Freeze-dried Live Attenuated Measles/Rubella Combined Vaccine (Schwarz FF-8 Strain/TO-336 Strain) Specified Drug-use Survey of Vaccinees After the Second Vaccination

Browse trials for

• Measles 134
• Rubella 85

Keywords

• Pharmacological therapy

Measles

134 studies on the registry are indexed under Measles; 17 are open to participants now.

This study's enrollment of 3,331 is above the median of 282 across 26 observational studies indexed under Measles.

Lead sponsor

Takeda is the lead sponsor of 1,026 studies on the registry; 89 are open to participants now.

Of its 178 completed or terminated interventional studies of FDA-regulated products, 154 (87%) have results posted.

Study population

Groups and cohorts

• Live attenuated measles/rubella combined vaccine

  Live attenuated measles/rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain) is dissolved in 0.7 mL of accompanying reconstitution fluid (water for injection \[Japanese Pharmacopoeia\]), and a 0.5-mL portion is typically administered subcutaneously as a single dose.

  Drug: Freeze-dried live attenuated measles and rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain)

Interventions

• DrugFreeze-dried live attenuated measles and rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain)

  Freeze-dried live attenuated measles and rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain)

  Also known as: Freeze-dried live attenuated measles and rubella combined vaccine "Takeda"

Primary outcomes

1. Number of Participants With Serious Adverse Drug Reactions (ADRs)

   Serious ADRs are defined as serious adverse events (SAE) which are in the investigator's opinion of causal relationship to the study treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Frequency of adverse events and factors that may influence safety were not to be assessed as endpoints of this study and were registered as endpoints by mistake. Instead, ADRs were assessed as endpoint.

   Time frame: Up to Day 28

Secondary outcomes

1. Number of Participants With Adverse Drug Reactions (ADRs)

   ADRs are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AE are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.

   Time frame: Up to Day 28

Baseline characteristics

4 further baseline measures are reported on the registry.

Individual participant data

Plan to share: No