Coadministration of Measles-rubella and Rotavirus Vaccines - Full Text View

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:

MedlinePlus related topics: Measles Rubella

Drug Information available for: RIX4414 vaccine

Genetic and Rare Diseases Information Center resources: Measles Rubella

U.S. FDA Resources

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 (Child)
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


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 Vaccines Immunologic Factors Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 30, 2016