Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' 10-valent Pneumococcal Conjugate Vaccine

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00344318
First received: June 23, 2006
Last updated: September 21, 2011
Last verified: September 2011
  Purpose

This study will evaluate safety, reactogenicity and immunogenicity of GSK Biologicals' pneumococcal conjugate vaccine compared to Prevenar™ when co-administered with DTPw-HBV/Hib and OPV or IPV vaccines, according to 2 different schedules: 6-10-14 weeks or 2-4-6 months of age.

The study has 2 groups.

  • One group of subjects will receive a 3-dose primary vaccination with the GSK Biologicals' pneumococcal conjugate vaccine (three different lots will be used and randomly allocated).
  • The 2nd group of subjects will receive a 3-dose primary vaccination with Prevenar™.

All children will receive concomitantly DTPw-HBV/Hib and OPV or IPV vaccines. This protocol posting deals with objectives & outcome measures of the primary study. The objectives & outcome measures of the Booster study are presented in a separate protocol posting (NCT number =00547248).


Condition Intervention Phase
Pneumococcal Infections
Biological: Pneumococcal conjugate vaccine GSK1024850A
Biological: Prevenar
Biological: Tritanrix-HepB
Biological: Hiberix
Biological: Polio Sabin.
Biological: Poliorix.
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: To Assess the Safety, Reactogenicity and Immunogenicity of GSK Bio Pneumococcal Conjugate Vaccine Compared to Prevenar™, Co-admin With DTPw-HBV/Hib & OPV or IPV Vaccines as a 3-dose Primary Immunization Course During the First 6 mo of Age

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Occurrence of fever with rectal temperature>39°C [ Time Frame: Within 4 days after at least one vaccination. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Occurrence of solicited local symptoms [ Time Frame: Within 4 days after each vaccination. ] [ Designated as safety issue: Yes ]
  • Occurrence of solicited general symptoms [ Time Frame: Within 4 days after each vaccination. ] [ Designated as safety issue: Yes ]
  • Occurrence of unsolicited adverse events [ Time Frame: Within 31 days after each vaccination. ] [ Designated as safety issue: Yes ]
  • Occurrence of serious adverse events [ Time Frame: Throughout the active phase of the study. ] [ Designated as safety issue: Yes ]
  • Occurrence of serious adverse events. [ Time Frame: During the extended safety follow-up. ] [ Designated as safety issue: Yes ]
  • Concentrations of antibodies against vaccine pneumococcal serotypes [ Time Frame: One month after the administration of the 3rd vaccine dose of Pneumococcal conjugate vaccine GSK1024850A vaccine or Prevenar ] [ Designated as safety issue: No ]
  • Opsonophagocytic activity against vaccine pneumococcal serotypes [ Time Frame: One month after the administration of the 3rd vaccine dose of Pneumococcal conjugate vaccine GSK1024850A or Prevenar ] [ Designated as safety issue: No ]
  • Concentrations of antibodies against cross-reactive pneumococcal serotypes [ Time Frame: One month after the administration of the 3rd vaccine dose of Pneumococcal vaccine conjugate GSK1024850A or Prevenar ] [ Designated as safety issue: No ]
  • Opsonophagocytic activity against cross-reactive pneumococcal serotypes [ Time Frame: One month after the administration of the 3rd vaccine dose of Pneumococcal conjugate vaccine GSK1024850A or Prevenar ] [ Designated as safety issue: No ]
  • Concentrations of antibodies against protein D. [ Time Frame: One month after the administration of the 3rd vaccine dose of Pneumococcal conjugate vaccine GSK1024850A or Prevenar ] [ Designated as safety issue: No ]
  • Anti-diphtheria and anti-tetanus toxoids, anti-PRP, anti- B. pertussis, anti-hepatitis B antibody concentrations, and anti-polio type 1, 2 and 3 antibody titers. [ Time Frame: One month after the administration of the 3rd vaccine dose of DTPw-HBV/Hib + OPV or IPV in a subset of subjects of each immunization schedule ] [ Designated as safety issue: No ]
  • Primary vaccine response to B. pertussis [ Time Frame: One month after the administration of the 3rd vaccine dose of DTPw-HBV/Hib + OPV or IPV in a subset of subjects of each immunization schedule ] [ Designated as safety issue: No ]

Enrollment: 806
Study Start Date: August 2006
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Receiving pneumococcal conjugate vaccine GSK1024850A
Biological: Pneumococcal conjugate vaccine GSK1024850A
3 Intramuscular injections.
Biological: Tritanrix-HepB
3 Intramuscular injections
Other Name: DTPw-HBV
Biological: Hiberix
Reconstituted with Tritanrix before injection
Other Name: Hib
Biological: Polio Sabin.
3 oral doses.
Other Name: OPV
Biological: Poliorix.
3 intramuscular injections
Other Name: IPV
Active Comparator: Group B
Receiving Prevenar
Biological: Prevenar
3 Intramuscular injections
Biological: Tritanrix-HepB
3 Intramuscular injections
Other Name: DTPw-HBV
Biological: Hiberix
Reconstituted with Tritanrix before injection
Other Name: Hib
Biological: Polio Sabin.
3 oral doses.
Other Name: OPV
Biological: Poliorix.
3 intramuscular injections
Other Name: IPV

Detailed Description:

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

  Eligibility

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

Inclusion Criteria:

  • Male or female between, and including, 6-12 weeks (42 to 90 days) of age at the time of the first vaccination.
  • Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol
  • 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.
  • Born after a gestation period between 36 and 42 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
  • Chronic administration (defined as more than 14 days) 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 period starting one month before each dose of vaccine(s) and ending 7 days after dose 1 and dose 2 or 1 month after dose 3.
  • Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, and/or S. pneumoniae with the exception of vaccines where the first dose can be given within the first two weeks of life according to the national recommendations
  • History of or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio, and Haemophilus influenzae type b diseases.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
  • History of seizures (this criterion does not apply to subjects who have had a single, uncomplicated febrile convulsion in the past) or neurological disease.
  • Acute disease at the time of enrolment
  • Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical
  • 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 active phase of the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00344318

Locations
Philippines
GSK Investigational Site
Muntinlupa, Philippines, 1781
Poland
GSK Investigational Site
Gdansk, Poland, 80-394
GSK Investigational Site
Lodz, Poland, 91-347
GSK Investigational Site
Trzebnica, Poland, 55-100
GSK Investigational Site
Tuchola, Poland, 89-500
GSK Investigational Site
Wroclaw, Poland, 52-312
GSK Investigational Site
Wroclaw, Poland, 50345
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:
Schuerman L et al. Population variability of opsonophagocytic activity following 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate (PHiD-CV) vaccination more limited than antibody responses. Abstract presented at the 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD). Tel Aviv, Israel, 14-18 March 2010.
Bermal N et al. Immunogenicity of a 10 valent pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine (PHiD-CV) co-administered with routine paediatric vaccines in Asian infants. Abstract presented at the 3rd Vaccine Congress. Singapore, Singapore, 4-6 October 2009.
Hausdorff WP et al. (2009) Estimating the direct impact of new conjugate vaccines against invasive pneumococcal disease. Vaccine. doi:10.1016/j.vaccine.2009.09.11
Schuerman L et al. Population variability in antibody responses following pneumococcal conjugate vaccination: experience with the non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV). Abstract presented at the 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD). Tel Aviv, Israel, 14-18 March 2010.

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00344318     History of Changes
Other Study ID Numbers: 107007
Study First Received: June 23, 2006
Last Updated: September 21, 2011
Health Authority: Poland: Ministry of Health

Keywords provided by GlaxoSmithKline:
Immunogenicity
Safety
Pneumococcal vaccine
Pneumococcal disease

Additional relevant MeSH terms:
Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on April 22, 2014