Community Academic Profiles–

Ann M. Arvin

Back to Profile

Ontogeny of Measles Immunity in Infants

Contact Information

Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305

Primary Contact:

Hayley Gans (650) 723-5682
To view all clinical trials at Stanford, please see the Clinical Trials Directory.

Brief

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.

Recruiting Status:

Recruiting

Stanford Recruiting Status:

Recruiting

Condition(s):

Intervention(s):

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

Phase:

Phase 4

Eligibility

Ages Eligible for Study:

6 months to Any Age

Genders Eligible for Study:

Male and Female

Health of Volunteers:

People with the conditions listed in this trial can not participate as controls.

Key Inclusion Criteria:

Subjects must meet all of the following criteria in order to be enrolled:
a. Healthy infants 6, 9, or 12 months (+ 3 weeks) of age
b. Free of obvious health problems as established by medical history and clinical examination before entering into the study
c. Parent/legal guardian willing and capable of signing written informed consent
d. Parent/legal guardian expected to be available for entire study
e. Parent/legal guardian can be reached by telephone

Key Exclusion Criteria:

All subjects meeting any of the following exclusion criteria at baseline will be excluded from study participation:
a. Former premature infants (<36 weeks)
b. Birth weight < 2500grams
c. Significant underlying chronic illness
d. Immunodeficiency disease or immunosuppressive therapy in the participant
e. Any other condition which in the clinical judgment of the investigator might interfere with vaccine evaluation
f. Allergy to any components of the vaccine, including anaphylaxis or anyphalaxoid reaction to neomycin or eggs
g. Administration of an investigational drug
h. Blood products within 3 months of initial enrollment
i. Current febrile respiratory illness or other active febrile infection
j. Family history of congenital/hereditary immunodeficiency, unless immune competence of subject has been determined.
k. Blood dyscrasias, leukemia, lymphomas of any type or other malignant neoplasms affecting the bone marrow or lymphatic systems.

Additional Study Details

Official Title:

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

Anticipated start date:

7/1/1993

Lead Sponsor:

Stanford University

Investigator(s):

Study Type:

Observational

Purpose:

NOTNEEDED

Duration:

Longitudinal

Selection:

Defined Population

Timing:

Prospective

Total Number to be Enrolled:

555

Total Number to be Enrolled at Stanford:

100

More Information

Trial Unique Id: SU-11142008-1344

Secondary ID(s):

  • DMID Protocol #05-0039

Locations & Contacts

Stanford Locations & Contacts:

Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305

Primary Contact:

Hayley Gans (650) 723-5682

Non-Stanford Locations:

This study is being conducted at multiple locations, including non-Stanford locations.

This listing was last updated:

10/22/2009

PLEASE NOTE:

Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.

Stanford Medicine Resources:

Footer Links: