A Study of ProQuad™ in Healthy Children in Korea (V221-023)

A Multicenter, Randomized, Open-Label Study to Compare the Immunogenicity, Safety, and Tolerability of Measles, Mumps, Rubella, and Varicella of Combination Vaccine ProQuad With Concomitant Administration of M-M-R II and VARIVAX in Healthy Korean Children

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00839917

Enrollment

Registered

2009-02-10

Start date

2008-02-29

Completion date

2008-05-31

Last updated

2017-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Measles, Mumps, Rubella, Varicella

Keywords

Measles, Mumps, Rubella, Varicella

Brief summary

This study will compare ProQuad™ and concomitant administration of M-M-R™ II and Varivax™ with respect to immunogenicity, safety and tolerability. The primary hypothesis to be tested is that the antibody response rates to measles, mumps, rubella, and varicella 6 weeks after vaccination with ProQuad™ will be non-inferior to the antibody response rates after vaccination with concomitant M-M-R™ II and Varivax™.

Interventions

BIOLOGICALMeasles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (ProQuad™)

Single administration of 0.5 mL subcutaneous injection

BIOLOGICALM-M-R™ II and Varivax™

Single administration of 0.5 mL subcutaneous injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Months to 23 Months

Healthy volunteers

Yes

Inclusion criteria

* Subject is in good health * Subject has a negative clinical history for measles, mumps, rubella, varicella and zoster

Exclusion criteria

* Subject has previously received measles, mumps, rubella and/or varicella vaccine, either alone or in any combination * Subject has any congenital or acquired immune deficiency, neoplastic disease or depressed immunity * Subject has a history of seizure disorder * Subject had exposure to measles, mumps, rubella, varicella and/or zoster in the last 4 weeks * Subject has received an inactivated vaccine within the past 14 days * Subject has received a live vaccine within the past 30 days * Subject has received immune globulin within the past 5 months * Subject has a recent history of fever (within the last 72 hours)

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Participants With Measles Antibody Levels ≥255 mIU/mL	6 weeks postvaccination	Antibody response to measles at 6 weeks after vaccination for participants initially seronegative (\<255 mIU/mL) to measles at baseline
Percentage of Participants With Varicella-zoster Virus (VZV) Antibody Levels ≥5 Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Units/mL	6 weeks postvaccination	Antibody response to VZV at 6 weeks after vaccination for participants initially seronegative (\<5 gpELISA units/mL) to VZV at baseline
Percentage of Participants With Rubella Antibody Levels ≥10 IU/mL	6 weeks postvaccination	Antibody response to rubella at 6 weeks after vaccination for participants initially seronegative (\<10 IU/mL) to rubella at baseline
Percentage of Participants With Mumps Antibody Levels ≥10 Mumps Antibody Units/mL	6 weeks postvaccination	Antibody response to mumps at 6 weeks after vaccination for participants initially seronegative (\<10 units/mL) to mumps at baseline

Secondary

Measure	Time frame	Description
Geometric Mean Titer of Measles Antibodies	6 weeks postvaccination	Mean measles antibody response at 6 weeks after vaccination for participants initially seronegative (\<255 mIU/mL) to measles at baseline
Geometric Mean Titer of Mumps Antibodies	6 weeks postvaccination	Mean mumps antibody response at 6 weeks after vaccination for participants initially seronegative (\<10 Units/mL) to mumps at baseline
Geometric Mean Titer of Rubella Antibodies	6 weeks postvaccination	Mean rubella antibody response at 6 weeks postvaccination for participants initially seronegative (\<10 IU/mL) to rubella at baseline
Geometric Mean Titer of VZV (gpELISA) Antibodies	6 weeks postvaccination	Mean VZV antibody response at 6 weeks after vaccination for participants initially seronegative (\<5 gpELISA Units/mL) to VZV at baseline

Other

Measure	Time frame	Description
Percentage of Participants With Zoster-like Rash	Through 6 weeks postvaccination	—
Percentage of Participants With Rubella-like Rash	Through 6 weeks postvaccination	—
Percentage of Participants With Varicella-like Rash	Through 6 weeks postvaccination	—
Percentage of Participants With Any Systemic Adverse Experience	Through 6 weeks postvaccination	An adverse experience is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience. A systemic adverse experience is any adverse experience other than injection-site adverse experiences.
Percentage of Participants With Injection-site Adverse Experiences	Through 6 weeks postvaccination	An adverse experience is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience. An injection-site adverse experience is an adverse experience that occurs at the injection site only.
Percentage of Participants With Fever (≥101.0°F [38.3°C] Axillary or ≥103.0°F [39.4°C] Rectal)	Through 6 weeks postvaccination	—
Percentage of Participants With Measles-like Rash	Through 6 weeks postvaccination	—

Participant flow

Recruitment details

The study was planned to enroll 360 participants; however the study was terminated early because it was not possible to complete enrollment before expiration of the investigational vaccine lot

Participants by arm

Arm	Count
ProQuad™ Single subcutaneous 0.5 mL vaccination	13
M-M-R™ II and Varivax™ Single subcutaneous 0.5 mL vaccination	17
Total	30

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Did not receive vaccine	0	1
Overall Study	Lost to Follow-up	1	0

Baseline characteristics

Characteristic	ProQuad™	M-M-R™ II and Varivax™	Total
Age, Customized 12 to 15 months	13 participants	17 participants	30 participants
Sex: Female, Male Female	7 Participants	6 Participants	13 Participants
Sex: Female, Male Male	6 Participants	11 Participants	17 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	8 / 13	9 / 16
serious Total, serious adverse events	0 / 13	1 / 16

Outcome results

Primary

Percentage of Participants With Measles Antibody Levels ≥255 mIU/mL

Antibody response to measles at 6 weeks after vaccination for participants initially seronegative (\<255 mIU/mL) to measles at baseline