Age: 21.0
Sex: F
Vaccine: MNQ
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Haemorrhage, Stress, Ultrasound scan abnormal
Clinical narrative: Initial report received on 26 October 2007. The following is verbatim from that report. "Summary: The subject is a 21 year-old, HIV infected, female, enrolled on September 6, 2007 in a study, who experienced grade 2 miscarriage on October 9, 2007. The subject had negative pregnancy tests at study screening on August 23, 2007 and at study entry on September 6, 2007. She also admitted to using birth control as required in the eligibility criteria. On September 2007, the subject received one single dose of the study agent, Quadrivalent Meningococcal Conjugated vaccine. On study day 33, the subject informed the site that she had spontaneous abortion of a 5 weeks gestation. She reported going through some stress condition before the abortion, because her 2 year-old child was hospitalized for trauma a day before she experienced excessive bleeding. She further stated that, prior to the study entry; she had a past history of tubal pregnancy loss. On October 10, 2007, the subject had an abdominal ultrasound done, the report of which was still pending, as at the time of this report." "Assessment of Relationship: The site Principal Investigator has assessed the event of miscarriage as probably not related to the study agent, Quadrivalent Meningococcal Conjugate vaccine. The DAIDS Medical Officer has assessed the event of miscarriage as probably not related to, but could not rule out the relationship to the study agent, Quadrivalent Meningococcal Conjugate vaccine. After review of the clinical details and investigator comments pertaining to the adverse event, and based upon our experience with this agent, the Division of AIDS does not believe that changes to the conduct of this trial are warranted." "Previous Reports: There has been no similar safety reports previously submitted for this IND." "Patient History and Clinical Evaluation: Clinical Evaluation: The subject is a 21 year-old, HIV infected, female, enrolled on September 6, 2007 in a study, who experienced grade 2 miscarriage on October 9, 2007. The subject had negative pregnancy tests at study screening on August 23, 2007, and at study entry on September 6, 2007. She also admitted to using unspecified birth control as required in the eligibility criteria. On September 6, 2007, the subject received one single dose of the study agent, Quadrivalent Meningococcal Conjugate vaccine. On study day 33, the subject informed the site that she had spontaneous abortion of a 5 weeks gestation (by ultrasound), according to her. She reported that she was stressed out before the abortion, because her 2 year-old child fell on the stairs, sustained skull fracture, and loss of consciousness, which required admission to a local hospital. The next day after the child's accident, she experienced excessive bleeding, which was diagnosed as early loss of pregnancy. She further stated that, prior to the study entry; she had a past history of tubal pregnancy loss. With the past history of tubal pregnancy loss, and the traumatic, stressful experience of the subject, the site believed that the miscarriage was probably not related to the study agent. On October 10, 2007, when the subject was seen at the clinic, she was well groomed, and had an appropriate conversation with the social worker. She was never hospitalized or received any medical or operative intervention for this miscarriage. During this visit, she had an abdominal ultrasound done, the report of which was still pending, as at the time of this report. The site will obtain the subject's medical record from her obstetrician/gynecologist, including the ultrasound report, and send a follow up report for this event. Past medical history is significant for HIV infection and tubal pregnancy loss. The subject was not taking any concomitant medications at the time of the event." "Assessment of relationship: The site Principal Investigator has assessed the event of miscarriage as probably not related to the study agent, Quadrivalent Meningococcal Conjugate vaccine. The DAIDS Medical Officer has assessed the event of miscarriage as probably not related to, but could not rule out the relationship to the study agent, Quadrivalent Meningococcal Conjugate vaccine." "After review of the clinical details and investigator comments pertaining to this adverse event, and based upon our experience with this agent, the Division of AIDS does not believe that changes to the conduct of this trial are warranted."