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: Rotarix

U.S. FDA Resources

Further study details as provided by Program for Appropriate Technology in Health:

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:	June 2013
Estimated Primary Completion Date:	June 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	Recruiting
Dhaka, Bangladesh
Contact: K Zaman, MBBS, PhD 880-1713047100 kzaman@icddrb.org
Principal Investigator: K Zaman, MBBS, PhD

Sponsors and Collaborators

Program for Appropriate Technology in Health

Investigators

Principal Investigator:

K Zaman, MBBS, PhD, MPH

International Centre for Diarrhoeal Disease Research, Bangladesh

More Information

No publications provided

Responsible Party:	Program for Appropriate Technology in Health
ClinicalTrials.gov Identifier:	NCT01700621 History of Changes
Other Study ID Numbers:	HS677
Study First Received:	October 2, 2012
Last Updated:	January 15, 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 Program for Appropriate Technology in Health:

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 May 16, 2013