GSK: Protocol Summary for 112933

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Protocol Summary for 112933

Protocol Summary
Protocol Id:	112933
Secondary Ids:	N/A
Title:	Booster vaccination with pneumococcal vaccine GSK1024850A or Prevenar™ co-administered with Hiberix™ in children primed with the same vaccines
Phase:	phase 3
Acronym:
FDA Regulated Intervention?:	Yes
Section 801 Clinical Trial?:	Yes
Delayed Posting:	No
IND/IDE Protocol?:	no
Study Type:	Interventional
Oversight Authority:	Korea: Korea Food & Drug Administration
Collaborators:	N/A
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.
Detailed Description:
Record Verification Date:	November 2011
Status:	Completed
Why Study Stopped:
Study Start Date:	June 2009
Study Completion Date:	January 2010
Study Completion Date Type:	Actual
Primary Completion Date:	January 2010
Primary Completion Date Type:	Actual
Primary Purpose:	prevention
Allocation:	Non-randomized
Masking:	Single Blind
Masked Subject:	yes
Masked Caregiver:	no
Masked Investigator:	no
Masked Assessor:	no
Study Design (Assignment):	Parallel Assignment
Study Classification (Endpoint):	Safety Study
Primary Outcomes:	Number of subjects reporting grade 3 adverse events Within 31 days (Day 0 - Day 30) after booster vaccination.
Secondary Outcomes:	Concentration of antibodies against cross-reactive pneumococcal serotypes 6A and 19A One month after booster vaccination Concentration of antibodies against vaccine pneumococcal serotypes One month after booster vaccination Number of subjects reporting serious adverse events After booster vaccination up to study end (Visit 1 to Visit 2). Concentration of antibodies against polyribosyl-ribitol-phosphate (PRP) One month after booster vaccination Opsonophagocytic activity against vaccine pneumococcal serotypes One month after booster vaccination Opsonophagocytic activity against cross-reactive pneumococcal serotypes 6A and 19A One month after booster vaccination Number of subjects reporting unsolicited adverse events Within 31 days after booster vaccination Number of subjects reporting solicited symptoms Within 4 days after booster vaccination Concentration of antibodies against protein D (PD) One month after booster vaccination
Conditions:	Pneumococcal diseases Streptococcus pneumoniae
Keywords:	Safety Pneumococcal vaccine Immunogenicity Pneumococcal disease Booster vaccination
Eligibility Criteria:	Click to view inclusion/exclusion 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.
Gender:	Both
Minimum Age:	12 Months
Maximum Age:	18 Months
Enrollment:	450
Enrollment Type:	Actual
Healthy Volunteers?:	yes
Central Contact:	Call Center
Central Contact Phone:	877-379-3718
Central Contact Email:	GSKClinicalSupportHD@gsk.com
Backup Central Contact:
Backup Central Contact Phone:
Backup Central Contact Email:
Overall Study Official:	GSK Clinical Trials
Overall Study Official Affiliation:	GlaxoSmithKline
Overall Study Official Role:	Study Director
Responsible Party Name/Official Title:	Cheri Hudson; Clinical Disclosure Advisor
Responsible Party Organization:	GSK Clinical Disclosure
Location and Contact Information:	Click to view location information South Korea (click to view all sites in South Korea) GSK Investigational Site Daejeon, 301-723; COMPLETED; Contact: Kyung Yil Lee, Principal Investigator, . GSK Investigational Site Pusan, 602-739; COMPLETED; Contact: Su Eun Park, Principal Investigator, . GSK Investigational Site Wonju-si Kangwon-do, 220-701; COMPLETED; Contact: Hwang Min Kim, Principal Investigator, . GSK Investigational Site Iksan, 570-711; COMPLETED; Contact: Jong-Duck Kim, Principal Investigator, . GSK Investigational Site Seoul, 158-710; COMPLETED; Contact: Kyung-Hyo Kim, Principal Investigator, . GSK Investigational Site Seoul, 150-719; COMPLETED; Contact: Kwang-Nam Kim, Principal Investigator, . GSK Investigational Site Gyeonggi-do, 411-706; COMPLETED; Contact: Nam Hee Kim, Principal Investigator, . GSK Investigational Site Ansan, 425-707; COMPLETED; Contact: Yun-Kyung Kim, Principal Investigator, . GSK Investigational Site Bucheon-Si, GyeongGi-do,, 420-767; COMPLETED; Contact: Chang-Hwi Kim, Principal Investigator, . GSK Investigational Site GyeongSangNam-do, 641-560; COMPLETED; Contact: Sang Hyuk Ma, Principal Investigator, . GSK Investigational Site Seoul, 130-702; COMPLETED; Contact: Sung Ho Cha, Principal Investigator, . GSK Investigational Site Suwon City, Gyeonggi-do, 442-723; COMPLETED; Contact: Jong-Hyun Kim, Principal Investigator, . GSK Investigational Site Jeonju Jeonbuk, 561-712; COMPLETED; Contact: Jung Soo Kim, Principal Investigator, . GSK Investigational Site Jeju City, 690-121; COMPLETED; Contact: Jung-Yun Hong, Principal Investigator, .

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Protocol Summary for 112933