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Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' Pneumococcal Vaccine 2830930A Administered in Toddlers

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ClinicalTrials.gov Identifier: NCT01485406
Recruitment Status : Completed
First Posted : December 5, 2011
Last Update Posted : February 10, 2021
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Description
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Brief Summary:
The purpose of this study is to assess the safety, reactogenicity and immunogenicity of the GSK Biologicals' pneumococcal vaccine 2830930A in toddlers aged 12 to 23 months at study entry.

Condition or disease Intervention/treatment Phase
Infections, Streptococcal Biological: Pneumococcal vaccine GSK2830930A Biological: Synflorix™ Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Safety and Immunogenicity Study of GSK Biologicals' Pneumococcal Vaccine 2830930A When Administered as a Single Dose in Healthy Toddlers Aged 12-23 Months
Actual Study Start Date : December 12, 2011
Actual Primary Completion Date : March 15, 2012
Actual Study Completion Date : March 15, 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaccines

Arms and Interventions
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Arm Intervention/treatment
Experimental: Pn Group
Toddlers 12-23 months of age receiving GSK2830930A vaccine.
 Biological: Pneumococcal vaccine GSK2830930A
1 dose administered intramuscularly
Active Comparator: Control Group
Toddlers 12-23 months of age receiving Synflorix.
 Biological: Synflorix™
1 dose administered intramuscularly


Outcome Measures
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Primary Outcome Measures :
  1. Occurrence of each grade 3 solicited adverse event with relationship to vaccination [ Time Frame: Within 7 days (Day 0-Day 6) after vaccination ]
  2. Occurrence of grade 3 unsolicited adverse events with relationship to vaccination [ Time Frame: Within 31 days (Day 0-Day 30) after vaccination ]
  3. Occurrence of serious adverse events with relationship to vaccination [ Time Frame: During the entire study (from Month 0 up to Month 1) ]

Secondary Outcome Measures :
  1. Occurrence of each solicited adverse event [ Time Frame: Within 7 days (Day 0-Day 6) after vaccination ]
  2. Occurrence of each unsolicited adverse event [ Time Frame: Within 31 days (Day 0-Day 30) after vaccination ]
  3. Occurrence of serious adverse event [ Time Frame: During the entire study (from Month 0 up to Month 1) ]
  4. Evaluation of the immune responses to the components of the 2830930A vaccine [ Time Frame: One month post-vaccination ]

Eligibility Criteria
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Ages Eligible for Study:   12 Months to 23 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LARs) can and will comply with the requirements of the protocol.
  • A male or female between, and including 12 to 23 months of age at the time of vaccination.
  • Written informed consent obtained from the parents/LAR(s) of the subject.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • Born after a gestation period of at least 36 weeks.
  • Previously completed three-dose vaccination course with Synflorix.

Exclusion Criteria:

  • Child in care.
  • Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Chronic administration of immunosuppressants or other immune-modifying drugs since birth.

  • Planned administration/administration of a vaccine containing diphtheria- or tetanus- toxoid or CRM197 and not foreseen by the study protocol during any time of the study period, or of any other vaccines not foreseen by the protocol in the period starting from 30 days before the vaccine dose and ending 30 days after, with the exception of licensed influenza vaccines.

    • The licensed influenza vaccines are always allowed, even if concomitantly administered with the study vaccines but should be documented in the "Concomitant vaccination" of the electronic Case Report Form.
  • 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
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
  • Family history of congenital or hereditary immunodeficiency.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
  • Major congenital defects or serious chronic illness, including Kawasaki's syndrome.
  • History of any neurological disorders or seizures, including conditions such as hypotensive-hyporesponsive episodes, encephalopathy and any convulsions (afebrile and febrile).
  • Acute disease and/or fever at the time of enrolment.
  • Administration of immunoglobulins and/or any blood products within the 3 months preceding vaccination or planned administration during study period.
  • Any medical condition which might interfere with the assessment of the study objectives in the opinion of the investigator.
  • Previous receipt of a booster dose (fourth dose) of Synflorix.
  • Anaphylaxis following previous administration of vaccines.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01485406


Locations
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Germany
GSK Investigational Site
Kehl, Baden-Wuerttemberg, Germany, 77694
GSK Investigational Site
Berchtesgaden, Bayern, Germany, 83471
GSK Investigational Site
Braunatal, Hessen, Germany, 34225
GSK Investigational Site
Berlin, Germany, 13055
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
More Information
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Publications:

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01485406    
Other Study ID Numbers: 115373
2011-002225-22 ( EudraCT Number )
First Posted: December 5, 2011    Key Record Dates
Last Update Posted: February 10, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD for this study is available via the Clinical Study Data Request site.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: IPD is available via the Clinical Study Data Request site (copy the URL below to your browser)
Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
URL: https://clinicalstudydatarequest.com/Posting.aspx?ID=20770
Keywords provided by GlaxoSmithKline:
Haemophilus influenzae
Safety
Pneumococcal vaccine
 Streptococcus pneumoniae
Immunogenicity
Toddlers
Additional relevant MeSH terms:
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Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
 Infections
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs