Types of studies we have conducted:

• Vaccines and biologicals
• Asthma
• Otitis Media
• Pharyngitis
• Conjunctivitis
• Allergy
• Formula
• Antibiotics
• Survey Research
• ADHD
• Disease of Premature Infants
• Dental studies

Senders Pediatrics specializes in immunogenicity studies. Other areas of particular interest to us include:

• Conjunctivitis
• Pharyngitis
• Allergic Rhinitis
• Asthma
• Community acquired pneumonia
• ADHD
• Respiratory Syncytial Virus (RSV)
• Atopic Dermatitis
• Influenza
• H1N1
• Meningococcal meningitis
• Strep Throat

Sponsors we have worked with:

Contract Research Organizations CROs we have worked with:

• Covance
• ICON
• Kendle
• Pharmaceutical Product Development (PPD)
• PRA International
• Quintiles
• Pharmaseek
• Parexel
• inc. Research
• PharmaNet
• BRANY
• Chiltern
• i3 Research
• MDS
• RPS

Central IRBs we have worked with:

• Quorum
• Sterling
• Aspire
• Western
• Copernicus
• Chesapeake
• WIRB
• Schulman

Studies Completed:

• A safety and immunogenicity study A safety and immunogenicity study of a meningococcal vaccine in Infants and Toddlers. January 2010-
• A safety and immunogenicity study of a meningococcal vaccine administered concomitantly with routine vaccines infants aged 2 mos. January 2010-April 2010
• A safety and immunogenicity study of an influenza medication with different dosing regimens. November 2009-
• A safety and immunogenicity study of a pneumococcal vaccine compared to Prevnarâ„¢ in adults and toddlers. December 2009-March 2010
• A safety and immunogenicity study of a HPV vaccine given concomitantly with routine vaccines in 11-15 year olds. December 2009-
• An observational study of premature infants with respiratory events. October 2009-February 2010
• An epidemiology strep study of children 3-12 years of age. May 2009- July 2009.
• A safety and efficacy of a topical ophthalmic solution for the treatment of bacterial conjunctivitis in children. March 2009
• The safety and immunogenicity of a varicella vaccine administered concomitantly in healthy children 12-23 months of age. February 2009- November 2009.
• Evaluation of the perisistence of antibody responses among adolescents who previously received a meningococcal vaccine. February 2009-
• An observational study of premature infants with respiratory events. February 2009
• Exploratory evaluation of a two-dose schedule vs a one-dose schedule of a meningococcal vaccine in children in the US. June 2008-July 2008
• Evaluation of the persistence of bactericidal antibodies in adolescents and adults who received a single dose of a meningococcal vaccine 4 to 8 years earlier. December 2008- February 2009.
• A safety study of pediatric vaccines administered concomitantly with a meningococcal vaccine to toddlers. December 2008- October 2009
• The safety, tolerability and immunogenicity of a Pneumococcal vaccine in healthy children aged 15 months to 17 years in the United States. November 2008- December 2009
• The safety and immunogenicity of 2 flu vaccines administered intramuscularly in children 6 to 35 months of age. October 2008
• The safety and immunogenicity of one dose of an investigational meningococcal vaccine compared with one dose of licensed meningococcal vaccine administered to healthy children 2-10 years of age. July 2008- March 2009
• The safety and immunogenicity of one dose of investigational meningococcal vaccine compared with one dose of licensed meningococcal vaccine administered to healthy toddlers. June 2008-October 2008
• A safety and immunogenicity study of a meningococcal vaccine co-administered with a common pediatric vaccine as compared to another common pediatric vaccine given at 2, 4, and 6 months of age and alternatively at 15-18 months. March 2008-August 2008
• An asthma questionnaire study. Jan 2009-Apr 2009
• Exploratory evaluation of a two-dose schedule versus a one-dose schedule of a meningococcal vaccine in children in the US. Jun 2008-Jul 2008
• Evaluation of the persistence of bactericidal antibodies in adolescents and adults who received a single dose of a meningococcal vaccine 4 to 8 years earlier. Dec 2008-Feb 2009
• A safety study of pediatric vaccines administered concomitantly with a meningococcal vaccine to toddlers. Dec 2008
• The safety, tolerability and immunogenicity of a pneumococcal vaccine in healthy children aged 15 months to 17 years in the United States. Nov 2008
• Dec 2008
• The safety and immunogenicity of 2 flu vaccines administered intramuscularly in children 6 to 35 months of age. Oct 2008-Oct 2008
• The safety and immunogenicity of 2 different meningococcal vaccines administered to healthy children 2-10 years of age. Jul 2008-Mar 2009
• The safety and immunogenicity of one dose of investigational meningococcal vaccine compared with one dose of licensed meningococcal vaccine administered to healthy toddlers. Jun 2008-Oct 2008
• A safety and immunogenicity study of a meningococcal vaccine co-administered with a common pediatric vaccine as compared to another common pediatric vaccine given at 2, 4 and 6 months of age and alternatively at 15-18 months. Mar 2008-Aug 2008
• An Asthma questionnaire study. Jan 2008-Mar 2008
• A safety and immunogenicity study of two approved diphtheria-tetanus vaccines given as booster doses in children. Jan 2008
• A safety and efficacy study of a topical ophthalmic solution compared with another topical ophthalmic solution for the treatment of presumed bacterial conjunctivitis in newborns. Sep 2007
• A safety and immunogenicity study of 3 lots of an investigational pneumococcal vaccine given with routine pediatric vaccinations in infants. Sep 2007-Dec 2007
• A safety and immunogenicity study of pediatric vaccines administered concomitantly with a meningococcal vaccine to toddlers. Jun 2007-Mar 2008
• A safety and immunogenicity study of a meningicoccal vaccine when administered with pediatric vaccinations to infants. May 2007-Mar 2008
• A study to evaluate the lot to lot consistency and the safety and immunogenicity of two types of meningococcal vaccines when administered to adolescents. May 2007-Jun 2007
• A study to evaluate the immunogenicity, safety and non-interference of two common pediatric vaccines to toddlers. Dec 2006-Feb 2007
• A study to evaluate the safety and immunogenicity of two approved vaccines in adolescents. 2007-
• An immunogenicity and safety study of two doses of a meningococcal vaccine given to infants. Oct 2006-Nov 2006
• A safety and immunogenicity study of an HPV vaccine co-administered with two different meningococcal vaccines, according to different dose schedule combinations, as compared to the administration of HPV vaccine, tetanus or menenigococcal vaccine alone in females 11-18 years. May 2006
• Aug 2006
• A safety and immunogenicity study of a common vaccine in infants. Oct 2005-Dec 2006
• A study to assess the immunogenicity of a different formulation of the drug used to prevent a serious illness in high-risk infants. Oct 2005
• A study to determine the effectiveness and safety of two medications for adolescents diagnosed with a common childhood illness. 2005
• A study to determine the effectiveness and safety of two medications for children 6 months to 13 years old diagnosed with a common childhood illness. 2005
• A study to determine the effectiveness and safety of two medications for children 6 months to 6 years old diagnosed with a common childhood illness. 2005
• A co-administration study of a meningitis vaccine and another vaccine. Nov 2006-Mar 2007
• A study of two types of a medication for the treatment of a common childhood illness. Aug 2005
• A follow-up study for two tetanus vaccines in adolescents. Feb 2005 -Jun 2005
• A study of an ointment vs. an oral medication in children with infected skin conditions. Feb 2005
• A safety, tolerability and immunogenicity study of two types of MMR vaccines in toddlers. Oct 2004 -Apr 2005
• A safety and relative efficacy study of an intranasal flu vaccine versus intramuscular flu vaccine in children. Oct 2004 -Oct 2004
• An extension study of two types of an MMR vaccine in children. Aug 2004 Apr 2005
• A study to evaluate the immunogenicity, reactogenicity and safety of a combined vaccine vs. an approved, recommended vaccine co-administered with other approved, recommended vaccines in health infants and toddlers. Aug 2004' Feb 2005
• A double-blind, randomized, controlled study to evaluate the immunogenicity and safety of herpes simplex candidate vaccine in healthy HSV seronegative and seropositive female subjects aged 10-17 years. Mar 2004 Jun 2005
• A phase IIIb, open, randomized, controlled, multicenter study of the immunogenicity and safety of hepatitis A vaccine administered on a 0, 6 month schedule concomitantly with other recommended vaccine in healthy children 15 months of age. Sep 2003 -May 2004
• A phase III, double-blind, randomized, comparative, multi-center study of the immunogenicity and safety of three doses of hepatitis B vaccine compared to licensed hepatitis B vaccine in the first two weeks of life. May 2003 -Mar 2004
• A randomized, multi-center, placebo and active-controlled, double-blind, therapeutic confirmatory study evaluating the safety and efficacy of inhaled medication to placebo. Apr 2003 -Jul 2003
• A phase III, open-labeled, multi-center, clinical study of the safety of DTPa when administered as a booster dose at 15-18 months following primary immunization in two previous studies. Feb 2003 -Dec 2003
• A phase IIIb, open, multi-center study of the immunogenicity and safety of one dose of inactivated hepatitis A vaccine administered to healthy children who were seropositive for hepatitis prior to a primary vaccination course and to a control group of healthy children who are non-immune for hepatitis A. Dec 2002 -Jul 2003
• A phase III, observer-blinded, randomized, multi-center, clinical study of the safety, immunogenicity and consistency of three manufacturing lots of a dTpa candidate vaccine as compared to a US licensed Td vaccine. Nov 2002 -May 2003
• A comparison of the safety, tolerability, and immunogenicity of a refrigerator-stable measles, mumps, rubella, and varicella combination vaccine (refrigerated) versus (frozen) in healthy children. Oct 2002 Feb 2003
• Combination vaccine. Jul 2002 -Mar 2003
• A phase III, open-labeled, randomized, multi-center, clinical study of the safety and immunogenicity of a primary series of combination candidate vaccine co-administered with other recommended vaccines to healthy infants at 2, 4, And 6 months of age as compared to the separate administration of recommended vaccines and to combination candidate vaccine co-administered with Hib. Apr 2002 -Aug 2002
• Safety and immunogenicity of tetanus and diphtheria toxoids adsorbed combined with component pertussis vaccine compared to tetanus and diphtheria toxoids adsorbed in adolescents and adults 11-64 years of age. Feb 2002' Mar 2002
• A phase III, open-labeled, randomized, multi-center, clinical study of the safety of a primary series of combination candidate vaccine co-administered with Hib and pneumococcal vaccine to healthy infants at 2, 4, and 6 months of age as compared to the separate administration of recommended vaccines. Dec 2001-Apr 2002
• A comparison of the safety, tolerability, and Iimmunogenicity of MMR manufactured with recombinant Human Albumin (rHA) versus MMR manufactured with pooled-donor Human Serum Albumin (HSA) in healthy children 12 to 18 months of age. Dec 2001-Oct 2002
• A randomized, placebo-controlled trial to assess safety, Ttolerability, and immunogenicity of influenza virus vaccine and measles, mumps, rubella, and varicella vaccines administered concurrently to healthy children. Jun 2001-Oct 2001
• A multi-center, randomized, double blind, placebo-controlled, parallel group study of antibiotic syrup in pediatric subjects 6 months to 11 months of age. May 2001 -Jul 2001
• Administration of frozen measles, mumps, rubella, and varicella vaccine to healthy children at 4 to 6 years of age. Apr 2001 -Jan 2002
• Open, randomized, multi-center study of the safety, tolerability, and immunogenicity of frozen MMRV given concomitantly versus not concomitantly with other pediatric vaccines in healthy children 12 to 15 months of age. Jan 2001-Jun 2001
• Safety and immunogenicity of three lots of tetanus and diphtheria toxoids adsorbed combined with five-component pertussis in adolescents 11-17 years of age. Jan 2001-Aug 2001
• The effect on stool characteristics and tolerance in infants fed iron fortified infant formulas. Feb 2001 -Mar 2001
• A phase I double-blind, randomized, placebo-controlled study of two doses of live attenuated human rotavirus vaccine at different virus concentrations in healthy infants (at 2 months of age) following a 0, 2 month schedule and previously uninfected with human rotavirus. Dec 2000 -Sep 2001
• A phase III open, randomized, multi-center study of the safety, tolerability, and immunogenicity of frozen MMRV given concomitantly with other pediatric vaccines in healthy children ages 12-15 months. Sep 2000 -Jan 2001
• A phase II randomized, control study to determine the safety and immunogenicity of two combination vaccines in healthy infants. Jan 2000 -Jun 2001
• Comparative safety and efficacy of antibiotic and antibiotic suspensions in the treatment of children with acute otitis media. Jan 2000 -Apr 2000
• A phase IV, open, comparative, multicenter study of the immunogenicity and safety of hepatitis A vaccine on a 0, 6 month schedule, administered by intramuscular injection, either to children aged (1) 15 to 18 months old or (2) 11 to 13 months old, when compared to 23 to 25 month-old children; and to determine the immune responses following co-administration of routine childhood vaccines, DTPa and Hib in the 15 to 18 month age group. Oct 1999 -Jun 2000
• A phase III open, randomized, multi-center controlled study of the safety and immunogenicity of three doses of combination vaccine administered at 2, 4, and 6 months following a birth dose of HBV compared to three doses of combination vaccine administered at 2, 4, and 6 months without a birth dose of HBV. Mar 1999 -Sep 1999
• A multi-center growth study of a term infant soy-based formula with reduced phytate. Nov 1998 -Sep 1999
• A phase III, blinded, randomized, multi-center study evaluating the clinical consistency of three lots of MMR and comparability to MMR vaccine administered to healthy children 12-18 mos. Sep 1998 -Feb 1999
• Efficacy and safety of higher doses of antibiotic in difficult to treat otitis media. Nov 1997 -May 1998
• A study of the safety and immunogenicity of initiating a primary vaccination series of DTPa administered at 2-4-6 months with combination vaccine and completing the series with combination vaccine and DTPa. Jun 1997 -May 1998
• A single-blind, randomized, multicenter study to assess the safety and efficacy of 5 days of antibiotic every 12 hours compared with antibiotic every 24 hours in the treatment of acute otitis media in infants and children. Mar 1997 -Jun 1997
• A comparison of the safety and efficacy of every 12 hour antibiotic and every 12 hour antibiotic in the treatment of otitis media in children. Dec 1996 -Feb 1997
• Acetaminophen suspension and Ibuprofen suspension in the treatment of febrile children. Nov 1996
• A tolerance to 3 forms of experimental soy formula in healthy, term infants. Mar 1996 -Jan 1997
• A single-blind, immunogenicity and safety study to determine the consistency of consecutively released lots of rotavirus vaccine. Apr 1995 -Dec 1995
• Safety and tolerability of combination vaccine to reconstitute Hib compared to combination vaccine and Hib given concomitantly, but at separate sites. 1995
• Comparison of the efficacy and safety of antibiotic every 12 hours for ten days and antibiotic every 12 hours and antibiotic every 8 hours in the treatment of acute otitis media in children. Nov 1993

• Shelly David Senders, MD
• Elizabeth Bucchieri, MD
• Jill Sangree, MD
• Douglas Fleck, MD
• Andrea Mann, DO
• Ann Witt, MD
• Kristina Banks CPNP
• Julia Cashera CPNP

Carrie E. O'Neill
Executive Director
12 years experience in clinical trials

Alycia Slaton, CCRC
Project Manager
8 years experience in clinical trials

Timothy Roberts, BS
Clinical Research Coordinator
1 year experience in clinical trials

Jason Soltis, BS, CCRC
Clinical Research Coordinator
2 years experience in clinical trials

John Dannug, BS
Program Coordinator
2 years experience in clinical trials

Trevi Harris
Research Assistant
2 years experience in clinical trials

Katie Zinn, BA, MSSA, LSW
Research Assistant
1 year experience in clinical trials

Our patient base of 7800 patients is drawn from a diverse racial, cultural and socioeconomic base. We are located in one of the inner ring suburbs of Cleveland, Ohio, known for its diversity and have patients from over 80 different countries represented in our practice. Demographically, we are:

• 60% Caucasian
• 30% African American
• 10% Asian
• 10-15% of our practice is on Medicaid and we have a wide spread in socioeconomic groups represented.
• 50% of our patient population is drawn from a 3-5 mile radius but the remainder comes from up to 50 miles away.

As you can see, we can provide excellent diversity for any study undertaken.

Pediatrics/Neonatology