Trial Outcomes & Findings for V221 Concomitant Use Study With Pneumococcal Conjugate Vaccine (V221-019) (NCT NCT00109343)

NCT ID: NCT00109343

Last Updated: 2017-04-12

Results Overview

Antibody Response to Measles at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer \<255 mIU/mL) to Measles at Baseline.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 1027 participants
• Primary outcome timeframe: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone
• Results posted on: 2017-04-12

Participant Flow

24 clinical sites in the United States Date first participant visit: 06-Mar-2006 Date last participant visit: 14-Sep-2007

Participant milestones

Measure	Group 1 - ProQuad™ + PREVNAR™ Group 1 - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.	Group 2 - PREVNAR™ Followed by ProQuad™ Group 2 - Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 1. ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 133) after the first dose.	Group 3 - ProQuad™ Followed by PREVNAR™ Group 3 - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 1. Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
Overall Study STARTED	510	258	259
Overall Study Vaccinated at Visit 1	510	258	259
Overall Study Vaccinated at Visit 2	0	246	246
Overall Study Vaccinated at Visit 4	466	235	240
Overall Study COMPLETED	446	221	229
Overall Study NOT COMPLETED	64	37	30

Reasons for withdrawal

Measure	Group 1 - ProQuad™ + PREVNAR™ Group 1 - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.	Group 2 - PREVNAR™ Followed by ProQuad™ Group 2 - Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 1. ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 133) after the first dose.	Group 3 - ProQuad™ Followed by PREVNAR™ Group 3 - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 1. Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
Overall Study Adverse Event	1	0	2
Overall Study Lack of Efficacy	1	0	0
Overall Study Lost to Follow-up	35	20	14
Overall Study Protocol Violation	1	2	2
Overall Study Withdrawal by Subject	15	11	10
Overall Study Subject Moved	6	2	1
Overall Study Other	5	2	1

Baseline Characteristics

V221 Concomitant Use Study With Pneumococcal Conjugate Vaccine (V221-019)

Baseline characteristics by cohort

Measure	Group 1 - ProQuad™ + PREVNAR™ n=510 Participants Group 1 - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.	Group 2 - PREVNAR™ Followed by ProQuad™ n=258 Participants Group 2 - Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 1. ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 133) after the first dose.	Group 3 - ProQuad™ Followed by PREVNAR™ n=259 Participants Group 3 - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 1. Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.	Total n=1027 Participants Total of all reporting groups
Age, Continuous	12.6 Months STANDARD_DEVIATION 0.96 • n=5 Participants	12.5 Months STANDARD_DEVIATION 0.93 • n=7 Participants	12.6 Months STANDARD_DEVIATION 0.98 • n=5 Participants	12.6 Months STANDARD_DEVIATION 0.96 • n=4 Participants
Sex: Female, Male Female	230 Participants n=5 Participants	120 Participants n=7 Participants	117 Participants n=5 Participants	467 Participants n=4 Participants
Sex: Female, Male Male	280 Participants n=5 Participants	138 Participants n=7 Participants	142 Participants n=5 Participants	560 Participants n=4 Participants
Race/Ethnicity, Customized Asian	18 participants n=5 Participants	5 participants n=7 Participants	8 participants n=5 Participants	31 participants n=4 Participants
Race/Ethnicity, Customized Black	83 participants n=5 Participants	36 participants n=7 Participants	36 participants n=5 Participants	155 participants n=4 Participants
Race/Ethnicity, Customized Hispanic	46 participants n=5 Participants	31 participants n=7 Participants	26 participants n=5 Participants	103 participants n=4 Participants
Race/Ethnicity, Customized White	335 participants n=5 Participants	161 participants n=7 Participants	174 participants n=5 Participants	670 participants n=4 Participants
Race/Ethnicity, Customized Other	28 participants n=5 Participants	25 participants n=7 Participants	15 participants n=5 Participants	68 participants n=4 Participants

PRIMARY outcome

Timeframe: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone

Population: Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to measles at baseline, and followed protocol procedures.

Antibody Response to Measles at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <255 mIU/mL) to Measles at Baseline.

Outcome measures

Measure	Group 1 - ProQuad™ + PREVNAR™ n=406 Participants Group 1 - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.	Group 3 - ProQuad™ Followed by PREVNAR™ n=204 Participants Group 3 - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 1. Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥255 mIU/mL	395 Participants	203 Participants

PRIMARY outcome

Timeframe: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone

Population: Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to mumps at baseline, and followed protocol procedures.

Antibody Response to Mumps at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <10 ELISA Ab units/mL) to Mumps at Baseline.

Outcome measures

Measure	Group 1 - ProQuad™ + PREVNAR™ n=403 Participants Group 1 - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.	Group 3 - ProQuad™ Followed by PREVNAR™ n=208 Participants Group 3 - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 1. Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥10 Ab Units/mL	390 Participants	205 Participants

PRIMARY outcome

Timeframe: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone

Population: Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to rubella at baseline, and followed protocol procedures.

Antibody Response to Rubella at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <10 IU/mL) to Rubella at Baseline.

Outcome measures

Measure	Group 1 - ProQuad™ + PREVNAR™ n=377 Participants Group 1 - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.	Group 3 - ProQuad™ Followed by PREVNAR™ n=195 Participants Group 3 - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 1. Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥10 IU/mL	372 Participants	191 Participants

PRIMARY outcome

Timeframe: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone

Population: Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, Varicella Antibody Titer \<1.25 gpELISA units/mL at baseline, and followed protocol procedures.

Antibody Response to Varicella at 6 Weeks Postvaccination for Subjects Initially With Varicella Antibody Titer <1.25 gpELISA units/mL at Baseline

Outcome measures

Measure	Group 1 - ProQuad™ + PREVNAR™ n=379 Participants Group 1 - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.	Group 3 - ProQuad™ Followed by PREVNAR™ n=192 Participants Group 3 - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 1. Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
Number of Participants With Postvaccination Varicella Antibody Titer ≥1.25 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Units/mL and ≥5 gpELISA Units/mL Number of Participants ≥1.25 gpELISA units/mL	374 Participants	187 Participants
Number of Participants With Postvaccination Varicella Antibody Titer ≥1.25 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Units/mL and ≥5 gpELISA Units/mL Number of Participants ≥5 gpELISA units/mL	350 Participants	169 Participants

PRIMARY outcome

Timeframe: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone

Population: Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.

Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 4

Outcome measures

Measure	Group 1 - ProQuad™ + PREVNAR™ n=410 Participants Group 1 - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.	Group 3 - ProQuad™ Followed by PREVNAR™ n=193 Participants Group 3 - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 1. Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
Antibody Response to S. Pneumoniae Serotype 4 - Geometric Mean Titer	1.54 mcg/mL Interval 1.41 to 1.67	1.34 mcg/mL Interval 1.19 to 1.51

PRIMARY outcome

Timeframe: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone.

Population: Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.

Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 6B

Outcome measures

Measure	Group 1 - ProQuad™ + PREVNAR™ n=410 Participants Group 1 - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.	Group 3 - ProQuad™ Followed by PREVNAR™ n=192 Participants Group 3 - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 1. Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
Antibody Response to S. Pneumoniae Serotype 6B - Geometric Mean Titer	9.17 mcg/mL Interval 8.4 to 10.02	8.22 mcg/mL Interval 7.17 to 9.41

PRIMARY outcome

Timeframe: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone

Population: Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.

Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 9V

Outcome measures

Measure	Group 1 - ProQuad™ + PREVNAR™ n=409 Participants Group 1 - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.	Group 3 - ProQuad™ Followed by PREVNAR™ n=193 Participants Group 3 - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 1. Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
Antibody Response to S. Pneumoniae Serotype 9V - Geometric Mean Titer	2.98 mcg/mL Interval 2.76 to 3.21	2.71 mcg/mL Interval 2.44 to 3.02

PRIMARY outcome

Timeframe: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone

Population: Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.

Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 14

Outcome measures

Measure	Group 1 - ProQuad™ + PREVNAR™ n=408 Participants Group 1 - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.	Group 3 - ProQuad™ Followed by PREVNAR™ n=193 Participants Group 3 - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 1. Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
Antibody Response to S. Pneumoniae Serotype 14 - Geometric Mean Titer	6.88 mcg/mL Interval 6.32 to 7.48	5.61 mcg/mL Interval 4.95 to 6.36

PRIMARY outcome

Timeframe: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone

Population: Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.

Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 18C

Outcome measures

Measure	Group 1 - ProQuad™ + PREVNAR™ n=408 Participants Group 1 - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.	Group 3 - ProQuad™ Followed by PREVNAR™ n=193 Participants Group 3 - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 1. Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
Antibody Response to S. Pneumoniae Serotype 18C - Geometric Mean Titer	2.35 mcg/mL Interval 2.14 to 2.58	2.23 mcg/mL Interval 1.96 to 2.55

PRIMARY outcome

Timeframe: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone

Population: Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.

Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 19F

Outcome measures

Measure	Group 1 - ProQuad™ + PREVNAR™ n=408 Participants Group 1 - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.	Group 3 - ProQuad™ Followed by PREVNAR™ n=192 Participants Group 3 - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 1. Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
Antibody Response to S. Pneumoniae Serotype 19F - Geometric Mean Titer	3.59 mcg/mL Interval 3.31 to 3.91	3.22 mcg/mL Interval 2.85 to 3.64

PRIMARY outcome

Timeframe: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone

Population: Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.

Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 23F

Outcome measures

Measure	Group 1 - ProQuad™ + PREVNAR™ n=413 Participants Group 1 - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.	Group 3 - ProQuad™ Followed by PREVNAR™ n=197 Participants Group 3 - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 1. Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
Antibody Response to S. Pneumoniae Serotype 23F - Geometric Mean Titer	4.24 mcg/mL Interval 3.85 to 4.67	3.71 mcg/mL Interval 3.16 to 4.36

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone

Population: Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.

Outcome measures

Measure	Group 1 - ProQuad™ + PREVNAR™ n=410 Participants Group 1 - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.	Group 3 - ProQuad™ Followed by PREVNAR™ n=193 Participants Group 3 - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 1. Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 4	403 Participants	193 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone

Population: Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.

Outcome measures

Measure	Group 1 - ProQuad™ + PREVNAR™ n=410 Participants Group 1 - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.	Group 3 - ProQuad™ Followed by PREVNAR™ n=192 Participants Group 3 - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 1. Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 6B	408 Participants	192 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone

Population: Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.

Outcome measures

Measure	Group 1 - ProQuad™ + PREVNAR™ n=409 Participants Group 1 - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.	Group 3 - ProQuad™ Followed by PREVNAR™ n=193 Participants Group 3 - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 1. Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 9V	407 Participants	193 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone

Population: Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.

Outcome measures

Measure	Group 1 - ProQuad™ + PREVNAR™ n=408 Participants Group 1 - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.	Group 3 - ProQuad™ Followed by PREVNAR™ n=193 Participants Group 3 - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 1. Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 14	407 Participants	193 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone

Population: Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.

Outcome measures

Measure	Group 1 - ProQuad™ + PREVNAR™ n=408 Participants Group 1 - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.	Group 3 - ProQuad™ Followed by PREVNAR™ n=193 Participants Group 3 - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 1. Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 18C	404 Participants	191 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone

Population: Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.

Outcome measures

Measure	Group 1 - ProQuad™ + PREVNAR™ n=408 Participants Group 1 - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.	Group 3 - ProQuad™ Followed by PREVNAR™ n=192 Participants Group 3 - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 1. Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 19F	407 Participants	192 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone

Population: Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.

Outcome measures

Measure	Group 1 - ProQuad™ + PREVNAR™ n=413 Participants Group 1 - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.	Group 3 - ProQuad™ Followed by PREVNAR™ n=197 Participants Group 3 - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 1. Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 23F	412 Participants	194 Participants

Adverse Events

ProQuad™ + Prevnar™ (After Dose 1)

Serious events: 4 serious events

Other events: 367 other events

Deaths: 0 deaths

ProQuad™ Alone (After Dose 1)

Serious events: 3 serious events

Other events: 311 other events

Deaths: 0 deaths

ProQuad™ (After Dose 2)

Serious events: 0 serious events

Other events: 499 other events

Deaths: 0 deaths

Serious adverse events

Measure	ProQuad™ + Prevnar™ (After Dose 1) n=498 participants at risk ProQuad™ + Prevnar™ (After Dose 1) includes Days 1 to 28 after the first dose of ProQuad™ (safety follow-up period 1 for Group 1)	ProQuad™ Alone (After Dose 1) n=495 participants at risk ProQuad™ Alone (After Dose 1) includes Days 1 to 28 after the first dose of ProQuad™ (safety follow-up period 1 for Group 3 and safety follow-up period 2 for Group 2).	ProQuad™ (After Dose 2) n=910 participants at risk ProQuad™ (After Dose 2) includes Days 1 to 28 after the second dose of ProQuad™ (safety follow-up period 3 for Group 1, Group 2, and Group 3).
Infections and infestations Pneumonia	0.40% 2/498 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.	0.00% 0/495 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.	0.00% 0/910 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.
Infections and infestations Pneumonia Viral	0.20% 1/498 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.	0.00% 0/495 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.	0.00% 0/910 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.
Respiratory, thoracic and mediastinal disorders Respiratory Distress	0.20% 1/498 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.	0.00% 0/495 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.	0.00% 0/910 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.
Respiratory, thoracic and mediastinal disorders Asthma	0.20% 1/498 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.	0.00% 0/495 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.	0.00% 0/910 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.
Infections and infestations Osteomyelitis	0.20% 1/498 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.	0.00% 0/495 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.	0.00% 0/910 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.
Infections and infestations Croup Infectious	0.00% 0/498 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.	0.20% 1/495 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.	0.00% 0/910 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.
Nervous system disorders Febrile Convulsion	0.00% 0/498 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.	0.20% 1/495 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.	0.00% 0/910 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroblastoma	0.00% 0/498 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.	0.20% 1/495 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.	0.00% 0/910 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.

Other adverse events

Measure	ProQuad™ + Prevnar™ (After Dose 1) n=498 participants at risk ProQuad™ + Prevnar™ (After Dose 1) includes Days 1 to 28 after the first dose of ProQuad™ (safety follow-up period 1 for Group 1)	ProQuad™ Alone (After Dose 1) n=495 participants at risk ProQuad™ Alone (After Dose 1) includes Days 1 to 28 after the first dose of ProQuad™ (safety follow-up period 1 for Group 3 and safety follow-up period 2 for Group 2).	ProQuad™ (After Dose 2) n=910 participants at risk ProQuad™ (After Dose 2) includes Days 1 to 28 after the second dose of ProQuad™ (safety follow-up period 3 for Group 1, Group 2, and Group 3).
Infections and infestations Viral Rash	1.4% 7/498 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.	1.0% 5/495 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.	0.55% 5/910 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.
Eye disorders Conjunctivitis	2.0% 10/498 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.	1.2% 6/495 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.	0.77% 7/910 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.
Gastrointestinal disorders Diarrhoea	6.2% 31/498 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.	3.2% 16/495 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.	2.7% 25/910 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.
Gastrointestinal disorders Vomiting	3.2% 16/498 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.	3.2% 16/495 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.	2.7% 25/910 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.
General disorders Irritability	5.4% 27/498 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.	3.2% 16/495 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.	1.4% 13/910 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.
General disorders Pyrexia	22.5% 112/498 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.	22.0% 109/495 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.	15.2% 138/910 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.
Infections and infestations Gastroenteritis	1.8% 9/498 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.	2.4% 12/495 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.	1.6% 15/910 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.
Infections and infestations Nasopharyngitis	1.4% 7/498 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.	4.2% 21/495 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.	4.4% 40/910 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.
Infections and infestations Otitis Media	5.6% 28/498 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.	6.5% 32/495 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.	6.3% 57/910 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.
Infections and infestations Otitis Media Acute	2.6% 13/498 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.	0.40% 2/495 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.	0.77% 7/910 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.
Infections and infestations Pharyngitis	1.0% 5/498 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.	0.40% 2/495 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.	0.66% 6/910 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.
Infections and infestations Pneumonia	1.0% 5/498 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.	0.40% 2/495 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.	0.44% 4/910 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.
Infections and infestations Sinusitis	1.2% 6/498 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.	0.61% 3/495 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.	1.2% 11/910 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.
Immune system disorders Upper Respiratory Tract Infection	11.8% 59/498 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.	9.3% 46/495 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.	10.3% 94/910 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.
Infections and infestations Viral Infection	2.0% 10/498 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.	2.0% 10/495 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.	1.3% 12/910 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.
Infections and infestations Arthropod Bite	0.40% 2/498 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.	1.2% 6/495 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.	0.33% 3/910 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.
Respiratory, thoracic and mediastinal disorders Cough	3.6% 18/498 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.	2.8% 14/495 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.	4.3% 39/910 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.
Respiratory, thoracic and mediastinal disorders Nasal Congestion	2.2% 11/498 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.	1.2% 6/495 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.	1.2% 11/910 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	4.2% 21/498 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.	3.2% 16/495 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.	4.0% 36/910 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.
Skin and subcutaneous tissue disorders Dermatitis Diaper	5.2% 26/498 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.	2.2% 11/495 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.	2.1% 19/910 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.
Skin and subcutaneous tissue disorders Eczema	1.4% 7/498 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.	0.81% 4/495 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.	1.2% 11/910 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.
Skin and subcutaneous tissue disorders Rash	4.6% 23/498 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.	3.8% 19/495 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.	1.5% 14/910 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.
Skin and subcutaneous tissue disorders Rash Morbilliform	5.4% 27/498 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.	4.8% 24/495 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.	1.6% 15/910 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.
Skin and subcutaneous tissue disorders Rash Vesicular	2.0% 10/498 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.	1.2% 6/495 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.	0.44% 4/910 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.
Skin and subcutaneous tissue disorders Injection Site Bruising (Prevnar Injection-site)	1.6% 8/498 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.	— 0/0 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.	— 0/0 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.
Skin and subcutaneous tissue disorders Injection Site Erythema (Prevnar Injection-site)	21.3% 106/498 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.	— 0/0 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.	— 0/0 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.
Skin and subcutaneous tissue disorders Injection Site Pain (Prevnar Injection-site)	31.5% 157/498 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.	— 0/0 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.	— 0/0 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.
Skin and subcutaneous tissue disorders Injection Site Rash (Prevnar Injection-site)	1.0% 5/498 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.	— 0/0 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.	— 0/0 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.
Skin and subcutaneous tissue disorders Injection Site Swelling (Prevnar Injection-site)	18.5% 92/498 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.	— 0/0 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.	— 0/0 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.
Skin and subcutaneous tissue disorders Injection Site Bruising (ProQuad Injection-site)	2.0% 10/498 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.	1.6% 8/495 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.	0.33% 3/910 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.
Skin and subcutaneous tissue disorders Injection Site Erythema (ProQuad Injection-site)	13.9% 69/498 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.	13.5% 67/495 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.	16.8% 153/910 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.
Skin and subcutaneous tissue disorders Injection Site Pain (ProQuad Injection-site)	25.1% 125/498 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.	25.7% 127/495 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.	17.9% 163/910 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.
Skin and subcutaneous tissue disorders Injection Site Rash (ProQuad Injection-site)	1.2% 6/498 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.	2.4% 12/495 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.	0.99% 9/910 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.
Skin and subcutaneous tissue disorders Injection Site Swelling (ProQuad Injection-site)	11.6% 58/498 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.	10.9% 54/495 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.	13.0% 118/910 • 28 days post-dose The number of participants listed as "at risk" is the number of participants with follow-up.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp

Phone: 1-800-672-6372

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