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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01485406
First received: December 1, 2011
Last updated: August 9, 2012
Last verified: August 2012
  Purpose

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 Intervention Phase
Haemophilus Influenzae Infections
Streptococcus Pneumoniae Disease
Biological: Pneumococcal vaccine GSK2830930A
Biological: Synflorix™
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Occurrence of each grade 3 solicited adverse event with relationship to vaccination [ Time Frame: Within 7 days (Day 0-Day 6) after vaccination ] [ Designated as safety issue: No ]
  • Occurrence of grade 3 unsolicited adverse events with relationship to vaccination [ Time Frame: Within 31 days (Day 0-Day 30) after vaccination ] [ Designated as safety issue: No ]
  • Occurrence of serious adverse events with relationship to vaccination [ Time Frame: During the entire study (from Month 0 up to Month 1) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurrence of each solicited adverse event [ Time Frame: Within 7 days (Day 0-Day 6) after vaccination ] [ Designated as safety issue: No ]
  • Occurrence of each unsolicited adverse event [ Time Frame: Within 31 days (Day 0-Day 30) after vaccination ] [ Designated as safety issue: No ]
  • Occurrence of serious adverse event [ Time Frame: During the entire study (from Month 0 up to Month 1) ] [ Designated as safety issue: No ]
  • Evaluation of the immune responses to the components of the 2830930A vaccine [ Time Frame: One month post-vaccination ] [ Designated as safety issue: No ]

Enrollment: 61
Study Start Date: December 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   12 Months to 23 Months
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01485406

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01485406     History of Changes
Other Study ID Numbers: 115373
Study First Received: December 1, 2011
Last Updated: August 9, 2012
Health Authority: Germany: PEI PauI-Ehrlich-Institut (Bundesinstitut für Impfstoffe und biomedizinische Arzneimittel)

Keywords provided by GlaxoSmithKline:
Haemophilus influenzae
Safety
Pneumococcal vaccine
Streptococcus pneumoniae
Immunogenicity
Toddlers

Additional relevant MeSH terms:
Influenza, Human
Pneumonia
Haemophilus Infections
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Lung Diseases
Pasteurellaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on April 16, 2014