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Trial record 1 of 11 for:    "Rubella" | "Heptavalent Pneumococcal Conjugate Vaccine"
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V221 Concomitant Use Study With Pneumococcal Conjugate Vaccine (V221-019)

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ClinicalTrials.gov Identifier: NCT00109343
Recruitment Status : Completed
First Posted : April 27, 2005
Results First Posted : February 10, 2010
Last Update Posted : April 12, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Measles
Mumps
Rubella
Varicella
Interventions Biological: Comparator: ProQuad™ (V221)
Biological: Comparator: PREVNAR™ (pneumococcal 7-valent conjugate vaccine)
Enrollment 1027
Recruitment Details

24 clinical sites in the United States

Date first participant visit: 06-Mar-2006

Date last participant visit: 14-Sep-2007

Pre-assignment Details  
Arm/Group Title Group 1 - ProQuad™ + PREVNAR™ Group 2 - PREVNAR™ Followed by ProQuad™ Group 3 - ProQuad™ Followed by PREVNAR™
Hide Arm/Group Description 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 – 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™ (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.
Period Title: Overall Study
Started 510 258 259
Vaccinated at Visit 1 510 258 259
Vaccinated at Visit 2 0 [1] 246 246
Vaccinated at Visit 4 466 235 240
Completed 446 221 229
Not Completed 64 37 30
Reason Not Completed
Adverse Event             1             0             2
Lack of Efficacy             1             0             0
Lost to Follow-up             35             20             14
Protocol Violation             1             2             2
Withdrawal by Subject             15             11             10
Subject Moved             6             2             1
Other             5             2             1
[1]
Per-protocol, subjects in Group 1 were not vaccinated at Visit 2
Arm/Group Title Group 1 - ProQuad™ + PREVNAR™ Group 2 - PREVNAR™ Followed by ProQuad™ Group 3 - ProQuad™ Followed by PREVNAR™ Total
Hide Arm/Group Description 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 – 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™ (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 of all reporting groups
Overall Number of Baseline Participants 510 258 259 1027
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 510 participants 258 participants 259 participants 1027 participants
12.6  (0.96) 12.5  (0.93) 12.6  (0.98) 12.6  (0.96)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 510 participants 258 participants 259 participants 1027 participants
Female
230
  45.1%
120
  46.5%
117
  45.2%
467
  45.5%
Male
280
  54.9%
138
  53.5%
142
  54.8%
560
  54.5%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 510 participants 258 participants 259 participants 1027 participants
Asian 18 5 8 31
Black 83 36 36 155
Hispanic 46 31 26 103
White 335 161 174 670
Other 28 25 15 68
1.Primary Outcome
Title Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥255 mIU/mL
Hide Description Antibody Response to Measles at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <255 mIU/mL) to Measles at Baseline.
Time Frame 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group 1 - ProQuad™ + PREVNAR™ Group 3 - ProQuad™ Followed by PREVNAR™
Hide Arm/Group Description:
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™ (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 Number of Participants Analyzed 406 204
Measure Type: Number
Unit of Measure: Participants
395 203
2.Primary Outcome
Title Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥10 Ab Units/mL
Hide Description Antibody Response to Mumps at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <10 ELISA Ab units/mL) to Mumps at Baseline.
Time Frame 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group 1 - ProQuad™ + PREVNAR™ Group 3 - ProQuad™ Followed by PREVNAR™
Hide Arm/Group Description:
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™ (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 Number of Participants Analyzed 403 208
Measure Type: Number
Unit of Measure: Participants
390 205
3.Primary Outcome
Title Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥10 IU/mL
Hide Description Antibody Response to Rubella at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <10 IU/mL) to Rubella at Baseline.
Time Frame 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group 1 - ProQuad™ + PREVNAR™ Group 3 - ProQuad™ Followed by PREVNAR™
Hide Arm/Group Description:
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™ (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 Number of Participants Analyzed 377 195
Measure Type: Number
Unit of Measure: Participants
372 191
4.Primary Outcome
Title Number of Participants With Postvaccination Varicella Antibody Titer ≥1.25 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Units/mL and ≥5 gpELISA Units/mL
Hide Description Antibody Response to Varicella at 6 Weeks Postvaccination for Subjects Initially With Varicella Antibody Titer <1.25 gpELISA units/mL at Baseline
Time Frame 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group 1 - ProQuad™ + PREVNAR™ Group 3 - ProQuad™ Followed by PREVNAR™
Hide Arm/Group Description:
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™ (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 Number of Participants Analyzed 379 192
Measure Type: Number
Unit of Measure: Participants
Number of Participants ≥1.25 gpELISA units/mL 374 187
Number of Participants ≥5 gpELISA units/mL 350 169
5.Primary Outcome
Title Antibody Response to S. Pneumoniae Serotype 4 – Geometric Mean Titer
Hide Description Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 4
Time Frame 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.
Arm/Group Title Group 1 - ProQuad™ + PREVNAR™ Group 2 - PREVNAR™ Followed by ProQuad™
Hide Arm/Group Description:
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 – 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.
Overall Number of Participants Analyzed 410 193
Geometric Mean (95% Confidence Interval)
Unit of Measure: mcg/mL
1.54
(1.41 to 1.67)
1.34
(1.19 to 1.51)
6.Primary Outcome
Title Antibody Response to S. Pneumoniae Serotype 6B – Geometric Mean Titer
Hide Description Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 6B
Time Frame 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone.
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.
Arm/Group Title Group 1 - ProQuad™ + PREVNAR™ Group 2 - PREVNAR™ Followed by ProQuad™
Hide Arm/Group Description:
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 – 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.
Overall Number of Participants Analyzed 410 192
Geometric Mean (95% Confidence Interval)
Unit of Measure: mcg/mL
9.17
(8.40 to 10.02)
8.22
(7.17 to 9.41)
7.Primary Outcome
Title Antibody Response to S. Pneumoniae Serotype 9V – Geometric Mean Titer
Hide Description Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 9V
Time Frame 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.
Arm/Group Title Group 1 - ProQuad™ + PREVNAR™ Group 2 - PREVNAR™ Followed by ProQuad™
Hide Arm/Group Description:
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 – 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.
Overall Number of Participants Analyzed 409 193
Geometric Mean (95% Confidence Interval)
Unit of Measure: mcg/mL
2.98
(2.76 to 3.21)
2.71
(2.44 to 3.02)
8.Primary Outcome
Title Antibody Response to S. Pneumoniae Serotype 14 – Geometric Mean Titer
Hide Description Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 14
Time Frame 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.
Arm/Group Title Group 1 - ProQuad™ + PREVNAR™ Group 2 - PREVNAR™ Followed by ProQuad™
Hide Arm/Group Description:
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 – 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.
Overall Number of Participants Analyzed 408 193
Geometric Mean (95% Confidence Interval)
Unit of Measure: mcg/mL
6.88
(6.32 to 7.48)
5.61
(4.95 to 6.36)
9.Primary Outcome
Title Antibody Response to S. Pneumoniae Serotype 18C – Geometric Mean Titer
Hide Description Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 18C
Time Frame 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.
Arm/Group Title Group 1 - ProQuad™ + PREVNAR™ Group 2 - PREVNAR™ Followed by ProQuad™
Hide Arm/Group Description:
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 – 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.
Overall Number of Participants Analyzed 408 193
Geometric Mean (95% Confidence Interval)
Unit of Measure: mcg/mL
2.35
(2.14 to 2.58)
2.23
(1.96 to 2.55)
10.Primary Outcome
Title Antibody Response to S. Pneumoniae Serotype 19F – Geometric Mean Titer
Hide Description Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 19F
Time Frame 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.
Arm/Group Title Group 1 - ProQuad™ + PREVNAR™ Group 2 - PREVNAR™ Followed by ProQuad™
Hide Arm/Group Description:
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 – 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.
Overall Number of Participants Analyzed 408 192
Geometric Mean (95% Confidence Interval)
Unit of Measure: mcg/mL
3.59
(3.31 to 3.91)
3.22
(2.85 to 3.64)
11.Primary Outcome
Title Antibody Response to S. Pneumoniae Serotype 23F – Geometric Mean Titer
Hide Description Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 23F
Time Frame 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.
Arm/Group Title Group 1 - ProQuad™ + PREVNAR™ Group 2 - PREVNAR™ Followed by ProQuad™
Hide Arm/Group Description:
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 – 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.
Overall Number of Participants Analyzed 413 197
Geometric Mean (95% Confidence Interval)
Unit of Measure: mcg/mL
4.24
(3.85 to 4.67)
3.71
(3.16 to 4.36)
12.Other Pre-specified Outcome
Title Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 4
Hide Description [Not Specified]
Time Frame 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.
Arm/Group Title Group 1 - ProQuad™ + PREVNAR™ Group 2 - PREVNAR™ Followed by ProQuad™
Hide Arm/Group Description:
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 – 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.
Overall Number of Participants Analyzed 410 193
Measure Type: Number
Unit of Measure: Participants
403 193
13.Other Pre-specified Outcome
Title Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 6B
Hide Description [Not Specified]
Time Frame 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.
Arm/Group Title Group 1 - ProQuad™ + PREVNAR™ Group 2 - PREVNAR™ Followed by ProQuad™
Hide Arm/Group Description:
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 – 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.
Overall Number of Participants Analyzed 410 192
Measure Type: Number
Unit of Measure: Participants
408 192
14.Other Pre-specified Outcome
Title Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 9V
Hide Description [Not Specified]
Time Frame 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.
Arm/Group Title Group 1 - ProQuad™ + PREVNAR™ Group 2 - PREVNAR™ Followed by ProQuad™
Hide Arm/Group Description:
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 – 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.
Overall Number of Participants Analyzed 409 193
Measure Type: Number
Unit of Measure: Participants
407 193
15.Other Pre-specified Outcome
Title Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 14
Hide Description [Not Specified]
Time Frame 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.
Arm/Group Title Group 1 - ProQuad™ + PREVNAR™ Group 2 - PREVNAR™ Followed by ProQuad™
Hide Arm/Group Description:
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 – 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.
Overall Number of Participants Analyzed 408 193
Measure Type: Number
Unit of Measure: Participants
407 193
16.Other Pre-specified Outcome
Title Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 18C
Hide Description [Not Specified]
Time Frame 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.
Arm/Group Title Group 1 - ProQuad™ + PREVNAR™ Group 2 - PREVNAR™ Followed by ProQuad™
Hide Arm/Group Description:
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 – 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.
Overall Number of Participants Analyzed 408 193
Measure Type: Number
Unit of Measure: Participants
404 191
17.Other Pre-specified Outcome
Title Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 19F
Hide Description [Not Specified]
Time Frame 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.
Arm/Group Title Group 1 - ProQuad™ + PREVNAR™ Group 2 - PREVNAR™ Followed by ProQuad™
Hide Arm/Group Description:
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 – 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.
Overall Number of Participants Analyzed 408 192
Measure Type: Number
Unit of Measure: Participants
407 192
18.Other Pre-specified Outcome
Title Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 23F
Hide Description [Not Specified]
Time Frame 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone
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Hide Analysis Population Description
Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.
Arm/Group Title Group 1 - ProQuad™ + PREVNAR™ Group 2 - PREVNAR™ Followed by ProQuad™
Hide Arm/Group Description:
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 – 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.
Overall Number of Participants Analyzed 413 197
Measure Type: Number
Unit of Measure: Participants
412 194
Time Frame 28 days post-dose
Adverse Event Reporting Description The number of participants listed as "at risk" is the number of participants with follow-up.
 
Arm/Group Title ProQuad™ + Prevnar™ (After Dose 1) ProQuad™ Alone (After Dose 1) ProQuad™ (After Dose 2)
Hide Arm/Group Description 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) 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) includes Days 1 to 28 after the second dose of ProQuad™ (safety follow-up period 3 for Group 1, Group 2, and Group 3).
All-Cause Mortality
ProQuad™ + Prevnar™ (After Dose 1) ProQuad™ Alone (After Dose 1) ProQuad™ (After Dose 2)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
ProQuad™ + Prevnar™ (After Dose 1) ProQuad™ Alone (After Dose 1) ProQuad™ (After Dose 2)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/498 (0.80%)   3/495 (0.61%)   0/910 (0.00%) 
Infections and infestations       
Pneumonia * 1  2/498 (0.40%)  0/495 (0.00%)  0/910 (0.00%) 
Pneumonia Viral * 1  1/498 (0.20%)  0/495 (0.00%)  0/910 (0.00%) 
Osteomyelitis * 1  1/498 (0.20%)  0/495 (0.00%)  0/910 (0.00%) 
Croup Infectious * 1  0/498 (0.00%)  1/495 (0.20%)  0/910 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Neuroblastoma * 1  0/498 (0.00%)  1/495 (0.20%)  0/910 (0.00%) 
Nervous system disorders       
Febrile Convulsion * 1  0/498 (0.00%)  1/495 (0.20%)  0/910 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Respiratory Distress * 1  1/498 (0.20%)  0/495 (0.00%)  0/910 (0.00%) 
Asthma * 1  1/498 (0.20%)  0/495 (0.00%)  0/910 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 10.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
ProQuad™ + Prevnar™ (After Dose 1) ProQuad™ Alone (After Dose 1) ProQuad™ (After Dose 2)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   367/498 (73.69%)   311/495 (62.83%)   499/910 (54.84%) 
Eye disorders       
Conjunctivitis * 1  10/498 (2.01%)  6/495 (1.21%)  7/910 (0.77%) 
Gastrointestinal disorders       
Diarrhoea * 1  31/498 (6.22%)  16/495 (3.23%)  25/910 (2.75%) 
Vomiting * 1  16/498 (3.21%)  16/495 (3.23%)  25/910 (2.75%) 
General disorders       
Irritability * 1  27/498 (5.42%)  16/495 (3.23%)  13/910 (1.43%) 
Pyrexia * 1  112/498 (22.49%)  109/495 (22.02%)  138/910 (15.16%) 
Immune system disorders       
Upper Respiratory Tract Infection * 1  59/498 (11.85%)  46/495 (9.29%)  94/910 (10.33%) 
Infections and infestations       
Gastroenteritis * 1  9/498 (1.81%)  12/495 (2.42%)  15/910 (1.65%) 
Nasopharyngitis * 1  7/498 (1.41%)  21/495 (4.24%)  40/910 (4.40%) 
Otitis Media * 1  28/498 (5.62%)  32/495 (6.46%)  57/910 (6.26%) 
Otitis Media Acute * 1  13/498 (2.61%)  2/495 (0.40%)  7/910 (0.77%) 
Pharyngitis * 1  5/498 (1.00%)  2/495 (0.40%)  6/910 (0.66%) 
Pneumonia * 1  5/498 (1.00%)  2/495 (0.40%)  4/910 (0.44%) 
Sinusitis * 1  6/498 (1.20%)  3/495 (0.61%)  11/910 (1.21%) 
Viral Infection * 1  10/498 (2.01%)  10/495 (2.02%)  12/910 (1.32%) 
Viral Rash * 1  7/498 (1.41%)  5/495 (1.01%)  5/910 (0.55%) 
Arthropod Bite * 1  2/498 (0.40%)  6/495 (1.21%)  3/910 (0.33%) 
Respiratory, thoracic and mediastinal disorders       
Cough * 1  18/498 (3.61%)  14/495 (2.83%)  39/910 (4.29%) 
Nasal Congestion * 1  11/498 (2.21%)  6/495 (1.21%)  11/910 (1.21%) 
Rhinorrhoea * 1  21/498 (4.22%)  16/495 (3.23%)  36/910 (3.96%) 
Skin and subcutaneous tissue disorders       
Dermatitis Diaper * 1  26/498 (5.22%)  11/495 (2.22%)  19/910 (2.09%) 
Eczema * 1  7/498 (1.41%)  4/495 (0.81%)  11/910 (1.21%) 
Rash * 1  23/498 (4.62%)  19/495 (3.84%)  14/910 (1.54%) 
Rash Morbilliform * 1  27/498 (5.42%)  24/495 (4.85%)  15/910 (1.65%) 
Rash Vesicular * 1  10/498 (2.01%)  6/495 (1.21%)  4/910 (0.44%) 
Injection Site Bruising (Prevnar Injection-site) * 1  8/498 (1.61%)  0/0  0/0 
Injection Site Erythema (Prevnar Injection-site)  1  106/498 (21.29%)  0/0  0/0 
Injection Site Pain (Prevnar Injection-site)  1  157/498 (31.53%)  0/0  0/0 
Injection Site Rash (Prevnar Injection-site) * 1  5/498 (1.00%)  0/0  0/0 
Injection Site Swelling (Prevnar Injection-site)  1  92/498 (18.47%)  0/0  0/0 
Injection Site Bruising (ProQuad Injection-site) * 1  10/498 (2.01%)  8/495 (1.62%)  3/910 (0.33%) 
Injection Site Erythema (ProQuad Injection-site)  1  69/498 (13.86%)  67/495 (13.54%)  153/910 (16.81%) 
Injection Site Pain (ProQuad Injection-site)  1  125/498 (25.10%)  127/495 (25.66%)  163/910 (17.91%) 
Injection Site Rash (ProQuad Injection-site) * 1  6/498 (1.20%)  12/495 (2.42%)  9/910 (0.99%) 
Injection Site Swelling (ProQuad Injection-site)  1  58/498 (11.65%)  54/495 (10.91%)  118/910 (12.97%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 10.1
One subject (Group 3-ProQuad™ followed by PREVNAR™) was diagnosed (Day 8) with Stage IV neuroblastoma (considered not related to study vaccine by investigator) and discontinued from the study. Subject died (Day 218) due to neuroblastoma.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00109343     History of Changes
Other Study ID Numbers: V221-019
2005_027
First Submitted: April 27, 2005
First Posted: April 27, 2005
Results First Submitted: September 23, 2009
Results First Posted: February 10, 2010
Last Update Posted: April 12, 2017