Completed

Non-interference and Safety of Concomitant Administration of Measles-rubella and Rotavirus Vaccines at 9 Months of Age in Rural Bangladesh

What is being tested

Rotarix vaccine

+ measles-rubella vaccine

Biological

Who is being recruted

From 9 to 11 Months

+13 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Prevention Study

Phase 4

Interventional

Study Start: January 2013

See protocol details

Summary

Principal SponsorPATH

Last updated: March 13, 2019

Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2013

Actual date on which the first participant was enrolled.

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.

NCT01700621

Principal SponsorPATH

Last updated: March 13, 2019

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

482 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 9 to 11 Months

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

4 inclusion criteria required to participate

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

9 exclusion criteria prevent from participating

acute diarrhea (defined as >= 3 loose stools within a 24-hour period) or vomiting (defined as projectile vomiting or any vomiting at the discretion of the clinician) at the time of enrollment or within the last 24 hours

acute febrile illness (defined as a temperature of >= 38°C) at the time of enrollment

any participant who reports planning to leave the study area before the completion of the study

current enrolment in any other intervention trial or use of any investigational drug or vaccine throughout the study period

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

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

Group II

Active Comparator

receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine at 9 months of age

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

ICDDR,B

Dhaka, BangladeshOpen ICDDR,B in Google Maps

CompletedOne Study Center