Study Evaluating the Impact of the 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Alaskan Native Children.
NCT ID: NCT00743652
Last Updated: 2012-03-15
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
373 participants
INTERVENTIONAL
2009-01-31
2010-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study Evaluating the Effiacy of a 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) in Adults
NCT00744263
Immunogenicity and Reactogenicity of Pneumococcal Polysaccharide and Conjugate Vaccines in Native Elders
NCT00153543
Study Evaluating 13-valent Pneumococcal Conjugate Vaccine Catch-Up Regimens in Older Infants and Children
NCT00452452
20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 4-Dose Series in Healthy Infants
NCT04382326
Study Evaluating 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Healthy Children Aged 15 Months to 17 Years
NCT00761631
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group1
Subjects 6 weeks to \<10 months of age with 0 prior dose of Prevnar.
13-valent Pneumococcal Conjugate Vaccine
4 doses of 13vPnC (0.5ml, IM) will be administered. (3 doses infant series, and 1 toddler dose)
Group 2
Subjects \<12 months of age with 1 prior dose of Prevnar.
13-valent Pneumococcal Conjugate Vaccine
3 doses of 13vPnC (0.5ml, IM) will be administered. (2 doses for infant series catch-up, and 1 toddler dose)
Group 3
Subjects \<12 months of age with 2 prior doses of Prevnar.
13-valent Pneumococcal Conjugate Vaccine
2 doses of 13vPnC (0.5ml, IM) will be administered. (1 dose infant series catch-up, and 1 toddler dose)
Group 4
Subjects ≥12 months to \<2 years of age.
13-valent Pneumococcal Conjugate Vaccine
2 doses of 13vPnC (0.5ml, IM) will be administered. (2 catch-up dose(s) greater than 60 days apart )
Group 5
Subjects ≥2 years to \<5 years of age
13-valent Pneumococcal Conjugate Vaccine
1 dose of 13vPnC (0.5ml, IM) will be administered. (1 catch-up dose)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
13-valent Pneumococcal Conjugate Vaccine
4 doses of 13vPnC (0.5ml, IM) will be administered. (3 doses infant series, and 1 toddler dose)
13-valent Pneumococcal Conjugate Vaccine
3 doses of 13vPnC (0.5ml, IM) will be administered. (2 doses for infant series catch-up, and 1 toddler dose)
13-valent Pneumococcal Conjugate Vaccine
2 doses of 13vPnC (0.5ml, IM) will be administered. (1 dose infant series catch-up, and 1 toddler dose)
13-valent Pneumococcal Conjugate Vaccine
2 doses of 13vPnC (0.5ml, IM) will be administered. (2 catch-up dose(s) greater than 60 days apart )
13-valent Pneumococcal Conjugate Vaccine
1 dose of 13vPnC (0.5ml, IM) will be administered. (1 catch-up dose)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Infants who have received Prevnar are eligible to participate, but this is not required.
* Infants participating in the blood draws must live in a specific identified area (Yukon Kuskokwim Delta region)
Exclusion Criteria
42 Days
5 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Pfizer
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Pfizer Investigational Site
Akiak, Alaska, United States
Pfizer Investigational Site
Bethel, Alaska, United States
Pfizer Investigational Site
Chefornak, Alaska, United States
Pfizer Investigational Site
Chevak, Alaska, United States
Pfizer Investigational Site
Eek, Alaska, United States
Pfizer Investigational Site
Emmonak, Alaska, United States
Pfizer Investigational Site
Hooper Bay, Alaska, United States
Pfizer Investigational Site
Kalskag, Alaska, United States
Pfizer Investigational Site
Kasigluk, Alaska, United States
Pfizer Investigational Site
Kongiganak, Alaska, United States
Pfizer Investigational Site
Kotlik, Alaska, United States
Pfizer Investigational Site
Kwethluk, Alaska, United States
Pfizer Investigational Site
Kwigillingok, Alaska, United States
Pfizer Investigational Site
Mountain Village, Alaska, United States
Pfizer Investigational Site
Napaskiak, Alaska, United States
Pfizer Investigational Site
Newtok, Alaska, United States
Pfizer Investigational Site
Nunapitchuk, Alaska, United States
Pfizer Investigational Site
Russian Mission, Alaska, United States
Pfizer Investigational Site
Scammon Bay, Alaska, United States
Pfizer Investigational Site
Toksook Bay, Alaska, United States
Pfizer Investigational Site
Tuluksak, Alaska, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
To obtain contact information for a study center near you, click here.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
B1851009
Identifier Type: -
Identifier Source: secondary_id
6096A1-3010
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.