Ontogeny of Measles Immunity in Infants

NCT00240916 | Completed

• 2 other identifiers: SU-11142008-1344DMID Protocol #05-0039
• Study Type: observational
• Target: 750
• Locations: 1 country
• Sites: 2

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.

Conditions

Measles

Outcome Measures

Primary Outcomes (1)

• Immune response to measles vaccine

  6 months

Secondary Outcomes (1)

• Affect of maternal antibodies on immune response to measles vaccine.

  6 mo

Interventions

Attenuvax (Measles Virus Live Vaccine, 0.5ml subcutaneous) BIOLOGICAL

MMR-II (Measles-Mumps-Rubella Virus Live Vaccine, 0.5ml subcutaneous) BIOLOGICAL

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Healthy infants 6, 9, or 12 months (+ 3 weeks) of age
• Free of obvious health problems as established by medical history and clinical examination before entering into the study
• Parent/legal guardian willing and capable of signing written informed consent
• Parent/legal guardian expected to be available for entire study
• Parent/legal guardian can be reached by telephone

You may not qualify if:

• Former premature infants (\<36 weeks)
• Birth weight \< 2500grams
• Significant underlying chronic illness
• Immunodeficiency disease or immunosuppressive therapy in the participant
• Any other condition which in the clinical judgment of the investigator might interfere with vaccine evaluation
• Allergy to any components of the vaccine, including anaphylaxis or anyphalaxoid reaction to neomycin or eggs
• Administration of an investigational drug
• Blood products within 3 months of initial enrollment
• Current febrile respiratory illness or other active febrile infection
• Family history of congenital/hereditary immunodeficiency, unless immune competence of subject has been determined.
• Blood dyscrasias, leukemia, lymphomas of any type or other malignant neoplasms affecting the bone marrow or lymphatic systems.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (2)

Palo Alto Medical Foundation/Department of Pediatrics

Palo Alto, California, 94301, United States

Location

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

white cells, serum

MeSH Terms

Conditions

Measles

Interventions

Measles Vaccine; Injections, Subcutaneous

Condition Hierarchy (Ancestors)

Morbillivirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures; Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Hayley Altman Gans

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: October 14, 2005
• First Posted: October 18, 2005
• Study Start: July 1, 1993
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2013
• Last Updated: June 9, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Is available

Locations

US (2)