children Primed With the Same Vaccine

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