ChickenpoxNCT00156559
MMR and Varicella Vaccine in Premature Infants
An observational study of Chickenpox and Rubella, run by University of Rochester at 1 site in United States.
Trial summary
This research is designed to address the question, "Does the relative deficit in vaccine immunogenicity in extremely premature infants persist beyond the first 6 months of life?" We propose to measure the immunogenicity of varicella and mumps-measles-rubella vaccines in relatively healthy, 12-to-15 month-old children… Read more about this study
- Who is it for?
- Ages 12 to 16 monthsHealthy volunteers can take part
- Conditions the study is for
- Chickenpox, Rubella, Rubeola
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2004to May 2005
- 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 12 to 16 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Subjects must meet all of the inclusion criteria to participate in this study.
- Premature infant < 29 weeks' gestation at birth or term infant >/= 37 weeks' gestation at birth.
- Postnatal age < 16 months, 0 days.
- Has not yet received MMR or varicella vaccines. (There are no restrictions on the administration of other vaccines at the time of MMR/varicella vaccination.)
- Parental permission.
- Agreement of primary care pediatrician/ health care provider.
- Receives primary pediatric care within an approximate 25-mile radius of the University of Rochester.
- Healthy status at enrollment.
Who cannot join
- Known immunodeficiency.
- Systemic corticosteroid therapy at the time of MMR/varicella vaccination.
- Requiring oxygen therapy.
- Clinically significant findings on review of medical history and physical exam determined by the investigator or sub-investigator to be sufficient for exclusion.
- Any condition determined by the investigator that would interfere with the evaluation of the vaccine or be a potential health risk to the subject.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: MMR and Varicella Vaccine Responses in Extremely Premature Infants
This research is designed to address the question, "Does the relative deficit in vaccine immunogenicity in extremely premature infants persist beyond the first 6 months of life?" We propose to measure the immunogenicity of varicella and mumps-measles-rubella vaccines in relatively healthy, 12-to-15 month-old children born at <29 weeks gestation, when compared to full-term infants, as measured by the relevant viral serologies.
Read the detailed description
Title: MMR and Varicella Vaccine Responses in Extremely Premature Infants
Phase: IV
Population: 16 generally healthy premature infants born at < 29 weeks' gestation, < 16 months old from the Rochester area 16 generally healthy full-term infants born at >/= 37 weeks' gestation, < 16 months old from the Rochester area
Number of Sites: University of Rochester
Study Duration: 1.5 - 8.5 months
Description of Agent or Intervention:
Subjects will make 2 study visits. The first, at 15 months of age, will coincide with a routine well child visit. Subjects will have 2 mL of blood drawn at the time of their routine, 15-month MMR, varicella, and pneumococcal conjugate immunizations. At a second study visit 4-6 weeks later, another 2 mL of blood will be drawn.
Objectives:
Primary: We propose to measure the immunogenicity of routinely administered varicella and mumps-measles-rubella vaccines in relatively healthy, 12-to-15 month-old children born at <29 weeks gestation (premature), when compared to that in full-term infants.
Measles titers will be measured by neutralization assay. Mumps and rubella titers will be measured by enzyme-linked florescent immunoassay. Varicella titers will be measured by enzyme linked immunosorbent assay.
Safety will be assessed by parental recall of vaccine-related adverse events and by active, prospective collection of blood-draw-associated adverse events.
Schematic of Study Design:
Subjects will be approached at 9-12 months of age for inclusion, and will consent at this time or at Visit 1
Visit 1 (15 mos):
Preterm N = 16, Full term N = 16, 2 ml blood draw
Routine MMR, varicella vaccines administered by primary pediatrician per standard of care (at Visit 1)
Visit 2 (16 mos):
Preterm N = 16, Full term N = 16, 2 ml blood draw
Varicella, mumps, measles and rubella vaccine titers measured by ELISA
- Conditions
- Chickenpox, Rubella, Rubeola, Mumps
- Keywords
- immunization, vaccine, low birth weight infant, premature infant
- Medical subject headings
- Chickenpox, Rubella, Measles, Mumps, Premature Birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startJan 2004
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ChickenpoxStudies of the same condition, open and under way.
- More trials run by University of RochesterThe 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
- Time perspective
- Prospective
- Enrolment
- 32 participants
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carl D'Angio, University of Rochester
- Investigators
- Carl T. D'Angio, MD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00156559
- Sponsor's protocol ID
- DMID 03-140
- Other IDs
- N01-AI-25460
- Status last verified
- Sep 2015
- First submitted
- 8 Sep 2005
- Last updated
- 17 Sep 2015
- Results posted
- No
Publications
D'Angio CT, Boohene PA, Mowrer A, Audet S, Menegus MA, Schmid DS, Beeler JA. Measles-mumps-rubella and varicella vaccine responses in extremely preterm infants. Pediatrics. 2007 Mar;119(3):e574-9. doi: 10.1542/peds.2006-2241.
PubMed 17332177
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MMR and Varicella Vaccine Responses in Extremely Premature Infants
- ClinicalTrials.gov ID
- NCT00156559
- Acronym / sponsor ID
- DMID 03-140
- Conditions
- Chickenpox, Rubella, Rubeola, Mumps
- Keywords
- immunization, vaccine, low birth weight infant, premature infant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- Jan 2004
- Study completion
- May 2005 (actual)
- First posted
- 12 Sep 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 research is designed to address the question, "Does the relative deficit in vaccine immunogenicity in extremely premature infants persist beyond the first 6 months of life?" We propose to measure the immunogenicity of varicella and mumps-measles-rubella vaccines in relatively healthy, 12-to-15 month-old children born at <29 weeks gestation, when compared to full-term infants, as measured by the relevant viral serologies.
Detailed description
Title: MMR and Varicella Vaccine Responses in Extremely Premature Infants
Phase: IV
Population: 16 generally healthy premature infants born at < 29 weeks' gestation, < 16 months old from the Rochester area 16 generally healthy full-term infants born at >/= 37 weeks' gestation, < 16 months old from the Rochester area
Number of Sites: University of Rochester
Study Duration: 1.5 - 8.5 months
Description of Agent or Intervention:
Subjects will make 2 study visits. The first, at 15 months of age, will coincide with a routine well child visit. Subjects will have 2 mL of blood drawn at the time of their routine, 15-month MMR, varicella, and pneumococcal conjugate immunizations. At a second study visit 4-6 weeks later, another 2 mL of blood will be drawn.
Objectives:
Primary: We propose to measure the immunogenicity of routinely administered varicella and mumps-measles-rubella vaccines in relatively healthy, 12-to-15 month-old children born at <29 weeks gestation (premature), when compared to that in full-term infants.
Measles titers will be measured by neutralization assay. Mumps and rubella titers will be measured by enzyme-linked florescent immunoassay. Varicella titers will be measured by enzyme linked immunosorbent assay.
Safety will be assessed by parental recall of vaccine-related adverse events and by active, prospective collection of blood-draw-associated adverse events.
Schematic of Study Design:
Subjects will be approached at 9-12 months of age for inclusion, and will consent at this time or at Visit 1
Visit 1 (15 mos):
Preterm N = 16, Full term N = 16, 2 ml blood draw
Routine MMR, varicella vaccines administered by primary pediatrician per standard of care (at Visit 1)
Visit 2 (16 mos):
Preterm N = 16, Full term N = 16, 2 ml blood draw
Varicella, mumps, measles and rubella vaccine titers measured by ELISA
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 to 16 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Subjects must meet all of the inclusion criteria to participate in this study.
- Premature infant < 29 weeks' gestation at birth or term infant >/= 37 weeks' gestation at birth.
- Postnatal age < 16 months, 0 days.
- Has not yet received MMR or varicella vaccines. (There are no restrictions on the administration of other vaccines at the time of MMR/varicella vaccination.)
- Parental permission.
Key exclusion criteria (5 listed)
- Known immunodeficiency.
- Systemic corticosteroid therapy at the time of MMR/varicella vaccination.
- Requiring oxygen therapy.
- Clinically significant findings on review of medical history and physical exam determined by the investigator or sub-investigator to be sufficient for exclusion.
- Any condition determined by the investigator that would interfere with the evaluation of the vaccine or be a potential health risk to the subject.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 17 Sep 2015.
- Results publication: PubMed 17332177D'Angio CT, Boohene PA, Mowrer A, Audet S, Menegus MA, Schmid DS, Beeler JA. Measles-mumps-rubella and varicella vaccine responses in extremely preterm infants. Pediatrics. 2007 Mar;119(3):e574-9. doi: 10.1542/peds.2006-2241.
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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.
Carl T. D'Angio, MD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chickenpox and Rubella, run by University of Rochester at 1 site 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?
The sponsor lists 8 inclusion and 5 exclusion criteria. 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 17 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00156559, which also lists 1 linked publication.
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 17 Sep 2015.