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

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00338351

Purpose

Three dose primary vaccination study of reactogenicity and immunogenicity in healthy infants between 6-12 weeks of age at the time of the first vaccination against Streptococcus pneumoniae.

Condition	Intervention	Phase
Prophylaxis Pneumococcal Vaccine	Biological: Pneumococcal (vaccine)	Phase II

Drug Information available for: Heptavalent pneumococcal conjugate vaccine Pneumococcal Vaccines Infanrix hexa

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind, Parallel Assignment, Safety/Efficacy Study
Official Title:	To Assess Reactogenicity and Immunogenicity of GSK Biologicals' 10-Valent Pneumococcal Conjugate Vaccine, When co-Administered With GSK Biologicals' DTPa-HBV-IPV/Hib Vaccine (Infanrix™ Hexa) at 2, 4 and 6 Months of Age.

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

After each dose: Grade 3 AEs

Secondary Outcome Measures:

After each dose: solicited/unsolicited AEs (4/31 days),SAEs (whole study); 1 month post 3: antibody concns to vaccine antigens

Estimated Enrollment:	240
Study Start Date:	April 2006

Detailed Description:

Test groups: 2 (120 subjects/group). 1 group receiving GSK Biologicals' 10-valent pneumococcal conjugate vaccine + DTPa combined vaccine; Control group receiving GSK Biologicals' Havrix + DTPa combined vaccine

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 between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, free of obvious health problems and with written informed consent obtained from the parent/guardian of the subject.

Exclusion Criteria:

Use of any investigational or non-registered drug or vaccine other than the study vaccine 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 from one month before the first dose of vaccine(s) and during the entire study period.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00338351

Locations

Chile, Región Metro De Santiago
GSK Investigational Site
Santiago, Región Metro De Santiago, Chile

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	106208
Study First Received:	June 16, 2006
Last Updated:	December 23, 2008
ClinicalTrials.gov Identifier:	NCT00338351
Health Authority:	Chile:Ministerio de Salud de Chile

ClinicalTrials.gov processed this record on January 14, 2009