Trial Outcomes & Findings for Re-examination Study For Varivax (V210-059 AM2) (NCT NCT01062061)

NCT ID: NCT01062061

Last Updated: 2015-09-04

Results Overview

An adverse event 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 vaccine, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study vaccine, is also an adverse event. Changes resulting from normal growth and development which do not vary significantly in frequency or severity from expected levels are not to be considered adverse events. Examples of this may include, but are not limited to, teething, typical crying in infants and children, and onset of menses or menopause occurring at a physiologically appropriate time.

• Recruitment status: COMPLETED
• Target enrollment: 754 participants
• Primary outcome timeframe: Up to 42 days after vaccination
• Results posted on: 2015-09-04

Participant Flow

Participant milestones

Measure	VARIVAX Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.
Overall Study STARTED	754
Overall Study COMPLETED	727
Overall Study NOT COMPLETED	27

Reasons for withdrawal

Measure	VARIVAX Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.
Overall Study Enrolled more than once	2
Overall Study Investigated before study start	13
Overall Study Outside chief indications	10
Overall Study Failed to meet inclusion criteria	2

Baseline Characteristics

Re-examination Study For Varivax (V210-059 AM2)

Baseline characteristics by cohort

Measure	VARIVAX n=727 Participants Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.
Age, Continuous	1.19 years STANDARD_DEVIATION 0.92 • n=5 Participants
Age, Customized <2 years	686 Participants n=5 Participants
Age, Customized ≥2 years	41 Participants n=5 Participants
Sex: Female, Male Female	347 Participants n=5 Participants
Sex: Female, Male Male	380 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 42 days after vaccination

Population: Adverse events were reported for participants in the safety population: participants administered VARIVAX in usual practice and not discontinued for a reason given in the Participant Flow

An adverse event 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 vaccine, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study vaccine, is also an adverse event.

Changes resulting from normal growth and development which do not vary significantly in frequency or severity from expected levels are not to be considered adverse events. Examples of this may include, but are not limited to, teething, typical crying in infants and children, and onset of menses or menopause occurring at a physiologically appropriate time.

Outcome measures

Measure	VARIVAX n=727 Participants Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.	Female Participants Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.
Percentage of Participants With One or More Adverse Events (AEs)	37.69 Percentage of Participants	—

PRIMARY outcome

Timeframe: Up to 42 days after vaccination

Population: AEs were reported for participants in the safety population: participants administered VARIVAX in usual practice and not discontinued for a reason given in the Participant Flow

An adverse event 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 vaccine, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study vaccine, is also an adverse event.

Changes resulting from normal growth and development which do not vary significantly in frequency or severity from expected levels are not to be considered adverse events. Examples of this may include, but are not limited to, teething, typical crying in infants and children, and onset of menses or menopause occurring at a physiologically appropriate time.

Outcome measures

Measure	VARIVAX n=380 Participants Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.	Female Participants n=347 Participants Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.
Percentage of Participants With One or More AEs by Gender	37.63 percentage of participants	37.75 percentage of participants

PRIMARY outcome

Timeframe: Up to 42 days after vaccination

Population: AEs were reported for participants in the safety population: participants administered VARIVAX in usual practice and not discontinued for a reason given in the Participant Flow

An adverse event 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 vaccine, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study vaccine, is also an adverse event.

Changes resulting from normal growth and development which do not vary significantly in frequency or severity from expected levels are not to be considered adverse events. Examples of this may include, but are not limited to, teething, typical crying in infants and children, and onset of menses or menopause occurring at a physiologically appropriate time.

Outcome measures

Measure	VARIVAX n=686 Participants Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.	Female Participants n=41 Participants Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.
Percentage of Participants With One or More AEs by Age	36.01 percentage of participants	65.85 percentage of participants

PRIMARY outcome

Timeframe: Up to 42 days after vaccination

Population: ADRs were reported for participants in the safety population: participants administered VARIVAX in usual practice and not discontinued for a reason given in the Participant Flow

An ADR is an AE (defined above) for which relatedness to the use of the product cannot be ruled out

Outcome measures

Measure	VARIVAX n=727 Participants Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.	Female Participants Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.
Percentage of Participants With One or More Adverse Drug Reactions (ADRs)	3.30 percentage of participants	—

PRIMARY outcome

Timeframe: Up to 42 days after vaccination

Population: Unexpected AEs were reported for participants in the safety population: participants administered VARIVAX in usual practice and not discontinued for a reason given in the Participant Flow

Unexpected AEs differed from AEs reported in the VARIVAX product label with regard to their identity, severity, specificity, or outcome

Outcome measures

Measure	VARIVAX n=727 Participants Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.	Female Participants Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.
Percentage of Participants With One or More Unexpected AEs	26.00 percentage of participants	—

PRIMARY outcome

Timeframe: Up to 42 days after vaccination

Population: Unexpected ADRs were reported for participants in the safety population: participants administered VARIVAX in usual practice and not discontinued for a reason given in the Participant Flow

An unexpected ADR is an unexpected AE (defined above) for which relatedness to the use of the study vaccine cannot be ruled out

Outcome measures

Measure	VARIVAX n=727 Participants Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.	Female Participants Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.
Percentage of Participants With One or More Unexpected ADRs	0.14 percentage of participants	—

PRIMARY outcome

Timeframe: Up to 42 days after vaccination

Population: SAEs were reported for participants in the safety population: participants administered VARIVAX in usual practice and not discontinued for a reason given in the Participant Flow

An SAE is any AE that results in death, is life-threatening, results in persistent or significant disability/incapacity, results in or prolongs an existing inpatient hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is another important medical event based on appropriate medical judgment.

Outcome measures

Measure	VARIVAX n=727 Participants Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.	Female Participants Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.
Percentage of Participants With One or More Serious Adverse Events (SAEs)	0.55 percentage of participants	—

PRIMARY outcome

Timeframe: Up to 42 days after vaccination

Population: Serious ADRs were reported for participants in the safety population: participants administered VARIVAX in usual practice and not discontinued for a reason given in the Participant Flow

A serious ADR is an SAE (defined above) for which relatedness to the use of the product cannot be ruled out

Outcome measures

Measure	VARIVAX n=727 Participants Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.	Female Participants Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.
Percentage of Participants With One or More Serious ADRs	0 percentage of participants	—

PRIMARY outcome

Timeframe: Up to 42 days after vaccination

Unexpected SAEs differed from SAEs reported in the VARIVAX product label with regard to their identity, severity, specificity, or outcome

Outcome measures

Measure	VARIVAX n=727 Participants Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.	Female Participants Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.
Percentage of Participants With One or More Unexpected SAEs	0.28 percentage of participants	—

Adverse Events

VARIVAX

Serious events: 4 serious events

Other events: 105 other events

Deaths: 0 deaths

Serious adverse events

Measure	VARIVAX n=727 participants at risk Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.
General disorders Pyrexia	0.14% 1/727 • Number of events 1 • Up to 42 days after vaccination Adverse events were reported for participants in the safety population: participants administered VARIVAX in usual practice and not discontinued for a reason given in the Participant Flow
Infections and infestations Bronchitis	0.14% 1/727 • Number of events 1 • Up to 42 days after vaccination Adverse events were reported for participants in the safety population: participants administered VARIVAX in usual practice and not discontinued for a reason given in the Participant Flow
Infections and infestations Pneumonia	0.14% 1/727 • Number of events 1 • Up to 42 days after vaccination Adverse events were reported for participants in the safety population: participants administered VARIVAX in usual practice and not discontinued for a reason given in the Participant Flow
Metabolism and nutrition disorders Decreased appetite	0.14% 1/727 • Number of events 1 • Up to 42 days after vaccination Adverse events were reported for participants in the safety population: participants administered VARIVAX in usual practice and not discontinued for a reason given in the Participant Flow
Renal and urinary disorders Oliguria	0.14% 1/727 • Number of events 1 • Up to 42 days after vaccination Adverse events were reported for participants in the safety population: participants administered VARIVAX in usual practice and not discontinued for a reason given in the Participant Flow

Other adverse events

Measure	VARIVAX n=727 participants at risk Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.
General disorders Pyrexia	7.0% 51/727 • Number of events 59 • Up to 42 days after vaccination Adverse events were reported for participants in the safety population: participants administered VARIVAX in usual practice and not discontinued for a reason given in the Participant Flow
Infections and infestations Bronchitis	8.0% 58/727 • Number of events 62 • Up to 42 days after vaccination Adverse events were reported for participants in the safety population: participants administered VARIVAX in usual practice and not discontinued for a reason given in the Participant Flow

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
• Publication restrictions are in place