Clinical trial NCT01700621: Coadministration of Measles-rubella and Rotavirus Vaccines
Official title: Non-interference and Safety of Concomitant Administration of Measles-rubella and Rotavirus Vaccines at 9 Months of Age in Rural Bangladesh
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Measles Antibody Seroconversion
Rubella Antibody Seroconversion
Rotavirus Geometric Mean Titer (GMT)
Rotavirus Immunoglobulin A (IgA) Seropositivity
Keywords: rotavirus
Lead sponsor: PATH
Sponsor class: OTHER
First posted: 2012-10-04
Enrollment: 482
Sex: ALL
Minimum age (years): 9
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators aim to establish the non-inferiority of concomitant administration of measles-rubella and rotavirus vaccines to measles-rubella vaccine given alone in terms of measles seroconversion rates. The primary study hypothesis is the measles seroconversion rate as defined by the percentage of children seroconverting to measles with a measles serum antibody concentration of \>=1:120 at 8 weeks post vaccination after the concomitant administration of measles-rubella and rotavirus vaccines is non-inferior to that obtained when measles-rubella vaccine is given alone in children 9 months of age who have received a primary rotavirus vaccine series with the first dose between 6 and 10 weeks and the second at least 4 weeks later and are seronegative for measles antibody in the pre-vaccination sample.


Eligibility criteria: Inclusion Criteria:

* Child 9 months of age eligible for measles-rubella vaccination
* documented evidence of a primary rotavirus vaccine series with first dose between 6 and 10 weeks of age and second dose at least 4 weeks after first dose
* healthy infants free of chronic or serious medical condition as determined by history and physical examination at time of study enrollment
* parents/guardians of each participant are able to understand and follow study procedures and agree to participate in study by providing signed informed consent

Exclusion Criteria:

* hypersensitivity to any component of measles-rubella or Rotarix vaccine which would preclude administration of the vaccine
* history of intussusception, intestinal malformations, or abdominal surgery
* known history of measles and/or rubella disease
* history of previous receipt of measles and/or rubella vaccine
* use of any immunosuppressive drugs or immunoglobulin and/or blood products since birth or anticipated during study period
* current enrolment in any other intervention trial or use of any investigational drug or vaccine throughout the study period
* any participant who reports planning to leave the study area before the completion of the study
* acute diarrhea (defined as ≥3 loose stools within a 24-hour period) or vomiting (defined as projectile vomiting or any vomiting at the discretion of the clinician) at the time of enrollment or within the last 24 hours
* acute febrile illness (defined as a temperature of ≥38°C) at the time of enrollment.

Primary outcomes:
measure: Percentage/Number of Subjects With Seroprotection for Measles Virus Serum Neutralization Antibodies
timeFrame: 8 weeks post vaccination
measure: Percentage/Number of Subjects With Seroprotection for Anti-measles Virus Immunoglobulin G (IgG)
timeFrame: 8 weeks post vaccination
Secondary outcomes:
measure: Percentage/Number of Subjects With Seroconversion for Anti-rubella Virus Immunoglobulin G (IgG)
timeFrame: 8 weeks post vaccination
measure: Geometric Mean Concentration (GMC) for Anti-rubella Virus Immunoglobulin G (IgG)
timeFrame: 8 weeks post vaccination
measure: Percentage/Number of Subjects Seropositive for Anti-rotavirus Immunoglobulin A (IgA)
timeFrame: Visit 1 (pre-vaccination) and 8 weeks post vaccination
measure: Geometric Mean Titer (GMT) of Anti-rotavirus Immunoglobulin A (IgA)
timeFrame: Visit 1 (pre-vaccination) and 8 weeks post vaccination
measure: Percentage/Number of Subjects Seropositive for Anti-rotavirus Immunoglobulin G (IgG)
timeFrame: Visit 1 (pre-vaccination) and 8 weeks post vaccination
measure: Geometric Mean Titer (GMT) of Anti-rotavirus Immunoglobulin G (IgG)
timeFrame: Visit 1 (pre-vaccination) and 8 weeks post vaccination
measure: Percentage/Number of Subjects With Seroconversion for Anti-rotavirus Immunoglobulin A (IgA)
timeFrame: 8 weeks post vaccination
measure: Percentage/Number of Subjects With Seroconversion for Anti-rotavirus Immunoglobulin G (IgG)
timeFrame: 8 weeks post vaccination
measure: Number/Percentage of Subjects Experiencing Immediate Post-vaccination Reactions Following Administration of Vaccine
timeFrame: 30 minutes post-vaccination
measure: Number/Percentage of Subjects Experiencing Solicited Adverse Events
timeFrame: 14 days post-vaccination
measure: Number/Percentage of Subjects Experiencing Unsolicited Non-serious Adverse Events
timeFrame: 14 days post-vaccination
measure: Number/Percentage of Subjects Experiencing Serious Adverse Events
timeFrame: 2 months after vaccination
Other outcomes:
measure: Geometric Mean Concentration (GMC) for Measles Virus Serum Neutralization Antibodies
timeFrame: 8 weeks post vaccination
measure: Number of Participants With Rotavirus Vaccine Shedding
timeFrame: Day 0, Day 4 and Day 7
Locations:
city: Dhaka
country: Bangladesh
facility: ICDDR,B
Study officials:
affiliation: International Centre for Diarrhoeal Disease Research, Bangladesh
name: K Zaman, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zaman K, Fleming JA, Victor JC, Yunus M, Bari TI, Azim T, Rahman M, Mowla SM, Bellini WJ, McNeal M, Icenogle JP, Lopman B, Parashar U, Cortese MM, Steele AD, Neuzil KM. Noninterference of Rotavirus Vaccine With Measles-Rubella Vaccine at 9 Months of Age and Improvements in Antirotavirus Immunity: A Randomized Trial. J Infect Dis. 2016 Jun 1;213(11):1686-93. doi: 10.1093/infdis/jiw024. Epub 2016 Jan 27.