Phase 4
N=480
Coadministration of Measles-rubella and Rotavirus Vaccines
Measles Antibody Seroconversion · Rubella Antibody Seroconversion · Rotavirus Geometric Mean Titer (GMT) · Rotavirus Immunoglobulin A (IgA) Seropositivity
Bottom Line
View on ClinicalTrials.gov: NCT01700621 ↗Enrolled (actual)
480
Serious AEs
3.3%
Results posted
Feb 2019
Primary outcome: Primary: Percentage/Number of Subjects With Seroprotection for Measles Virus Serum Neutralization Antibodies — 171; 173; 56; 60 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Rotarix vaccine (Biological); measles-rubella vaccine (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- PATH
- Primary completion
- Sep 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage/Number of Subjects With Seroprotection for Measles Virus Serum Neutralization Antibodies |
171; 173; 56; 60 | — |
| PRIMARY Percentage/Number of Subjects With Seroprotection for Anti-measles Virus Immunoglobulin G (IgG) |
219; 227; 8; 5 | — |
| SECONDARY Percentage/Number of Subjects With Seroconversion for Anti-rubella Virus Immunoglobulin G (IgG) |
228; 233; 0; 1 | — |
| SECONDARY Geometric Mean Concentration (GMC) for Anti-rubella Virus Immunoglobulin G (IgG) |
191.9; 177.8 | — |
| SECONDARY Percentage/Number of Subjects Seropositive for Anti-rotavirus Immunoglobulin A (IgA) |
126; 113; 113; 127; 160; 110 | — |
| SECONDARY Geometric Mean Titer (GMT) of Anti-rotavirus Immunoglobulin A (IgA) |
43.6; 39.2; 60.6; 38.1 | — |
| SECONDARY Percentage/Number of Subjects Seropositive for Anti-rotavirus Immunoglobulin G (IgG) |
159; 140; 81; 100; 204; 135 | — |
| SECONDARY Geometric Mean Titer (GMT) of Anti-rotavirus Immunoglobulin G (IgG) |
79.2; 63.2; 168.6; 60.1 | — |
| SECONDARY Percentage/Number of Subjects With Seroconversion for Anti-rotavirus Immunoglobulin A (IgA) |
48; 8; 62; 118 | — |
| SECONDARY Percentage/Number of Subjects With Seroconversion for Anti-rotavirus Immunoglobulin G (IgG) |
55; 7; 25; 92 | — |
| SECONDARY Number/Percentage of Subjects Experiencing Immediate Post-vaccination Reactions Following Administration of Vaccine |
0; 0; 240; 240 | — |
| SECONDARY Number/Percentage of Subjects Experiencing Solicited Adverse Events |
25; 34; 4; 4; 2; 0 | — |
| SECONDARY Number/Percentage of Subjects Experiencing Unsolicited Non-serious Adverse Events |
0; 0; 63; 68; 177; 172 | — |
| SECONDARY Number/Percentage of Subjects Experiencing Serious Adverse Events |
10; 6; 230; 234 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT01700621). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.