Coadministration of Measles-rubella and Rotavirus Vaccines

PATH

Status and phase: Completed; Phase 4

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

Treatments: Biological: measles-rubella vaccine; Biological: Rotarix vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT01700621

HS677

Details and patient eligibility

About

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.

Enrollment: 482 patients

Sex: All

Ages: 9 to 11 months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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482 participants in 2 patient groups

measles-rubella and rotavirus vaccines

Experimental group

Description:

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

Treatment:

Biological: Rotarix vaccine

Biological: measles-rubella vaccine

measles-rubella vaccine

Active Comparator group

Description:

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

Treatment:

Biological: measles-rubella vaccine