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

Booster Vaccination With Pneumococcal Vaccine GSK1024850A or Prevenar™ Co-administered With Hiberix™ in Children Primed With the Same Vaccines

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.

Study Overview

• Status: Completed
• Conditions: Infections, Streptococcal
• Intervention / Treatment: Biological: GSK Biologicals' Synflorix™ (Pneumococcal vaccine GSK1024850A); Biological: GSK Biologicals' Hiberix™; Biological: Wyeth-Lederle's Prevenar™

• Study Type: Interventional
• Enrollment (Actual): 450
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Ansan, Korea, Republic of, 425-707
    • GSK Investigational Site
  • Bucheon-Si, GyeongGi-do,, Korea, Republic of, 420-767
    • GSK Investigational Site
  • Daejeon, Korea, Republic of, 301-723
    • GSK Investigational Site
  • GyeongSangNam-do, Korea, Republic of, 641-560
    • GSK Investigational Site
  • Gyeonggi-do, Korea, Republic of, 411-706
    • GSK Investigational Site
  • Iksan, Korea, Republic of, 570-711
    • GSK Investigational Site
  • Jeju City, Korea, Republic of, 690-121
    • GSK Investigational Site
  • Jeonju Jeonbuk, Korea, Republic of, 561-712
    • GSK Investigational Site
  • Pusan, Korea, Republic of, 602-739
    • GSK Investigational Site
  • Seoul, Korea, Republic of, 150-719
    • GSK Investigational Site
  • Seoul, Korea, Republic of, 130-702
    • GSK Investigational Site
  • Seoul, Korea, Republic of, 158-710
    • GSK Investigational Site
  • Suwon City, Gyeonggi-do, Korea, Republic of, 442-723
    • GSK Investigational Site
  • Wonju-si Kangwon-do, Korea, Republic of, 220-701
    • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 1 year (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Synflorix Group; 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.	Biological: GSK Biologicals' Synflorix™ (Pneumococcal vaccine GSK1024850A); Intramuscular injection, administered as a single dose; Other Names: Pneumococcal vaccine GSK1024850A; Biological: GSK Biologicals' Hiberix™; Intramuscular injection, administered as a single dose; Other Names: Hib
Active Comparator: Prevenar Group; 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.	Biological: GSK Biologicals' Hiberix™; Intramuscular injection, administered as a single dose; Other Names: Hib; Biological: Wyeth-Lederle's Prevenar™; Intramuscular injection, administered as a single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects Reporting Grade 3 Adverse Events	Grade 3 adverse events are severe symptoms that prevent normal, everyday activities.	Within 31 days (Day 0 - Day 30) after booster vaccination.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Within 4 days (Days 0 to 3) after booster vaccination
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.	Within 31 days (Days 0 to 30) after booster vaccination
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.	After booster vaccination up to study end (Month 0 to Month 1)
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.	One month after booster vaccination (Month 1)
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.	One month after booster vaccination (Month 1)
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.	One month after booster vaccination (Month 1)
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.	One month after booster vaccination (Month 1)
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).	One month after booster vaccination (Month 1)
Concentration of Antibodies Against Polyribosyl-ribitol-phosphate (PRP)	Concentrations of antibodies are presented as geometric mean concentrations expressed as microgram per milliliter.	One month after booster vaccination (Month 1)

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Helpful Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Study record dates

Study Major Dates

• Study Start: June 11, 2009
• Primary Completion (Actual): January 11, 2010
• Study Completion (Actual): January 11, 2010

Study Registration Dates

• First Submitted: May 28, 2009
• First Submitted That Met QC Criteria: May 28, 2009
• First Posted (Estimate): June 1, 2009

Study Record Updates

• Last Update Posted (Actual): September 20, 2018
• Last Update Submitted That Met QC Criteria: August 21, 2018
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Safety; Immunogenicity; Pneumococcal vaccine; Booster vaccination; Pneumococcal disease
• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Streptococcal Infections; Physiological Effects of Drugs; Immunologic Factors; Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
• Other Study ID Numbers: 112933

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

1. Informed Consent Form
   Information identifier: 112933
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Dataset Specification
   Information identifier: 112933
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Individual Participant Data Set
   Information identifier: 112933
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Annotated Case Report Form
   Information identifier: 112933
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Study Protocol
   Information identifier: 112933
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
6. Statistical Analysis Plan
   Information identifier: 112933
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
7. Clinical Study Report
   Information identifier: 112933
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register