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
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.
|Condition or disease||Intervention/treatment|
|Measles||Biological: Attenuvax (Measles Virus Live Vaccine, 0.5ml subcutaneous) Biological: MMR-II (Measles-Mumps-Rubella Virus Live Vaccine, 0.5ml subcutaneous)|
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|
|Estimated Enrollment :||555 participants|
|Official Title:||Ontogeny of Vaccine-Induced Measles Immunity Child Participant-6 and 9 Months|
|Study Start Date :||July 1993|
|Estimated Primary Completion Date :||July 2010|
|Estimated Study Completion Date :||July 2010|
- Immune response to measles vaccine [ Time Frame: 6 months ]
- Affect of maternal antibodies on immune response to measles vaccine. [ Time Frame: 6 mo ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00240916
|Contact: Ross DeHovitz, MD||(650) firstname.lastname@example.org|
|United States, California|
|Palo Alto Medical Foundation/Department of Pediatrics||Recruiting|
|Palo Alto, California, United States, 94301|
|Contact: Ross DeHovitz, MD 650-853-6022 email@example.com|
|Sub-Investigator: Ross DeHovitz|
|Stanford University School of Medicine||Recruiting|
|Stanford, California, United States, 94305|
|Contact: Hayley Gans, MD 650-723-5682 firstname.lastname@example.org|
|Sub-Investigator: Ann Margaret Arvin|
|Principal Investigator: Hayley Altman Gans|
|Principal Investigator:||Hayley Altman Gans||Stanford University|