Frozen ProQuad Administered Concomitantly Versus Nonconcomitantly With Other Pediatric Vaccines

Phase 3

Completed

• Conditions: Measles; Mumps; Rubella; Varicella
• Interventions: Biological: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live

• Registration Number: NCT00984295
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2000-06
• Primary Completion: 2001-10
• Study Completion: 2001-12
• Study First Submitted: 2009-09-23
• Study First Submitted QC: 2009-09-24
• Study First Posted: 2009-09-25
• Results First Submitted: 2010-02-03
• Results First Submitted QC: 2010-02-03
• Results First Posted: 2010-02-25
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-16
• Last Update Posted: 2015-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1913

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live	ProQuad at Day 0, Tripedia + Comvax at Day 42(Nonconcomitant)
1	Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live	ProQuad + Tripedia + Comvax at Day 0 (Concomitant)

Primary Outcome Measures

Name	Time	Method
Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥10 Ab Units/mL	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
Number of Participants With Postvaccination Diphtheria Vero Cell Culture Assay Antibody Titer ≥0.1 IU/mL	6 weeks Postvaccination	Antibody response to Diphtheria at 6 weeks postvaccination
Number of Participants With ≥4-fold Rise in Pertussis Filamentous Hemagglutinin (FHA) EIA Antibody Titer	6 weeks Postvaccination	Antibody response to pertussis FHA(titers of pertussis filamentous hemagglutinin antibodies were measured with an indirect, noncompetitive EIA).
Antibody Response to Hepatitis B at 6 Weeks Postvaccination - GMT	6 weeks Postvaccination	Postvaccination Observed Geometric Mean Titer of Antibody to Hepatitis B. (Titers measured using the Quantitative AUSAB™ radioimmunoassay (RIA).)
Number of Participants With Postvaccination Tetanus Enzyme Immunoassay (EIA) Antibody Titer ≥0.1 IU/mL	6 weeks Postvaccination	Antibody response to Tetanus (tetanus antitoxin were measured with an indirect, noncompetitive enzyme immunoassay (EIA)) at 6 weeks postvaccination.
Number of Participants With ≥4-fold Rise in Pertussis Toxin (PT) EIA Antibody Titer	6 weeks Postvaccination	Antibody response to Pertussis Toxin (titers of pertussis toxin antibodies were measured with an indirect, noncompetitive EIA).
Antibody Response to Haemophilus Influenzae Type B (Hib) at 6 Weeks Postvaccination - GMT	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.)
Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥120 mIU/mL	6 Weeks Postvaccination	Antibody Response to Measles at 6 Weeks Postvaccination for Participants Initially Seronegative (a titer \<120 mIU/mL) to Measles at Baseline
Number of Participants With Postvaccination Hepatitis B (Quantitative AUSAB™ Radioimmunoassay (RIA)) Antibody Titer ≥10 mIU/mL	6 weeks Postvaccination	Antibody response to Hepatitis B (titers measured using the Quantitative AUSAB™ radioimmunoassay (RIA)).
Number of Participants With Postvaccination Haemophilus Influenzae Type B (Hib) Radioimmunoassay (RIA) Antibody Titer ≥ 1 mcg/mL	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.)
Antibody Response to Varicella at 6 Weeks Postvaccination for Participants Initially Seronegative to Varicella at Baseline - GMT	6 weeks Postvaccination	Postvaccination Observed Geometric Mean Titer of Antibody to Varicella. (Titers measured using VZV gpELISA.)
Antibody Response to Pertussis Filamentous Hemagglutinin (FHA) at 6 Weeks Postvaccination - GMT	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).)
Antibody Response to Tetanus at 6 Weeks Postvaccination - GMT	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).)
Antibody Response to Mumps at 6 Weeks Postvaccination for Participants Initially Seronegative to Mumps at Baseline - GMT	6 weeks Postvaccination	Postvaccination observed GMT of antibody to mumps. (Titers measured using mumps ELISA.)
Antibody Response to Pertussis Toxin (PT) at 6 Weeks Postvaccination - GMT	6 weeks Postvaccination	Postvaccination Observed Geometric Mean Titer of Antibody to Pertussis Toxin (PT). Titers measured using an indirect, noncompetitive Pertussis enzyme immunoassay (EIA).
Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥10 IU/mL	6 weeks Postvaccination	Antibody Response to Rubella at 6 Weeks Postvaccination for Participants Initially Seronegative (a titer \<10 IU/mL) to Rubella at Baseline
Number of Participants With Postvaccination Varicella-Zoster Virus (VZV) Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Antibody Titer ≥5 gpELISA Units/mL	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
Antibody Response to Measles at 6 Weeks Postvaccination for Participants Initially Seronegative to Measles at Baseline - Geometric Mean Titer (GMT)	6 weeks Postvaccination	Postvaccination Observed Geometric Mean Titer of Antibody to Measles. (Titers measured using Measles ELISA.)
Antibody Response to Rubella at 6 Weeks Postvaccination for Participants Initially Seronegative to Rubella at Baseline - GMT	6 weeks Postvaccination	Postvaccination Observed Geometric Mean Titer of Antibody to Rubella. (Titers measured using Rubella ELISA.)
Antibody Response to Diphtheria at 6 Weeks Postvaccination - GMT	6 weeks Postvaccination	Postvaccination Observed Geometric Mean Titer of Antibody to Diphtheria. (Titers measured using Vero Cell Culture Assay.)