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Completed

NCT Number: NCT00985166

A Study of ProQuad in Healthy 4 to 6 Year Old Children (V221-014)

The study was conducted to determine if ProQuad may be used in place of the second dose of M-M-R II routinely given to children 4 to 6 years old who were previously immunized with M-M-R II and Varivax.

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Key information

Conditions

Measles Chickenpox DNA Virus Infections Herpesviridae Infections Infections Mononegavirales Infections Morbillivirus Infections Mouth Diseases Mumps Paramyxoviridae Infections Parotid Diseases Parotitis RNA Virus Infections Rubella Rubivirus Infections Rubulavirus Infections Salivary Gland Diseases Stomatognathic Diseases Togaviridae Infections Varicella Varicella Zoster Virus Infection Virus Diseases

Age range

4 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • In good health
  • Received primary dose of M-M-R II at less than or equal to 12 months of age
  • Received primary dose of Varivax at less than or equal to 12 months of age
  • Negative history of varicella, zoster, measles, mumps, and rubella

Exclusion criteria

  • history of receiving more than once dose of M-M-R II or Varivax
  • Any immune impairment or deficiency
  • Exposure to measles, mumps, rubella, varicella, or zoster in the 4 weeks prior to vaccination
  • Vaccination with an inactive vaccine with in the past 14 days
  • Vaccination with a live vaccine within the past 30 days
  • Receipt of immune globulin, or blood product in the past 5 months

Treatment and study plan

ProQuad (Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live)

Biological

A Single 0.5 mL subcutaneous injection at Day 1

Other names: ProQuad

Comparator: M-M-R II

Biological

A Single 0.5 mL subcutaneous injection at Day 1

Comparator: Varivax

Biological

A Single 0.5 mL subcutaneous injection at Day 1

Comparator: Placebo

Biological

A Single 0.5 mL subcutaneous placebo injection at Day 1

Primary outcomes

  1. Antibody Response to Varicella for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer

    Time frame: 6 weeks Postvaccination

    Postvaccination observed Geometric Mean Titer of antibody to Varicella

  2. Antibody Response to Measles for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer

    Time frame: 6 weeks Postvaccination

    Postvaccination observed Geometric Mean Titer of antibody to Measles

  3. Antibody Response to Mumps for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer

    Time frame: 6 weeks Postvaccination

    Postvaccination observed Geometric Mean Titer of antibody to Mumps

  4. Antibody Response to Rubella for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer

    Time frame: 6 weeks Postvaccination

    Postvaccination observed Geometric Mean Titer of antibody to Rubella

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

Administration of Frozen Measles, Mumps, Rubella, and Varicella (MMRV) Vaccine to Healthy Children at 4 to 6 Years of Age

Important dates

Study start
2000
Primary completion
2002
Study completion
2003
First posted
Sep 28, 2009
Registry last updated
Jul 28, 2015

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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