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NCT00581620 Clinical Trial

Study Evaluating Prevenar Immunogenicity in High Risk Children

Vaccines, Pneumococcal Conjugate Vaccine Clinical Trial

Official title:
To Evaluate the Humoral Immune Response to a Conjugated Pneumococcus Vaccine 7-Valent (Prevenar®) in Children From High Risk Groups.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00581620
Other study ID # 0887X-100974
Secondary ID
Status Completed
Phase Phase 4
First received December 21, 2007
Last updated December 21, 2007
Start date November 2002
Est. completion date September 2007

Study information
Verified date December 2007
Source Wyeth is now a wholly owned subsidiary of Pfizer
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical Trial Summary

To determine immunogenicity of the heptavalent CRM197 pneumococcal conjugate in children with immunodeficiency condition. To evaluate tolerability of Prevenar® in that population.

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

Recruitment information / eligibility
Status Completed
Enrollment 160
Est. completion date September 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 2 Months to 9 Years
Eligibility Inclusion Criteria:

- Children between 2 months to 9 years old.

- Children with HIV+; Sickle Cell disease; Neprotic symdrome; Chronic pulmonary disease

- No history of seizures

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

  • Vaccines, Pneumococcal Conjugate Vaccine

Intervention

Biological:
• pneumococcus conjugate vaccine
Infants from 1 to 6 months: 3 doses at 2; 4; 6 m and booster from 12 to 15 months.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Outcome
Type Measure Description Time frame Safety issue
Primary To determine immunogenicity of the heptavalent CRM197 pneumococcal conjugate in children with immunodeficiency condition 4 months No
Secondary To evaluate tolerability of Prevenar* in that population. 4 months Yes
See also
  Status Clinical Trial Phase
Completed NCT00574795 - Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Japanese Infants Phase 3
Completed NCT00269672 - Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Elderly Subjects Phase 2
Completed NCT00580684 - Study Comparing Prevenar® to Pneumo 23 in Reducing Carriage in Children Phase 4
Completed NCT00500357 - Study Evaluating a 13-valent Pneumococcal Conjugate Vaccine in Elderly Subjects Phase 3
Completed NCT00475033 - Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants Phase 3
Completed NCT00980655 - Study to Evaluate 13 Valent Pneumococcal Conjugate Vaccine (13vPnC) Vaccine Followed by 23-valent Pneumococcal Polysaccharide Vaccine (23vPS) Vaccine in Allogeneic Hematopoietic Stem Cell Transplant Recipients Phase 3
Completed NCT00676091 - Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants in Brazil Phase 3
Completed NCT00683410 - Post-Marketing Study of the Safety of Prevenar (Pneumococcal Conjugate Vaccine, 7-valent) N/A