Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00240916
Status:
COMPLETED
Last Update Posted:
2022-06-09
First Post:
2005-10-14
Brief Title:
Ontogeny of Measles Immunity in Infants
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
Ontogeny of Vaccine-Induced Measles Immunity Child Participant-6 and 9 Months
Status:
COMPLETED
Status Verified Date:
2022-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 n70 9 n70 or 12 n70 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 05 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DMID Protocol 05-0039 | None | None | None |