Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' 10-valent Pneumococcal Conjugate Vaccine.
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ClinicalTrials.gov Identifier: NCT00338351 |
Recruitment Status
:
Completed
First Posted
: June 20, 2006
Last Update Posted
: September 28, 2016
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Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
Tracking Information | |||||
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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 |
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 |
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 |
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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. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE |
240 | ||||
Original Enrollment ICMJE | Same as current | ||||
Actual Study Completion Date | October 2006 | ||||
Primary Completion Date | Not Provided | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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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 |
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Responsible Party | GlaxoSmithKline | ||||
Study Sponsor ICMJE | GlaxoSmithKline | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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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 |