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

NCT ID: NCT00911144

Last Updated: 2018-09-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 450 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-11
• Study Completion Date: 2010-01-11

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.

Conditions

Infections, Streptococcal

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

GSK Biologicals' Synflorix™ (Pneumococcal vaccine GSK1024850A)

Intervention Type: BIOLOGICAL

Intramuscular injection, administered as a single dose

GSK Biologicals' Hiberix™

Intervention Type: BIOLOGICAL

Intramuscular injection, administered as a single dose

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.

Group Type: ACTIVE_COMPARATOR

Wyeth-Lederle's Prevenar™

Intervention Type: BIOLOGICAL

Intramuscular injection, administered as a single dose

GSK Biologicals' Hiberix™

Intervention Type: BIOLOGICAL

Intramuscular injection, administered as a single dose

Interventions

GSK Biologicals' Synflorix™ (Pneumococcal vaccine GSK1024850A)

Intramuscular injection, administered as a single dose

Intervention Type: BIOLOGICAL

Wyeth-Lederle's Prevenar™

Intramuscular injection, administered as a single dose

Intervention Type: BIOLOGICAL

GSK Biologicals' Hiberix™

Intramuscular injection, administered as a single dose

Intervention Type: BIOLOGICAL

Other Intervention Names

Pneumococcal vaccine GSK1024850A; Hib

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.

• Minimum Eligible Age: 12 Months
• Maximum Eligible Age: 18 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Ansan, , South Korea

GSK Investigational Site

Bucheon-Si, GyeongGi-do,, , South Korea

GSK Investigational Site

Daejeon, , South Korea

GSK Investigational Site

Gyeonggi-do, , South Korea

GSK Investigational Site

GyeongSangNam-do, , South Korea

GSK Investigational Site

Iksan, , South Korea

GSK Investigational Site

Jeju City, , South Korea

GSK Investigational Site

Jeonju Jeonbuk, , South Korea

GSK Investigational Site

Pusan, , South Korea

GSK Investigational Site

Seoul, , South Korea

GSK Investigational Site

Seoul, , South Korea

GSK Investigational Site

Seoul, , South Korea

GSK Investigational Site

Suwon City, Gyeonggi-do, , South Korea

GSK Investigational Site

Wonju-si Kangwon-do, , South Korea

Countries

South Korea

References

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.

Reference Type: BACKGROUND

PMID: 21817957 (View on PubMed)

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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

Study Documents

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

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

Other Identifiers

112933

Identifier Type: -

Identifier Source: org_study_id