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Ontogeny of Measles Immunity in Infants

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ClinicalTrials.gov Identifier: NCT00240916
Recruitment Status : Unknown
Verified November 2009 by Stanford University.
Recruitment status was:  Recruiting
First Posted : October 18, 2005
Last Update Posted : November 9, 2009
Sponsor:
Information provided by:
Stanford University

Tracking Information
First Submitted Date October 14, 2005
First Posted Date October 18, 2005
Last Update Posted Date November 9, 2009
Study Start Date July 1993
Estimated Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 5, 2009)
Immune response to measles vaccine [ Time Frame: 6 months ]
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00240916 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: November 5, 2009)
Affect of maternal antibodies on immune response to measles vaccine. [ Time Frame: 6 mo ]
Original Secondary Outcome Measures Not Provided
Current Other Outcome Measures Not Provided
Original Other Outcome Measures Not Provided
 
Descriptive Information
Brief Title Ontogeny of Measles Immunity in Infants
Official Title Ontogeny of Vaccine-Induced Measles Immunity Child Participant-6 and 9 Months
Brief Summary

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.

Detailed Description

This is an open-label immunogenicity and safety study of live attenuated Measles Vaccine (Attenuvax) and Measles-Mumps-Rubella (MMR-II) vaccine administered to healthy children at 6 (n=70), 9 (n=70), or 12 (n=70) months of age. Attenuvax (Measles Virus Vaccine Live, Merck & Co., Inc) and MMR-II (Measles-Mumps-Rubella Virus Vaccine Live, Merck & Co., Inc) will be delivered as 0.5 mL per dose, administered subcutaneously. Both vaccines are licensed for use in infants in the United States. MMR-II is recommended as part of the childhood immunization schedule by the AAP and ACIP, and Attenuvax is recommended for use as a single component vaccine in infants 6-11 months particularly for foreign travel and in measles outbreaks79. Infants vaccinated with Attenuvax at 6 or 9 months receive MMR-II at 12 months of age as recommended for follow-up vaccination. Immunization against measles is given as a trivalent formulation with mumps and rubella and is indicated as a primary dose at 12-15 months of age with a second dose recommended routinely at time of school entry, 4-6 years of age, but can be given at any earlier age provided that the interval between the first and second doses is at least 4 weeks .

Two hundred and ten healthy children attending the Palo Alto Medical Clinic will be recruited into one of three cohorts over a five year period. (Table 1). All children in cohort 1 and 2 (6 and 9 month old infants) will receive Attenuvax as part of their participation in this study followed by MMR-II at 12 months of age as part of their routine WCC and not as a study vaccine. Infants recruited into cohort 3, (twelve month old infants) will receive one dose of MMR-II at 12 months. All infants in the study (cohort 1, 2 or 3) are receiving MMR-II at 12 months as part of their routine childhood vaccines. The vaccination schedules is summarized in Table 1. Other immunizations as required for routine WCC will be administered simultaneously. Participation will entail 2-4 visits, 2-3 blood samples, and 1-2 immunizations and will end after the 9-18 month visit, totaling 3 to 12 months time of participation for a subject depending on cohort and if participants opt for a second follow-up blood sample.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
white cells, serum
Sampling Method Probability Sample
Study Population Study populations include infants who are 6, 9, and 12 months of age, and healthy adults older than 18 years.
Condition Measles
Intervention
  • Biological: Attenuvax (Measles Virus Live Vaccine, 0.5ml subcutaneous)
  • Biological: MMR-II (Measles-Mumps-Rubella Virus Live Vaccine, 0.5ml subcutaneous)
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: November 5, 2009)
555
Original Enrollment
 (submitted: October 14, 2005)
210
Estimated Study Completion Date July 2010
Estimated Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 6 Months and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00240916
Other Study ID Numbers SU-11142008-1344
DMID Protocol #05-0039
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Hayley Altman Gans, Stanford University School of Medicine
Study Sponsor Stanford University
Collaborators Not Provided
Investigators
Principal Investigator: Hayley Altman Gans Stanford University
PRS Account Stanford University
Verification Date November 2009