Pediatric Trials

Ontogeny of Measles Immunity in Infants

This is an immunogenicity study evaluating the development of the immune response of healthy infants following primary vaccination with Attenuvax at 6 or 9 months of age compared with responses in 12 month-old infants receiving MMR-II. Responses of infants receiving an early two dose measles vaccine regimen with the first dose given at 6 or 9 months followed by a second dose administered at 12 months will also be compared to infants given a single dose at 12 months of age (Table 2). The current approved regimen for measles vaccination is a first vaccination at 12-15 months and a subsequent vaccination at school entry.

A secondary endpoint of this study will be to assess the safety of measles vaccine administered as Attenuvax at 6 or 9 months of age and in an early two dose measles vaccine regimen with Attenuvax administered at 6 or 9 months followed by MMR-II at 12 months of age.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Stanford University

Stanford Investigator(s):

Intervention(s):

  • Biological: Attenuvax (Measles Virus Live Vaccine, 0.5ml subcutaneous)
  • Biological: MMR-II (Measles-Mumps-Rubella Virus Live Vaccine, 0.5ml subcutaneous)

Eligibility


Inclusion Criteria:Subjects must meet all of the following criteria in order to be
enrolled:

   1. Healthy infants 6, 9, or 12 months (+ 3 weeks) of age

   2. Free of obvious health problems as established by medical history and clinical
   examination before entering into the study

   3. Parent/legal guardian willing and capable of signing written informed consent

   4. Parent/legal guardian expected to be available for entire study

   5. Parent/legal guardian can be reached by telephone

Exclusion Criteria:All subjects meeting any of the following exclusion criteria at baseline
will be excluded from study participation:

   1. Former premature infants (<36 weeks)

   2. Birth weight < 2500grams

   3. Significant underlying chronic illness

   4. Immunodeficiency disease or immunosuppressive therapy in the participant

   5. Any other condition which in the clinical judgment of the investigator might interfere
   with vaccine evaluation

   6. Allergy to any components of the vaccine, including anaphylaxis or anyphalaxoid
   reaction to neomycin or eggs

   7. Administration of an investigational drug

   8. Blood products within 3 months of initial enrollment

   9. Current febrile respiratory illness or other active febrile infection

10. Family history of congenital/hereditary immunodeficiency, unless immune competence of
   subject has been determined.

11. Blood dyscrasias, leukemia, lymphomas of any type or other malignant neoplasms
   affecting the bone marrow or lymphatic systems.

Ages Eligible for Study

6 Months - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Hayley Gans, MD
650-723-5682
Recruiting