Coadministration of Measles-rubella and Rotavirus Vaccines

NCT ID: NCT01700621

Last Updated: 2019-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 482 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2013-09-30

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.

Conditions

Measles Antibody Seroconversion; Rubella Antibody Seroconversion; Rotavirus Geometric Mean Titer (GMT); Rotavirus Immunoglobulin A (IgA) Seropositivity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Rotarix vaccine

Intervention Type: BIOLOGICAL

one 1.0 ml dose of oral rotavirus vaccine at 9 months of age

measles-rubella vaccine

Intervention Type: BIOLOGICAL

one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine

measles-rubella vaccine

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

Group Type: ACTIVE_COMPARATOR

measles-rubella vaccine

Intervention Type: BIOLOGICAL

one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine

Interventions

Rotarix vaccine

one 1.0 ml dose of oral rotavirus vaccine at 9 months of age

Intervention Type: BIOLOGICAL

measles-rubella vaccine

one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine

Intervention Type: BIOLOGICAL

Other Intervention Names

rotavirus vaccine; Measles-Rubella Virus Vaccine Live US Pharmacopeia (USP)

Eligibility 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 the study area before the completion of the study
• 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.

• Minimum Eligible Age: 9 Months
• Maximum Eligible Age: 11 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

PATH

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

K Zaman, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

International Centre for Diarrhoeal Disease Research, Bangladesh

Locations

ICDDR,B

Dhaka, , Bangladesh

Countries

Bangladesh

References

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.

Reference Type: DERIVED

PMID: 26823338 (View on PubMed)

Other Identifiers

HS677

Identifier Type: -

Identifier Source: org_study_id