Coadministration of Measles-rubella and Rotavirus Vaccines

Study Description

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Brief Summary:

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 or disease	Intervention/treatment	Phase
Measles Antibody Seroconversion; Rubella Antibody Seroconversion; Rotavirus GMT; Rotavirus IgA Seropositivity	Biological: Rotarix vaccine; Biological: measles-rubella vaccine	Phase 4

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	480 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (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
Study Start Date :	January 2013
Actual Primary Completion Date :	September 2013
Actual Study Completion Date :	September 2013

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. measles serum antibody concentration [ Time Frame: 8 weeks post vaccination ]
   seroconversion defined as measles serum antibody concentration >=1:120 8 weeks post vaccination in a child seronegative pre-vaccination

Secondary Outcome Measures :

1. safety [ Time Frame: Day 0 to Day 56 post vaccination ]
   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
2. rubella IgG antibody seroconversion [ Time Frame: 8 weeks post vaccination ]
   seroconversion defined as rubella serum IgG antibody concentration >=10 IU/mL 8 weeks post vaccination in a child seronegative pre-vaccination
3. rotavirus IgA and IgG seroresponses [ Time Frame: Day 0 and Day 56 ]
   rotavirus IgA and IgG geometric mean titers (GMT) measured by ELISA before and after concomitant administration of measles-rubella and rotavirus vaccines
4. rotavirus IgA seropositivity [ Time Frame: Day 0 and Day 56 ]
   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:

1. measles antibody level (GMC) [ Time Frame: 8 weeks post vaccination ]
   measles antibody level measured as the geometric mean concentration (GMC) of serum antibody to measles as measured by PRNT
2. rotavirus vaccine shedding [ Time Frame: 4 and/or 7 days post vaccination ]
   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

Eligibility Criteria

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Ages Eligible for Study:	9 Months to 11 Months (Child)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Zaman K, Fleming JA, Victor JC, Yunus M, Bari TI, Azim T, Rahman M, Mowla SM, Bellini WJ, McNeal M, Icenogle JP, Lopman B, Parashar U, Cortese MM, Steele AD, Neuzil KM. Noninterference of Rotavirus Vaccine With Measles-Rubella Vaccine at 9 Months of Age and Improvements in Antirotavirus Immunity: A Randomized Trial. J Infect Dis. 2016 Jun 1;213(11):1686-93. doi: 10.1093/infdis/jiw024. Epub 2016 Jan 27.

Responsible Party:	PATH
ClinicalTrials.gov Identifier:	NCT01700621 History of Changes
Other Study ID Numbers:	HS677
First Posted:	October 4, 2012
Last Update Posted:	May 7, 2014
Last Verified:	May 2014

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