Phase 3
N=1,913
Frozen ProQuad Administered Concomitantly Versus Nonconcomitantly With Other Pediatric Vaccines
Measles · Mumps · Rubella · Varicella
Bottom Line
View on ClinicalTrials.gov: NCT00984295 ↗Enrolled (actual)
1,913
Serious AEs
0.8%
Results posted
Feb 2010
Primary outcome: Primary: Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥120 mIU/mL — 741; 383; 124 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (Biological); Comparator: Tripedia (Biological); Comparator: Comvax (Biological); Comparator: Varivax (Biological); Comparator: M-M-R II (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Oct 2001
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥120 mIU/mL |
741; 383; 124 | — |
| PRIMARY Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥10 Ab Units/mL |
774; 395; 143 | — |
| PRIMARY Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥10 IU/mL |
817; 418; 148 | — |
| PRIMARY Number of Participants With Postvaccination Varicella-Zoster Virus (VZV) Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Antibody Titer ≥5 gpELISA Units/mL |
679; 348; 130 | — |
| PRIMARY Number of Participants With Postvaccination Diphtheria Vero Cell Culture Assay Antibody Titer ≥0.1 IU/mL |
667; 333; 94 | — |
| PRIMARY Number of Participants With Postvaccination Tetanus Enzyme Immunoassay (EIA) Antibody Titer ≥0.1 IU/mL |
796; 386; 114 | — |
| PRIMARY Number of Participants With ≥4-fold Rise in Pertussis Toxin (PT) EIA Antibody Titer |
554; 321; 56 | — |
| PRIMARY Number of Participants With ≥4-fold Rise in Pertussis Filamentous Hemagglutinin (FHA) EIA Antibody Titer |
502; 309; 53 | — |
| PRIMARY Number of Participants With Postvaccination Hepatitis B (Quantitative AUSAB™ Radioimmunoassay (RIA)) Antibody Titer ≥10 mIU/mL |
791; 391; 121 | — |
| PRIMARY Number of Participants With Postvaccination Haemophilus Influenzae Type B (Hib) Radioimmunoassay (RIA) Antibody Titer ≥ 1 mcg/mL |
778; 384; 119 | — |
| PRIMARY Antibody Response to Measles at 6 Weeks Postvaccination for Participants Initially Seronegative to Measles at Baseline - Geometric Mean Titer (GMT) |
3504.9; 3506.2; 2562.1 | — |
| PRIMARY Antibody Response to Mumps at 6 Weeks Postvaccination for Participants Initially Seronegative to Mumps at Baseline - GMT |
89.4; 84.1; 98.1 | — |
| PRIMARY Antibody Response to Rubella at 6 Weeks Postvaccination for Participants Initially Seronegative to Rubella at Baseline - GMT |
98.7; 99.9; 126.3 | — |
| PRIMARY Antibody Response to Varicella at 6 Weeks Postvaccination for Participants Initially Seronegative to Varicella at Baseline - GMT |
13.8; 15.4; 15.8 | — |
| PRIMARY Antibody Response to Diphtheria at 6 Weeks Postvaccination - GMT |
1.33; 1.72; 1.59 | — |
| PRIMARY Antibody Response to Pertussis Toxin (PT) at 6 Weeks Postvaccination - GMT |
42.9; 55.7; 46.3 | — |
| PRIMARY Antibody Response to Pertussis Filamentous Hemagglutinin (FHA) at 6 Weeks Postvaccination - GMT |
58.1; 81.2; 65.0 | — |
| PRIMARY Antibody Response to Hepatitis B at 6 Weeks Postvaccination - GMT |
758; 996; 1135 | — |
| PRIMARY Antibody Response to Haemophilus Influenzae Type B (Hib) at 6 Weeks Postvaccination - GMT |
11.2; 12.1; 12.9 | — |
| PRIMARY Antibody Response to Tetanus at 6 Weeks Postvaccination - GMT |
3.93; 5.74; 4.36 | — |
Summary
This study will assess the safety and immunogenicity of ProQuad when administered concomitantly and nonconcomitantly with Tripedia and Comvax.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00984295). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.