Measles-Rubella Vaccine Immunogenicity at 6 and 9 Months of Age (NCT03071575) | Clinical Trial Compass
CompletedPhase 4
Measles-Rubella Vaccine Immunogenicity at 6 and 9 Months of Age
Bangladesh637 participantsStarted 2017-03-09
Plain-language summary
This is an open-label, randomized, 2-arm clinical trial in healthy infants in Bangladesh. The primary purpose of the study is to assess the immunogenicity of measles-rubella (MR) vaccine when delivered at 6 months. In addition, the study will establish the equality of MR vaccine seroconversion administered at 9 months following administration of an earlier MR vaccine dose at 6 months of age compared to MR vaccine dose administered at 9 months without previous MR vaccination. This study will also provide additional data on safety and tolerance of MR vaccine given at 6 months, and impact of maternal antibodies on immunogenicity of MR vaccine at 6 months.
* Primary objectives:
1. To assess immunogenicity of MR vaccine at 6 months of age
2. To assess immunogenicity of MR vaccine at 9 months of age among children without prior measles and rubella vaccination, compared with MR vaccine immunogenicity among those who had a prior MR vaccination at 6 months of age
* Secondary objectives
1. To assess the frequency of adverse reactions following administration of MR vaccine at 6 months
2. To compare the immunogenicity of the MR vaccine first dose administered at 6 months vs at 9 months.
3. To assess the proportion of mothers with undetectable, detectable and protective levels of measles and rubella antibodies
4. To determine the extent of variation in measles antibodies in women of child bearing age in a population with a long standing measles vaccination program
5. To determine the extent of variation in rubella antibodies in women of child bearing age in a population where rubella vaccine have been recently introduced
6. To determine if variation in antibody levels in infants at 6 months is predominately explained by variation in starting antibody levels in the mother in this population
7. To estimate the half-life of decay of measles and rubella antibodies in infants
Who can participate
Age range
173 Days – 187 Days
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Age is based on the age of the infant.
Inclusion Criteria: INFANTS:
* Healthy infants at 6 months (180 days, +/- 7 days) of age
* A parent or guardian that consents for participation in the full length of the study
* A parent or guardian that is able to understand and comply with planned study procedures
Inclusion criteria: MOTHERS:
* Mothers of infants that meet inclusion criteria.
* ≥18 years of age
* Mothers who consent to participate in the full length of the study
Exclusion Criteria: INFANTS:
* Family that is unable to participate in the full length of the study
* A diagnosis or suspicion of immunodeficiency disorder either in the infant or mother
* A diagnosis or suspicion of bleeding disorder that would contraindicate parenteral administration of MR vaccine or collection of blood by venipuncture
* Acute infection or illness at the time of enrollment (6 months) that would require infant's admission to a hospital
* Receipt of any measles or rubella containing vaccine prior to enrolment (i.e., before age 6 months) outside of study based upon documentation or parental recall
* Known history of laboratory confirmed measles or rubella infection
* A diagnosis of rubella infection in mother during pregnancy
* A diagnosis of congenital rubella syndrome in infant
* Known allergy/sensitivity or reaction to measles-rubella containing vaccine or contents of measles-rubella containing vaccine
* Persons with a history of an anaphylactic reaction to any components of the vaccine…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percent of Infants Who Were Seropositive After Immunization at 6 Months (Assessed at 9-month Visit)
Timeframe: Infant antibody titer at 9 months.
2
Percent of Infants Who Were Seropositive After Immunization at 9 Months (Assessed at 11-month Visit)