Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' 10-Valent Pneumococcal Conjugate Vaccine - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00345358

Purpose

The purpose of this phase IIIb study is to determine whether children who have not received a 3-dose primary vaccination with the pneumococcal conjugate vaccine before their 6 months of age, can receive the vaccine as part of a catch-up immunization schedule. The immunogenicity, safety and reactogenicity of GSK Biologicals' pneumococcal conjugate vaccine will be evaluated for four different age groups with different schedules:

< 6 months of age group: 3-dose primary vaccination + a booster dose. 7 to 11 months of age group: 2-dose primary vaccination + a booster dose. 12 to 23 months of age group: 2-dose vaccination; no booster dose. 24 months to 5 years of age group: 1-dose vaccination; no booster dose. Children below 6 months of age will receive concomitantly a DTPa-IPV/Hib vaccine.

Condition	Intervention	Phase
Pneumococcal Disease	Biological: Pneumococcal conjugate vaccine GSK1024850A. Biological: Infanrix IPV/Hib	Phase III

MedlinePlus related topics: Childhood Immunization

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, Safety/Efficacy Study
Official Title:	Evaluate Immunogenicity, Safety & Reactogenicity of GSK Biologicals' 10-Valent Pneumococcal Conjugate Vaccine Given as Catch-up Immunization in Children Older Than 7 mo of Age or as 3-Dose Primary Immunization in Children Before 6 mo of Age

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Concentrations of antibodies against vaccine pneumococcal serotypes [ Time Frame: 1 month after the administration of the primary or the full vaccination course with GSK Biologicals' 10-valent pneumococcal conjugate vaccine ]

Secondary Outcome Measures:

Opsonophagocytic activity against vaccine pneumococcal serotypes [ Time Frame: 1 month after the administration of the primary or the full vaccination course, with GSK Biologicals' 10-valent pneumococcal conjugate vaccine ]
Concentrations of antibodies against cross-reactive pneumococcal serotypes [ Time Frame: 1 month after the administration of the primary or the full vaccination course, with GSK Biologicals' 10-valent pneumococcal conjugate vaccine ]
Opsonophagocytic activity against cross-reactive pneumococcal serotypes. [ Time Frame: 1 month after the administration of the primary or the full vaccination course, with GSK Biologicals' 10-valent pneumococcal conjugate vaccine ]
Concentrations of antibodies against protein D. [ Time Frame: 1 month after the administration of the primary or the full vaccination course, with GSK Biologicals' 10-valent pneumococcal conjugate vaccine ]
Concentrations of antibodies against vaccine pneumococcal serotypes. [ Time Frame: Before and one month after the booster dose with GSK Biologicals' 10-valent pneumococcal conjugate vaccine for the < 6 Mo and 7-11 Mo groups ]
Opsonophagocytic activity against vaccine pneumococcal serotypes [ Time Frame: Before and one month after the booster dose with GSK Biologicals' 10-valent pneumococcal conjugate vaccine for the < 6 Mo and 7-11 Mo groups ]
Concentrations of antibodies against cross-reactive pneumococcal serotypes [ Time Frame: Before and one month after the booster dose with GSK Biologicals' 10-valent pneumococcal conjugate vaccine for the < 6 Mo and 7-11 Mo groups ]
Opsonophagocytic activity against cross-reactive pneumococcal serotypes [ Time Frame: Before and one month after the booster dose with GSK Biologicals' 10-valent pneumococcal conjugate vaccine for the < 6 Mo and 7-11 Mo groups ]
Concentrations of antibodies against protein D. [ Time Frame: Before and one month after the booster dose with GSK Biologicals' 10-valent pneumococcal conjugate vaccine for the < 6 Mo and 7-11 Mo groups ]
Anti-diphtheria and anti-tetanus toxoids, anti-PRP, anti-pertussis, anti-HBs antibody concentrations and anti-polio type 1, 2 and 3 titres. [ Time Frame: 1 month after the administration of the primary vaccination course, before & 1 mth after the booster dose with GSK Biologicals' DTPa-IPV/Hib vaccine when co-administered with GSK Biologicals' 10-valent pneumococcal conjugate vaccine in the < 6 Mo gr ]
Booster vaccine response to pertussis [ Time Frame: One month after the booster dose in the < 6 Mo group ]
Occurrence of solicited local symptoms [ Time Frame: Within 4 days after each vaccination. ]
Occurrence of solicited general symptoms [ Time Frame: Within 4 days after each vaccination. ]
Occurrence of unsolicited adverse events [ Time Frame: Within 31 days after each vaccination. ]
Occurrence of serious adverse events. [ Time Frame: Throughout the whole study period ]

Enrollment:	600
Study Start Date:	September 2006
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
<6 Mo: Active Comparator Children of 9-12 weeks of age at the time of first vaccination receiving 3-dose primary vaccination of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix IPV/Hib) at 3-4-5 months of age and a booster dose at 12-15 months of age.	Biological: Pneumococcal conjugate vaccine GSK1024850A. 1, 2, 3 or 4 Intramuscular injections, depending on age group Biological: Infanrix IPV/Hib 4 intramuscular injections
12-23 Mo: Experimental Children between 12 to 23 months of age at the time of first vaccination receiving 2-dose primary vaccination of pneumococcal conjugate vaccine GSK1024850A with at least 8 weeks interval	Biological: Pneumococcal conjugate vaccine GSK1024850A. 1, 2, 3 or 4 Intramuscular injections, depending on age group
>=24 Mo: Experimental Children between 24 months to 5 years of age at the time of first vaccination receiving single dose of pneumococcal conjugate vaccine GSK1024850A	Biological: Pneumococcal conjugate vaccine GSK1024850A. 1, 2, 3 or 4 Intramuscular injections, depending on age group
7-11 Mo: Experimental Children between 7 to 11 months of age at the time of first vaccination receiving 2-dose primary vaccination of pneumococcal conjugate vaccine GSK1024850A with at least 4 weeks interval and a booster dose at 12-15 months	Biological: Pneumococcal conjugate vaccine GSK1024850A. 1, 2, 3 or 4 Intramuscular injections, depending on age group

Detailed Description:

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007

Eligibility

Ages Eligible for Study:	9 Weeks to 5 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Male or female between, and including
- 9-12 weeks of age at the time of first vaccination for the <6 Mo group.
- 7-11 months of age at the time of first vaccination for the 7-11 Mo group.
- 12-23 months of age at the time of first vaccination for the 12-23 Mo group.
- 24 months to 5 years at the time of first vaccination for the >= 24 Mo group.
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 within 30 days preceding the first dose of study vaccine, or planned use during the entire study period for each age-group.
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 and ending one month after each dose of vaccine(s).
Previous vaccination against S. pneumoniae.
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 examination
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 entire study period.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00345358

Locations

Finland
GSK Investigational Site
Helsinki, Finland, 00930
GSK Investigational Site
Espoo, Finland, 02100
GSK Investigational Site
Vantaa, Finland, 01600
GSK Investigational Site
Helsinki, Finland, 00100
GSK Investigational Site
Vantaa, Finland, 01300
GSK Investigational Site
Kotka, Finland, 48600
GSK Investigational Site
Tampere, Finland, 33100
GSK Investigational Site
Jarvenpaa, Finland, 04400
GSK Investigational Site
Seinajoki, Finland, 60100

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	107058
Study First Received:	June 27, 2006
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00345358
Health Authority:	Czech Republic: State Institute for Drug Control

Keywords provided by GlaxoSmithKline:

Pneumococcal vaccine
Pneumococcal disease
Safety

Immunogenicity
Booster vaccination
Catch-up vaccination

ClinicalTrials.gov processed this record on January 13, 2009