A Clinical Trial to Study the Effect and Safety of Rotavirus Vaccine Against Severe Rotavirus Gastroenteritis in Healthy Indian Infants

Rotavirus Gastroenteritis Clinical Trial

Official title:

Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Live Attenuated Bovine-Human Rotavirus Reassortant Pentavalent Vaccine (BRV-PV) Against Severe Rotavirus Gastroenteritis in Healthy Indian Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02133690
• Other study ID #: ROTA:03/12
• Status: Completed
• Phase: Phase 3
• Start date: May 2014
• Est. completion date: March 2017

Study information

• Verified date: September 2018
• Source: Serum Institute of India Pvt. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a Phase 3 multicentre, randomized, double blind, placebo-controlled study to determine the effectiveness of the rotavirus vaccine.

Description:

The hypothesis is that a three dose series of BRV-PV administered orally to healthy Indian infants, with the initial dose given at 6-8 weeks of age and followed by vaccinations at monthly intervals, will significantly reduce the incidence of severe rotavirus gastroenteritis (SRVGE). Duration of follow-up is until aged 2 years of each enrolled child. The study is powered to detect vaccine efficacy significantly greater than 10% (95% confidence interval lower bound > 10%) if the true vaccine efficacy is 50% or higher.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7500
• Est. completion date: March 2017
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Weeks to 8 Weeks

Eligibility

Inclusion Criteria:

• Healthy infants as established by medical history and clinical examination before entering the study.

• Age: 6-8 weeks at the time of enrollment.

• Parental ability and willingness to provide informed consent.

• Parent who intends to remain in the area with the child during the study period.

Exclusion Criteria:

• Presence of diarrhea or vomiting in the previous 72 hours or on the day of enrollment (temporary exclusion)

• Presence of fever on the day of enrollment (temporary exclusion).

• Acute disease at the time of enrollment (temporary exclusion)

• Concurrent participation in another clinical trial throughout the entire timeframe for this study.

• Presence of significant malnutrition (weight-for-height z-score <-3SD median) or 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 subject's health or is likely to result in nonconformance to the protocol. History of congenital abdominal disorders, intussusception or abdominal surgery

• Known or suspected impairment of immunological function based on medical history and physical examination.

• Household contact with an immunosuppressed individual or pregnant woman.

• Prior receipt of rotavirus vaccine.

• A known sensitivity or allergy to any components of the study vaccine.

• Major 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 weekly 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/infant which, in the judgment of the investigator, would interfere with or serves as a contraindication to protocol adherence or a participant's parents' ability to give informed consent.

Related Conditions & MeSH terms

• Gastroenteritis
• Rotavirus Gastroenteritis

Intervention

Biological:
• Live Attenuated Pentavalent (G1-G2-G3-G4-G9) Human X Bovine Reassortant Rotavirus Vaccine (BRV-PV)
Live Attenuated Pentavalent (G1-G2-G3-G4-G9) Human X Bovine Reassortant Rotavirus Vaccine (BRV-PV), at a dosage of = Log10^5.6 fluorescent focus units (FFU)/Serotype/Dose in 2.5 ml of buffered diluent

Other:
• Placebo
Lyophilized minimal essential medium (MEM) + excipients reconstituted in 2.5 ml of buffered diluents

Locations

Country	Name	City	State
India	Dr Dinesh Kumar Government Medical College, Jammu Department of Community Medicine, Government Medical College	Jammu	Jammu & Kashmir
India	National Institute of Cholera & Enteric Diseases	Kolkata	West Bengal
India	Kasturba Medical College, Manipal	Manipal	Karnataka
India	Center for Health Research and Development (CHRD) -Society for applied studies (SAS)	New Delhi	Delhi
India	KEM Hospital and Research Centre	Pune	Maharashtra
India	Dr. Sushila Nayar School of Public Health ,Mahatma Ghandi School of Medicine	Sewagram	Maharashtra

Sponsors (2)

Lead Sponsor	Collaborator
Serum Institute of India Pvt. Ltd.	PATH

Country where clinical trial is conducted

India, 

References & Publications (1)

Kulkarni PS, Desai S, Tewari T, Kawade A, Goyal N, Garg BS, Kumar D, Kanungo S, Kamat V, Kang G, Bavdekar A, Babji S, Juvekar S, Manna B, Dutta S, Angurana R, Dewan D, Dharmadhikari A, Zade JK, Dhere RM, Fix A, Power M, Uprety V, Parulekar V, Cho I, Chand — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	occurrence of Severe Rotavirus Gastroenteritis	Laboratory confirmed cases of severe rotavirus gastroenteritis occurring in infants receiving the complete vaccination regimen occurring from 14 days after the third vaccine dose until 122 cases are accrued, or until all participating infants reach two years of age (per protocol analysis).	Up to 2 years of age of participants
Secondary	Safety	Occurrence of SAE; Solicited post-vaccination reactions; SAEs; Severe AEs; Unsolicited AEs; Intussusception; Death	Until completion of 2 years age of participant

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