Trial Outcomes & Findings for A Study of ProQuad™ in Healthy Children in Korea (V221-023) (NCT NCT00839917)

NCT ID: NCT00839917

Last Updated: 2017-04-12

Results Overview

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

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 30 participants
• Primary outcome timeframe: 6 weeks postvaccination
• Results posted on: 2017-04-12

Participant Flow

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

Participant milestones

Measure	ProQuad™ Single subcutaneous 0.5 mL vaccination	M-M-R™ II and Varivax™ Single subcutaneous 0.5 mL vaccination
Overall Study STARTED	13	17
Overall Study COMPLETED	12	16
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Measure	ProQuad™ Single subcutaneous 0.5 mL vaccination	M-M-R™ II and Varivax™ Single subcutaneous 0.5 mL vaccination
Overall Study Lost to Follow-up	1	0
Overall Study Did not receive vaccine	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	ProQuad™ n=13 Participants Single subcutaneous 0.5 mL vaccination	M-M-R™ II and Varivax™ n=17 Participants Single subcutaneous 0.5 mL vaccination	Total n=30 Participants Total of all reporting groups
Age, Customized 12 to 15 months	13 participants n=5 Participants	17 participants n=7 Participants	30 participants n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	11 Participants n=7 Participants	17 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks postvaccination

Population: Analysis was performed on the per-protocol population, defined as all participants who had both pre- and post-vaccination blood samples, were seronegative at baseline, and followed all protocol procedures. Too few participants were enrolled in the study to perform non-inferiority analysis for this outcome measure.

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

Outcome measures

Measure	ProQuad™ n=10 Participants Single subcutaneous 0.5 mL vaccination	M-M-R™ II and Varivax™ n=8 Participants Single subcutaneous 0.5 mL vaccination
Percentage of Participants With Measles Antibody Levels ≥255 mIU/mL	100.0 percentage of participants Interval 74.1 to 100.0	87.5 percentage of participants Interval 52.9 to 99.4

PRIMARY outcome

Timeframe: 6 weeks postvaccination

Population: Analysis was performed on the per-protocol population, defined as all participants who had both pre- and post-vaccination blood samples, were seronegative at baseline, and followed all protocol procedures. Too few participants were enrolled in the study to perform non-inferiority analysis for this outcome measure.

Antibody response to mumps at 6 weeks after vaccination for participants initially seronegative (<10 units/mL) to mumps at baseline

Outcome measures

Measure	ProQuad™ n=10 Participants Single subcutaneous 0.5 mL vaccination	M-M-R™ II and Varivax™ n=8 Participants Single subcutaneous 0.5 mL vaccination
Percentage of Participants With Mumps Antibody Levels ≥10 Mumps Antibody Units/mL	100.0 percentage of participants Interval 74.1 to 100.0	100.0 percentage of participants Interval 68.8 to 100.0

PRIMARY outcome

Timeframe: 6 weeks postvaccination

Population: Analysis was performed on the per-protocol population, defined as all participants who had both pre- and post-vaccination blood samples, were seronegative at baseline, and followed all protocol procedures. Too few participants were enrolled in the study to perform non-inferiority analysis for this outcome measure.

Antibody response to rubella at 6 weeks after vaccination for participants initially seronegative (<10 IU/mL) to rubella at baseline

Outcome measures

Measure	ProQuad™ n=10 Participants Single subcutaneous 0.5 mL vaccination	M-M-R™ II and Varivax™ n=8 Participants Single subcutaneous 0.5 mL vaccination
Percentage of Participants With Rubella Antibody Levels ≥10 IU/mL	100.0 percentage of participants Interval 74.1 to 100.0	100.0 percentage of participants Interval 68.8 to 100.0

PRIMARY outcome

Timeframe: 6 weeks postvaccination

Population: Analysis was performed on the per-protocol population, defined as all participants who had both pre- and post-vaccination blood samples, were seronegative at baseline, and followed all protocol procedures. Too few participants were enrolled in the study to perform non-inferiority analysis for this outcome measure.

Antibody response to VZV at 6 weeks after vaccination for participants initially seronegative (<5 gpELISA units/mL) to VZV at baseline

Outcome measures

Measure	ProQuad™ n=10 Participants Single subcutaneous 0.5 mL vaccination	M-M-R™ II and Varivax™ n=8 Participants Single subcutaneous 0.5 mL vaccination
Percentage of Participants With Varicella-zoster Virus (VZV) Antibody Levels ≥5 Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Units/mL	90.0 percentage of participants Interval 60.6 to 99.5	100.0 percentage of participants Interval 68.8 to 100.0

SECONDARY outcome

Timeframe: 6 weeks postvaccination

Population: Analysis was performed on the per-protocol population, defined as all participants who had both pre- and post-vaccination blood samples, were seronegative at baseline, and followed all protocol procedures. Too few participants were enrolled in the study to perform non-inferiority analysis for this outcome measure.

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

Outcome measures

Measure	ProQuad™ n=10 Participants Single subcutaneous 0.5 mL vaccination	M-M-R™ II and Varivax™ n=8 Participants Single subcutaneous 0.5 mL vaccination
Geometric Mean Titer of Measles Antibodies	5270.7 mIU/mL Interval 3952.0 to 7029.3	3516.2 mIU/mL Interval 1188.8 to 10396.5

SECONDARY outcome

Timeframe: 6 weeks postvaccination

Population: Analysis was performed on the per-protocol population, defined as all participants who had both pre- and post-vaccination blood samples, were seronegative at baseline, and followed all protocol procedures. Too few participants were enrolled in the study to perform non-inferiority analysis for this outcome measure.

Mean mumps antibody response at 6 weeks after vaccination for participants initially seronegative (<10 Units/mL) to mumps at baseline

Outcome measures

Measure	ProQuad™ n=10 Participants Single subcutaneous 0.5 mL vaccination	M-M-R™ II and Varivax™ n=8 Participants Single subcutaneous 0.5 mL vaccination
Geometric Mean Titer of Mumps Antibodies	159.2 Units/mL Interval 93.1 to 271.8	104.4 Units/mL Interval 59.2 to 183.5

SECONDARY outcome

Timeframe: 6 weeks postvaccination

Population: Analysis was performed on the per-protocol population, defined as all participants who had both pre- and post-vaccination blood samples, were seronegative at baseline, and followed all protocol procedures. Too few participants were enrolled in the study to perform non-inferiority analysis for this outcome measure.

Mean rubella antibody response at 6 weeks postvaccination for participants initially seronegative (<10 IU/mL) to rubella at baseline

Outcome measures

Measure	ProQuad™ n=10 Participants Single subcutaneous 0.5 mL vaccination	M-M-R™ II and Varivax™ n=8 Participants Single subcutaneous 0.5 mL vaccination
Geometric Mean Titer of Rubella Antibodies	105.8 IU/mL Interval 69.6 to 160.5	147.1 IU/mL Interval 105.6 to 204.9

SECONDARY outcome

Timeframe: 6 weeks postvaccination

Population: Analysis was performed on the per-protocol population, defined as all participants who had both pre- and post-vaccination blood samples, were seronegative at baseline, and followed all protocol procedures. Too few participants were enrolled in the study to perform non-inferiority analysis for this outcome measure.

Mean VZV antibody response at 6 weeks after vaccination for participants initially seronegative (<5 gpELISA Units/mL) to VZV at baseline

Outcome measures

Measure	ProQuad™ n=10 Participants Single subcutaneous 0.5 mL vaccination	M-M-R™ II and Varivax™ n=8 Participants Single subcutaneous 0.5 mL vaccination
Geometric Mean Titer of VZV (gpELISA) Antibodies	10.4 gpELISA units/mL Interval 6.9 to 15.5	11.9 gpELISA units/mL Interval 7.6 to 18.4

OTHER_PRE_SPECIFIED outcome

Timeframe: Through 6 weeks postvaccination

Population: The safety population included all participants who received study vaccination

Outcome measures

Measure	ProQuad™ n=13 Participants Single subcutaneous 0.5 mL vaccination	M-M-R™ II and Varivax™ n=16 Participants Single subcutaneous 0.5 mL vaccination
Percentage of Participants With Measles-like Rash	0.0 percentage of participants	12.5 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Through 6 weeks postvaccination

Population: The safety population included all participants who received study vaccination

Outcome measures

Measure	ProQuad™ n=13 Participants Single subcutaneous 0.5 mL vaccination	M-M-R™ II and Varivax™ n=16 Participants Single subcutaneous 0.5 mL vaccination
Percentage of Participants With Varicella-like Rash	0.0 percentage of participants	0.0 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Through 6 weeks postvaccination

Population: The safety population included all participants who received study vaccination

Outcome measures

Measure	ProQuad™ n=13 Participants Single subcutaneous 0.5 mL vaccination	M-M-R™ II and Varivax™ n=16 Participants Single subcutaneous 0.5 mL vaccination
Percentage of Participants With Rubella-like Rash	0.0 percentage of participants	0.0 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Through 6 weeks postvaccination

Population: The safety population included all participants who received study vaccination

Outcome measures

Measure	ProQuad™ n=13 Participants Single subcutaneous 0.5 mL vaccination	M-M-R™ II and Varivax™ n=16 Participants Single subcutaneous 0.5 mL vaccination
Percentage of Participants With Zoster-like Rash	0.0 percentage of participants	0.0 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Through 6 weeks postvaccination

Population: The safety population included all participants who received study vaccination

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.

Outcome measures

Measure	ProQuad™ n=13 Participants Single subcutaneous 0.5 mL vaccination	M-M-R™ II and Varivax™ n=16 Participants Single subcutaneous 0.5 mL vaccination
Percentage of Participants With Any Systemic Adverse Experience	53.9 percentage of participants	56.3 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Through 6 weeks postvaccination

Population: The safety population included all participants who received study vaccination

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.

Outcome measures

Measure	ProQuad™ n=13 Participants Single subcutaneous 0.5 mL vaccination	M-M-R™ II and Varivax™ n=16 Participants Single subcutaneous 0.5 mL vaccination
Percentage of Participants With Injection-site Adverse Experiences	15.4 percentage of participants	0.0 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Through 5 days postvaccination

Population: The safety population included all participants who received study vaccination

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.

Outcome measures

Measure	ProQuad™ n=13 Participants Single subcutaneous 0.5 mL vaccination	M-M-R™ II and Varivax™ n=16 Participants Single subcutaneous 0.5 mL vaccination
Percentage of Participants With Injection-site Adverse Experiences	7.7 percentage of participants	0.0 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Through 6 weeks postvaccination

Population: The safety population included all participants who received study vaccination

Outcome measures

Measure	ProQuad™ n=13 Participants Single subcutaneous 0.5 mL vaccination	M-M-R™ II and Varivax™ n=16 Participants Single subcutaneous 0.5 mL vaccination
Percentage of Participants With Fever (≥101.0°F [38.3°C] Axillary or ≥103.0°F [39.4°C] Rectal)	7.7 percentage of participants	12.5 percentage of participants

Adverse Events

ProQuad™

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

M-M-R™ II and Varivax™

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Measure	ProQuad™ n=13 participants at risk Single subcutaneous 0.5 mL vaccination	M-M-R™ II and Varivax™ n=16 participants at risk Single subcutaneous 0.5 mL vaccination
General disorders Pyrexia	0.00% 0/13 • Through 28 days postvaccination The safety population included all participants who received study vaccination	6.2% 1/16 • Number of events 1 • Through 28 days postvaccination The safety population included all participants who received study vaccination
Skin and subcutaneous tissue disorders Rash	0.00% 0/13 • Through 28 days postvaccination The safety population included all participants who received study vaccination	6.2% 1/16 • Number of events 1 • Through 28 days postvaccination The safety population included all participants who received study vaccination

Other adverse events

Measure	ProQuad™ n=13 participants at risk Single subcutaneous 0.5 mL vaccination	M-M-R™ II and Varivax™ n=16 participants at risk Single subcutaneous 0.5 mL vaccination
Eye disorders Eye discharge	0.00% 0/13 • Through 28 days postvaccination The safety population included all participants who received study vaccination	6.2% 1/16 • Number of events 1 • Through 28 days postvaccination The safety population included all participants who received study vaccination
Gastrointestinal disorders Colitis	7.7% 1/13 • Number of events 1 • Through 28 days postvaccination The safety population included all participants who received study vaccination	0.00% 0/16 • Through 28 days postvaccination The safety population included all participants who received study vaccination
Gastrointestinal disorders Diarrhoea	0.00% 0/13 • Through 28 days postvaccination The safety population included all participants who received study vaccination	12.5% 2/16 • Number of events 2 • Through 28 days postvaccination The safety population included all participants who received study vaccination
Gastrointestinal disorders Vomiting	0.00% 0/13 • Through 28 days postvaccination The safety population included all participants who received study vaccination	6.2% 1/16 • Number of events 1 • Through 28 days postvaccination The safety population included all participants who received study vaccination
General disorders Pyrexia	0.00% 0/13 • Through 28 days postvaccination The safety population included all participants who received study vaccination	12.5% 2/16 • Number of events 4 • Through 28 days postvaccination The safety population included all participants who received study vaccination
General disorders Swelling	7.7% 1/13 • Number of events 1 • Through 28 days postvaccination The safety population included all participants who received study vaccination	0.00% 0/16 • Through 28 days postvaccination The safety population included all participants who received study vaccination
Infections and infestations Bronchitis	7.7% 1/13 • Number of events 1 • Through 28 days postvaccination The safety population included all participants who received study vaccination	12.5% 2/16 • Number of events 2 • Through 28 days postvaccination The safety population included all participants who received study vaccination
Infections and infestations Gastroenteritis	7.7% 1/13 • Number of events 1 • Through 28 days postvaccination The safety population included all participants who received study vaccination	0.00% 0/16 • Through 28 days postvaccination The safety population included all participants who received study vaccination
Infections and infestations Nasopharyngitis	23.1% 3/13 • Number of events 3 • Through 28 days postvaccination The safety population included all participants who received study vaccination	0.00% 0/16 • Through 28 days postvaccination The safety population included all participants who received study vaccination
Infections and infestations Pharyngitis	7.7% 1/13 • Number of events 1 • Through 28 days postvaccination The safety population included all participants who received study vaccination	0.00% 0/16 • Through 28 days postvaccination The safety population included all participants who received study vaccination
Infections and infestations Pharyngotonsillitis	15.4% 2/13 • Number of events 3 • Through 28 days postvaccination The safety population included all participants who received study vaccination	18.8% 3/16 • Number of events 3 • Through 28 days postvaccination The safety population included all participants who received study vaccination
Infections and infestations Pneumonia	7.7% 1/13 • Number of events 1 • Through 28 days postvaccination The safety population included all participants who received study vaccination	12.5% 2/16 • Number of events 2 • Through 28 days postvaccination The safety population included all participants who received study vaccination
Infections and infestations Rhinitis	0.00% 0/13 • Through 28 days postvaccination The safety population included all participants who received study vaccination	6.2% 1/16 • Number of events 1 • Through 28 days postvaccination The safety population included all participants who received study vaccination
Infections and infestations Upper respiratory tract infection	15.4% 2/13 • Number of events 2 • Through 28 days postvaccination The safety population included all participants who received study vaccination	18.8% 3/16 • Number of events 3 • Through 28 days postvaccination The safety population included all participants who received study vaccination
Respiratory, thoracic and mediastinal disorders Cough	15.4% 2/13 • Number of events 2 • Through 28 days postvaccination The safety population included all participants who received study vaccination	12.5% 2/16 • Number of events 2 • Through 28 days postvaccination The safety population included all participants who received study vaccination
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	15.4% 2/13 • Number of events 2 • Through 28 days postvaccination The safety population included all participants who received study vaccination	12.5% 2/16 • Number of events 2 • Through 28 days postvaccination The safety population included all participants who received study vaccination
Skin and subcutaneous tissue disorders Dermatitis atopic	0.00% 0/13 • Through 28 days postvaccination The safety population included all participants who received study vaccination	6.2% 1/16 • Number of events 1 • Through 28 days postvaccination The safety population included all participants who received study vaccination
Skin and subcutaneous tissue disorders Dermatitis diaper	7.7% 1/13 • Number of events 1 • Through 28 days postvaccination The safety population included all participants who received study vaccination	0.00% 0/16 • Through 28 days postvaccination The safety population included all participants who received study vaccination
Skin and subcutaneous tissue disorders Erythema	7.7% 1/13 • Number of events 1 • Through 28 days postvaccination The safety population included all participants who received study vaccination	0.00% 0/16 • Through 28 days postvaccination The safety population included all participants who received study vaccination
Skin and subcutaneous tissue disorders Pigmentation disorder	0.00% 0/13 • Through 28 days postvaccination The safety population included all participants who received study vaccination	6.2% 1/16 • Number of events 1 • Through 28 days postvaccination The safety population included all participants who received study vaccination
Skin and subcutaneous tissue disorders Rash	15.4% 2/13 • Number of events 2 • Through 28 days postvaccination The safety population included all participants who received study vaccination	12.5% 2/16 • Number of events 2 • Through 28 days postvaccination The safety population included all participants who received study vaccination

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: ClinicalTrialsDisclosure@merck.com

Results disclosure agreements

• Principal investigator is a sponsor employee The sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission.
• Publication restrictions are in place

Restriction type: OTHER