Long-term Follow-up Study of Children Previously Primed With GSK Pneumococcal Vaccine (GSK1024850A) and of Unprimed Children

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00950833
First received: July 30, 2009
Last updated: January 19, 2012
Last verified: January 2012
  Purpose

The objective of this study is to evaluate the immune memory through the administration of an additional dose of GSK Biologicals' pneumococcal conjugate vaccine GSK1024850A, the antibody persistence and long-term effect on nasopharyngeal carriage of S. pneumoniae and H. influenzae in subjects primed and boosted with GSK Biologicals' pneumococcal conjugate vaccine GSK1024850A in previous primary and booster studies. For subjects that did not receive the investigational vaccine during the primary and booster study, the objective is to evaluate immunogenicity, safety and reactogenicity of a 2-dose catch-up vaccination with GSK Biologicals' pneumococcal conjugate vaccine GSK1024850A.

This protocol posting deals with objectives & outcome measures of the extension phase. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT00370318). The objectives & outcome measures of the booster phase are presented in a separate protocol posting (NCT00496015).


Condition Intervention Phase
Streptococcus Pneumoniae
Pneumococcal Disease
Biological: Pneumococcal vaccine GSK1024850A
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Vaccination Course in Children Primed and Boosted With Pneumococcal Vaccine GSK 1024850A and in Age-matched Unprimed Children

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Demonstration of immune memory through the evaluation of early immune responses in terms of concentration of antibodies against components of the investigational vaccine [ Time Frame: 7-10 days after the single/first dose of investigational vaccine ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Persistence of immune responses and evaluation of immune memory through the evaluation of early immune responses to components of the investigational vaccine for additional parameters [ Time Frame: prior to and 7-10 days after the single/first dose of investigational vaccine ] [ Designated as safety issue: No ]
  • Evaluation of the immune responses to components of the investigational vaccine for additional parameters in the unprimed group [ Time Frame: one month post-dose II ] [ Designated as safety issue: No ]
  • Persistence of immune responses in terms of antibody titres against components of the meningococcal conjugate vaccine in the unprimed group [ Time Frame: 25-36 months post-vaccination in previous study NCT00496015 ] [ Designated as safety issue: No ]
  • Occurrence of each solicited adverse event [ Time Frame: within 4 days after each vaccination ] [ Designated as safety issue: No ]
  • Occurrence of unsolicited adverse event [ Time Frame: within 31 days after each vaccination ] [ Designated as safety issue: No ]
  • Occurrence of serious adverse events [ Time Frame: During the entire study period (day 0 - mth 10 for AP-AP group and NAP group and day 0- mth 12 for unprimed group) ] [ Designated as safety issue: No ]
  • Occurrence of S. pneumoniae and H. influenzae in the nasopharynx [ Time Frame: at 31-44 months of age and prior to the single/first dose of investigational vaccine at 40-48 months of age ] [ Designated as safety issue: No ]

Enrollment: 467
Study Start Date: August 2009
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: AP-AP Group
subjects from the AP-AP group, previously vaccinated with pneumococcal conjugate vaccine GSK1024850A in study NCT00496015, receiving an additional dose of pneumococcal conjugate vaccine GSK1024850A for immune memory assessment
Biological: Pneumococcal vaccine GSK1024850A
1 or 2 intramuscular injections
Active Comparator: NAP-pre Group
subjects from the NAP-pre group, previously vaccinated with pneumococcal conjugate vaccine GSK1024850A in study NCT00496015 receiving an additional dose of pneumococcal conjugate vaccine GSK1024850A for immune memory assessment
Biological: Pneumococcal vaccine GSK1024850A
1 or 2 intramuscular injections
Active Comparator: Unprimed Group
Age-matched subjects from the unprimed group of the NCT00496015 study, not previously vaccinated with any pneumococcal vaccine, receiving two doses of pneumococcal conjugate vaccine GSK1024850A
Biological: Pneumococcal vaccine GSK1024850A
1 or 2 intramuscular injections

Detailed Description:

This protocol posting has been updated according to Protocol Amendment 1, July 2009

  Eligibility

Ages Eligible for Study:   31 Months to 44 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who the investigator believes that their parents/ guardians can and will comply with the requirements of the protocol should be enrolled in the study.
  • A male or female between, and including, 31 and 34 months of age at the time of the enrolment.
  • Subjects who previously participated in study NCT00496015
  • For the subjects in the primed AP-AP and NAP-pre groups: subjects who received a booster dose of the pneumococcal conjugate vaccine prior to the study amendment 3.
  • For the subjects in the unprimed group: subjects who received a dose of the meningococcal vaccine GSK134612.
  • Written informed consent obtained from the parent or guardian of the subject.
  • Free of obvious health problems as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding enrolment, or planned use during the entire study period.
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs during the entire study period.
  • Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of study vaccine and ending 30 days after.
  • 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).
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
  • History of seizures or progressive neurological disease.
  • Acute disease at the time of enrolment, defined as the presence of a mild, moderate or severe illness with or without fever.
  • Administration or planned use of immunoglobulins and/ or any blood products during the entire study period.
  • A family history of congenital or hereditary immunodeficiency.
  • Major congenital defects or serious chronic illness.
  • Subjects of which both parents have a history of atopia (polinosis, asthma, atopic eczema).
  • Administration of any pneumococcal vaccine since the end of study NCT00496015.
  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: NCT00950833

Locations
Czech Republic
GSK Investigational Site
Brno, Czech Republic, 628 00
GSK Investigational Site
Hradec Kralove, Czech Republic, 500 01
GSK Investigational Site
Nachod, Czech Republic, 547 01
GSK Investigational Site
Ostrava, Czech Republic, 70800
GSK Investigational Site
Pardubice, Czech Republic, 532 03
GSK Investigational Site
Praha 5, Czech Republic, 150 00
GSK Investigational Site
Praha 6, Czech Republic, 160 00
GSK Investigational Site
Praha 9, Czech Republic, 190 00
GSK Investigational Site
Znojmo, Czech Republic, 669 00
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00950833     History of Changes
Other Study ID Numbers: 112801
Study First Received: July 30, 2009
Last Updated: January 19, 2012
Health Authority: Czech: State Institute for Drug Control

Keywords provided by GlaxoSmithKline:
Catch-up vaccination
Pneumococcal vaccine
Immune memory
Nasopharyngeal carriage
Immunogenicity
Pneumococcal disease
Safety

ClinicalTrials.gov processed this record on October 23, 2014