Clinical Trials Logo

Clinical Trial Summary

This study will test the safety and how well the body's immune system responds to a live, but weakened varicella (chickenpox) vaccine, known as Varivax, given with and without ProQuad, another measles, mumps, rubella, and varicella virus vaccine (MMR-II). One hundred five healthy children will be enrolled in the study when they are 12 months old. All subjects will be vaccinated at 12 months of age and some subjects will receive a second vaccination at 18 months of age. All subjects will participate for 1 year. This study is a single-site, two-year trial with post-licensure vaccines.


Clinical Trial Description

This clinical trial is a phase I/II exploratory immunogenicity and safety study of live attenuated Varicella (Varivax), Measles-Mumps-Rubella (MMR-II), or combination Varicella/Measles, Mumps/Rubella (Pro-Quad) vaccines administered to healthy children at 12 and 18 months of age. A total of 105 healthy children, 12 months old at the time of study entry, will be recruited from the Palo Alto Medical Foundation clinics in Palo Alto, Fremont and Los Altos, California. The study is designed to focus on time of primary Varivax immunization and immunologic benefits of a two-dose vaccine regimen compared to a single Varivax dose. In addition, the investigators will evaluate the use of Varivax with and without concomitant administration of the MMR-II, further measuring immunologic responses to a two-dose MMR-II regimen. The first study objective is to determine the immunogenicity of one dose of Varivax administered at 12 versus 18 months of age. Participants will receive either MMR vaccine and Varivax, or ProQuad depending on availability of the vaccines. Immunogenicity to be measured as humoral responses utilizing plaque reduction neutralization (PRN) assay for measles and gpELISA for varicella antibodies, and T cell immunity determined by flow cytometric T cell assays. The second study objective is to determine the immunogenicity of administering two doses of Varivax and MMR-II to children at 12 and 18 months of age compared with children receiving one dose of MMR-II at 12 months and one dose of Varivax at 12 or 18 months of age. Participants will receive either MMR vaccine and Varivax, or ProQuad depending on availability of the vaccines. The third study objective is to determine the safety of administering two doses of Varivax and MMR-II to children at 12 and 18 months of age. Participants will receive either MMR vaccine and Varivax, or ProQuad depending on availability of the vaccine. Study personnel with documentation of all adverse events and serious adverse events will monitor safety using parental memory aids and telephone follow-up. The investigators hypothesize that infants receiving Varivax or ProQuad at 12 months of age will have comparable humoral immune responses to infants receiving the vaccine at 18 months of age, but that T cell immunity will be higher in those vaccinated at 18 months of age. In addition, infants receiving 2 doses of Varivax or ProQuad will have higher humoral and cell mediated immune responses compared with children receiving only one dose of Varivax or ProQuad. This hypothesis would explain the post-licensure observations that breakthrough disease is higher in those vaccinated at 12 versus 15 months of age and in children who received one vaccination compared with two. The investigators predict that there will be no differences in the humoral immune responses when measles is given concomitantly with Varivax compared to Varivax alone, but the immunosuppressive effects of the measles virus can influence effects on T cell immunity. It is expected that two doses of Varivax or Proquad will be well tolerated and that there will be fewer systemic adverse reactions after the second dose. The Varivax package insert reports that the incidence of injection site redness and swelling was slightly higher post dose 2, but the incidence of systemic clinical complaints was lower post dose 2. The incidence of adverse experiences both locally and systemically following a second dose of ProQuad was equal to or less than those reactions seen after the first dose. The investigators will evaluate the incidence of injection site reactogenicity to confirm these findings. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


NCT number NCT00258726
Study type Interventional
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact
Status Terminated
Phase Phase 1/Phase 2
Start date October 2005
Completion date July 2007

See also
  Status Clinical Trial Phase
Completed NCT04183114 - Immunogenicity & Safety of Bio Farma's Measles-Rubella (MR) Vaccine in Indonesian Infants (Bridging Study) Phase 2/Phase 3
Completed NCT00092430 - Study to Evaluate Frozen Versus Refrigerated MMRV (Combined Measles, Mumps, Rubella, and Varicella) Investigational Vaccine (V221-016) Phase 3
Completed NCT02196285 - Study to Evaluate Safety and Imunogenicity of Double Viral Vaccine (MR) for Measles and Rubella Phase 1
Completed NCT00384397 - A Study of 2 Doses of Menactra®, a Meningococcal Conjugate Vaccine in Healthy Toddlers Phase 3
Completed NCT00313950 - Immunogenicity and Safety of Hepatitis A Vaccine Given at the Same Time of Measles, Mumps, Rubella Combined Vaccine Phase 4
Completed NCT00402831 - ProQuad® Intramuscular vs Subcutaneous Phase 3
Completed NCT00560755 - Safety Study of ProQuad® rHA in Infants (V221-037) Phase 3
Completed NCT01878435 - Randomized Controlled Trial of the Impact of Mobile Phone Delivered Reminders and Travel Subsidies to Improve Childhood Immunization Coverage Rates and Timeliness in Western Kenya N/A
Completed NCT01777529 - Comparative Study of the Immunogenicity of MMR (Measles, Mumps and Rubella) Single Dose and Multidose Presentations Phase 4
Completed NCT00109278 - A Measles, Mumps, and Rubella Investigational Vaccine Trial (V205C-010)(COMPLETED) Phase 2
Not yet recruiting NCT05771779 - Co-administration Study of OCV, TCV and MR Phase 3
Completed NCT02880865 - Immunogenicity and Safety of Japanese Encephalitis Vaccine When Given With Measles-Mumps-Rubella (MMR) Vaccine Phase 4
Completed NCT01681992 - Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Combined Measles-mumps-rubella (MMR) Vaccine in Children in Their Second Year of Life Phase 3
Completed NCT00751348 - Immunogenicity & Safety Study of GSK Biologicals' Combined Measles-mumps-rubella-varicella Vaccine 208136 Phase 3
Completed NCT01702428 - Consistency Study of GlaxoSmithKline (GSK) Biologicals' MMR Vaccine (209762) (Priorix) Comparing Immunogenicity and Safety to Merck & Co., Inc.'s MMR Vaccine (M-M-R II), in Children 12 to 15 Months of Age Phase 3
Completed NCT00969436 - Comparison of GSK Measles-mumps-rubella-varicella (MMRV) Vaccine Versus PriorixTM Phase 3
Completed NCT00566527 - Comparative Study of Immunogenicity and Safety of a 2-dose Regimen of ProQuad® Manufactured With rHA (V221-038) Phase 3
Completed NCT00127010 - Immunogenicity and Safety of a Combined Vaccine to Prevent Measles, Mumps, Rubella and Chickenpox Diseases Phase 3
Completed NCT00388440 - Assess GSK Biologicals' MMR Vaccine (Priorix) When Given to Healthy Children at the Age of 12 to 18 Months in Singapore. Phase 4
Completed NCT03148990 - Study to Evaluate the Immunogenicity, Reatogenicity and Safety of Double Viral Vaccine (MR) for Measles and Rubella Phase 2/Phase 3