Health Condition 1: O360- Maternal care for rhesus isoimmunization
Conditions
Interventions
Intervention1: AntiD (recombinant anti-Rho (D) immunoglobulin?: Dose - Single-dose of 300 mcg/ 150 mcg
Route of administered- Intramuscular
Duration of treatment is a single day within 72 hours of s
Sponsors
Bharat Serums and Vaccines Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Rh negative female subjects = 18 years of age with negative ICT (nonsensitized). 2. Rh negative female subjects who would receive AntiD™ as per approved indications. 3. Subjects able to adhere to the study visit schedule and other protocol requirements. 4. Subjects willing to participate in the study by giving written informed consent.
Exclusion criteria
Exclusion criteria: 1. Subjects suffering from any medical condition that in the investigator’s opinion could compromise the subject’s ability to participate in the trial. 2. Subjects participating in another clinical trial in the four weeks before the screening visit. 3. History of anaphylactic or other severe systemic reaction to immunoglobulins. 4. Subjects requiring blood transfusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidences of Serious adverse events (SAEs) and adverse events (AEs) throughout the studyTimepoint: Throughout the study Day 1, Day 3, Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcome.Timepoint: No secondary outcome | — |
Countries
India
Contacts
Public ContactAnirban Roy Chowdhury
Bharat serums and Vaccines LTd
Outcome results
None listed