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Safety and Immunogenicity of 7-Valent Pneumococcal Conjugate Vaccine in Children Receiving Solid Organ Transplants

NCT00213265 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2021-02-15

No results posted yet for this study

Summary

We plan to study whether the 7-valent pneumococcal conjugate vaccine (Prevnar™) is safe and effective in protecting children who have had a solid organ transplantation and healthy children from pneumococcal infections.

We expect that two or more doses of Prevnar™ will result in similar antibody responses among transplant recipients compared with healthy control subjects, and that children who have undergone solid organ transplant will have a similar number of serious vaccine-related adverse events within 7 days after Prevnar™ as the healthy patients.

Conditions

  • Organ Transplant
  • Immunosuppression

Interventions

BIOLOGICAL

7-valent pneumococcal conjugate vaccine

For transplant patients, vaccination will be started at 4 months or greater after transplantation. The second dose will be given 8 weks following the frist, the third dose 8 weeks after the second, and the fourth will be given 8 weeks after the third.

BIOLOGICAL

Pneumococcal 7-valent Conjugate Vaccine

Healthy infants: The Prevnar schedule for healthy infants consists of 3 doses of 0.5 ml each, at approximately 2 month intervals, followed by a fourth dose of 0.5 ml at 12-15 months of age (i.e., 2, 4, 6, and 12-15 months) Previously unvaccinated older infants and children, who are beyond the age of the routine infant schedule, should receive the follwong schedule: 7-11 months of age: 3 doses (2 doses at least 4 weeks apart with the third dose after the first birthday and separated from the second dose by at least two months) 12-23 months of age: 2 doses (at least 2 months apart) ≥24 months through 9 years of age: 1 dose

Sponsors & Collaborators

  • The Hospital for Sick Children

    lead OTHER

Principal Investigators

  • Upton Allen, MD · The Hospital for Sick Children, Toronto Canada

  • Upton Allen · The Hospital for Sick Children

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Months
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-07-31
Primary Completion
2017-02-28
Completion
2017-02-28

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00213265 on ClinicalTrials.gov