Your Health. Your Family. Your Choice.
Administered by: Unknown Purchased by: Unknown
Life Threatening? No
Write-up: This subject is a 17 month old male, who was noted to have vomiting and an abdominal mass while enrolled in a Comparative post-marketing safety study of CPDT Vaccine Adsorbed administered with other recommended vaccines according to the standard of care, at 2, 4, and 6 months of age in infants and as a booster to toddlers, Protocol Number P3T08. The subject received four doses of Infanrix. The last dose prior to the event was given on 6/30/03. Other vaccines given on the same date were IPV, PRP-T, MMR and VZV. The subject developed vomiting and an abdominal mass was found, 14 days post-immunization. The subject underwent a tumor biopsy on 7/25/03, along with bone marrow aspirations and biopsies. The pt was diagnosed as a stage 4 Neuroblastoma and was started on the COG A3973 protocol. According to the protocol, the pt was due to have a stem cell harvest after two cycles of chemotherapy. The subject was to have a future autologous stem cell transplant if enough stem cells were harvested and other requirements of the protocol has been completed. There was unanimous agreement among the transplant committee that this subject was a candidate for a stem cell transplant assuming the subject remained on the COG protocol, and the subject met transplant criteria. The subject died on 9/1/03. The event of neuroblastoma, secondary brain/ spine cancer, anoxic brain damage, pneumonia, and pulmonary collapse was reported by the investigator as not related to the study vaccine. Autopsy is pending. A 15-day follow up report received 12/19/2003 adds no new info.
Copyright © 2019 National Vaccine Information Center. All rights reserved.
21525 Ridgetop Circle, Suite 100, Sterling, VA 20166