Abstract | BACKGROUND: OBJECTIVE: To describe the combined results obtained from the studies conducted during the clinical development program for ProQuad. METHODS: A total of 5833 healthy children, 12-23 months of age, and 399 healthy children, 4-6 years of age, received 1 or 2 doses of ProQuad in five controlled clinical trials. M-M-R II and VARIVAX were used as the control for most studies. Safety was evaluated for six weeks postvaccination and immunogenicity was assessed six weeks after each dose by a sensitive assay (ELISA or gpELISA). RESULTS: A single dose of ProQuad in 12- to 23-month-old children was shown to be as immunogenic as a single dose of M-M-R II and VARIVAX and was generally well tolerated. ProQuad can be used concomitantly with other vaccines (hepatitis B and Hoemophilus influenzoe b). A higher rate of fever was reported after 1 dose of ProQuad compared to M-M-R II and VARIVAX, but fever episodes were transient without long-term sequelae. Both a 2-dose regimen of ProQuad in 12- to 23-month-olds and use of ProQuad in place of M-M-R II at 4-6 years were shown to be immunogenic and well tolerated. The incidence of adverse experiences following a second dose of ProQuad was lower than that following the initial dose. CONCLUSIONS: A single dose of ProQuad is as immunogenic as M-M-R II and VARIVAX and is well tolerated in a 1- or 2-dose schedule. ProQuad should easily fit into the routine immunization schedule.
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Authors | Barbara J Kuter, Michelle L Hoffman Brown, Jonathan Hartzel, Wendy R Williams, A EvesiKaren, Steve Black, Henry Shinefield, Keith S Reisinger, Colin D Marchant, Bradley J Sullivan, Marci Thear, Stephanie Klopfer, Jin Xu, Jacqueline O Gress, Florian Schödel, Study Group for ProQuad |
Journal | Human vaccines
(Hum Vaccin)
2006 Sep-Oct
Vol. 2
Issue 5
Pg. 205-14
ISSN: 1554-8600 [Print] United States |
PMID | 17035730
(Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
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Chemical References |
- Antibodies, Viral
- Chickenpox Vaccine
- Measles Vaccine
- Mumps Vaccine
- Rubella Vaccine
- Vaccines, Combined
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Topics |
- Antibodies, Viral
(blood)
- Chickenpox Vaccine
(adverse effects, immunology)
- Child
- Child, Preschool
- Enzyme-Linked Immunosorbent Assay
- Humans
- Infant
- Logistic Models
- Measles Vaccine
(adverse effects, immunology)
- Mumps Vaccine
(adverse effects, immunology)
- Randomized Controlled Trials as Topic
- Rubella Vaccine
(adverse effects, immunology)
- Vaccines, Combined
(adverse effects, immunology)
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