MeaslesNCT00240916
Ontogeny of Measles Immunity in Infants
An observational study of Measles, run by Stanford University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months and olderHealthy volunteers can take part
- Conditions the study is for
- Measles
- What is being tested?
- Attenuvax (Measles Virus Live Vaccine, 0.5ml subcutaneous) and MMR-II (Measles-Mumps-Rubella Virus Live Vaccine, 0.5ml subcutaneous)
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- 750 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 1993to Jul 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Study populations include infants who are 6, 9, and 12 months of age, and healthy adults older than 18 years.
Inclusion Criteria:Subjects must meet all of the following criteria in order to be enrolled:
- 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
Exclusion Criteria:All subjects meeting any of the following exclusion criteria at baseline will be excluded from study participation:
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Palo Alto Medical Foundation/Department of Pediatrics
Palo Alto, California, 94301
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: Ontogeny of Vaccine-Induced Measles Immunity Child Participant-6 and 9 Months
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.
Read the 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.
- Conditions
- Measles
- Being tested
- Attenuvax (Measles Virus Live Vaccine, 0.5ml subcutaneous), MMR-II (Measles-Mumps-Rubella Virus Live Vaccine, 0.5ml subcutaneous)
- Medical subject headings
- Measles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Attenuvax (Measles Virus Live Vaccine, 0.5ml subcutaneous)Biological
MMR-II (Measles-Mumps-Rubella Virus Live Vaccine, 0.5ml subcutaneous)Biological
What is being measured
The primary outcome is the main question the study is designed to answer.
Immune response to measles vaccine
Measured: 6 months
Secondary outcomes (1)
Affect of maternal antibodies on immune response to measles vaccine.
Measured: 6 mo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2005 (estimated)
- Study startJul 1993
- Primary completionJul 2011
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MeaslesStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 750 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hayley Altman Gans, Stanford University
- Investigators
- Hayley Altman Gans, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00240916
- Sponsor's protocol ID
- SU-11142008-1344
- Other IDs
- DMID Protocol #05-0039
- Status last verified
- Jun 2022
- First submitted
- 14 Oct 2005
- Last updated
- 9 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data is shared as requested by other investigators including raw data and summarized data
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ontogeny of Vaccine-Induced Measles Immunity Child Participant-6 and 9 Months
- ClinicalTrials.gov ID
- NCT00240916
- Acronym / sponsor ID
- SU-11142008-1344
- Conditions
- Measles
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 750 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Jul 1993
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 18 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Study populations include infants who are 6, 9, and 12 months of age, and healthy adults older than 18 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Attenuvax (Measles Virus Live Vaccine, 0.5ml subcutaneous) | Biological | – |
| MMR-II (Measles-Mumps-Rubella Virus Live Vaccine, 0.5ml subcutaneous) | Biological | – |
Primary outcome
Immune response to measles vaccine
Time frame: 6 months
1 secondary outcome
Affect of maternal antibodies on immune response to measles vaccine.
Time frame: 6 mo
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2022.
- Individual participant dataSharing planned: Yes. Data is shared as requested by other investigators including raw data and summarized data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hayley Altman Gans principal investigator
Stanford University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Measles, run by Stanford University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immune response to measles vaccine (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2022.