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
1 other identifier
interventional
450
1 country
14
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2009
Shorter than P25 for phase_3
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 28, 2009
CompletedFirst Posted
Study publicly available on registry
June 1, 2009
CompletedStudy Start
First participant enrolled
June 11, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 11, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 11, 2010
CompletedResults Posted
Study results publicly available
January 19, 2011
CompletedSeptember 20, 2018
October 1, 2016
7 months
May 28, 2009
January 6, 2011
August 21, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (9)
Number of Subjects Reporting Solicited Symptoms
Within 4 days (Days 0 to 3) after booster vaccination
Number of Subjects Reporting Unsolicited Adverse Events
Within 31 days (Days 0 to 30) after booster vaccination
Number of Subjects Reporting Serious Adverse Events
After booster vaccination up to study end (Month 0 to Month 1)
Concentration of Antibodies Against Vaccine Pneumococcal Serotypes
One month after booster vaccination (Month 1)
Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes
One month after booster vaccination (Month 1)
- +4 more secondary outcomes
Study Arms (2)
Synflorix Group
EXPERIMENTALSubjects 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.
Prevenar Group
ACTIVE COMPARATORSubjects 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.
Interventions
Intramuscular injection, administered as a single dose
Intramuscular injection, administered as a single dose
Intramuscular injection, administered as a single dose
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (14)
GSK Investigational Site
Ansan, 425-707, South Korea
GSK Investigational Site
Bucheon-Si, GyeongGi-do,, 420-767, South Korea
GSK Investigational Site
Daejeon, 301-723, South Korea
GSK Investigational Site
Gyeonggi-do, 411-706, South Korea
GSK Investigational Site
GyeongSangNam-do, 641-560, South Korea
GSK Investigational Site
Iksan, 570-711, South Korea
GSK Investigational Site
Jeju City, 690-121, South Korea
GSK Investigational Site
Jeonju Jeonbuk, 561-712, South Korea
GSK Investigational Site
Pusan, 602-739, South Korea
GSK Investigational Site
Seoul, 130-702, South Korea
GSK Investigational Site
Seoul, 150-719, South Korea
GSK Investigational Site
Seoul, 158-710, South Korea
GSK Investigational Site
Suwon City, Gyeonggi-do, 442-723, South Korea
GSK Investigational Site
Wonju-si Kangwon-do, 220-701, South Korea
Related Publications (4)
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.
PMID: 21817957BACKGROUNDKim 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.
BACKGROUNDKim 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.
BACKGROUNDKim 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.
BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 28, 2009
First Posted
June 1, 2009
Study Start
June 11, 2009
Primary Completion
January 11, 2010
Study Completion
January 11, 2010
Last Updated
September 20, 2018
Results First Posted
January 19, 2011
Record last verified: 2016-10
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.