Study of BBIL's ROTAVAC® and ROTAVAC 5CM Vaccines in Zambia

NCT03602053 | Completed Phase 2 Results

• 1 other identifier: CVIA 066
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

Brief Summary

The study is being conducted to evaluate and compare the immunogenicity of ROTAVAC® and ROTAVAC 5D 28 days after the last dose of the vaccine, when administered to infants in a three-dose schedule at 6, 10 and 14 weeks 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 with ROTAVAC® and ROTAVAC 5D, and of Rotarix® when administered to infants in a two-dose schedule at 6 and 10 weeks of age.

Conditions

Diarrhea; Diarrhea Rotavirus

Keywords

diarrhea; Rotavirus; ROTAVAC; Rotavirus vaccine

Outcome Measures

Primary Outcomes (1)

• Geometric Mean Concentration Using WC3 as the Viral Lysate

  GMC of serum anti-rotavirus IgA antibodies as measured by enzyme linked immunosorbent assay (ELISA) using WC3 (heterologous to vaccine strain) as the viral lysate. WC3 strain of rotavirus used in the ELISA assay was heterologous to the 116E strain contained in the vaccines ROTAVAC 5D® and ROTAVAC®.

  28 day after last dose of the study vaccine

Secondary Outcomes (8)

• Immediate Adverse Events

  within 30 minutes' post-vaccination.

• Solicited Adverse Events

  7 day period after each vaccination.

• Unsolicited Adverse Events

  From first vaccination through 4 weeks after the last vaccination.

• Serious Adverse Events

  From first vaccination through 4 weeks after the last vaccination of each study participant. Immunogenicity

• Seroconversion Rate in Each of the Three Arms as Measured by ELISA Using WC3 as the Viral Lysate

  28 days after last dose of study vaccine.

Other Outcomes (4)

• Geometric Mean Concentrations Using Strain 89-12 as the Viral Lysate

  28 days after the last dose of a study vaccine.

• Seroconversion Using Strain 89-12 as the Viral Lysate

  28 days after the last dose of a study vaccine.

• Seropositivity Using Strain 89-12 as the Viral Lysate

  at baseline and 28 days after last dose of study vaccine

Study Arms (3)

ROTAVAC 5D

EXPERIMENTAL

Bharat Biotech International Ltd's new Rotavirus vaccine, ROTAVAC 5D is a live, attenuated G9P\[11\] monovalent vaccine at a dose of 0.5mL containing NLT log 10\^5.0 focus forming units (FFU) per dose. 5D is in liquid form.

Biological: ROTAVAC 5D

ROTAVAC®

EXPERIMENTAL

Bharat Biotech International Ltd's licensed rotavirus vaccine, ROTAVAC® is a live, attenuated G9P\[11\] monovalent vaccine at a dose of 0.5mL containing NLT log 10\^5.0 focus forming units (FFU) per dose. ROTAVAC® is in frozen form and is thawed till fully liquid prior to administration.

Biological: ROTAVAC®

Rotarix®

ACTIVE COMPARATOR

GSK Biologicals' licensed rotavirus vaccine, Rotarix® is a live attenuated RIX4414 strain of human rotavirus of the G1P\[8\] type containing not less than 106.0 CCID50 (cell culture infectious dose 50%) of the RIX 4414 strain of human rotavirus.

Biological: Rotarix®

Interventions

ROTAVAC® BIOLOGICAL

0.5 ml of the vaccine will be administered orally thrice at 6, 10 and 14 weeks of age.

ROTAVAC®

ROTAVAC 5D BIOLOGICAL

0.5 ml of the vaccine will be administered orally thrice at 6, 10 and 14 weeks of age.

ROTAVAC 5D

Rotarix® BIOLOGICAL

1.5 ml of the liquid vaccine will be administered orally twice at 6 and 10 weeks of age.

Rotarix®

Eligibility Criteria

• Age: 6 Weeks - 8 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy infant as established by medical history and clinical examination before entering the study.
• Age: 6-8 weeks (42-56 days, both days inclusive) confirmed by Immunization Record.
• Infants received age-appropriate EPI vaccines till enrolment.
• Ability and willingness to provide informed consent as per local consenting procedures.
• Parent can be contacted on phone and confirms intention to remain in the study area with the participant during the study period.

You may not qualify if:

• Concurrent participation in another clinical trial throughout the entire timeframe of this study.
• Presence of severe malnutrition (weight-for-height z-score \< -3SD median).
• 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 child's health or is likely to result in non-conformance to the protocol.
• History of congenital abdominal disorders, intussusception, abdominal surgery
• Known or suspected impairment of immunological function based on medical history and physical examination.
• Prior receipt or intent to receive rotavirus and other age specified EPI vaccines outside of the study center and during study participation.
• A known sensitivity or allergy to any component of the study vaccine.
• Clinically detectable significant congenital or genetic defect.
• History of persistent diarrhea (defined as diarrhea more than 14 days).
• Participant's parents not able, available or willing to accept active follow-up by the study staff.
• Has received any immunoglobulin therapy and/or blood products since birth or planned administration during the study period.
• 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.
• History of any neurologic disorders or seizures.
• Any medical condition in the parents/infants that, in the judgment of the investigator, would interfere with or serves as a contraindication to protocol adherence or a participant's parent's/legally acceptable representative's ability to give informed consent.
• Participant is a direct descendant (child or grandchild) of any person employed by the Sponsor, the CRO, the PI or study site personnel.

Sponsors & Collaborators

• Centre for Infectious Disease Research in Zambia: lead
• PATH: collaborator
• Christian Medical College, Vellore, India: collaborator
• Children's Hospital Medical Center, Cincinnati: collaborator
• Bharat Biotech International Limited: collaborator

Study Sites (1)

George Research Centre

Lusaka, 10101, Zambia

Location

Related Publications (40)

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Related Links

• Rotarix (Product Information).
• Rotateq (Product Information).
• PATH welcomes new promising study results for rotavirus vaccine candidate.
• Bharat Biotech receives National Technology Award for Rotavac from President of India

MeSH Terms

Conditions

Diarrhea

Interventions

RIX4414 vaccine

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr Niraj Rathi, MD; Senior Medical Officer
• Organization: PATH

nrathi@path.org

+91 11 4064 0000

Study Officials

• Niraj Rathi, MD

  PATH

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Scientific Officer

Model Details: Phase IIb, single center, randomized, controlled, open label study

Study Record Dates

• First Submitted: July 18, 2018
• First Posted: July 26, 2018
• Study Start: January 22, 2019
• Primary Completion: October 4, 2019
• Study Completion: October 4, 2019
• Last Updated: December 19, 2020
• Results First Posted: December 19, 2020

Record last verified: 2020-12

Locations

ZA (1)