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

October 2, 2012
May 5, 2014
January 2013
September 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01700621 on ClinicalTrials.gov Archive Site
  • 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
Same as current
  • 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
Same as current
 
Coadministration of Measles-rubella and Rotavirus Vaccines
Non-interference and Safety of Concomitant Administration of Measles-rubella and Rotavirus Vaccines at 9 Months of Age in Rural Bangladesh

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Measles Antibody Seroconversion
  • Rubella Antibody Seroconversion
  • Rotavirus GMT
  • Rotavirus IgA Seropositivity
  • 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
  • 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
    Interventions:
    • Biological: Rotarix vaccine
    • Biological: measles-rubella vaccine
  • Active Comparator: measles-rubella vaccine
    receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine at 9 months of age
    Intervention: Biological: measles-rubella vaccine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
480
September 2013
September 2013   (final data collection date for primary outcome measure)

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
Both
9 Months to 11 Months
Yes
Contact information is only displayed when the study is recruiting subjects
Bangladesh
 
NCT01700621
HS677
Yes
PATH
PATH
Not Provided
Principal Investigator: K Zaman, MBBS, PhD, MPH International Centre for Diarrhoeal Disease Research, Bangladesh
PATH
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP