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

PHASE3CompletedINTERVENTIONAL
Enrollment

81

Participants

Timeline

Start Date

July 31, 2002

Primary Completion Date

February 28, 2017

Study Completion Date

February 28, 2017

Conditions
Organ TransplantImmunosuppression
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"

Trial Locations (1)

M5G 1X8

The Hospital for Sick Children, Toronto

All Listed Sponsors
lead

The Hospital for Sick Children

OTHER

NCT00213265 - Safety and Immunogenicity of 7-Valent Pneumococcal Conjugate Vaccine in Children Receiving Solid Organ Transplants | Biotech Hunter | Biotech Hunter