Safety & Immunogenicity of Pneumococcal Vaccine 2189242A in Children Aged 12-23 Months at the Time of First Vaccination

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00985751
First received: September 24, 2009
Last updated: May 26, 2011
Last verified: May 2011
  Purpose

This study will assess the safety, reactogenicity and immunogenicity of different formulations of GSK Biologicals' pneumococcal vaccine 2189242A when administered alone or in combination with the 10-valent pneumococcal conjugate vaccine (GSK1024850A vaccine) as a 2-dose primary vaccination course followed by a booster dose in healthy children aged 12-23 months at the time of first vaccination. Considering that febrile reactions are frequently observed following pneumococcal vaccination, usually co-administered with other routine paediatric vaccines, the primary study objective will focus on evaluating the increase in grade 3 fever (i.e. rectal temperature >40.0°C).


Condition Intervention Phase
Pneumococcal Disease
Haemophilus Influenzae Infections
Biological: Pneumococcal vaccine GSK2189242A (formulation 1)
Biological: Pneumococcal vaccine GSK2189242A (formulation 2)
Biological: Pneumococcal vaccine GSK2189242A combined with pneumococcal vaccine GSK1024850A (formulation 3)
Biological: Pneumococcal vaccine GSK2189242A combined with pneumococcal vaccine GSK1024850A (formulation 4)
Biological: Pneumococcal vaccine GSK1024850A
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Safety, Reactogenicity & Immunogenicity of GSK Biologicals' Pneumococcal Vaccine 2189242A in Children Aged 12-23 Months at the Time of First Vaccination

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Occurrence of fever >40.0°C (rectal temperature) [ Time Frame: Within 7 days (Day 0-6) following at least one dose of the primary vaccinations. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurrence of each solicited local and general adverse events [ Time Frame: Within 7 days (Day 0-6) after each vaccination ] [ Designated as safety issue: No ]
  • Occurrence of unsolicited adverse events [ Time Frame: Within 31 days (Day 0-30) after each vaccination ] [ Designated as safety issue: No ]
  • Occurrence of serious adverse events [ Time Frame: From the first vaccine dose up to study end ] [ Designated as safety issue: No ]
  • Evaluation of the immune responses to components of the investigational vaccines [ Time Frame: One month post-dose 2, before booster dose and one month post-booster dose ] [ Designated as safety issue: No ]

Enrollment: 257
Study Start Date: November 2009
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1 Biological: Pneumococcal vaccine GSK2189242A (formulation 1)
Three doses will be administered intramuscularly, at Month 0, 2 and 6.
Experimental: Group 2 Biological: Pneumococcal vaccine GSK2189242A (formulation 2)
Three doses will be administered intramuscularly, at Month 0, 2 and 6
Experimental: Group 3 Biological: Pneumococcal vaccine GSK2189242A combined with pneumococcal vaccine GSK1024850A (formulation 3)
Three doses will be administered intramuscularly, at Month 0, 2 and 6
Experimental: Group 4 Biological: Pneumococcal vaccine GSK2189242A combined with pneumococcal vaccine GSK1024850A (formulation 4)
Three doses will be administered intramuscularly, at Month 0, 2 and 6
Experimental: Control Group Biological: Pneumococcal vaccine GSK1024850A
Three doses will be administered intramuscularly, at Month 0, 2 and 6

  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) (LAR) can and will comply with the requirements of the protocol
  • Male or female between, and including, 12 and 23 months of age at the time of the first 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.

Exclusion Criteria:

  • 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 within six months prior to the first vaccine dose.
  • Planned administration/administration of a vaccine not foreseen by the study protocol during the study period starting from 30 days before each dose and ending 30 days after each dose of vaccine(s).
  • Previous vaccination against S. pneumoniae since birth.
  • History of any hypersensitivity reaction following any previous vaccination.
  • Eczema and any history of allergy
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required), including human immunodeficiency virus infection.
  • A family history of congenital or hereditary immunodeficiency.
  • Major congenital defects or any chronic illness.
  • History of any neurologic disorders or seizures.
  • Acute disease and/or fever at the time of enrolment.
  • Fever is defined as temperature >= 37.5°C on oral or axillary setting, or >= 38.0°C on rectal setting.
  • Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
  • Administration of immunoglobulins and/ or any blood products within the 3 months preceding the first dose of study vaccine or planned use during the study period.
  • Child in care.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00985751

Locations
Czech Republic
GSK Investigational Site
Chomutov, Czech Republic, 43003
GSK Investigational Site
Decin, Czech Republic, 405 01
GSK Investigational Site
Nachod, Czech Republic, 547 01
GSK Investigational Site
Odolena voda, Czech Republic, 25070
GSK Investigational Site
Ostrava - Poruba, Czech Republic, 70868
GSK Investigational Site
Pardubice, Czech Republic, 532 03
GSK Investigational Site
Plzen, Czech Republic, 305 99
GSK Investigational Site
Praha 4, Czech Republic, 140 00
GSK Investigational Site
Praha 6, Czech Republic, 1600
GSK Investigational Site
Znojmo, Czech Republic, 669 00
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00985751     History of Changes
Other Study ID Numbers: 113171
Study First Received: September 24, 2009
Last Updated: May 26, 2011
Health Authority: Czech: State Institute for Drug Control

Keywords provided by GlaxoSmithKline:
immunogenicity
toddlers
Pneumococcal vaccine
Haemophilus influenzae
safety
Streptococcus pneumoniae
Streptococcus Pneumoniae Vaccines

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

ClinicalTrials.gov processed this record on July 22, 2014