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Vaccination Course in Primed Children and Age-matched Unprimed Children With Pneumococcal Vaccine GSK1024850A

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00792909
First received: November 17, 2008
Last updated: November 15, 2012
Last verified: November 2012
History of Changes
  Purpose

The purpose of this study is to assess the immune memory induced by primary and booster vaccination with pneumococcal conjugate vaccine GSK1024850A in the first year of life through evaluation of the immune responses following vaccination with a booster dose of pneumococcal conjugate vaccine GSK1024850A in the fourth year of life and to assess immune responses following vaccination with a single dose of pneumococcal conjugate vaccine GSK1024850A in age-matched unprimed children.

The study also aims to assess the antibody persistence in the fourth year of life following primary and booster vaccination with pneumococcal conjugate vaccine GSK1024850A in the first year of life.

The study is also designed to evaluate the immunogenicity in terms of antibody response and the safety/reactogenicity in terms of solicited and unsolicited symptoms and serious adverse events following a 2-dose vaccination with pneumococcal conjugate vaccine GSK1024850A in the fourth year of life.

This protocol posting deals with objectives & outcome measures of the booster phase. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = 00307034)


Condition Intervention Phase
Pneumococcal Disease
 Biological: Pneumococcal conjugate vaccine GSK1024850A
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Vaccination Course in Children Primed and Boosted With Pneumococcal Vaccine GSK 1024850A and in Age-matched Unprimed Children

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Concentrations of antibodies against vaccine pneumococcal serotypes [ Time Frame: 7-10 days after immunization or the first vaccine dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Immune responses (= antibody concentrations) against components of the investigational pneumococcal conjugate vaccine [ Time Frame: Prior to immunization (day 0) ] [ Designated as safety issue: No ]
  • Immune responses (= antibody concentrations) against components of the investigational pneumococcal conjugate vaccine. [ Time Frame: 7-10 days after immunization or the first vaccine dose ] [ Designated as safety issue: No ]
  • Immune responses (= antibody concentrations) against components of investigational pneumococcal conjugate vaccine [ Time Frame: Prior to immunization and 7-10 days after immunization or the first vaccine dose ] [ Designated as safety issue: No ]
  • In a subset of subjects: immune responses (= antibody concentrations) against components of the investigational pneumococcal conjugate vaccine [ Time Frame: One month after the second vaccine dose (month 3) ] [ Designated as safety issue: No ]
  • Occurrence of solicited adverse events [ Time Frame: Within 4 (day 0-3) days after vaccination ] [ Designated as safety issue: No ]
  • Occurrence of unsolicited adverse events [ Time Frame: Within 31 (day 0-30) days after vaccination ] [ Designated as safety issue: No ]
  • Occurrence of serious adverse events [ Time Frame: Following vaccination (day 0) and throughout the entire study period (until Month 1 or Month 3) ] [ Designated as safety issue: No ]

Enrollment: 172
Study Start Date: December 2008
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Subjects previously vaccinated with pneumococcal conjugate vaccine GSK1024850A according to a 2+1 schedule in the first year of life receiving a booster dose of GSK1024850A in the fourth year of life.
 Biological: Pneumococcal conjugate vaccine GSK1024850A
Intramuscular injection, 1 dose
Experimental: Group B
Subjects previously vaccinated with pneumococcal conjugate vaccine GSK1024850A according to a 3+1 schedule in the first year of life receiving a booster dose of GSK1024850A in the fourth year of life.
 Biological: Pneumococcal conjugate vaccine GSK1024850A
Intramuscular injection, 1 dose
Active Comparator: Group C
Age-matched unprimed subjects receiving 2 doses of pneumococcal conjugate vaccine GSK1024850A in the fourth year of life.
 Biological: Pneumococcal conjugate vaccine GSK1024850A
Intramuscular injection, 2 doses

  Eligibility

Ages Eligible for Study:   36 Months to 46 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female between, and including, +- 36-46 months of age at the time of vaccination.
  • For primed subjects: having completed the full vaccination course with GSK1024850A in the primary study (NCT00307034).
  • Subjects for whom the investigator believes that their parent(s)/guardian(s) can and will comply with the requirements of the protocol.
  • Written informed consent obtained from the parent(s)/guardian(s) of the subject.
  • Free of obvious health problems as established by medical history and clinical examination before entering into the study

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.
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to vaccination.
  • For primed subjects: administration of any pneumococcal vaccine since the end of the primary study (NCT00307034).
  • For unprimed subjects: previous vaccination with any pneumococcal vaccine.
  • Administration of immunoglobulins and/or any blood products less than 6 months prior to the vaccination or planned administration during the study period.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
  • History of reactions or allergic disease likely to be exacerbated by any component of the study vaccine.
  • Acute disease at the time of enrolment.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00792909

Locations
Slovakia
GSK Investigational Site
Dlha nad Oravou, Slovakia, 027 55
GSK Investigational Site
Dolny Kubin, Slovakia, 026 01
GSK Investigational Site
Ruzomberok, Slovakia, 034 01
Sweden
GSK Investigational Site
Umeå, Sweden, SE-901 85
GSK Investigational Site
Örebro, Sweden, SE-701 16
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:
Silfverdal SA et al. Assessment of immunological memory following PHiD-CV immunisation according to 2+1 or 3+1 schedules in the first year of life. Abstract presented at the 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD). Tel Aviv, Israel, 14-18 March 2010.
Silfverdal SA et al. (2011) Anamnestic immune response in 3- to 4-year-old children previously immunized with 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine as 2 dose or 3 dose priming and a booster dose in the first year of life. Pediatr Infect Dis J. 30(9):155-163.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00792909     History of Changes
Other Study ID Numbers: 111736
Study First Received: November 17, 2008
Last Updated: November 15, 2012
Health Authority: Slovakia: State Institute for Drug Control
Sweden: Medical Products Agency

Keywords provided by GlaxoSmithKline:
Pneumococcal vaccine
Pneumococcal disease
Safety
Immunogenicity

ClinicalTrials.gov processed this record on May 16, 2013