Ontogeny of Measles Immunity in Infants
Trial ID or NCT#
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.
Ontogeny of Vaccine-Induced Measles Immunity Child Participant-6 and 9 Months
- 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
- 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.
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Hayley Gans, MD