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Phase III Study of Liquid Formulation of ROTAVIN

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ClinicalTrials.gov Identifier: NCT03703336
Recruitment Status : Not yet recruiting
First Posted : October 11, 2018
Last Update Posted : October 19, 2018
Sponsor:
Collaborators:
PATH
National Institute of Hygiene and Epidemiology, Vietnam
Children's Hospital Medical Center, Cincinnati
Information provided by (Responsible Party):
Center for Research and Production of Vaccines and Biologicals, Vietnam

Brief Summary:

This study is conducted to demonstrate non-inferiority in the immunogenicity of the liquid formulation of ROTAVIN in comparison to currently licensed frozen formulation of the Vaccine (ROTAVIN-M1), 28 days after the second vaccination when administered as two dose series starting at 2-3 months of age.

The study will also assess the reactogenicity of the vaccine 7 days after each vaccination and safety from first vaccination up to 4 weeks after the last vaccination.


Condition or disease Intervention/treatment Phase
Diarrhea Diarrhea Rotavirus Biological: ROTAVIN (liquid formulation) Biological: ROTAVIN-M1 (frozen formulation) Phase 3

Detailed Description:

The study is designed as a phase III, randomized, partially double-blinded, active controlled study with two groups of infants receiving vaccines at the ratio of 2:1 (550 participants receiving the liquid formulation of ROTAVIN and 275 participants receiving the frozen formulation ROTAVIN-M1), to compare their immunogenicity and safety. Two doses of vaccine will be administered 8 weeks apart with the first vaccine administration between 60-91 days of age. All childhood vaccines as per the Expanded Program for Immunization of the Government of Vietnam (including Diphtheria, Tetanus, Pertussis, Haemophilus influenzae type b and Hepatitis B vaccine (DTwPHib-HepB), and OPV at at 2, 3 and 4 months of age) will be allowed as per the immunization schedule.

Active surveillance for vaccine reactogenicity (solicited reactions) over the 7-day period after each vaccination, unsolicited AEs for 4 weeks after each vaccination and SAEs including intussusception over the period between first vaccination and four weeks after the last vaccination will be conducted for all infants.

This trial will generate immunogenicity and safety data which would be submitted to Ministry of Health in Vietnam for license of new formulation of ROTAVIN vaccine.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 825 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Eligible infants will be randomized to receive either ROTAVIN or ROTAVIN-M1 vaccines in the ratio of 2:1. Two doses of vaccine will be administered 8 weeks apart, with the first administration given at 2-3 months (60-91 days) of age. All childhood vaccines as per the Expanded Program for Immunization of the Government of Vietnam will be allowed as per the immunization schedule.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase III, Randomized, Partially Double- Blind, Active Control Study to Compare the Immunogenicity and Safety of a Liquid Formulation of ROTAVIN With the Currently Licensed Frozen Formulation of the Vaccine (ROTAVIN-M1), in Healthy Vietnamese Infants
Estimated Study Start Date : December 2018
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea

Arm Intervention/treatment
Experimental: Study arm
ROTAVIN (liquid formulation) New formulation by POLYVAC. ROTAVIN is live attenuated human rotavirus G1P[8] strain at dose of 2 ml containing ≥ 2x 10^6 plaque focus units (PFU)
Biological: ROTAVIN (liquid formulation)
Two doses of the vaccine will be administered 8 weeks apart, with the first administration given at 2-3 months (60-91 days) of age.

Active Comparator: Control arm
ROTAVIN - M1 (frozen formulation) This vaccine produced by POLYVAC, licensed in 2012 in Vietnam. ROTAVIN-M1 is live attenuated human rotavirus G1P[8] strain at dose of 2 ml containing ≥ 2x 10^6 plaque focus units (PFU)
Biological: ROTAVIN-M1 (frozen formulation)
Two doses of the vaccine will be administered 8 weeks apart, with the first administration given at 2-3 months (60-91 days) of age.




Primary Outcome Measures :
  1. Geometric mean concentration (GMC) of serum anti-rotavirus IgA antibody [ Time Frame: 28 days after the second vaccination ]
    Comparison of GMC of serum anti-rotavirus IgA antibodies as measured by enzyme linked immunosorbent assay (ELISA) in the two study arms

  2. Solicited reactions after each dose of vaccine [ Time Frame: Day 1 to day 7 after each vaccination ]
    Percentage of infants reporting solicited post-vaccination reactogenicity (fever, diarrhea, vomiting, decreased appetite, irritability, decreased activity level)


Secondary Outcome Measures :
  1. Seroconversion [ Time Frame: 28 days after the second vaccination ]
    Percentage of infants with seroconversion. Seroconversion is defined as a post-vaccination serum anti-rotavirus IgA antibody concentration of at least 20 U/mL if a baseline concentration is < 20 U/mL or a post- vaccination serum anti-rotavirus IgA antibody concentration of ≥ 4-fold baseline level if a baseline concentration is ≥ 20 U/mL

  2. Seropositivity [ Time Frame: 28 days after the second vaccination ]
    Percentage of infants with seropositive titers. Seropositivity is defined as serum IgA antibody concentration ≥ 20 IU/ml

  3. Immediate adverse events [ Time Frame: Within 30 minutes after each vaccination. ]
    Percentage of infants reporting immediate adverse events after each vaccination

  4. Unsolicited adverse events [ Time Frame: From vaccination through four weeks after each dose. ]
    Percentage of infants reporting unsolicited AEs.

  5. SAEs including intussusception [ Time Frame: From first vaccination through four weeks after the last vaccination. ]
    Percentage of infants reporting SAEs



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Days to 91 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy infants as established by medical history and clinical examination before entering the study.
  2. Age: 60-91 days (both days inclusive) at the time of enrollment.
  3. Parental/LAR ability and willingness to provide written informed consent.
  4. Parent/LAR who intends to remain in the area with the child during the study period.

Exclusion Criteria:

  1. Presence of diarrhea or vomiting in the previous 72 hours or on the day of enrollment (temporary exclusion).
  2. Presence of fever on the day of enrollment (temporary exclusion).
  3. Acute disease at the time of enrollment (temporary exclusion).
  4. Concurrent participation in another clinical trial at any point throughout the entire timeframe for this study.
  5. Presence of significant malnutrition (weight-for-height z-score < -3SD median)
  6. Presence of any systemic disorder (cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological, endocrine, immunological, dermatological, neurological, cancer, or autoimmune disease) as determined by medical history and / or physical examination which would compromise the participant's health or is likely to result in nonconformance to the protocol.
  7. History of congenital abdominal disorders, intussusception, or abdominal surgery.
  8. Known or suspected impairment of immunological function based on medical history and physical examination.
  9. Household contact with an immunosuppressed individual or pregnant woman.
  10. Prior receipt or intent to receive rotavirus vaccine outside of the study center during study participation.
  11. A known sensitivity or allergy to any components of the study vaccine or EPI vaccine planned to be administered.
  12. History of allergy to antibiotic kanamycin.
  13. Clinically detectable significant congenital or genetic defect.
  14. History of persistent diarrhea (defined as diarrhea that lasts 14 days or longer).
  15. Receipt of immunoglobulin therapy and / or blood products since birth or planned administration during the study period.
  16. History of chronic administration (defined as more than 14 days) of immunosuppressants including corticosteroids. Infants on inhaled or topical steroids may be permitted to participate in the study.
  17. History of any neurologic disorders or seizures.
  18. Any medical condition in the parent/LAR or infant which, in the judgment of the Investigator, would interfere with or serves as a contraindication to protocol adherence.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03703336


Contacts
Contact: Thang C Tran, MD +84 913301883 thangtran@path.org
Contact: Huong T Nguyen, MD +84 912514309 huong72us@yahoo.com

Sponsors and Collaborators
Center for Research and Production of Vaccines and Biologicals, Vietnam
PATH
National Institute of Hygiene and Epidemiology, Vietnam
Children's Hospital Medical Center, Cincinnati
Investigators
Study Director: Niraj Rathi, MD PATH India

Responsible Party: Center for Research and Production of Vaccines and Biologicals, Vietnam
ClinicalTrials.gov Identifier: NCT03703336     History of Changes
Other Study ID Numbers: CVIA 068
First Posted: October 11, 2018    Key Record Dates
Last Update Posted: October 19, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Center for Research and Production of Vaccines and Biologicals, Vietnam:
ROTAVIN
Rotavirus vaccine
Rotavirus
Diarrhea

Additional relevant MeSH terms:
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms
Vaccines
Immunologic Factors
Physiological Effects of Drugs