Measles, Mumps, Rubella, Varicella
Conditions
Brief summary
This study will assess the safety and immunogenicity of ProQuad when administered concomitantly and nonconcomitantly with Tripedia and Comvax.
Interventions
A single 0.5 mL subcutaneous injection at Day 0
BIOLOGICALComparator: Tripedia
A single 0.5 mL intramuscular injection (at Day 0 or Day 42)
BIOLOGICALComparator: Comvax
A single 0.5 mL intramuscular injection (at Day 0 or Day 42)
BIOLOGICALComparator: Varivax
A single 0.5 mL subcutaneous injection at Day 0
BIOLOGICALComparator: M-M-R II
A single 0.5 mL subcutaneous injection at Day 0
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 * Negative clinical history of varicella, zoster, measles, mumps, rubella, diptheria, tetanus, pertussis, invasive Hib disease and hepatitis B * Had completed either a 2-dose primary series of PedvaxHIB or COMVAX or any 3-dose primary series of a licensed Hib vaccine * Had received 2 or 3 doses of any hepatitis B vaccine or COMVAX prior to entry into trial
Exclusion criteria
* Previous receipt of measles, mumps, rubella or varicella vaccine either alone or in combination * Any immune impairment or deficiency * Recent household, daycare or school exposure to invasive Hib disease or hepatitis B * Exposure to measles, mumps, rubella, varicella, or zoster in the 4 weeks prior to vaccination * Vaccination with an inactive vaccine with in the past 14 days * Vaccination with a live vaccine within the past 30 days * Receipt of immune globulin, blood transfusion or blood-derived product in the past 3 months * Recent history of fever or underlying medical problems
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥120 mIU/mL | 6 Weeks Postvaccination | Antibody Response to Measles at 6 Weeks Postvaccination for Participants Initially Seronegative (a titer \<120 mIU/mL) to Measles at Baseline |
| Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥10 Ab Units/mL | 6 weeks Postvaccination | Antibody Response to Mumps at 6 Weeks Postvaccination for Participants Initially Seronegative (a titer \<10 Ab units/mL) to Mumps at Baseline |
| Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥10 IU/mL | 6 weeks Postvaccination | Antibody Response to Rubella at 6 Weeks Postvaccination for Participants Initially Seronegative (a titer \<10 IU/mL) to Rubella at Baseline |
| Number of Participants With Postvaccination Varicella-Zoster Virus (VZV) Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Antibody Titer ≥5 gpELISA Units/mL | 6 weeks Postvaccination | Antibody Response to Varicella-Zoster Virus (VZV) at 6 Weeks Postvaccination for Participants Initially Seronegative (a titer \<0.6 gpELISA units/mL) to VZV at Baseline |
| Number of Participants With Postvaccination Diphtheria Vero Cell Culture Assay Antibody Titer ≥0.1 IU/mL | 6 weeks Postvaccination | Antibody response to Diphtheria at 6 weeks postvaccination |
| Number of Participants With Postvaccination Tetanus Enzyme Immunoassay (EIA) Antibody Titer ≥0.1 IU/mL | 6 weeks Postvaccination | Antibody response to Tetanus (tetanus antitoxin were measured with an indirect, noncompetitive enzyme immunoassay (EIA)) at 6 weeks postvaccination. |
| Number of Participants With ≥4-fold Rise in Pertussis Toxin (PT) EIA Antibody Titer | 6 weeks Postvaccination | Antibody response to Pertussis Toxin (titers of pertussis toxin antibodies were measured with an indirect, noncompetitive EIA). |
| Number of Participants With ≥4-fold Rise in Pertussis Filamentous Hemagglutinin (FHA) EIA Antibody Titer | 6 weeks Postvaccination | Antibody response to pertussis FHA(titers of pertussis filamentous hemagglutinin antibodies were measured with an indirect, noncompetitive EIA). |
| Number of Participants With Postvaccination Hepatitis B (Quantitative AUSAB™ Radioimmunoassay (RIA)) Antibody Titer ≥10 mIU/mL | 6 weeks Postvaccination | Antibody response to Hepatitis B (titers measured using the Quantitative AUSAB™ radioimmunoassay (RIA)). |
| Number of Participants With Postvaccination Haemophilus Influenzae Type B (Hib) Radioimmunoassay (RIA) Antibody Titer ≥ 1 mcg/mL | 6 weeks Postvaccination | Antibody response to Haemophilus influenzae type B (Hib). (Anti-polyribosylribitol phosphate (PRP) was measured by radioimmunoassay (RIA) using radiolabeled-PRP according to a standard Farr technique and with a standard provided by the U.S. FDA.) |
| Antibody Response to Measles at 6 Weeks Postvaccination for Participants Initially Seronegative to Measles at Baseline - Geometric Mean Titer (GMT) | 6 weeks Postvaccination | Postvaccination Observed Geometric Mean Titer of Antibody to Measles. (Titers measured using Measles ELISA.) |
| Antibody Response to Mumps at 6 Weeks Postvaccination for Participants Initially Seronegative to Mumps at Baseline - GMT | 6 weeks Postvaccination | Postvaccination observed GMT of antibody to mumps. (Titers measured using mumps ELISA.) |
| Antibody Response to Rubella at 6 Weeks Postvaccination for Participants Initially Seronegative to Rubella at Baseline - GMT | 6 weeks Postvaccination | Postvaccination Observed Geometric Mean Titer of Antibody to Rubella. (Titers measured using Rubella ELISA.) |
| Antibody Response to Varicella at 6 Weeks Postvaccination for Participants Initially Seronegative to Varicella at Baseline - GMT | 6 weeks Postvaccination | Postvaccination Observed Geometric Mean Titer of Antibody to Varicella. (Titers measured using VZV gpELISA.) |
| Antibody Response to Diphtheria at 6 Weeks Postvaccination - GMT | 6 weeks Postvaccination | Postvaccination Observed Geometric Mean Titer of Antibody to Diphtheria. (Titers measured using Vero Cell Culture Assay.) |
| Antibody Response to Pertussis Toxin (PT) at 6 Weeks Postvaccination - GMT | 6 weeks Postvaccination | Postvaccination Observed Geometric Mean Titer of Antibody to Pertussis Toxin (PT). Titers measured using an indirect, noncompetitive Pertussis enzyme immunoassay (EIA). |
| Antibody Response to Pertussis Filamentous Hemagglutinin (FHA) at 6 Weeks Postvaccination - GMT | 6 weeks Postvaccination | Postvaccination Observed Geometric Mean Titer of Antibody to Pertussis Filamentous Hemagglutinin (FHA). (Titers measured using an indirect, noncompetitive Pertussis enzyme immunoassay (EIA).) |
| Antibody Response to Hepatitis B at 6 Weeks Postvaccination - GMT | 6 weeks Postvaccination | Postvaccination Observed Geometric Mean Titer of Antibody to Hepatitis B. (Titers measured using the Quantitative AUSAB™ radioimmunoassay (RIA).) |
| Antibody Response to Haemophilus Influenzae Type B (Hib) at 6 Weeks Postvaccination - GMT | 6 weeks Postvaccination | Postvaccination observed GMT of antibody to Hib. (Anti-polyribosylribitol phosphate (PRP) was measured by RIA using radiolabeled-PRP according to a standard Farr technique and with a standard provided by the U.S. FDA.) |
| Antibody Response to Tetanus at 6 Weeks Postvaccination - GMT | 6 weeks Postvaccination | Postvaccination Observed Geometric Mean Titer of Antibody to Tetanus. (Titers of tetanus antitoxin were measured with an indirect, noncompetitive enzyme immunoassay (EIA).) |
Participant flow
Recruitment details
48 clinical sites in the United States Date first participant visit: 27-Jun-2000 Date last participant visit: 23-Oct-2001
Participants by arm
| Arm | Count |
|---|---|
| Concomitant Group Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0. | 949 |
| Nonconcomitant Group Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42. | 485 |
| Control Group Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42. | 479 |
| Total | 1,913 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | CAE - discontinued test vaccine | 0 | 1 | 3 |
| Overall Study | Incomplete safety follow-up | 11 | 2 | 3 |
| Overall Study | Lost to Follow-up | 31 | 12 | 13 |
| Overall Study | Missed one or more blood samplings | 3 | 7 | 2 |
| Overall Study | Protocol Violation | 2 | 1 | 4 |
| Overall Study | Withdrawal by Subject | 18 | 9 | 12 |
Baseline characteristics
| Characteristic | Concomitant Group | Nonconcomitant Group | Control Group | Total |
|---|---|---|---|---|
| Age, Continuous | 12.4 years STANDARD_DEVIATION 0.7 | 12.3 years STANDARD_DEVIATION 0.7 | 12.4 years STANDARD_DEVIATION 0.7 | 12.4 years STANDARD_DEVIATION 0.7 |
| Race/Ethnicity, Customized African American | 101 participants | 52 participants | 42 participants | 195 participants |
| Race/Ethnicity, Customized Asian/Pacific | 103 participants | 54 participants | 57 participants | 214 participants |
| Race/Ethnicity, Customized Caucasian | 678 participants | 336 participants | 342 participants | 1356 participants |
| Race/Ethnicity, Customized Hispanic | 38 participants | 26 participants | 20 participants | 84 participants |
| Race/Ethnicity, Customized Native American | 3 participants | 0 participants | 1 participants | 4 participants |
| Race/Ethnicity, Customized Other | 26 participants | 17 participants | 17 participants | 60 participants |
| Sex: Female, Male Female | 442 Participants | 223 Participants | 246 Participants | 911 Participants |
| Sex: Female, Male Male | 507 Participants | 262 Participants | 233 Participants | 1002 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 | 831 / 929 | 435 / 479 | 411 / 467 |
| serious Total, serious adverse events | 11 / 929 | 3 / 479 | 1 / 467 |
Outcome results
Primary
Antibody Response to Diphtheria at 6 Weeks Postvaccination - GMT
Postvaccination Observed Geometric Mean Titer of Antibody to Diphtheria. (Titers measured using Vero Cell Culture Assay.)
Time frame: 6 weeks Postvaccination
Population: The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Concomitant Group | Antibody Response to Diphtheria at 6 Weeks Postvaccination - GMT | 1.33 IU/mL |
| Nonconcomitant Group | Antibody Response to Diphtheria at 6 Weeks Postvaccination - GMT | 1.72 IU/mL |
| Control Group | Antibody Response to Diphtheria at 6 Weeks Postvaccination - GMT | 1.59 IU/mL |
Primary
Antibody Response to Haemophilus Influenzae Type B (Hib) at 6 Weeks Postvaccination - GMT
Postvaccination observed GMT of antibody to Hib. (Anti-polyribosylribitol phosphate (PRP) was measured by RIA using radiolabeled-PRP according to a standard Farr technique and with a standard provided by the U.S. FDA.)
Time frame: 6 weeks Postvaccination
Population: The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Concomitant Group | Antibody Response to Haemophilus Influenzae Type B (Hib) at 6 Weeks Postvaccination - GMT | 11.2 mIU/mL |
| Nonconcomitant Group | Antibody Response to Haemophilus Influenzae Type B (Hib) at 6 Weeks Postvaccination - GMT | 12.1 mIU/mL |
| Control Group | Antibody Response to Haemophilus Influenzae Type B (Hib) at 6 Weeks Postvaccination - GMT | 12.9 mIU/mL |
Primary
Antibody Response to Hepatitis B at 6 Weeks Postvaccination - GMT
Postvaccination Observed Geometric Mean Titer of Antibody to Hepatitis B. (Titers measured using the Quantitative AUSAB™ radioimmunoassay (RIA).)
Time frame: 6 weeks Postvaccination
Population: The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Concomitant Group | Antibody Response to Hepatitis B at 6 Weeks Postvaccination - GMT | 758 mIU/mL |
| Nonconcomitant Group | Antibody Response to Hepatitis B at 6 Weeks Postvaccination - GMT | 996 mIU/mL |
| Control Group | Antibody Response to Hepatitis B at 6 Weeks Postvaccination - GMT | 1135 mIU/mL |
Primary
Antibody Response to Measles at 6 Weeks Postvaccination for Participants Initially Seronegative to Measles at Baseline - Geometric Mean Titer (GMT)
Postvaccination Observed Geometric Mean Titer of Antibody to Measles. (Titers measured using Measles ELISA.)
Time frame: 6 weeks Postvaccination
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 (GEOMETRIC_MEAN) |
|---|---|---|
| Concomitant Group | Antibody Response to Measles at 6 Weeks Postvaccination for Participants Initially Seronegative to Measles at Baseline - Geometric Mean Titer (GMT) | 3504.9 mIU/mL |
| Nonconcomitant Group | Antibody Response to Measles at 6 Weeks Postvaccination for Participants Initially Seronegative to Measles at Baseline - Geometric Mean Titer (GMT) | 3506.2 mIU/mL |
| Control Group | Antibody Response to Measles at 6 Weeks Postvaccination for Participants Initially Seronegative to Measles at Baseline - Geometric Mean Titer (GMT) | 2562.1 mIU/mL |
Primary
Antibody Response to Mumps at 6 Weeks Postvaccination for Participants Initially Seronegative to Mumps at Baseline - GMT
Postvaccination observed GMT of antibody to mumps. (Titers measured using mumps ELISA.)
Time frame: 6 weeks Postvaccination
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 (GEOMETRIC_MEAN) |
|---|---|---|
| Concomitant Group | Antibody Response to Mumps at 6 Weeks Postvaccination for Participants Initially Seronegative to Mumps at Baseline - GMT | 89.4 ELISA Ab units/mL |
| Nonconcomitant Group | Antibody Response to Mumps at 6 Weeks Postvaccination for Participants Initially Seronegative to Mumps at Baseline - GMT | 84.1 ELISA Ab units/mL |
| Control Group | Antibody Response to Mumps at 6 Weeks Postvaccination for Participants Initially Seronegative to Mumps at Baseline - GMT | 98.1 ELISA Ab units/mL |
Primary
Antibody Response to Pertussis Filamentous Hemagglutinin (FHA) at 6 Weeks Postvaccination - GMT
Postvaccination Observed Geometric Mean Titer of Antibody to Pertussis Filamentous Hemagglutinin (FHA). (Titers measured using an indirect, noncompetitive Pertussis enzyme immunoassay (EIA).)
Time frame: 6 weeks Postvaccination
Population: The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Concomitant Group | Antibody Response to Pertussis Filamentous Hemagglutinin (FHA) at 6 Weeks Postvaccination - GMT | 58.1 units/mL |
| Nonconcomitant Group | Antibody Response to Pertussis Filamentous Hemagglutinin (FHA) at 6 Weeks Postvaccination - GMT | 81.2 units/mL |
| Control Group | Antibody Response to Pertussis Filamentous Hemagglutinin (FHA) at 6 Weeks Postvaccination - GMT | 65.0 units/mL |
Primary
Antibody Response to Pertussis Toxin (PT) at 6 Weeks Postvaccination - GMT
Postvaccination Observed Geometric Mean Titer of Antibody to Pertussis Toxin (PT). Titers measured using an indirect, noncompetitive Pertussis enzyme immunoassay (EIA).
Time frame: 6 weeks Postvaccination
Population: The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Concomitant Group | Antibody Response to Pertussis Toxin (PT) at 6 Weeks Postvaccination - GMT | 42.9 units/mL |
| Nonconcomitant Group | Antibody Response to Pertussis Toxin (PT) at 6 Weeks Postvaccination - GMT | 55.7 units/mL |
| Control Group | Antibody Response to Pertussis Toxin (PT) at 6 Weeks Postvaccination - GMT | 46.3 units/mL |
Primary
Antibody Response to Rubella at 6 Weeks Postvaccination for Participants Initially Seronegative to Rubella at Baseline - GMT
Postvaccination Observed Geometric Mean Titer of Antibody to Rubella. (Titers measured using Rubella ELISA.)
Time frame: 6 weeks Postvaccination
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 (GEOMETRIC_MEAN) |
|---|---|---|
| Concomitant Group | Antibody Response to Rubella at 6 Weeks Postvaccination for Participants Initially Seronegative to Rubella at Baseline - GMT | 98.7 IU/mL |
| Nonconcomitant Group | Antibody Response to Rubella at 6 Weeks Postvaccination for Participants Initially Seronegative to Rubella at Baseline - GMT | 99.9 IU/mL |
| Control Group | Antibody Response to Rubella at 6 Weeks Postvaccination for Participants Initially Seronegative to Rubella at Baseline - GMT | 126.3 IU/mL |
Primary
Antibody Response to Tetanus at 6 Weeks Postvaccination - GMT
Postvaccination Observed Geometric Mean Titer of Antibody to Tetanus. (Titers of tetanus antitoxin were measured with an indirect, noncompetitive enzyme immunoassay (EIA).)
Time frame: 6 weeks Postvaccination
Population: The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Concomitant Group | Antibody Response to Tetanus at 6 Weeks Postvaccination - GMT | 3.93 IU/mL |
| Nonconcomitant Group | Antibody Response to Tetanus at 6 Weeks Postvaccination - GMT | 5.74 IU/mL |
| Control Group | Antibody Response to Tetanus at 6 Weeks Postvaccination - GMT | 4.36 IU/mL |
Primary
Antibody Response to Varicella at 6 Weeks Postvaccination for Participants Initially Seronegative to Varicella at Baseline - GMT
Postvaccination Observed Geometric Mean Titer of Antibody to Varicella. (Titers measured using VZV gpELISA.)
Time frame: 6 weeks Postvaccination
Population: The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Concomitant Group | Antibody Response to Varicella at 6 Weeks Postvaccination for Participants Initially Seronegative to Varicella at Baseline - GMT | 13.8 gpELISA units/mL |
| Nonconcomitant Group | Antibody Response to Varicella at 6 Weeks Postvaccination for Participants Initially Seronegative to Varicella at Baseline - GMT | 15.4 gpELISA units/mL |
| Control Group | Antibody Response to Varicella at 6 Weeks Postvaccination for Participants Initially Seronegative to Varicella at Baseline - GMT | 15.8 gpELISA units/mL |
Primary
Number of Participants With ≥4-fold Rise in Pertussis Filamentous Hemagglutinin (FHA) EIA Antibody Titer
Antibody response to pertussis FHA(titers of pertussis filamentous hemagglutinin antibodies were measured with an indirect, noncompetitive EIA).
Time frame: 6 weeks Postvaccination
Population: The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Concomitant Group | Number of Participants With ≥4-fold Rise in Pertussis Filamentous Hemagglutinin (FHA) EIA Antibody Titer | 502 Participants |
| Nonconcomitant Group | Number of Participants With ≥4-fold Rise in Pertussis Filamentous Hemagglutinin (FHA) EIA Antibody Titer | 309 Participants |
| Control Group | Number of Participants With ≥4-fold Rise in Pertussis Filamentous Hemagglutinin (FHA) EIA Antibody Titer | 53 Participants |
Primary
Number of Participants With ≥4-fold Rise in Pertussis Toxin (PT) EIA Antibody Titer
Antibody response to Pertussis Toxin (titers of pertussis toxin antibodies were measured with an indirect, noncompetitive EIA).
Time frame: 6 weeks Postvaccination
Population: The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Concomitant Group | Number of Participants With ≥4-fold Rise in Pertussis Toxin (PT) EIA Antibody Titer | 554 Participants |
| Nonconcomitant Group | Number of Participants With ≥4-fold Rise in Pertussis Toxin (PT) EIA Antibody Titer | 321 Participants |
| Control Group | Number of Participants With ≥4-fold Rise in Pertussis Toxin (PT) EIA Antibody Titer | 56 Participants |
Primary
Number of Participants With Postvaccination Diphtheria Vero Cell Culture Assay Antibody Titer ≥0.1 IU/mL
Antibody response to Diphtheria at 6 weeks postvaccination
Time frame: 6 weeks Postvaccination
Population: The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Concomitant Group | Number of Participants With Postvaccination Diphtheria Vero Cell Culture Assay Antibody Titer ≥0.1 IU/mL | 667 Participants |
| Nonconcomitant Group | Number of Participants With Postvaccination Diphtheria Vero Cell Culture Assay Antibody Titer ≥0.1 IU/mL | 333 Participants |
| Control Group | Number of Participants With Postvaccination Diphtheria Vero Cell Culture Assay Antibody Titer ≥0.1 IU/mL | 94 Participants |
Primary
Number of Participants With Postvaccination Haemophilus Influenzae Type B (Hib) Radioimmunoassay (RIA) Antibody Titer ≥ 1 mcg/mL
Antibody response to Haemophilus influenzae type B (Hib). (Anti-polyribosylribitol phosphate (PRP) was measured by radioimmunoassay (RIA) using radiolabeled-PRP according to a standard Farr technique and with a standard provided by the U.S. FDA.)
Time frame: 6 weeks Postvaccination
Population: The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Concomitant Group | Number of Participants With Postvaccination Haemophilus Influenzae Type B (Hib) Radioimmunoassay (RIA) Antibody Titer ≥ 1 mcg/mL | 778 Participants |
| Nonconcomitant Group | Number of Participants With Postvaccination Haemophilus Influenzae Type B (Hib) Radioimmunoassay (RIA) Antibody Titer ≥ 1 mcg/mL | 384 Participants |
| Control Group | Number of Participants With Postvaccination Haemophilus Influenzae Type B (Hib) Radioimmunoassay (RIA) Antibody Titer ≥ 1 mcg/mL | 119 Participants |
Primary
Number of Participants With Postvaccination Hepatitis B (Quantitative AUSAB™ Radioimmunoassay (RIA)) Antibody Titer ≥10 mIU/mL
Antibody response to Hepatitis B (titers measured using the Quantitative AUSAB™ radioimmunoassay (RIA)).
Time frame: 6 weeks Postvaccination
Population: The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Concomitant Group | Number of Participants With Postvaccination Hepatitis B (Quantitative AUSAB™ Radioimmunoassay (RIA)) Antibody Titer ≥10 mIU/mL | 791 Participants |
| Nonconcomitant Group | Number of Participants With Postvaccination Hepatitis B (Quantitative AUSAB™ Radioimmunoassay (RIA)) Antibody Titer ≥10 mIU/mL | 391 Participants |
| Control Group | Number of Participants With Postvaccination Hepatitis B (Quantitative AUSAB™ Radioimmunoassay (RIA)) Antibody Titer ≥10 mIU/mL | 121 Participants |
Primary
Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥120 mIU/mL
Antibody Response to Measles at 6 Weeks Postvaccination for Participants Initially Seronegative (a titer \<120 mIU/mL) to Measles at Baseline
Time frame: 6 Weeks Postvaccination
Population: The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges, were seronegative to measles at baseline, and followed protocol procedures.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Concomitant Group | Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥120 mIU/mL | 741 Participants |
| Nonconcomitant Group | Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥120 mIU/mL | 383 Participants |
| Control Group | Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥120 mIU/mL | 124 Participants |
Primary
Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥10 Ab Units/mL
Antibody Response to Mumps at 6 Weeks Postvaccination for Participants Initially Seronegative (a titer \<10 Ab units/mL) to Mumps at Baseline
Time frame: 6 weeks Postvaccination
Population: The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges, were seronegative to mumps at baseline, and followed protocol procedures.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Concomitant Group | Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥10 Ab Units/mL | 774 Participants |
| Nonconcomitant Group | Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥10 Ab Units/mL | 395 Participants |
| Control Group | Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥10 Ab Units/mL | 143 Participants |
Primary
Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥10 IU/mL
Antibody Response to Rubella at 6 Weeks Postvaccination for Participants Initially Seronegative (a titer \<10 IU/mL) to Rubella at Baseline
Time frame: 6 weeks Postvaccination
Population: The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges, were seronegative to rubella at baseline, and followed protocol procedures.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Concomitant Group | Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥10 IU/mL | 817 Participants |
| Nonconcomitant Group | Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥10 IU/mL | 418 Participants |
| Control Group | Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥10 IU/mL | 148 Participants |
Primary
Number of Participants With Postvaccination Tetanus Enzyme Immunoassay (EIA) Antibody Titer ≥0.1 IU/mL
Antibody response to Tetanus (tetanus antitoxin were measured with an indirect, noncompetitive enzyme immunoassay (EIA)) at 6 weeks postvaccination.
Time frame: 6 weeks Postvaccination
Population: The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Concomitant Group | Number of Participants With Postvaccination Tetanus Enzyme Immunoassay (EIA) Antibody Titer ≥0.1 IU/mL | 796 Participants |
| Nonconcomitant Group | Number of Participants With Postvaccination Tetanus Enzyme Immunoassay (EIA) Antibody Titer ≥0.1 IU/mL | 386 Participants |
| Control Group | Number of Participants With Postvaccination Tetanus Enzyme Immunoassay (EIA) Antibody Titer ≥0.1 IU/mL | 114 Participants |
Primary
Number of Participants With Postvaccination Varicella-Zoster Virus (VZV) Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Antibody Titer ≥5 gpELISA Units/mL
Antibody Response to Varicella-Zoster Virus (VZV) at 6 Weeks Postvaccination for Participants Initially Seronegative (a titer \<0.6 gpELISA units/mL) to VZV at Baseline
Time frame: 6 weeks Postvaccination
Population: The per-protocol analysis set included participants~who had pre- and post-randomization blood samples within predefined day ranges, were seronegative to~varicella at baseline, and followed protocol procedures.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Concomitant Group | Number of Participants With Postvaccination Varicella-Zoster Virus (VZV) Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Antibody Titer ≥5 gpELISA Units/mL | 679 Participants |
| Nonconcomitant Group | Number of Participants With Postvaccination Varicella-Zoster Virus (VZV) Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Antibody Titer ≥5 gpELISA Units/mL | 348 Participants |
| Control Group | Number of Participants With Postvaccination Varicella-Zoster Virus (VZV) Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Antibody Titer ≥5 gpELISA Units/mL | 130 Participants |