Measles, Mumps, Rubella, Varicella
Conditions
Brief summary
The study is being conducted to demonstrate that V221 may be administered concomitantly with pneumococcal conjugate vaccine without impairing the safety or immunogenicity of measles, mumps, rubella, varicella, or the 7 serotypes of S. pneumoniae.
Interventions
BIOLOGICALComparator: ProQuad™ (V221)
0.5-mL subcutaneous injection of measles, mumps, rubella, varicella virus vaccine live (MMRV)
0.5-mL intramuscular injection of pneumococcal 7-valent conjugate vaccine
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Months to 15 Months
Healthy volunteers
Yes
Inclusion criteria
* In good health * 12 to 15 months of age * Negative clinical history to measles, mumps, rubella, varicella and/or zoster * Received only the 3-dose primary series of a pneumococcal conjugate vaccine with at least 2 months prior to the receipt of any of the study vaccines * Signed consent
Exclusion criteria
* Previous administration of any measles, mumps, rubella, or varicella vaccine either alone or in any combination * Any condition resulting in depressed immunity * Any allergy to any vaccine component as stated in the package circulars * Exposure to measles, mumps, rubella, varicella, or zoster within 4 weeks prior to the study vaccination * History of seizure disorder * Receipt of an inactivated vaccine within 14 days prior to enrollment or live vaccine within 30 days * Recent febrile illness
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Antibody Response to S. Pneumoniae Serotype 23F - Geometric Mean Titer | 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone | Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 23F |
| Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥10 IU/mL | 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone | Antibody Response to Rubella at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer \<10 IU/mL) to Rubella at Baseline. |
| Number of Participants With Postvaccination Varicella Antibody Titer ≥1.25 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Units/mL and ≥5 gpELISA Units/mL | 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone | Antibody Response to Varicella at 6 Weeks Postvaccination for Subjects Initially With Varicella Antibody Titer \<1.25 gpELISA units/mL at Baseline |
| Antibody Response to S. Pneumoniae Serotype 4 - Geometric Mean Titer | 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone | Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 4 |
| Antibody Response to S. Pneumoniae Serotype 9V - Geometric Mean Titer | 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone | Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 9V |
| Antibody Response to S. Pneumoniae Serotype 14 - Geometric Mean Titer | 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone | Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 14 |
| Antibody Response to S. Pneumoniae Serotype 18C - Geometric Mean Titer | 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone | Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 18C |
| Antibody Response to S. Pneumoniae Serotype 19F - Geometric Mean Titer | 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone | Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 19F |
| Antibody Response to S. Pneumoniae Serotype 6B - Geometric Mean Titer | 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone. | Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 6B |
| Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥255 mIU/mL | 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone | Antibody Response to Measles at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer \<255 mIU/mL) to Measles at Baseline. |
| Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥10 Ab Units/mL | 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone | Antibody Response to Mumps at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer \<10 ELISA Ab units/mL) to Mumps at Baseline. |
Other
| Measure | Time frame |
|---|---|
| Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 6B | 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone |
| Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 9V | 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone |
| Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 14 | 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone |
| Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 18C | 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone |
| Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 19F | 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone |
| Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 23F | 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone |
| Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 4 | 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone |
Participant flow
Recruitment details
24 clinical sites in the United States Date first participant visit: 06-Mar-2006 Date last participant visit: 14-Sep-2007
Participants by arm
| Arm | Count |
|---|---|
| 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. | 510 |
| 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. | 258 |
| 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. | 259 |
| Total | 1,027 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| 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 | Other | 5 | 2 | 1 |
| Overall Study | Protocol Violation | 1 | 2 | 2 |
| Overall Study | Subject Moved | 6 | 2 | 1 |
| Overall Study | Withdrawal by Subject | 15 | 11 | 10 |
Baseline characteristics
| Characteristic | Group 1 - ProQuad™ + PREVNAR™ | Group 2 - PREVNAR™ Followed by ProQuad™ | Group 3 - ProQuad™ Followed by PREVNAR™ | Total |
|---|---|---|---|---|
| Age, Continuous | 12.6 Months STANDARD_DEVIATION 0.96 | 12.5 Months STANDARD_DEVIATION 0.93 | 12.6 Months STANDARD_DEVIATION 0.98 | 12.6 Months STANDARD_DEVIATION 0.96 |
| Race/Ethnicity, Customized Asian | 18 participants | 5 participants | 8 participants | 31 participants |
| Race/Ethnicity, Customized Black | 83 participants | 36 participants | 36 participants | 155 participants |
| Race/Ethnicity, Customized Hispanic | 46 participants | 31 participants | 26 participants | 103 participants |
| Race/Ethnicity, Customized Other | 28 participants | 25 participants | 15 participants | 68 participants |
| Race/Ethnicity, Customized White | 335 participants | 161 participants | 174 participants | 670 participants |
| Sex: Female, Male Female | 230 Participants | 120 Participants | 117 Participants | 467 Participants |
| Sex: Female, Male Male | 280 Participants | 138 Participants | 142 Participants | 560 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 367 / 498 | 311 / 495 | 499 / 910 |
| serious Total, serious adverse events | 4 / 498 | 3 / 495 | 0 / 910 |
Outcome results
Primary
Antibody Response to S. Pneumoniae Serotype 14 - Geometric Mean Titer
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
Population: Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1 - ProQuad™ + PREVNAR™ | Antibody Response to S. Pneumoniae Serotype 14 - Geometric Mean Titer | 6.88 mcg/mL |
| Group 3 - ProQuad™ Followed by PREVNAR™ | Antibody Response to S. Pneumoniae Serotype 14 - Geometric Mean Titer | 5.61 mcg/mL |
Primary
Antibody Response to S. Pneumoniae Serotype 18C - Geometric Mean Titer
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
Population: Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1 - ProQuad™ + PREVNAR™ | Antibody Response to S. Pneumoniae Serotype 18C - Geometric Mean Titer | 2.35 mcg/mL |
| Group 3 - ProQuad™ Followed by PREVNAR™ | Antibody Response to S. Pneumoniae Serotype 18C - Geometric Mean Titer | 2.23 mcg/mL |
Primary
Antibody Response to S. Pneumoniae Serotype 19F - Geometric Mean Titer
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
Population: Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1 - ProQuad™ + PREVNAR™ | Antibody Response to S. Pneumoniae Serotype 19F - Geometric Mean Titer | 3.59 mcg/mL |
| Group 3 - ProQuad™ Followed by PREVNAR™ | Antibody Response to S. Pneumoniae Serotype 19F - Geometric Mean Titer | 3.22 mcg/mL |
Primary
Antibody Response to S. Pneumoniae Serotype 23F - Geometric Mean Titer
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
Population: Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1 - ProQuad™ + PREVNAR™ | Antibody Response to S. Pneumoniae Serotype 23F - Geometric Mean Titer | 4.24 mcg/mL |
| Group 3 - ProQuad™ Followed by PREVNAR™ | Antibody Response to S. Pneumoniae Serotype 23F - Geometric Mean Titer | 3.71 mcg/mL |
Primary
Antibody Response to S. Pneumoniae Serotype 4 - Geometric Mean Titer
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
Population: Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1 - ProQuad™ + PREVNAR™ | Antibody Response to S. Pneumoniae Serotype 4 - Geometric Mean Titer | 1.54 mcg/mL |
| Group 3 - ProQuad™ Followed by PREVNAR™ | Antibody Response to S. Pneumoniae Serotype 4 - Geometric Mean Titer | 1.34 mcg/mL |
Primary
Antibody Response to S. Pneumoniae Serotype 6B - Geometric Mean Titer
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.
Population: Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1 - ProQuad™ + PREVNAR™ | Antibody Response to S. Pneumoniae Serotype 6B - Geometric Mean Titer | 9.17 mcg/mL |
| Group 3 - ProQuad™ Followed by PREVNAR™ | Antibody Response to S. Pneumoniae Serotype 6B - Geometric Mean Titer | 8.22 mcg/mL |
Primary
Antibody Response to S. Pneumoniae Serotype 9V - Geometric Mean Titer
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
Population: Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1 - ProQuad™ + PREVNAR™ | Antibody Response to S. Pneumoniae Serotype 9V - Geometric Mean Titer | 2.98 mcg/mL |
| Group 3 - ProQuad™ Followed by PREVNAR™ | Antibody Response to S. Pneumoniae Serotype 9V - Geometric Mean Titer | 2.71 mcg/mL |
Primary
Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥255 mIU/mL
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
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 - ProQuad™ + PREVNAR™ | Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥255 mIU/mL | 395 Participants |
| Group 3 - ProQuad™ Followed by PREVNAR™ | Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥255 mIU/mL | 203 Participants |
Primary
Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥10 Ab Units/mL
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
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 - ProQuad™ + PREVNAR™ | Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥10 Ab Units/mL | 390 Participants |
| Group 3 - ProQuad™ Followed by PREVNAR™ | Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥10 Ab Units/mL | 205 Participants |
Primary
Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥10 IU/mL
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
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 - ProQuad™ + PREVNAR™ | Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥10 IU/mL | 372 Participants |
| Group 3 - ProQuad™ Followed by PREVNAR™ | Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥10 IU/mL | 191 Participants |
Primary
Number of Participants With Postvaccination Varicella Antibody Titer ≥1.25 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Units/mL and ≥5 gpELISA Units/mL
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
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1 - ProQuad™ + PREVNAR™ | 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 |
| Group 1 - ProQuad™ + PREVNAR™ | 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 |
| Group 3 - ProQuad™ Followed by PREVNAR™ | 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 | 187 Participants |
| Group 3 - ProQuad™ Followed by PREVNAR™ | 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 | 169 Participants |
Other Pre-specified
Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for 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
Population: Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 - ProQuad™ + PREVNAR™ | Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 14 | 407 Participants |
| Group 3 - ProQuad™ Followed by PREVNAR™ | Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 14 | 193 Participants |
Other Pre-specified
Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for 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
Population: Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 - ProQuad™ + PREVNAR™ | Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 18C | 404 Participants |
| Group 3 - ProQuad™ Followed by PREVNAR™ | Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 18C | 191 Participants |
Other Pre-specified
Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for 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
Population: Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 - ProQuad™ + PREVNAR™ | Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 19F | 407 Participants |
| Group 3 - ProQuad™ Followed by PREVNAR™ | Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 19F | 192 Participants |
Other Pre-specified
Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for 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
Population: Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 - ProQuad™ + PREVNAR™ | Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 23F | 412 Participants |
| Group 3 - ProQuad™ Followed by PREVNAR™ | Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 23F | 194 Participants |
Other Pre-specified
Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for 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
Population: Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 - ProQuad™ + PREVNAR™ | Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 4 | 403 Participants |
| Group 3 - ProQuad™ Followed by PREVNAR™ | Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 4 | 193 Participants |
Other Pre-specified
Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for 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
Population: Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 - ProQuad™ + PREVNAR™ | Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 6B | 408 Participants |
| Group 3 - ProQuad™ Followed by PREVNAR™ | Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 6B | 192 Participants |
Other Pre-specified
Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for 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
Population: Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 - ProQuad™ + PREVNAR™ | Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 9V | 407 Participants |
| Group 3 - ProQuad™ Followed by PREVNAR™ | Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 9V | 193 Participants |