Trial Outcomes & Findings for A Study of ProQuad in Healthy 4 to 6 Year Old Children (V221-014) (NCT NCT00985166)

NCT ID: NCT00985166

Last Updated: 2015-07-28

Results Overview

Postvaccination observed Geometric Mean Titer of antibody to Varicella

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

801 participants

Primary outcome timeframe

6 weeks Postvaccination

Results posted on

2015-07-28

Participant Flow

17 clinical sites in the United States Date of first participant visit: 24-Aug-2000 Date of last participant visit: 06-May-2002

Prior to entering study, all subjects received primary dose of M-M-R II™ and Varivax™ at less than or equal to 12 months of age.

Participant milestones

Participant milestones
Measure	ProQuad™ + Placebo ProQuad™ (measles, mumps, rubella, and varicella vaccine) + placebo administered concomitantly at separate injection sites on Day 1.	M-M-R™ II + Placebo M-M-R™ II + placebo administered concomitantly at separate injection sites on Day 1.	M-M-R™ II + VARIVAX™ VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 1.
Overall Study STARTED	401	205	195
Overall Study Vaccinated at Visit 1	399	205	195
Overall Study COMPLETED	392	201	188
Overall Study NOT COMPLETED	9	4	7

Reasons for withdrawal

Reasons for withdrawal
Measure	ProQuad™ + Placebo ProQuad™ (measles, mumps, rubella, and varicella vaccine) + placebo administered concomitantly at separate injection sites on Day 1.	M-M-R™ II + Placebo M-M-R™ II + placebo administered concomitantly at separate injection sites on Day 1.	M-M-R™ II + VARIVAX™ VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 1.
Overall Study Lost to Follow-up	3	2	2
Overall Study Withdrawal by Subject	3	2	0
Overall Study Test not done	2	0	4
Overall Study Other	1	0	1

Baseline Characteristics

A Study of ProQuad in Healthy 4 to 6 Year Old Children (V221-014)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ProQuad™ + Placebo n=399 Participants ProQuad™ (measles, mumps, rubella, and varicella vaccine) + placebo administered concomitantly at separate injection sites on Day 1.	M-M-R™ II + Placebo n=205 Participants M-M-R™ II + placebo administered concomitantly at separate injection sites on Day 1.	M-M-R™ II + VARIVAX™ n=195 Participants VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 1.	Total n=799 Participants Total of all reporting groups
Age, Continuous	4.3 years STANDARD_DEVIATION 0.5 • n=93 Participants	4.3 years STANDARD_DEVIATION 0.5 • n=4 Participants	4.3 years STANDARD_DEVIATION 0.5 • n=27 Participants	4.3 years STANDARD_DEVIATION 0.5 • n=483 Participants
Sex: Female, Male Female	191 Participants n=93 Participants	105 Participants n=4 Participants	77 Participants n=27 Participants	373 Participants n=483 Participants
Sex: Female, Male Male	208 Participants n=93 Participants	100 Participants n=4 Participants	118 Participants n=27 Participants	426 Participants n=483 Participants
Race/Ethnicity, Customized African American	49 participants n=93 Participants	19 participants n=4 Participants	25 participants n=27 Participants	93 participants n=483 Participants
Race/Ethnicity, Customized Asian/Pacific	8 participants n=93 Participants	5 participants n=4 Participants	3 participants n=27 Participants	16 participants n=483 Participants
Race/Ethnicity, Customized Caucasian	313 participants n=93 Participants	162 participants n=4 Participants	153 participants n=27 Participants	628 participants n=483 Participants
Race/Ethnicity, Customized Hispanic	15 participants n=93 Participants	10 participants n=4 Participants	7 participants n=27 Participants	32 participants n=483 Participants
Race/Ethnicity, Customized Other	14 participants n=93 Participants	9 participants n=4 Participants	7 participants n=27 Participants	30 participants n=483 Participants

PRIMARY outcome

Timeframe: 6 weeks Postvaccination

Population: Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, received M-M-R™ II + VARIVAX™ prior to entering the study, and followed protocol procedures.

Postvaccination observed Geometric Mean Titer of antibody to Varicella

Outcome measures

Outcome measures
Measure	ProQuad™ + Placebo n=367 Participants ProQuad™ (measles, mumps, rubella, and varicella vaccine) + placebo administered concomitantly at separate injection sites on Day 1.	M-M-R™ II + VARIVAX™ n=171 Participants VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 1.	M-M-R™ II + VARIVAX™ VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 1.
Antibody Response to Varicella for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer	322.2 gpELISA units/mL Interval 278.9 to 372.2	209.3 gpELISA units/mL Interval 171.2 to 255.9	—

PRIMARY outcome

Timeframe: 6 weeks Postvaccination

Postvaccination observed Geometric Mean Titer of antibody to Measles

Outcome measures

Outcome measures
Measure	ProQuad™ + Placebo n=367 Participants ProQuad™ (measles, mumps, rubella, and varicella vaccine) + placebo administered concomitantly at separate injection sites on Day 1.	M-M-R™ II + VARIVAX™ n=185 Participants VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 1.	M-M-R™ II + VARIVAX™ n=171 Participants VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 1.
Antibody Response to Measles for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer	1985.9 mIU/mL Interval 1817.6 to 2169.9	2046.9 mIU/mL Interval 1815.2 to 2308.2	2084.3 mIU/mL Interval 1852.3 to 2345.5

PRIMARY outcome

Timeframe: 6 weeks Postvaccination

Postvaccination observed Geometric Mean Titer of antibody to Mumps

Outcome measures

Outcome measures
Measure	ProQuad™ + Placebo n=367 Participants ProQuad™ (measles, mumps, rubella, and varicella vaccine) + placebo administered concomitantly at separate injection sites on Day 1.	M-M-R™ II + VARIVAX™ n=185 Participants VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 1.	M-M-R™ II + VARIVAX™ n=171 Participants VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 1.
Antibody Response to Mumps for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer	206.0 ELISA AB units/mL Interval 188.2 to 225.4	308.5 ELISA AB units/mL Interval 269.6 to 352.9	295.9 ELISA AB units/mL Interval 262.5 to 333.5

PRIMARY outcome

Timeframe: 6 weeks Postvaccination

Postvaccination observed Geometric Mean Titer of antibody to Rubella

Outcome measures

Outcome measures
Measure	ProQuad™ + Placebo n=367 Participants ProQuad™ (measles, mumps, rubella, and varicella vaccine) + placebo administered concomitantly at separate injection sites on Day 1.	M-M-R™ II + VARIVAX™ n=185 Participants VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 1.	M-M-R™ II + VARIVAX™ n=171 Participants VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 1.
Antibody Response to Rubella for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer	217.3 IU/mL Interval 200.1 to 236.0	174.0 IU/mL Interval 157.3 to 192.6	154.1 IU/mL Interval 138.9 to 170.9

Adverse Events

ProQuad™ + Placebo

Serious events: 1 serious events

Other events: 292 other events

Deaths: 0 deaths

M-M-R™ II + Placebo

Serious events: 0 serious events

Other events: 150 other events

Deaths: 0 deaths

M-M-R™ II + VARIVAX™

Serious events: 0 serious events

Other events: 140 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	ProQuad™ + Placebo n=397 participants at risk ProQuad™ (measles, mumps, rubella, and varicella vaccine) + placebo administered concomitantly at separate injection sites on Day 1.	M-M-R™ II + Placebo n=205 participants at risk M-M-R™ II + placebo administered concomitantly at separate injection sites on Day 1.	M-M-R™ II + VARIVAX™ n=193 participants at risk VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 1.
Infections and infestations Pyelonephritis - Not other wise Specified (NOS)	0.25% 1/397 The number of participants listed as "at risk" is the number of participants with follow-up. 0/0 indicates that subjects in this treatment group did not receive the indicated vaccine.	0.00% 0/205 The number of participants listed as "at risk" is the number of participants with follow-up. 0/0 indicates that subjects in this treatment group did not receive the indicated vaccine.	0.00% 0/193 The number of participants listed as "at risk" is the number of participants with follow-up. 0/0 indicates that subjects in this treatment group did not receive the indicated vaccine.

Other adverse events

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER