Study Evaluating Prevenar Immunogenicity in High Risk Children
NCT00581620
Last updated date
ABOUT THIS STUDY
To determine immunogenicity of the heptavalent CRM197 pneumococcal conjugate in children with
immunodeficiency condition. To evaluate tolerability of Prevenar® in that population.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
Vaccines, Pneumococcal Conjugate Vaccine
Sex
Females and Males
Age
2-9 months
Inclusion Criteria
Show details
- Children between 2 months to 9 years old.
- Children with HIV+; Sickle Cell disease; Neprotic symdrome; Chronic pulmonary disease
- No history of seizures
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Advanced Information
Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | Study Evaluating Prevenar Immunogenicity in High Risk Children | |||
Official Title ICMJE | To Evaluate the Humoral Immune Response to a Conjugated Pneumococcus Vaccine 7-Valent (Prevenar®) in Children From High Risk Groups. | |||
Brief Summary | To determine immunogenicity of the heptavalent CRM197 pneumococcal conjugate in children with immunodeficiency condition. To evaluate tolerability of Prevenar® in that population. | |||
Detailed Description | This study will require 24 months to be completed. Each child will participate for a period of time according to age of the 1st dose of vaccination: infants up to 6 months of age will be evaluated for 5 months; infants between 7 to 11 months will be evaluated for 3 months; children between 12 months up to 9 years of age will be evaluate for 2 months | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Prevention | |||
Condition ICMJE | Vaccines, Pneumococcal Conjugate Vaccine | |||
Intervention ICMJE | Biological: pneumococcus conjugate vaccine
Infants from 1 to 6 months: 3 doses at 2; 4; 6 m and booster from 12 to 15 months. | |||
Study Arms ICMJE |
| |||
Publications * | Not Provided | |||
* 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 | |||
Actual Enrollment ICMJE | 160 | |||
Original Actual Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | September 2007 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 2 Months to 9 Years (Child) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Not Provided | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00581620 | |||
Other Study ID Numbers ICMJE | 0887X-100974 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth | |||
Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Verification Date | December 2007 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |