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Completed

NCT Number: NCT00985153

Safety, Tolerability, and Immunogenicity of 3 Frozen ProQuad Consistency Lots in Healthy Children (V221-012)(COMPLETED)

This study will compare three consistency lots of ProQuad to each other as well as to M-M-R II and Varivax, administered concomitantly at different injection sites, with respect to immunogenicity, safety, and tolerability.

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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 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

Treatment and study plan

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

Biological

A Single 0.5 mL subcutaneous injection at Day 0

Other names: ProQuad

Comparator: Varivax

Biological

A Single 0.5 mL subcutaneous injection at Day 0

Comparator: M-M-R II

Biological

A Single 0.5 mL subcutaneous injection at Day 0

Primary outcomes

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

    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

  2. Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥ 120 mIU/mL

    Time frame: 6 weeks Postvaccination

    Antibody Response to Measles at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer < 120 mIU/mL) to Measles at Baseline

  3. Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥ 10 Ab Units/mL

    Time frame: 6 weeks Postvaccination

    Antibody Response to Mumps at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer < 10 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

  5. Antibody Response to Varicella for Subjects Initially With Varicella Antibody Titer < 1.25 gpELISA Units/mL at Baseline - Geometric Mean Titer

    Time frame: 6 weeks Postvaccination

    Postvaccination observed Geometric Mean Titer of antibody to Varicella

  6. Antibody Response to Measles for Subjects Initially Seronegative (a Titer < 120 mIU/mL) to Measles at Baseline - Geometric Mean Titer

    Time frame: 6 weeks Postvaccination

    Postvaccination observed Geometric Mean Titer of antibody to Measles.

  7. Antibody Response to Mumps for Subjects Initially Seronegative (a Titer < 10 Ab Units/mL) to Mumps at Baseline - Geometric Mean Titer

    Time frame: 6 weeks Postvaccination

    Postvaccination observed Geometric Mean Titer of antibody to Mumps.

  8. Antibody Response to Rubella for Subjects Initially Seronegative (a Titer < 10 IU/mL) to Rubella at Baseline - Geometric Mean Titer

    Time frame: 6 weeks Postvaccination

    Postvaccination observed Geometric Mean Titer of antibody to Rubella

  9. Number of Participants With Serious Vaccine-related CAEs

    Time frame: 6 weeks Postvaccination

    Subjects 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).

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

Comparison of the Safety, Tolerability, and Immunogenicity of 3 Consistency Lots of Frozen Measles, Mumps, Rubella, and Varicella Vaccine (ProQuad) in Healthy Children

Important dates

Study start
2000
Primary completion
2001
Study completion
2001
First posted
Sep 28, 2009
Registry last updated
Nov 23, 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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