Last updated: 11/03/2018 13:53:21

Booster Vaccination Study with a Pneumococcal Vaccine in children primed with the same vaccine

GSK study ID
112933
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Booster vaccination with pneumococcal vaccine GSK1024850A or Prevenar™ co-administered with Hiberix™ in children primed with the same vaccines
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Single (Participant)
Allocation:
Non-randomized
Primary outcomes:

Number of subjects reporting grade 3 adverse events

Timeframe: Within 31 days (Day 0 - Day 30) after booster vaccination.

Secondary outcomes:

Number of subjects reporting solicited symptoms

Timeframe: Within 4 days (Days 0 to 3) after booster vaccination

Number of subjects reporting unsolicited adverse events

Timeframe: Within 31 days (Days 0 to 30) after booster vaccination

Number of subjects reporting serious adverse events

Timeframe: After booster vaccination up to study end (Month 0 to Month 1)

Concentration of antibodies against vaccine pneumococcal serotypes

Timeframe: One month after booster vaccination (Month 1)

Opsonophagocytic activity against vaccine pneumococcal serotypes

Timeframe: One month after booster vaccination (Month 1)

Concentration of antibodies against cross-reactive pneumococcal serotypes 6A and 19A

Timeframe: One month after booster vaccination (Month 1)

Opsonophagocytic activity against cross-reactive pneumococcal serotypes 6A and 19A

Timeframe: One month after booster vaccination (Month 1)

Concentration of antibodies against protein D (PD)

Timeframe: One month after booster vaccination (Month 1)

Concentration of antibodies against polyribosyl-ribitol-phosphate (PRP)

Timeframe: One month after booster vaccination (Month 1)

Interventions:
Biological/vaccine: GSK Biologicals’ Synflorix™ (Pneumococcal vaccine GSK1024850A)
Biological/vaccine: Wyeth-Lederle’s Prevenar™
Biological/vaccine: GSK Biologicals’ Hiberix™
Enrollment:
450
Observational study model:
Not applicable
Primary completion date:
2010-11-01
Time perspective:
Not applicable
Clinical publications:
Kim CH et al. (2011) Response to Primary and Booster vaccination with 10-valent Pneumococcal nontypeable Haemophilus influenzae Protein D conjugate vaccine in Korean Infants. Pediatr Infect Dis J. 30(12):e235-e243.
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.
Medical condition
Infections, Streptococcal
Product
GSK1024850A
Collaborators
Not applicable
Study date(s)
June 2009 to January 2010
Type
Interventional
Phase
3

Participation criteria

Sex
Female & Male
Age
12 - 18 months
Accepts healthy volunteers
Yes
  • 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.
  • 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).

Trial location(s)

Location
Status
Contact us
Contact us
Location
GSK Investigational Site
Iksan, South Korea, 570-711
Status
Study Complete
Location
GSK Investigational Site
Jeju City, South Korea, 690-121
Status
Study Complete
Location
GSK Investigational Site
Bucheon-Si, GyeongGi-do,, South Korea, 420-767
Status
Study Complete
Location
GSK Investigational Site
Gyeonggi-do, South Korea, 411-706
Status
Study Complete
Location
GSK Investigational Site
Suwon City, Gyeonggi-do, South Korea, 442-723
Status
Study Complete
Location
GSK Investigational Site
Seoul, South Korea, 150-719
Status
Study Complete
Location
GSK Investigational Site
GyeongSangNam-do, South Korea, 641-560
Status
Study Complete
Location
GSK Investigational Site
Ansan, South Korea, 425-707
Status
Study Complete
Location
GSK Investigational Site
Jeonju Jeonbuk, South Korea, 561-712
Status
Study Complete
Location
GSK Investigational Site
Daejeon, South Korea, 301-723
Status
Study Complete
Location
GSK Investigational Site
Pusan, South Korea, 602-739
Status
Study Complete
Location
GSK Investigational Site
Wonju-si Kangwon-do, South Korea, 220-701
Status
Study Complete

Study documents

Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English

If you wish to request for full study report, please contact - [email protected]

Results overview

Results posted on ClinicalTrials.gov

Recruitment status
Completed
Actual primary completion date
2010-11-01
Actual study completion date
2010-11-01

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

Participate in clinical trial
Additional information
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Click here
Access to clinical trial data by researchers
Visit website