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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00344318
First received: June 23, 2006
Last updated: November 3, 2016
Last verified: November 2016
  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
Infections, Streptococcal
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 Biologicals' Pneumococcal Conjugate Vaccine Compared to Prevenar™, Co-administered With DTPw-HBV/Hib & OPV or IPV Vaccines as a 3-dose Primary Immunization Course During the First 6 Months of Age

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of subjects reporting rectal temperature above (>) 39.0 degrees Celsius (°C) [ Time Frame: Within 4 day (Days 0-3) after each dose and across doses ] [ Designated as safety issue: Yes ]
    Fever was measured as rectal temperature. Assessment of occurrences of fever > 39.0 °C was performed post doses 1, 2 and 3 and across doses of 10Pn-PD-DiT or 7Pn vaccine.


Secondary Outcome Measures:
  • Number of subjects with any and any Grade 3 solicited local symptoms [ Time Frame: Within 4 day (Days 0-3) after each dose and across doses ] [ Designated as safety issue: No ]
    Solicited local symptoms assessed include pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger than (>) 30 millimeters (mm). "Any" is defined as incidence of the specified symptom regardless of intensity.

  • Number of subjects with any, Grade 3 and related solicited general symptoms [ Time Frame: Within 4-day (Days 0-3) after each dose and across doses ] [ Designated as safety issue: No ]
    Solicited general symptoms assessed include drowsiness, fever (defined as rectal temperature ≥ 38.0°C), irritability, and loss of appetite. Grade 3 (G3) drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 (G3) fever was defined as fever (rectal temperature) above (>) 40.0 degree Celsius (°C). Grade 3 (G3) irritability was defined as crying that could not be comforted/preventing normal activity. Grade 3 (G3) loss of appetite was defined as the subject not eating at all. "Any" is defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination. Related (REL) = Symptom assessed by the investigator as causally related to vaccination.

  • Number of subjects with unsolicited adverse events (AEs) [ Time Frame: Within 31 days (Days 0-30) after each vaccination ] [ Designated as safety issue: No ]
    An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. "Any" is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.

  • Number of subjects with serious adverse events (SAEs) [ Time Frame: Throughout the active phase of the study ] [ Designated as safety issue: No ]
    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

  • Number of subjects with serious adverse (SAEs) [ Time Frame: From study Day 0 until the 6-month extended safety follow-up ] [ Designated as safety issue: No ]
    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

  • Concentrations of antibodies against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F [ 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 ]
    Seropositivity status, defined as Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations ≥ 0.05 microgram per milliliter (µg/mL).

  • Number of subjects with anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations equal to or above (≥) 0.2 microgram per milliliter (µg/mL) [ 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 ]
    Cut-off values assessed were greater than or equal to 0.2 microgram per milliliter (µg/mL) in the sera of subjects seronegative before vaccination.

  • Number of subjects with anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations equal to or above (≥) 0.05 microgram per liter (µg/mL) [ 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 ]
    Cut-off values assessed were greater than or equal to 0.05 microgram per liter (µg/mL) in the sera of subjects seronegative before vaccination.

  • Opsonophagocytic activity (OPA) against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F [ Time Frame: One month after the administration of the 3rd vaccine dose of Pneumococcal conjugate vaccine GSK1024850A or Prevenar ] [ Designated as safety issue: No ]
    Seropositivity status, defined as Opsonophagocytic activity against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ 8

  • 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: October 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   (Child)
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
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: 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, 50345
GSK Investigational Site
Wroclaw, Poland, 52-312
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Study Data/Documents: Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 107007
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 107007
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 107007
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 107007
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 107007
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 107007
For additional information about this study please refer to the GSK Clinical Study Register

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00344318     History of Changes
Other Study ID Numbers: 107007 
Study First Received: June 23, 2006
Last Updated: November 3, 2016
Health Authority: Poland: Ministry of Health
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Keywords provided by GlaxoSmithKline:
Immunogenicity
Safety
Pneumococcal vaccine
Pneumococcal disease

Additional relevant MeSH terms:
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 09, 2016