Coadministration of Measles-rubella and Rotavirus Vaccines

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
PATH
ClinicalTrials.gov Identifier:
NCT01700621
First received: October 2, 2012
Last updated: August 28, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Measles Antibody Seroconversion
Rubella Antibody Seroconversion
Rotavirus GMT
Rotavirus IgA Seropositivity
Biological: Rotarix vaccine
Biological: measles-rubella vaccine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Non-interference and Safety of Concomitant Administration of Measles-rubella and Rotavirus Vaccines at 9 Months of Age in Rural Bangladesh

Resource links provided by NLM:


Further study details as provided by PATH:

Primary Outcome Measures:
  • measles serum antibody concentration [ Time Frame: 8 weeks post vaccination ] [ Designated as safety issue: No ]
    seroconversion defined as measles serum antibody concentration >=1:120 8 weeks post vaccination in a child seronegative pre-vaccination


Secondary Outcome Measures:
  • safety [ Time Frame: Day 0 to Day 56 post vaccination ] [ Designated as safety issue: Yes ]
    Immediate reactogenicity, solicited adverse events (diarrhea, fever, vomiting, loss of appetite, irritability, intussusception), and all serious adverse events will be recorded from time of vaccination through Day 56 post vaccination

  • rubella IgG antibody seroconversion [ Time Frame: 8 weeks post vaccination ] [ Designated as safety issue: No ]
    seroconversion defined as rubella serum IgG antibody concentration >=10 IU/mL 8 weeks post vaccination in a child seronegative pre-vaccination

  • rotavirus IgA and IgG seroresponses [ Time Frame: Day 0 and Day 56 ] [ Designated as safety issue: No ]
    rotavirus IgA and IgG geometric mean titers (GMT) measured by ELISA before and after concomitant administration of measles-rubella and rotavirus vaccines

  • rotavirus IgA seropositivity [ Time Frame: Day 0 and Day 56 ] [ Designated as safety issue: No ]
    seroconversion defined as rotavirus serum IgA titer of >=1:20 U/mL measured by ELISA before and after concomitant administration of measles-rubella and rotavirus vaccines


Other Outcome Measures:
  • measles antibody level (GMC) [ Time Frame: 8 weeks post vaccination ] [ Designated as safety issue: No ]
    measles antibody level measured as the geometric mean concentration (GMC) of serum antibody to measles as measured by PRNT

  • rotavirus vaccine shedding [ Time Frame: 4 and/or 7 days post vaccination ] [ Designated as safety issue: No ]
    vaccine shedding defined as presence of vaccine-type rotavirus in stool at 4 (+/-1) and/or 7 (+/-1) days post rotavirus vaccination detected by ELISA and typed by RT-PCR


Estimated Enrollment: 480
Study Start Date: December 2012
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: measles-rubella and rotavirus vaccines
receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine and one 1.0 ml dose of oral Rotarix vaccine at 9 months of age
Biological: Rotarix vaccine
one 1.0 ml dose of oral rotavirus vaccine at 9 months of age
Other Name: rotavirus vaccine
Biological: measles-rubella vaccine
one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine
Other Name: Measels and Rubella Virus Vaccine Live USP
Active Comparator: measles-rubella vaccine
receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine at 9 months of age
Biological: measles-rubella vaccine
one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine
Other Name: Measels and Rubella Virus Vaccine Live USP

  Eligibility

Ages Eligible for Study:   9 Months to 11 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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 teh study area before the completion of the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01700621

Locations
Bangladesh
ICDDR,B
Dhaka, Bangladesh
Sponsors and Collaborators
PATH
Investigators
Principal Investigator: K Zaman, MBBS, PhD, MPH International Centre for Diarrhoeal Disease Research, Bangladesh
  More Information

No publications provided

Responsible Party: PATH
ClinicalTrials.gov Identifier: NCT01700621     History of Changes
Other Study ID Numbers: HS677
Study First Received: October 2, 2012
Last Updated: August 28, 2013
Health Authority: ICDDR,B Data Safety Monitoring Board, Bangladesh:
ICDDR,B Research Review Committee, Bangladesh:
Center for Disease Control and Prevention, United States:

Keywords provided by PATH:
rotavirus

Additional relevant MeSH terms:
Measles
Rubella
Morbillivirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases
Rubivirus Infections
Togaviridae Infections

ClinicalTrials.gov processed this record on April 15, 2014