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Primary Vaccination Study With a Pneumococcal Conjugate Vaccine in Healthy Children 6 to 12wks of Age
This study has been completed.

First Received on June 20, 2007.   Last Updated on December 1, 2011   History of Changes
Sponsor: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00489554
  Purpose

The purpose of this study is to assess the immunogenicity in terms of antibody response and the safety/reactogenicity in terms of solicited and unsolicited symptoms and serious adverse events following primary vaccination of Mexican infants with pneumococcal conjugate vaccine GSK 1024850A co-administered with a diphtheria, tetanus, acellular pertussis (DTPa)-combined vaccine (Infanrix Hexa) and rotavirus vaccine (Rotarix) in children during the first 6 months of age.


Condition Intervention Phase
Pneumococcal Disease
Biological: Pneumococcal conjugate vaccine GSK1024850A.
Biological: Infanrix hexa.
Biological: Rotarix.
Phase III

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Primary Vaccination Course in Children Receiving the Pneumococcal Vaccine GSK 1024850A, Infanrix Hexa and Rotarix

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Concentrations of antibodies against vaccine pneumococcal serotypes and protein D. [ Time Frame: One month after the administration of the 3rd vaccine dose. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Opsonophagocytic activity against vaccine pneumococcal serotypes. [ Time Frame: One month after the administration of the 3rd vaccine dose. ] [ Designated as safety issue: No ]
  • Concentrations of antibodies against vaccine pneumococcal serotypes. [ Time Frame: One month after the administration of the 3rd vaccine dose. ] [ 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. ] [ Designated as safety issue: No ]
  • Opsonophagocytic activity against cross-reactive pneumococcal serotypes. [ Time Frame: One month after the administration of the 3rd vaccine dose. ] [ Designated as safety issue: No ]
  • Occurrence of solicited local symptoms. [ Time Frame: Within 4 days after each vaccination dose. ] [ Designated as safety issue: No ]
  • Occurrence of solicited general symptoms. [ Time Frame: Within 4 days after each vaccination dose. ] [ Designated as safety issue: No ]
  • Occurrence of unsolicited adverse events. [ Time Frame: Within 31 days after each vaccination dose. ] [ Designated as safety issue: No ]
  • Occurrence of serious adverse events. [ Time Frame: Following the administration of the first dose of study vaccine throughout the entire study period up. ] [ Designated as safety issue: No ]

Enrollment: 230
Study Start Date: July 2007
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 10Pn group
Subjects receiving pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) at 2-4-6 months of age, and co-administered with HRV (Rotarix) at 2-4 months of age.
Biological: Pneumococcal conjugate vaccine GSK1024850A.
Intramuscular injection, 3 doses.
Biological: Infanrix hexa.
Intramuscular injection, 3 doses.
Biological: Rotarix.
Oral, 2 doses.

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 subjects between and including 6-12 weeks 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 of 36 to 42 weeks inclusive.

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.
  • Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting one month before each dose of vaccines and ending 7 days after dose 1 and dose 2 and one month after dose 3.
  • Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
  • 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.
  • Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, rotavirus and/or Streptococcus pneumoniae; with the exception of vaccines where the first dose may be given at birth within the first two weeks of life according to national recommendations (e.g. Hepatitis B and BCG).
  • History of, or intercurrent, diphtheria, tetanus, pertussis, polio, hepatitis B and Haemophilus influenzae type b disease.
  • Gastroenteritis within 7 days preceding the study vaccine administration (warrants deferral of the vaccination).
  • Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal (GI) tract, intussusception (IS) or other medical condition determined to be serious by the investigator.
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00489554

Locations
Mexico
GSK Investigational Site
Mexico, Mexico, 14080
GSK Investigational Site
Mexico city, Mexico, 14000
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:
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.
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

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: NCT00489554     History of Changes
Other Study ID Numbers: 109661
Study First Received: June 20, 2007
Last Updated: December 1, 2011
Health Authority: Mexico: Comisión de autorización Sanitaria - Dirección Ejecutiva de Autorización de Productos y Establecimientos

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

ClinicalTrials.gov processed this record on February 12, 2012