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OpenTrials
Completed

NCT Number: NCT00984295

Frozen ProQuad Administered Concomitantly Versus Nonconcomitantly With Other Pediatric Vaccines

This study will assess the safety and immunogenicity of ProQuad when administered concomitantly and nonconcomitantly with Tripedia and Comvax.

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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–15 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, zoster, measles, mumps, rubella, diptheria, tetanus, pertussis, invasive Hib disease and hepatitis B
  • Had completed either a 2-dose primary series of PedvaxHIB or COMVAX or any 3-dose primary series of a licensed Hib vaccine
  • Had received 2 or 3 doses of any hepatitis B vaccine or COMVAX prior to entry into trial

Exclusion criteria

  • Previous receipt of measles, mumps, rubella or varicella vaccine either alone or in combination
  • Any immune impairment or deficiency
  • Recent household, daycare or school exposure to invasive Hib disease or hepatitis B
  • 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, blood transfusion or blood-derived product in the past 3 months
  • Recent history of fever or underlying medical problems

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: Tripedia

Biological

A single 0.5 mL intramuscular injection (at Day 0 or Day 42)

Comparator: Comvax

Biological

A single 0.5 mL intramuscular injection (at Day 0 or Day 42)

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 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 Participants Initially Seronegative (a titer <120 mIU/mL) to Measles at Baseline

  2. 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 Participants Initially Seronegative (a titer <10 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 for Participants Initially Seronegative (a titer <10 IU/mL) to Rubella at Baseline

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

    Time frame: 6 weeks Postvaccination

    Antibody Response to Varicella-Zoster Virus (VZV) at 6 Weeks Postvaccination for Participants Initially Seronegative (a titer <0.6 gpELISA units/mL) to VZV at Baseline

  5. Number of Participants With Postvaccination Diphtheria Vero Cell Culture Assay Antibody Titer ≥0.1 IU/mL

    Time frame: 6 weeks Postvaccination

    Antibody response to Diphtheria at 6 weeks postvaccination

  6. Number of Participants With Postvaccination Tetanus Enzyme Immunoassay (EIA) Antibody Titer ≥0.1 IU/mL

    Time frame: 6 weeks Postvaccination

    Antibody response to Tetanus (tetanus antitoxin were measured with an indirect, noncompetitive enzyme immunoassay (EIA)) at 6 weeks postvaccination.

  7. Number of Participants With ≥4-fold Rise in Pertussis Toxin (PT) EIA Antibody Titer

    Time frame: 6 weeks Postvaccination

    Antibody response to Pertussis Toxin (titers of pertussis toxin antibodies were measured with an indirect, noncompetitive EIA).

  8. Number of Participants With ≥4-fold Rise in Pertussis Filamentous Hemagglutinin (FHA) EIA Antibody Titer

    Time frame: 6 weeks Postvaccination

    Antibody response to pertussis FHA(titers of pertussis filamentous hemagglutinin antibodies were measured with an indirect, noncompetitive EIA).

  9. Number of Participants With Postvaccination Hepatitis B (Quantitative AUSAB™ Radioimmunoassay (RIA)) Antibody Titer ≥10 mIU/mL

    Time frame: 6 weeks Postvaccination

    Antibody response to Hepatitis B (titers measured using the Quantitative AUSAB™ radioimmunoassay (RIA)).

  10. Number of Participants With Postvaccination Haemophilus Influenzae Type B (Hib) Radioimmunoassay (RIA) Antibody Titer ≥ 1 mcg/mL

    Time frame: 6 weeks Postvaccination

    Antibody response to Haemophilus influenzae type B (Hib). (Anti-polyribosylribitol phosphate (PRP) was measured by radioimmunoassay (RIA) using radiolabeled-PRP according to a standard Farr technique and with a standard provided by the U.S. FDA.)

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

    Time frame: 6 weeks Postvaccination

    Postvaccination Observed Geometric Mean Titer of Antibody to Measles. (Titers measured using Measles ELISA.)

  12. Antibody Response to Mumps at 6 Weeks Postvaccination for Participants Initially Seronegative to Mumps at Baseline - GMT

    Time frame: 6 weeks Postvaccination

    Postvaccination observed GMT of antibody to mumps. (Titers measured using mumps ELISA.)

  13. Antibody Response to Rubella at 6 Weeks Postvaccination for Participants Initially Seronegative to Rubella at Baseline - GMT

    Time frame: 6 weeks Postvaccination

    Postvaccination Observed Geometric Mean Titer of Antibody to Rubella. (Titers measured using Rubella ELISA.)

  14. Antibody Response to Varicella at 6 Weeks Postvaccination for Participants Initially Seronegative to Varicella at Baseline - GMT

    Time frame: 6 weeks Postvaccination

    Postvaccination Observed Geometric Mean Titer of Antibody to Varicella. (Titers measured using VZV gpELISA.)

  15. Antibody Response to Diphtheria at 6 Weeks Postvaccination - GMT

    Time frame: 6 weeks Postvaccination

    Postvaccination Observed Geometric Mean Titer of Antibody to Diphtheria. (Titers measured using Vero Cell Culture Assay.)

  16. Antibody Response to Pertussis Toxin (PT) at 6 Weeks Postvaccination - GMT

    Time frame: 6 weeks Postvaccination

    Postvaccination Observed Geometric Mean Titer of Antibody to Pertussis Toxin (PT). Titers measured using an indirect, noncompetitive Pertussis enzyme immunoassay (EIA).

  17. Antibody Response to Pertussis Filamentous Hemagglutinin (FHA) at 6 Weeks Postvaccination - GMT

    Time frame: 6 weeks Postvaccination

    Postvaccination Observed Geometric Mean Titer of Antibody to Pertussis Filamentous Hemagglutinin (FHA). (Titers measured using an indirect, noncompetitive Pertussis enzyme immunoassay (EIA).)

  18. Antibody Response to Hepatitis B at 6 Weeks Postvaccination - GMT

    Time frame: 6 weeks Postvaccination

    Postvaccination Observed Geometric Mean Titer of Antibody to Hepatitis B. (Titers measured using the Quantitative AUSAB™ radioimmunoassay (RIA).)

  19. Antibody Response to Haemophilus Influenzae Type B (Hib) at 6 Weeks Postvaccination - GMT

    Time frame: 6 weeks Postvaccination

    Postvaccination observed GMT of antibody to Hib. (Anti-polyribosylribitol phosphate (PRP) was measured by RIA using radiolabeled-PRP according to a standard Farr technique and with a standard provided by the U.S. FDA.)

  20. Antibody Response to Tetanus at 6 Weeks Postvaccination - GMT

    Time frame: 6 weeks Postvaccination

    Postvaccination Observed Geometric Mean Titer of Antibody to Tetanus. (Titers of tetanus antitoxin were measured with an indirect, noncompetitive enzyme immunoassay (EIA).)

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

An Open, Randomized, Multicenter Study of the Safety, Tolerability, and Immunogenicity of Frozen MMRV Given Concomitantly Versus Nonconcomitantly With Other Pediatric Vaccines in Healthy Children 12 to 15 Months of Age

Important dates

Study start
2000
Primary completion
2001
Study completion
2001
First posted
Sep 25, 2009
Registry last updated
Aug 7, 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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