Co-administration of Pneumococcal Conjugate Vaccine With DTPa-IPV-Hib Versus Co-administration With DTPa-HBV-IPV/Hib

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00652951
First received: March 21, 2008
Last updated: November 17, 2011
Last verified: October 2011
  Purpose

The purpose of this trial is to evaluate the immunogenicity and safety of a pneumococcal conjugate vaccine when co-administered with DTPa-IPV-Hib or DTPa-HBV-IPV/Hib in infants as a three-dose primary immunisation course during the first 6 months of life and as a booster dose at 11-12 months of age. The impact of the pneumococcal conjugate vaccine on nasopharyngeal carriage of S. pneumoniae and H. influenzae in children in their first two years of life will also be assessed. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.


Condition Intervention Phase
Pneumococcal Disease
Haemophilus Infection
Biological: GSK Biologicals´ Pneumococcal Conjugate Vaccine (GSK1024850A)
Biological: Infanrix™ hexa.
Biological: Pediacel™
Biological: Prevenar™
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Non-inferiority of Co-administration of GSK Biologicals'Pneumococcal Conjugate Vaccine GSK1024850A With DTPa-IPV-Hib Versus Co-administration With DTPa-HBV-IPV/Hib.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Antibody concentrations against vaccine pneumococcal serotypes [ Time Frame: One month after the administration of the third vaccine dose ] [ Designated as safety issue: No ]
  • Antibody concentration against protein D [ Time Frame: One month after the administration of the third vaccine dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pneumococcal conjugate vaccine: Anti-pneumococcal serotypes antibody concentrations >= 0.20 μg/mL [ Time Frame: One month after the administration of the third vaccine dose ] [ Designated as safety issue: No ]
  • Pneumococcal conjugate vaccine: Opsonophagocytic activity against pneumococcal vaccine serotypes [ Time Frame: One month after the administration of the third vaccine dose ] [ Designated as safety issue: No ]
  • Pneumococcal conjugate vaccine: Anti-pneumococcal cross-reactive serotypes antibody concentrations >= 0.20 μg/mL [ Time Frame: One month after the administration of the third vaccine dose ] [ Designated as safety issue: No ]
  • Pneumococcal conjugate vaccine: Antibody concentrations against pneumococcal cross-reactive serotypes [ Time Frame: One month after the administration of the third vaccine dose ] [ Designated as safety issue: No ]
  • Pneumococcal conjugate vaccine: Opsonophagocytic activity against pneumococcal cross-reactive [ Time Frame: One month after the administration of the third vaccine dose ] [ Designated as safety issue: No ]
  • Pneumococcal conjugate vaccine: Seropositivity status [ Time Frame: One month after the administration of the third vaccine dose ] [ Designated as safety issue: No ]
  • Anti-diphtheria & anti-tetanus toxoids, anti-polyribosyl-ribitol phosphate, anti-pertussis toxoid, anti-filamentous haemagglutinin & anti-pertactin, anti-hepatitis B surface antigen (HBs antibody concentrations, & anti-polio types 1,2 and 3 titres [ Time Frame: One month after the administration of the third vaccine dose ] [ Designated as safety issue: No ]
  • DTPa-HBV-IPV/Hib or DTPa-IPV-Hib vaccines: Seropositivity status [ Time Frame: One month after the administration of the third vaccine dose ] [ Designated as safety issue: No ]
  • DTPa-HBV-IPV/Hib or DTPa-IPV-Hib vaccines: Seroprotection status [ Time Frame: One month after the administration of the third vaccine dose ] [ Designated as safety issue: No ]
  • Pneumococcal conjugate vaccine: Anti-pneumococcal serotypes antibody concentrations >= 0.20 μg/mL. [ Time Frame: Prior to, 1 and 12 months after the administration of the booster dose ] [ Designated as safety issue: No ]
  • Pneumococcal conjugate vaccine: Antibody concentrations against pneumococcal serotypes [ Time Frame: Prior to, 1and 12 months after the administration of the booster dose ] [ Designated as safety issue: No ]
  • Pneumococcal conjugate vaccine: Opsonophagocytic activity against pneumococcal serotypes [ Time Frame: Prior to, 1 and 12 months after the administration of the booster dose ] [ Designated as safety issue: No ]
  • Pneumococcal conjugate vaccine: Anti-pneumococcal cross-reactive serotypes antibody concentrations >= 0.20 μg/mL. [ Time Frame: Prior to, 1 and 12 months after the administration of the booster dose ] [ Designated as safety issue: No ]
  • Pneumococcal conjugate vaccine: Antibody concentrations against pneumococcal cross-reactive serotypes [ Time Frame: Prior to, 1 and 12 months after the administration of the booster dose ] [ Designated as safety issue: No ]
  • Pneumococcal conjugate vaccine: Opsonophagocytic activity against pneumococcal cross-reactive serotypes [ Time Frame: Prior to, 1 and 12 months after the administration of the booster dose ] [ Designated as safety issue: No ]
  • Pneumococcal conjugate vaccine: Antibody concentration against protein D. [ Time Frame: Prior to, 1and 12 month after the administration of the booster dose ] [ Designated as safety issue: No ]
  • Pneumococcal conjugate vaccine: Seropositivity status [ Time Frame: Prior to, 1 and 12 month after the administration of the booster dose ] [ Designated as safety issue: No ]
  • DTPa-HBV-IPV/Hib or DTPa-IPV-Hib vaccines: Anti-diphtheria and anti-tetanus toxoids, anti-PRP, anti-PT, anti-FHA and anti-PRN, anti-HBs antibody concentrations, and anti-polio types 1, 2 and 3 titres. [ Time Frame: Prior to and one month after the administration of the booster dose ] [ Designated as safety issue: No ]
  • DTPa-HBV-IPV/Hib or DTPa-IPV-Hib vaccines: Seropositivity status [ Time Frame: Prior to and one month after the administration of the booster dose ] [ Designated as safety issue: No ]
  • DTPa-HBV-IPV/Hib or DTPa-IPV-Hib vaccines: Seroprotection status [ Time Frame: Prior to and one month after the administration of the booster dose ] [ Designated as safety issue: No ]
  • Booster vaccine response to PT, FHA and PRN [ Time Frame: Prior to and one month after the administration of the booster dose ] [ Designated as safety issue: No ]
  • Occurrence of H. influenza and/or S. pneumoniae in the nasopharynx [ Time Frame: One month after the administration of the third vaccine dose; prior to the booster dose, and at 14-15 months of age, 18-19 months of age and 23-24 months of ageTime point(s) at which outcome measure is assessed. ] [ Designated as safety issue: No ]
  • Acquisition of new H. influenzae and/or S. pneumoniae strains in the nasopharynx [ Time Frame: One month after the administration of the third vaccine dose; prior to the booster dose, and at 14-15 months of age, 18-19 months of age and 23-24 months of ageTime point(s) at which outcome measure is assessed. ] [ Designated as safety issue: No ]
  • Occurrence of solicited local symptoms (any and grade 3) [ Time Frame: Within 4 days (day 0 - day 3) after each vaccination ] [ Designated as safety issue: No ]
  • Occurrence of solicited general symptoms (any and grade 3) [ Time Frame: Within 4 days (day 0 - day 3) after each vaccination ] [ Designated as safety issue: No ]
  • Occurrence of unsolicited adverse events [ Time Frame: Within 31 days (day 0 - day 30) after each vaccination. ] [ Designated as safety issue: No ]
  • Occurrence of serious adverse events [ Time Frame: Throughout the entire study period. ] [ Designated as safety issue: No ]

Enrollment: 780
Study Start Date: April 2008
Study Completion Date: December 2010
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group A Biological: GSK Biologicals´ Pneumococcal Conjugate Vaccine (GSK1024850A)
Intramuscular injection, 3 doses in the primary vaccination and 1 dose in the booster vaccination
Biological: Infanrix™ hexa.
Intramuscular injection, , 3 doses in the primary vaccination and 1 dose in the booster vaccination
Experimental: Group B Biological: GSK Biologicals´ Pneumococcal Conjugate Vaccine (GSK1024850A)
Intramuscular injection, 3 doses in the primary vaccination and 1 dose in the booster vaccination
Biological: Pediacel™
Intramuscular injection, , 3 doses in the primary vaccination and 1 dose in the booster vaccination
Active Comparator: Group C Biological: Pediacel™
Intramuscular injection, , 3 doses in the primary vaccination and 1 dose in the booster vaccination
Biological: Prevenar™
Intramuscular injection, , 3 doses in the primary vaccination and 1 dose in the booster vaccination

  Eligibility

Ages Eligible for Study:   6 Weeks to 12 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who the investigator believes that their parents/guardian(s) can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) should be enrolled in the study.
  • A male or female between, and including, 6-12 weeks (42-90 days) of age at the time of the first vaccination.
  • Written informed consent obtained from both parents or from the guardian(s) of the subject.
  • Free of obvious health problems as established by medical history and clinical examination before entering into the study.
  • Born after a gestation period of at least 36 weeks.

Exclusion Criteria:

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Concurrently participating in another clinical study, at any time during the entire study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
  • Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting from one month (30 days) before and up to one month (30 days) after each dose of study vaccine.
  • Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b and/or Streptococcus pneumoniae.
  • Children for whom hepatitis B vaccination is required according to the local recommendations
  • History of or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio, Haemophilus influenzae type b disease.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
  • History of any neurologic disorders or seizures.
  • Acute disease at the time of enrolment.
  • 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 and/or any blood products since birth or planned administration during the study period.
  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: NCT00652951

Locations
Netherlands
GSK Investigational Site
Hoofddorp, Netherlands, 2134 TM
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:
Van den Bergh M R et al. Immunogenicity of PHiD-CV 3-dose primary vaccination co-administered with Pediacel™ or Infanrix hexa™ in the Netherlands. Abstract presented at the 28th Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID). Nice, France, 4-8 May 2010.

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: NCT00652951     History of Changes
Other Study ID Numbers: 110142, 111053
Study First Received: March 21, 2008
Last Updated: November 17, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Haemophilus Infections
Pasteurellaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on September 18, 2014