Guest guest Posted May 14, 2004 Report Share Posted May 14, 2004 Who's letting their child go first as the guinea pig?! I would hate to have my child be the first to get a new vaccine! > roQuad®, Merck's Investigational Combination Vaccine, Resulted in > Antibody Responses Similar to Those with M-M-R II® and Varivax® in > New Study > > > > > Also in the Study, ProQuad was Generally Well Tolerated as a Second > Dose in Children Four to Six Years Old Previously Vaccinated against > Measles, Mumps, Rubella and Chickenpox > > > WHITEHOUSE STATION, N.J., May 13, 2004 - In a new study, a single > shot of Merck's investigational combination vaccine ProQuad® > (Measles, Mumps, Rubella and Varicella [Oka/Merck] Virus Vaccine > Live) as a second dose in young children previously vaccinated > against measles, mumps, rubella and varicella (chickenpox) resulted > in antibody responses similar (non inferior) to those seen in > children given a second dose of M-M-R II® (Measles, Mumps, and > Rubella Virus Vaccine Live) and in children given concomitant second > doses of M-M-R II and Varivax® (Varicella Virus Vaccine Live > [Oka/Merck]). > > > > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted May 14, 2004 Report Share Posted May 14, 2004 I'll hazard a guess: all the experimental-herd kids were healthy when injected, thereby sparing vaccine-zealots from having to contemplate subgrous with increased susceptibility (which in a specific child can be acquired and/or genetic). Donna wrote: >roQuad®, Merck's Investigational Combination Vaccine, Resulted in >Antibody Responses Similar to Those with M-M-R II® and Varivax® in >New Study > > > > >Also in the Study, ProQuad was Generally Well Tolerated as a Second >Dose in Children Four to Six Years Old Previously Vaccinated against >Measles, Mumps, Rubella and Chickenpox > > >WHITEHOUSE STATION, N.J., May 13, 2004 - In a new study, a single >shot of Merck's investigational combination vaccine ProQuad® >(Measles, Mumps, Rubella and Varicella [Oka/Merck] Virus Vaccine >Live) as a second dose in young children previously vaccinated >against measles, mumps, rubella and varicella (chickenpox) resulted >in antibody responses similar (non inferior) to those seen in >children given a second dose of M-M-R II® (Measles, Mumps, and >Rubella Virus Vaccine Live) and in children given concomitant second >doses of M-M-R II and Varivax® (Varicella Virus Vaccine Live >[Oka/Merck]). > > > > > >Antibody responses and tolerability data from this study, the first >to explore whether ProQuad can be administered instead of a second >dose of M-M-R II or a second dose of M-M-R II and Varivax in >children four to six years old, are being presented today at the >National Immunization Conference in Nashville. > > " The study was designed to investigate whether one shot of the >investigational combination vaccine as a second dose could help >children achieve similar antibody responses to these viruses >compared to the responses seen with a second dose of M-M-R II and >seen with concomitant second doses of M-M-R II and Varivax given at >separate vaccination sites, " said Reisinger, M.D., M.P.H., a >pediatrician and medical director of Primary Physicians Research in >Pittsburgh, who presented the data at a poster session. " The >results were very encouraging; the antibody responses with ProQuad >in four to six year olds were similar to the comparator vaccines and >the investigational vaccine was generally well tolerated. " > >The current U.S. vaccination recommendation is for M-M-R II to be >administered at 12 to 15 months of age and at four to six years of >age and for Varivax to be administered at 12 to 18 months of age. > >Study methods >In the double-blind, multicenter study, 799 healthy children four to >six years of age who previously received M-M-R II and Varivax at 12 >months of age or older were randomized to one of three vaccination >groups: ProQuad and placebo (n=399); M-M-R II and placebo (n=205); >and M-M-R II and Varivax concomitantly (n=195) at separate injection >sites. Antibody responses (immunogenicity) were assessed by >measurement of geometric mean titers (GMTs) prior to vaccination and >at six weeks following vaccination. > >Blood samples were collected from the participants prior to >vaccination and approximately six weeks following vaccination. >Serology testing was performed to measure levels of anti-measles, >mumps, rubella and varicella antibodies (GMTs). Investigators >compared levels of antibodies from the three study groups to >determine similarity (non inferiority). Titers for participants >receiving ProQuad and placebo were compared to titers for those >receiving M-M-R II and placebo and receiving M-M-R II and Varivax, >respectively. Antibody titers pre- and post-vaccination were >measured by ELISA. Non inferiority hypothesis testing of GMTs (less >than two-fold difference) between groups was performed at the one- >sided 0.05 level (ANOVA). > >Increases in antibody responses with ProQuad similar (non inferior) >to comparators >In the study, participants who received ProQuad with placebo as a >second dose achieved antibody levels to measles, mumps and rubella >that were similar (non inferior) to levels seen in the groups >receiving M-M-R II and placebo and M-M-R II and Varivax >concomitantly when measured at six weeks after vaccination. >Antibody levels to those three viruses were also similar between the >group given M-M-R II and placebo and the group given M-M-R II and >Varivax. Those who received ProQuad with placebo also achieved >antibody levels to varicella that were similar (non inferior) to >levels achieved in the group receiving M-M-R II and Varivax at six >weeks after vaccination. Specific results are in Table 1 (PDF), >attached. > >ProQuad was well tolerated in study >Adverse events were monitored using Pediatric Vaccination Report >Cards for a 42-day period following vaccination. Parents or >caregivers filled out the report cards, which evaluated daily >temperatures, Systemic Adverse Experiences (e.g.: measles-like, >rubella-like, and varicella-like rashes, mumps-like symptoms, >measles, mumps, rubella, varicella and/or zoster) and local >vaccination site reactions (pain, swelling, redness and/or rash). > >In the study, ProQuad was generally well tolerated; the safety >profile of ProQuad with placebo was generally comparable to the >safety profiles observed in the comparator groups. Specific results >are in Table 2 (PDF), attached. > >No serious vaccine-related adverse experiences occurred in any of >the three treatment groups. >The percent of subjects with one or more overall, systemic and >injection-site adverse experiences as well as the number of subjects >with one or more instances of elevated temperature (temperatures > >102° F oral) was generally comparable between the group given >ProQuad and placebo and the M-M-R II and placebo group, and between >the group given ProQuad and placebo and the group given M-M-R II and >Varivax. >Although prompted for on the Vaccination Report Card, no rubella- >like rashes or mumps-like symptoms were reported in any treatment >group. The incidence rates of measles-like and varicella-like >rashes were very low (<1 percent of subjects) across all three >treatment groups. No differences in these adverse experiences were >noted. >Important information about M-M-R II and Varivax >M-M-R II is indicated for simultaneous vaccination against measles, >mumps and rubella in individuals 12 months of age or older. The >Advisory Committee on Immunization Practices (ACIP) recommends >administration of the first dose of M-M-R II at 12 to 15 months of >age and administration of the second dose of M-M-R II at four to six >years of age. M-M-R II is contraindicated in individuals with a >history of hypersensitivity to any component of the vaccine, >including gelatin. M-M-R II is contraindicated in individuals with >blood dyscrasias, leukemia, lymphomas of any type or other malignant >neoplasms affecting the bone marrow or lymphatic systems. Due >caution should be employed in administration of M-M-R II to persons >with a history of cerebral injury, individual or family histories of >convulsions, or any other condition in which stress due to fever >should be avoided. For a list of adverse reactions, please read the >attached prescribing information. As for any vaccine, vaccination >with M-M-R II may not result in protection in 100 percent of >vaccinees. > >Varivax is indicated for vaccination against varicella in >individuals 12 months of age and older. Varivax is contraindicated >in individuals with a history of hypersensitivity or an >anaphylactoid reaction to any component of the vaccine, including >gelatin or neomycin, or with any immunodeficient condition or >receiving immunosuppressive therapy. The duration of protection >from varicella infection after vaccination with Varivax is unknown. >There are insufficient data to assess the rate of protection against >the complications of varicella (e.g., encephalitis, hepatitis, >pneumonia) in children. In children, adolescents and adults >monitored for up to 42 days post vaccination, the adverse effects >most frequently reported were as follows: fever, injection-site >complaints; varicella-like rash (injection site) and varicella-like >rash (generalized). For a list of adverse reactions, please read >the attached prescribing information. Vaccination with Varivax may >not result in protection of all healthy susceptible children, >adolescents and adults. > >About the National Immunization Conference >The National Immunization Conference is an annual conference >sponsored by the U.S. Centers for Disease Control and Prevention and >examines topics pertaining to immunization coverage for all age >groups. > >About Merck >Merck & Co., Inc. is a global research-driven pharmaceutical >products company. Merck discovers, develops, manufactures and >markets a broad range of innovative products to improve human and >animal health, directly and through its joint ventures. > >Forward-Looking Statement >This press release contains " forward-looking statements " as that >term is defined in the Private Securities Litigation Reform Act of >1995. These statements involve risks and uncertainties, which may >cause results to differ materially from those set forth in the >statements. The forward-looking statements include statements >regarding product development. No forward-looking statement can be >guaranteed, and actual results may differ materially from those >projected. Merck undertakes no obligation to publicly update any >forward-looking statement, whether as a result of new information, >future events, or otherwise. Forward-looking statements in this >press release should be evaluated together with the many >uncertainties that affect Merck's business, particularly those >mentioned in the cautionary statements in Item 1 of Merck's Form 10- >K for the year ended Dec. 31, 2003, and in its periodic reports on >Form 10-Q and Form 8-K (if any) which Merck incorporates by >reference. > > >ProQuad® is the Merck registered trademark for Measles, Mumps, >Rubella and Varicella [Oka/Merck] Virus Vaccine Live. >M-M-R II® is the Merck registered trademark for Measles, Mumps, and >Rubella Virus Vaccine Live. >Varivax® is the Merck registered trademark for Varicella Virus >Vaccine Live [Oka/Merck]. > > > > Quote Link to comment Share on other sites More sharing options...
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