Frozen ProQuad Administered Concomitantly Versus Nonconcomitantly With Other Pediatric Vaccines

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Rubella; Varicella; Mumps; Measles

Treatments: Biological: Comparator: Tripedia; Biological: Comparator: Varivax; Biological: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live; Biological: Comparator: M-M-R II; Biological: Comparator: Comvax

Study type: Interventional

Funder types: Industry

Identifiers

NCT00984295

2009_666

V221-013

Details and patient eligibility

About

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

Enrollment: 1,913 patients

Sex: All

Ages: 12 to 15 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,913 participants in 3 patient groups

1

Experimental group

Description:

ProQuad + Tripedia + Comvax at Day 0 (Concomitant)

Treatment:

Biological: Comparator: Comvax

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

Biological: Comparator: Tripedia

2

Experimental group

Description:

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

Treatment:

Biological: Comparator: Comvax

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

Biological: Comparator: Tripedia

3

Active Comparator group

Description:

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

Treatment:

Biological: Comparator: Comvax

Biological: Comparator: Varivax

Biological: Comparator: M-M-R II

Biological: Comparator: Tripedia