Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' 10-valent Pneumococcal Conjugate Vaccine.

Tracking Information
First Submitted Date ICMJE	June 16, 2006
First Posted Date ICMJE	June 20, 2006
Last Update Posted Date	September 28, 2016
Study Start Date ICMJE	April 2006
Primary Completion Date	Not Provided
Current Primary Outcome Measures ICMJE; (submitted: June 16, 2006)	After each dose: Grade 3 AEs
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00338351 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: June 16, 2006)	After each dose: solicited/unsolicited AEs (4/31 days),SAEs (whole study); 1 month post 3: antibody concns to vaccine antigens
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' 10-valent Pneumococcal Conjugate Vaccine.
Official Title ICMJE	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.
Brief Summary	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.
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
Study Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single; Primary Purpose: Prevention
Condition ICMJE	Hepatitis A
Intervention ICMJE	Biological: Pneumococcal (vaccine)
Study Arms	Not Provided
Publications *	Lagos RE, Muñoz AE, Levine MM, Lepetic A, François N, Yarzabal JP, Schuerman L. Safety and immunogenicity of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in Chilean children. Hum Vaccin. 2011 May;7(5):511-22. Epub 2011 May 1.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Enrollment ICMJE; (submitted: June 16, 2006)	240
Original Enrollment ICMJE	Same as current
Actual Study Completion Date	October 2006
Primary Completion Date	Not Provided
Eligibility Criteria ICMJE	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.
Sex/Gender	Sexes Eligible for Study: All
Ages	6 Weeks to 12 Weeks (Child)
Accepts Healthy Volunteers	Yes
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Chile
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00338351
Other Study ID Numbers ICMJE	106208
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Plan to Share IPD: Yes Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Responsible Party	GlaxoSmithKline
Study Sponsor ICMJE	GlaxoSmithKline
Collaborators ICMJE	Not Provided
Investigators ICMJE	Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account	GlaxoSmithKline
Verification Date	September 2016
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP