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OpenTrials
Completed

NCT Number: NCT00432731

Safety Study of a Refrigerator-stable Formulation of VARIVAX®

Primary objective:

To describe the safety profile of a refrigerator-stable formulation of VARIVAX® as a first single dose injection in 12 to 15 month-old infants in the 42-day follow-up period post-vaccination.

Secondary objectives: NA

Completed

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy infants from 12 months of age to 15 months of age.
  • Consent form signed by both parents or by the legal representative(s), properly informed about the study,
  • Parent(s) able to understand the protocol requirements and to fill in the Diary Card.

Exclusion criteria

  • Prior receipt of measles, mumps, rubella or varicella vaccine either alone or in combination vaccine,
  • Known or suspected clinical history of infection with measles, mumps, rubella, varicella or zoster,
  • Any known recent (≤30 days) exposure to measles, mumps or rubella,
  • Any known recent (≤30 days) exposure to varicella or zoster involving:
  • Any recent (≤3 days) history of febrile illness (rectal temperature ≥38.0°C),
  • Active untreated tuberculosis,
  • Any known blood dyscrasia, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems,
  • Any immune impairment or humoral/cellular deficiency, neoplastic disease or depressed immunity,
  • Any previous (≤150 days) receipt of immune serum globulin or any blood-derived products or scheduled to be administered through visit 3,
  • Any recent receipt of an inactivated or a live vaccine (≤ 30 days) or scheduled vaccination through visit 3

Treatment and study plan

VARIVAX®

Biological

M-M-RTM II

Biological

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Double-blind, Randomised, Controlled, Multi-centre Safety Study of a Refrigerator-stable Formulation of VARIVAX® in Healthy 12 to 15 Month-old Infants.

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Feb 8, 2007
Registry last updated
Mar 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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