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Completed

NCT Number: NCT00986232

ProQuad Dose Selection Study (V221-011)(COMPLETED)

A Study comparing three different doses of ProQuad to concomitant administration of M-M-R II and PUVV (Process Upgrade Varicella Vaccine) vaccines.

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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 2

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 measles, mumps, rubella, varicella, and zoster

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 ProQuad (low, middle, or high dose) at Day 0 and Day 90

Other names: ProQuad

Comparator: M-M-R II

Biological

A single 0.5 mL subcutaneous injection at Day 0

Comparator: PUVV

Biological

A single 0.5 mL subcutaneous injection at Day 0

Primary outcomes

  1. Number of Participants With Varicella Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Antibody Titer ≥ 5 gpELISA Units

    Time frame: 6 weeks postvaccination

    Antibody response to Varicella at 6 weeks postvaccination in participants with baseline titer <1.25 gpELISA units

Secondary outcomes

  1. Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥ 207.5 mIU/mL

    Time frame: 6 weeks postvaccination

    Antibody response to measles at 6 weeks postvaccination in participants initially seronegative (a titer <207.5 mIU/mL) to measles at baseline

  2. 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 in participants initially seronegative (a titer < 2.0 Ab units/mL) to Mumps at baseline

  3. 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 in participants initially seronegative (a titer <10 IU/mL) to Rubella at baseline

  4. Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences (CAEs)

    Time frame: 6 weeks Postvaccination Visit 1 or Visit 2

    Participants with a serious vaccine-related CAE (an AE which is assessed by an investigator/qualified physician as being related to study vaccine and results in death, persistent or significant disability/incapacity, prolongs an existing inpatient hospitalization, is life-threatening, a congenital anomaly/birth defect, a cancer, or an overdose).

  5. Antibody Response to Varicella at 6 Weeks Postvaccination in Participants With Baseline Titer < 1.25 gpELISA Units - Geometric Mean Titer (GMT)

    Time frame: 6 weeks Postvaccination

    Postvaccination observed Geometric Mean Titer (GMT) of Varicella antibody. (Titers measured using Varicella zoster virus (VZV) gpELISA.)

  6. Antibody Response to Measles at 6 Weeks Postvaccination in Participants Initially Seronegative to Measles at Baseline - Geometric Mean Titer (GMT)

    Time frame: 6 weeks Postvaccination

    Postvaccination observed Geometric Mean Titer (GMT) of Measles antibody. (Titers measured using Measles ELISA.)

  7. Antibody Response to Mumps at 6 Weeks Postvaccination in Participants Initially Seronegative to Mumps at Baseline - Geometric Mean Titer (GMT)

    Time frame: 6 weeks Postvaccination

    Postvaccination observed Geometric Mean Titer (GMT) of Mumps antibody. (Titer measured using Mumps ELISA.)

  8. Antibody Response to Rubella at 6 Weeks Postvaccination in Participants Initially Seronegative to Rubella at Baseline - Geometric Mean Titer (GMT)

    Time frame: 6 weeks postvaccination

    Postvaccination observed Geometric Mean Titer (GMT) of Rubella antibody. (Titers measured using Rubella ELISA.)

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Dose Selection Study in Healthy Children Comparing Measles Mumps, Rubella, and Varicella (ProQuad) Vaccine to M-M-R II Given Concomitantly With Process Upgrade Varicella Vaccine (PUVV) in Separate Injections

Important dates

Study start
1999
Primary completion
2000
Study completion
2000
First posted
Sep 29, 2009
Registry last updated
Apr 10, 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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