Evaluate Safety and Immunogenicity of a Booster Dose of Pneumococcal Conjugate Vaccine in Preterm Born Infants.

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00609492
First received: January 25, 2008
Last updated: January 12, 2012
Last verified: March 2011
  Purpose

The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of a booster dose of GlaxoSmithKline (GSK) Biologicals´ pneumococcal conjugate vaccine co-administered with a booster dose of DTPa-IPV/Hib (Infanrix-IPV/Hib) in preterm born children at the age of 16-18 months. This protocol posting deals with objectives & outcome measures of the booster phase. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number =NCT00390910 ). Subjects participating in this study should have received three doses of pneumococcal vaccine in the primary study.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.


Condition Intervention Phase
Pneumococcal Disease
Streptococcus Pneumoniae Vaccines
Biological: GSK Biologicals´ Pneumococcal Conjugate Vaccine (GSK1024850A)
Biological: Infanrix™-IPV/Hib
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Safety, Reactogenicity and Immunogenicity Following Booster Dose of GSK Biologicals´ Pneumococcal Conjugate Vaccine When Co-administered With a Booster Dose of Infanrix-IPV/Hib in Preterm Born Children at 16-18 Months of Age

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Occurrence of core fever >39°C (rectal temperature) or >38.5°C (oral, axillary or tympanic temperature) [ Time Frame: Within 4 days after booster vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurrence of solicited local symptoms (any and grade 3) [ Time Frame: Within 4 days after booster vaccination ] [ Designated as safety issue: No ]
  • Occurrence of solicited general symptoms (any and grade 3) [ Time Frame: Within 4 days after booster vaccination ] [ Designated as safety issue: No ]
  • Occurrence of unsolicited adverse events [ Time Frame: Within 31 days after booster vaccination ] [ Designated as safety issue: No ]
  • Occurrence of serious adverse events [ Time Frame: Throughout the active phase of the study ] [ Designated as safety issue: No ]
  • Occurrence of serious adverse events [ Time Frame: Throughout the entire study period starting from Visit 1 up to the end of the extended safety follow-up ] [ Designated as safety issue: No ]
  • Anti-pneumococcal vaccine serotypes antibody concentrations ≥ 0.20 µg/mL [ Time Frame: Prior to and one month after the administration of the booster dose of GSK Biologicals´ 10-valent pneumococcal conjugate vaccine co-administered with the booster dose of DTPa-IPV/Hib vaccine ] [ Designated as safety issue: No ]
  • Antibody concentrations against vaccine pneumococcal serotypes. [ Time Frame: Prior to and one month after the administration of the booster dose of GSK Biologicals´ 10-valent pneumococcal conjugate vaccine co-administered with the booster dose of DTPa-IPV/Hib vaccine ] [ Designated as safety issue: No ]
  • Antibody concentrations against pneumococcal cross-reactive serotypes [ Time Frame: Prior to and one month after the administration of the booster dose of GSK Biologicals´ 10-valent pneumococcal conjugate vaccine co-administered with the booster dose of DTPa-IPV/Hib vaccine ] [ Designated as safety issue: No ]
  • Antibody concentrations against protein D [ Time Frame: Prior to and one month after the administration of the booster dose of GSK Biologicals´ 10-valent pneumococcal conjugate vaccine co-administered with the booster dose of DTPa-IPV/Hib vaccine ] [ Designated as safety issue: No ]
  • Anti-diphtheria and anti-tetanus toxoids, anti-PRP, anti-PT, anti-FHA and anti-PRN and anti-polio type 1, 2 and 3 antibody titres [ Time Frame: Prior to and one month after the administration of the booster dose of GSK Biologicals´ 10-valent pneumococcal conjugate vaccine co-administered with the booster dose of DTPa-IPV/Hib vaccine ] [ Designated as safety issue: No ]
  • Seropositivity status [ Time Frame: Prior to and one month after the administration of the booster dose of GSK Biologicals´ 10-valent pneumococcal conjugate vaccine co-administered with the booster dose of DTPa-IPV/Hib vaccine ] [ Designated as safety issue: No ]
  • Seroprotection status [ Time Frame: Prior to and one month after the administration of the booster dose of GSK Biologicals´ 10-valent pneumococcal conjugate vaccine co-administered with the booster dose of DTPa-IPV/Hib vaccine ] [ Designated as safety issue: No ]
  • Immune response to booster dose of PT, FHA and PRN [ Time Frame: Prior to the administration of the booster dose of GSK Biologicals´ 10-valent pneumococcal conjugate vaccine co-administered with the booster dose of DTPa-IPV/Hib vaccine ] [ Designated as safety issue: No ]
  • Anti-HBs antibody concentrations [ Time Frame: Prior to the administration of the booster dose of GSK Biologicals´ 10-valent pneumococcal conjugate vaccine co-administered with the booster dose of DTPa-IPV/Hib vaccine ] [ Designated as safety issue: No ]
  • Seroprotection status [ Time Frame: Prior to the administration of the booster dose of GSK Biologicals´ 10-valent pneumococcal conjugate vaccine co-administered with the booster dose of DTPa-IPV/Hib vaccine ] [ Designated as safety issue: No ]
  • Opsonophagocytic activity against vaccine pneumococcal serotypes. [ Time Frame: One month after the administration of the booster dose of GSK Biologicals´ 10-valent pneumococcal conjugate vaccine co-administered with the booster dose of DTPa-IPV/Hib vaccine ] [ Designated as safety issue: No ]
  • Opsonophagocytic activity against pneumococcal cross-reactive serotypes [ Time Frame: One month after the administration of the booster dose of GSK Biologicals´ 10-valent pneumococcal conjugate vaccine co-administered with the booster dose of DTPa-IPV/Hib vaccine ] [ Designated as safety issue: No ]
  • Seropositivity status [ Time Frame: One month after the administration of the booster dose of GSK Biologicals´ 10-valent pneumococcal conjugate vaccine co-administered with the booster dose of DTPa-IPV/Hib vaccine ] [ Designated as safety issue: No ]

Enrollment: 245
Study Start Date: January 2008
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Preterm I Group
Children born after a gestation period of 27-30 weeks
Biological: GSK Biologicals´ Pneumococcal Conjugate Vaccine (GSK1024850A)
Single dose, intramuscular injection
Biological: Infanrix™-IPV/Hib
Single dose, intramuscular injection
Experimental: Preterm II Group
Children born after a gestation period of 31-36 weeks
Biological: GSK Biologicals´ Pneumococcal Conjugate Vaccine (GSK1024850A)
Single dose, intramuscular injection
Biological: Infanrix™-IPV/Hib
Single dose, intramuscular injection
Active Comparator: Full term Group
Children born after a gestation period of more than 36 weeks
Biological: GSK Biologicals´ Pneumococcal Conjugate Vaccine (GSK1024850A)
Single dose, intramuscular injection
Biological: Infanrix™-IPV/Hib
Single dose, intramuscular injection

  Eligibility

Ages Eligible for Study:   16 Months to 18 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, 16-18 months of age at the time of the booster vaccination.
  • A male or female who previously participated in study 107737 and received three doses of pneumococcal conjugate vaccine.
  • 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:

  • Concurrently participating in another clinical study, at any time during the study period (active phase and extended safety follow-up), in which the subject has been or will be exposed to an investigational or a non-investigational product.
  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the booster dose of study vaccines, or planned use during the study period (active phase and 5 months extended safety follow-up).
  • Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months prior to the booster dose of study vaccine.
  • Planned administration/administration of a vaccine not foreseen by the study protocol, during the period starting from one month (30 days) before the booster dose of study vaccines (Visit 1) and up to the follow-up visit (Visit 2).
  • Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b and/or Streptococcus pneumoniae other than the study vaccines from study 107737
  • History of or intercurrent diphtheria, tetanus, hepatitis B, pertussis, polio, Haemophilus influenzae type b disease.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
  • History of seizures or progressive neurological disease
  • Acute disease at the time of enrolment.
  • Febrile illness defined as oral, axillary or tympanic temperature < 37.5°C / rectal temperature < 38°C. A temperature greater than or equal to these cut-offs warrants deferral of the vaccination pending recovery of the subject.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
  • A family history of congenital or hereditary immunodeficiency.
  • Major congenital defects or serious chronic illness.
  • Administration of immunoglobulins, with the exception of monoclonal antibodies against RSV, and/or any blood products within three months preceding the booster dose of study vaccines or planned administration during the active phase of the study.
  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: NCT00609492

Locations
Greece
GSK Investigational Site
Athens, Greece, 11527
GSK Investigational Site
Athens, Greece, 115 27
GSK Investigational Site
Ioannina, Greece, 452 21
GSK Investigational Site
Thessaloniki, Greece, 54636
Spain
GSK Investigational Site
Burgos, Spain, 09005
GSK Investigational Site
Madrid, Spain, 28047
GSK Investigational Site
Móstoles/Madrid, Spain, 28935
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: NCT00609492     History of Changes
Other Study ID Numbers: 109621
Study First Received: January 25, 2008
Last Updated: January 12, 2012
Health Authority: Spain: Spanish Agency of Medicines
Greece: National Drug Organisation

ClinicalTrials.gov processed this record on October 21, 2014