Ontogeny of Measles Immunity in Infants

Trial ID or NCT#

NCT00240916

Status

not recruiting iconNOT RECRUITING

Purpose

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.

Official Title

Ontogeny of Vaccine-Induced Measles Immunity Child Participant-6 and 9 Months

Eligibility Criteria

Ages Eligible for Study: Older than 6 Months
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes
Inclusion Criteria:
  1. Subjects must meet all of the following criteria in order to be enrolled:
    1. 1. Healthy infants 6, 9, or 12 months (+ 3 weeks) of age2. Free of obvious health problems as established by medical history and clinical examination before entering into the study3. Parent/legal guardian willing and capable of signing written informed consent4. Parent/legal guardian expected to be available for entire study5. Parent/legal guardian can be reached by telephone
Exclusion Criteria:
  1. All subjects meeting any of the following exclusion criteria at baseline will be excluded from study participation:
    1. 1. Former premature infants (\<36 weeks)2. Birth weight \< 2500grams3. Significant underlying chronic illness4. Immunodeficiency disease or immunosuppressive therapy in the participant5. Any other condition which in the clinical judgment of the investigator might interfere with vaccine evaluation6. Allergy to any components of the vaccine, including anaphylaxis or anyphalaxoid reaction to neomycin or eggs7. Administration of an investigational drug8. Blood products within 3 months of initial enrollment9. Current febrile respiratory illness or other active febrile infection10. 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.
View All Criteria
Show Less

Investigator(s)

Hayley Gans

Contact us to find out if this trial is right for you.

Contact

Hayley Gans, MD
650-723-5682

View on ClinicalTrials.gov