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OpenTrials
Completed

NCT Number: NCT00975507

ProQuad™ Versus M-M-R II™ and VARIVAX™ in Healthy Children (V221-009)(COMPLETED)

This study will compare Measles, Mumps, Rubella, and Varicella Vaccine (V221) and concomitant administration of Varivax and M-M-R II vaccines in healthy children.

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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

12 month–23 month

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
  • Negative clinical history of varicella, shingles, measles, mumps, and rubella

Exclusion criteria

  • Previous receipt of measles, mumps, rubella and/or varicella vaccine either alone or in combination
  • 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
  • Immune globulin or any blood product administered in the past 3 months

Treatment and study plan

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

Biological

a single 0.5 mL subcutaneous injection of V221 at Day 0 and Day 90

Other names: ProQuad™

Comparator: Placebo

Biological

a single 0.5 mL subcutaneous placebo injection at Day 0

Comparator: Varivax

Biological

a single 0.5 mL subcutaneous injection of Varivax at Day 0

Comparator: M-M-R II

Biological

a single 0.5 mL subcutaneous injection of M-M-R II at Day 0

Primary outcomes

  1. Number of Participants With Postvaccination Varicella Antibody Titer ≥5 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Units/mL for Subjects Initially Seronegative (a Titer of <0.6 gpELISA Units/mL) to Varicella at Baseline

    Time frame: 6 weeks Postvaccination

    Antibody Response to Varicella at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer of <0.6 gpELISA units/mL) to Varicella at Baseline

Secondary outcomes

  1. Number of Participants With Postvaccination Measles ELISA Antibody Titer ≥207.8 mIU/mL

    Time frame: 6 weeks Postvaccination

    Antibody Response to Measles at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <207.8 mIU/mL) to Measles at Baseline

  2. Number of Participants With Postvaccination Varicella Antibody Titer ≥5 gpELISA Units/mL for Subjects Initially With Varicella Antibody Titer <1.25 gpELISA Units/mL at Baseline

    Time frame: 6 weeks Postvaccination

    Antibody Response to Varicella at 6 Weeks Postvaccination for Subjects Initially With Varicella Antibody Titer <1.25 gpELISA units/mL at Baseline

  3. Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥2.0 Ab Units/mL

    Time frame: 6 weeks Postvaccination

    Antibody Response to Mumps at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <2.0 Ab Units/mL) to Mumps at Baseline

  4. Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥10 IU/mL

    Time frame: 6 weeks Postvaccination

    Antibody Response to Rubella at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <10 IU/mL) to Rubella at Baseline

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Pilot Study to Compare the Safety, Tolerability, and Immunogenicity of Measles, Mumps, Rubella, and Varicella (MMRV) Vaccine and the Concomitant Administration of the Currently Licensed VARIVAX™ and M-M-R II™ in Healthy Children

Important dates

Study start
1998
Primary completion
1999
Study completion
1999
First posted
Sep 11, 2009
Registry last updated
Oct 6, 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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