Coadministration of Measles-rubella and Rotavirus Vaccines

NCT01700621 | Completed Phase 4 Results DMC

• 1 other identifier: HS677
• Study Type: interventional
• Target: 482
• Locations: 1 country
• Sites: 1

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

Keywords

rotavirus

Outcome Measures

Primary Outcomes (2)

• Percentage/Number of Subjects With Seroprotection for Measles Virus Serum Neutralization Antibodies

  Detected by plaque reduction neutralization test (PRNT). Seroprotection defined as measles serum antibody concentration \>=1:120 8 weeks post vaccination. Assays were standardized using WHO Second International Standard for measles antibody containing 5000 mIU/ml, which enables the 50% neutralizing antibody end-point dose (titer, ND50) of test samples to be transformed to antibody concentrations in terms of mIU/ml. The analytical cut-off value in this assay was ND50 \< 1/8; this was the lowest dilution at which sera were tested.

  8 weeks post vaccination

• Percentage/Number of Subjects With Seroprotection for Anti-measles Virus Immunoglobulin G (IgG)

  Used commercially available indirect enzyme-linked IgG immunoassays (EIAs; Wampole Laboratories, Princeton, New Jersey). An index standard ratio (ISR) of ≥1.10 on both runs of the respective assay was considered evidence of seropositivity for measles virus. All measles virus and rubella virus assays were performed at the National Measles and Rubella Reference Laboratories, Measles, Mumps, Rubella, and Herpesviruses Branch, Division of Viral Diseases, Centers for Disease Control and Prevention (Atlanta, Georgia).

  8 weeks post vaccination

Secondary Outcomes (12)

• Percentage/Number of Subjects With Seroconversion for Anti-rubella Virus Immunoglobulin G (IgG)

  8 weeks post vaccination

• Geometric Mean Concentration (GMC) for Anti-rubella Virus Immunoglobulin G (IgG)

  8 weeks post vaccination

• Percentage/Number of Subjects Seropositive for Anti-rotavirus Immunoglobulin A (IgA)

  Visit 1 (pre-vaccination) and 8 weeks post vaccination

• Geometric Mean Titer (GMT) of Anti-rotavirus Immunoglobulin A (IgA)

  Visit 1 (pre-vaccination) and 8 weeks post vaccination

• Percentage/Number of Subjects Seropositive for Anti-rotavirus Immunoglobulin G (IgG)

  Visit 1 (pre-vaccination) and 8 weeks post vaccination

Other Outcomes (2)

• Geometric Mean Concentration (GMC) for Measles Virus Serum Neutralization Antibodies

  8 weeks post vaccination

• Number of Participants With Rotavirus Vaccine Shedding

  Day 0, Day 4 and Day 7

Study Arms (2)

measles-rubella and rotavirus vaccines

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

Biological: Rotarix vaccine; Biological: measles-rubella vaccine

measles-rubella vaccine

ACTIVE COMPARATOR

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

Biological: measles-rubella vaccine

Interventions

Rotarix vaccine BIOLOGICAL

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

Also known as: rotavirus vaccine

measles-rubella and rotavirus vaccines

measles-rubella vaccine BIOLOGICAL

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

Also known as: Measles-Rubella Virus Vaccine Live US Pharmacopeia (USP)

measles-rubella and rotavirus vaccines; measles-rubella vaccine

Eligibility Criteria

• Age: 9 Months - 11 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• PATH: lead

Study Sites (1)

ICDDR,B

Dhaka, Bangladesh

Location

Related Publications (1)

• 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.

  PMID: 26823338 DERIVED

MeSH Terms

Interventions

RIX4414 vaccine; Rotavirus Vaccines

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Jorge Flores
• Organization: PATH

jeflores@path.org

(202) 822-0033

Study Officials

• K Zaman, PhD, MPH

  International Centre for Diarrhoeal Disease Research, Bangladesh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2012
• First Posted: October 4, 2012
• Study Start: January 1, 2013
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: March 13, 2019
• Results First Posted: February 18, 2019

Record last verified: 2019-02

Locations

BA (1)