Coadministration of Measles-rubella and Rotavirus Vaccines

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
PATH
ClinicalTrials.gov Identifier:
NCT01700621
First received: October 2, 2012
Last updated: May 5, 2014
Last verified: May 2014
  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


Enrollment: 480
Study Start Date: January 2013
Study Completion Date: September 2013
Primary Completion Date: September 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: May 5, 2014
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 October 19, 2014