NCT00984295

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,913

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jun 2000

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2000

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2001

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2001

Completed
7.8 years until next milestone

First Submitted

Initial submission to the registry

September 23, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 25, 2009

Completed
5 months until next milestone

Results Posted

Study results publicly available

February 25, 2010

Completed
Last Updated

August 7, 2015

Status Verified

July 1, 2015

Enrollment Period

1.3 years

First QC Date

September 23, 2009

Results QC Date

February 3, 2010

Last Update Submit

July 16, 2015

Conditions

MeaslesMumpsRubellaVaricella

Outcome Measures

Primary Outcomes (20)

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

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

    6 Weeks Postvaccination

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

    Antibody Response to Mumps at 6 Weeks Postvaccination for Participants Initially Seronegative (a titer \<10 Ab units/mL) to Mumps at Baseline

    6 weeks Postvaccination

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

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

    6 weeks Postvaccination

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

    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

    6 weeks Postvaccination

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

    Antibody response to Diphtheria at 6 weeks postvaccination

    6 weeks Postvaccination

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

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

    6 weeks Postvaccination

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

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

    6 weeks Postvaccination

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

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

    6 weeks Postvaccination

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

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

    6 weeks Postvaccination

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

    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.)

    6 weeks Postvaccination

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

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

    6 weeks Postvaccination

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

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

    6 weeks Postvaccination

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

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

    6 weeks Postvaccination

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

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

    6 weeks Postvaccination

  • Antibody Response to Diphtheria at 6 Weeks Postvaccination - GMT

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

    6 weeks Postvaccination

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

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

    6 weeks Postvaccination

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

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

    6 weeks Postvaccination

  • Antibody Response to Hepatitis B at 6 Weeks Postvaccination - GMT

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

    6 weeks Postvaccination

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

    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.)

    6 weeks Postvaccination

  • Antibody Response to Tetanus at 6 Weeks Postvaccination - GMT

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

    6 weeks Postvaccination

Study Arms (3)

1

EXPERIMENTAL

ProQuad + Tripedia + Comvax at Day 0 (Concomitant)

Biological: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine LiveBiological: Comparator: TripediaBiological: Comparator: Comvax

2

EXPERIMENTAL

ProQuad at Day 0, Tripedia + Comvax at Day 42(Nonconcomitant)

Biological: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine LiveBiological: Comparator: TripediaBiological: Comparator: Comvax

3

ACTIVE COMPARATOR

Varivax + M-M-R II at Day 0, Tripedia + Comvax at Day 42 (Control)

Biological: Comparator: TripediaBiological: Comparator: ComvaxBiological: Comparator: VarivaxBiological: Comparator: M-M-R II

Interventions

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

A single 0.5 mL subcutaneous injection at Day 0

Also known as: ProQuad
12
Comparator: TripediaBIOLOGICAL

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

123
Comparator: ComvaxBIOLOGICAL

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

123
Comparator: VarivaxBIOLOGICAL

A single 0.5 mL subcutaneous injection at Day 0

3
Comparator: M-M-R IIBIOLOGICAL

A single 0.5 mL subcutaneous injection at Day 0

3

Eligibility Criteria

Age12 Months - 15 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Shinefield H, Black S, Thear M, Coury D, Reisinger K, Rothstein E, Xu J, Hartzel J, Evans B, Digilio L, Schodel F, Brown ML, Kuter B; 013 Study Group for ProQuad. Safety and immunogenicity of a measles, mumps, rubella and varicella vaccine given with combined Haemophilus influenzae type b conjugate/hepatitis B vaccines and combined diphtheria-tetanus-acellular pertussis vaccines. Pediatr Infect Dis J. 2006 Apr;25(4):287-92. doi: 10.1097/01.inf.0000207857.10947.1f.

    PMID: 16567978RESULT

MeSH Terms

Conditions

MeaslesMumpsRubellaChickenpox

Interventions

measles, mumps, rubella, varicella vaccine

Condition Hierarchy (Ancestors)

Morbillivirus InfectionsParamyxoviridae InfectionsMononegavirales InfectionsRNA Virus InfectionsVirus DiseasesInfectionsRubulavirus InfectionsParotitisParotid DiseasesSalivary Gland DiseasesMouth DiseasesStomatognathic DiseasesRubivirus InfectionsTogaviridae InfectionsVaricella Zoster Virus InfectionHerpesviridae InfectionsDNA Virus Infections

Limitations and Caveats

Two participants were incorrectly vaccinated and are not included in the efficacy/safety analyses. One received M-M-R™II+TRIPEDIA™+COMVAX™ and 1 received VARIVAX™+TRIPEDIA™+COMVAX™ instead of ProQuad™+TRIPEDIA™+COMVAX™

Results Point of Contact

Title
Senior Vice President, Global Clinical Development
Organization
Merck Sharp & Dohme Corp.
ClinicalTrialsDisclosure@merck.com
1-800-672-6372

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2009

First Posted

September 25, 2009

Study Start

June 1, 2000

Primary Completion

October 1, 2001

Study Completion

December 1, 2001

Last Updated

August 7, 2015

Results First Posted

February 25, 2010

Record last verified: 2015-07