Vaccination Course in Primed Children and Age-Matched Unprimed Children With Pneumococcal Vaccine GSK1024850A. - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00792909

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 asses 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 III

Drug Information available for: Heptavalent pneumococcal conjugate vaccine Pneumococcal Vaccines

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	Vaccination Course in Children Primed and Boosted With Pneumococcal Vaccine GSK 1024850A and in Age-Matched Unprimed Children.

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 against components of the investigational pneumococcal conjugate vaccine [ Time Frame: Prior to immunization ] [ Designated as safety issue: No ]
Immune responses 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 against components of the 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 against components of the investigational pneumococcal conjugate vaccine [ Time Frame: One month after the second vaccine dose ] [ 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:	210
Study Start Date:	December 2008
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group C: Active Comparator 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, 1 dose in Group A and B, 2 doses in Group C
Group A: Experimental 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 in Group A and B, 2 doses in Group C
Group B: Experimental 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 in Group A and B, 2 doses in Group C

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

Contacts

Contact: US GSK Clinical Trials Call Center

877-379-3718

Locations

Slovakia
GSK Investigational Site	Recruiting
Ruzomberok, Slovakia, 034 01
GSK Investigational Site	Recruiting
Dolny Kubin, Slovakia, 026 01
GSK Investigational Site	Recruiting
Ruzomberok, Slovakia
GSK Investigational Site	Recruiting
Dlha nad Oravou, Slovakia, 027 55
Sweden
GSK Investigational Site	Not yet recruiting
ÖREBRO, Sweden, SE-701 16
GSK Investigational Site	Not yet recruiting
UMEÅ, Sweden, SE-901 85

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	111736
Study First Received:	November 17, 2008
Last Updated:	December 23, 2008
ClinicalTrials.gov Identifier:	NCT00792909
Health Authority:	Sweden: Medical Products Agency

Keywords provided by GlaxoSmithKline:

Pneumococcal vaccine
Pneumococcal disease
Immunogenicity
Safety

ClinicalTrials.gov processed this record on January 15, 2009