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Primary Vaccination Study With a Pneumococcal Conjugate Vaccine in Healthy Children 6-12wks of Age
This study is currently recruiting participants.
Verified by GlaxoSmithKline, January 2009
Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00808444
  Purpose

The purpose of the present study is to demonstrate that the changes in the manufacturing process for the commercial lot of the pneumococcal conjugate vaccine GSK1024850A have no clinical impact and that the immune responses are non-inferior to the immune responses induced by the clinical lot. The study will be conducted in Singapore and Malaysia.


Condition Intervention Phase
Pneumococcal Disease
Biological: Pneumococcal conjugate vaccine GSK1024850A (different lots)
Biological: Infanrix-IPV/Hib
Biological: Infanrix hexa
Biological: Rotarix
Phase III

Drug Information available for: Heptavalent pneumococcal conjugate vaccine Pneumococcal Vaccines RotaTeq Infanrix hexa
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Double Blind (Caregiver, Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title: Non-Inferiority of a Commercial Lot of the Pneumococcal Vaccine GSK1024850A Compared to a Clinical Lot.

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Concentrations of antibodies against vaccine components of the investigational pneumococcal conjugate vaccine [ Time Frame: One month after primary immunization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Concentrations of antibodies and opsonophagocytic activity induced by components of the investigational pneumococcal conjugate vaccine [ Time Frame: One month after primary immunization ] [ Designated as safety issue: No ]
  • Subset of subjects: Concentrations and titres of antibodies against components of the co-administered DTPa-combined vaccine [ Time Frame: One month after primary immunization ] [ Designated as safety issue: No ]
  • Subset of subjects: Concentration of antibodies against the co-administered HRV vaccine, three months after the primary immunization course. [ Time Frame: One month after primary immunization ] [ Designated as safety issue: No ]
  • Occurrence of solicited adverse events [ Time Frame: Within 4 days after vaccination ] [ Designated as safety issue: Yes ]
  • Occurrence of unsolicited adverse events [ Time Frame: Within 31 days after vaccination ] [ Designated as safety issue: Yes ]
  • Occurrence of serious adverse events [ Time Frame: Following vaccination and throughout the entire study period ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 460
Study Start Date: January 2009
Estimated Study Completion Date: November 2009
Estimated Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Group B: Experimental
Subjects receiving the commercial lot of pneumococcal conjugate vaccine GSK1024850A co-administered with a DTPa-combined vaccine (Infanrix hexa or Infanrix-IPV/Hib) at 2-3-5 months of age and Rotarix at 2-3 months of age.
Biological: Pneumococcal conjugate vaccine GSK1024850A (different lots)
Intramuscular injection, 3 doses
Biological: Infanrix-IPV/Hib
Intramuscular injection, only for Visit 2 in Singapore
Biological: Infanrix hexa
Intramuscular injection, 3 doses in Malaysia and 2 doses in Singapore
Biological: Rotarix
Oral, 2 doses
Group A: Experimental
Subjects receiving the clinical lot of pneumococcal conjugate vaccine GSK1024850A co-administered with a DTPa-combined vaccine (Infanrix hexa or Infanrix-IPV/Hib) at 2-3-5 months of age and Rotarix at 2-3 months of age.
Biological: Pneumococcal conjugate vaccine GSK1024850A (different lots)
Intramuscular injection, 3 doses
Biological: Infanrix-IPV/Hib
Intramuscular injection, only for Visit 2 in Singapore
Biological: Infanrix hexa
Intramuscular injection, 3 doses in Malaysia and 2 doses in Singapore
Biological: Rotarix
Oral, 2 doses

  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 subjects between, and including 6-12 weeks of age at the time of the first vaccination.
  • Subjects for whom the investigator believes that their parent(s)/guardian(s) can and will comply with the requirements of the protocol.
  • Written or oral, signed or thumb-printed informed consent obtained from the parent(s)/guardian(s) of the child/ward.
  • Free of any known or suspected health problems (as established by medical history and clinical examination before entering into the study).
  • Born after a gestation period of >= 36 to <= 42 weeks.

Exclusion Criteria:

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of the study vaccines, or planned use during the study period.
  • Concurrently participating in another clinical study, at any time during the study period.
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
  • A family history of congenital or hereditary immunodeficiency.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
  • Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period (with the exception of hepatitis B immunoglobulins at birth).
  • Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, Haemophilus influenzae type b and/or Streptococcus pneumoniae (with the exception of vaccines where the first dose can be given within the first two weeks of life).
  • Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting 30 days before each dose of vaccine and ending 7 days after Dose 1 and Dose 2 and 30 days after Dose 3.
  • History of, or intercurrent diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, H. influenzae type b and rotavirus disease.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
  • History of any neurological disorders or seizures.
  • Major congenital defects or serious chronic illness.
  • Acute disease at the time of enrolment.
  • Gastroenteritis within 7 days preceding the study vaccine administration.
  • Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal tract, intussusception or other medical condition determined to be serious by the investigator.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00808444

Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718

Locations
Malaysia
GSK Investigational Site Active, not recruiting
Seremban, Negeri Sembilan, Malaysia, 70300
GSK Investigational Site Recruiting
Kuala Lumpur, Malaysia, 59100
Singapore
GSK Investigational Site Not yet recruiting
Singapore, Singapore, 119074
GSK Investigational Site Not yet recruiting
Singapore, Singapore, 229899
GSK Investigational Site Not yet recruiting
Singapore, Singapore, 308433
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GSK ( Study Director )
Study ID Numbers: 111654
Study First Received: December 11, 2008
Last Updated: January 8, 2009
ClinicalTrials.gov Identifier: NCT00808444  
Health Authority: Malaysia: Ministry of Health

Keywords provided by GlaxoSmithKline:
Pneumococcal vaccine
Pneumococcal disease
Immunogenicity
Safety
Primary vaccination

Study placed in the following topic categories:
Healthy

ClinicalTrials.gov processed this record on January 14, 2009