Frozen ProQuad Administered Concomitantly Versus Nonconcomitantly With Other Pediatric Vaccines

Merck Sharp & Dohme LLC1,913 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

1,913

Conditions

Measles Mumps Rubella Varicella

Interventions

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

A single 0.5 mL subcutaneous injection at Day 0

Comparator: TripediaBIOLOGICAL

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

Comparator: ComvaxBIOLOGICAL

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

Eligibility

Sex: ALLMin age: 12 MonthsMax age: 15 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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.

Time frame: 6 weeks Postvaccination

Data from ClinicalTrials.gov

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A single 0.5 mL subcutaneous injection at Day 0

Comparator: M-M-R IIBIOLOGICAL

A single 0.5 mL subcutaneous injection at Day 0

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).

Time frame: 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).

Time frame: 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)).

Time frame: 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.)

Time frame: 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.)

Time frame: 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.)

Time frame: 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.)

Time frame: 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.)

Time frame: 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.)

Time frame: 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).

Time frame: 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).)

Time frame: 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).)

Time frame: 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.)

Time frame: 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).)

Time frame: 6 weeks Postvaccination