Phase III Study on Rotavirus Vaccine to Evaluate Lot-to-lot Consistency and Interference With Routine UIP Immunization

Rotavirus Gastroenteritis Clinical Trial

Official title:

A Phase III, Multicenter, Open Label, Randomized Study of Bovine Rotavirus Pentavalent Vaccine (BRV-PV) to Evaluate Lot-To-Lot Consistency and to Investigate Potential Interference With Routine UIP Vaccinations in Healthy Infants in India.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02584816
• Other study ID #: ROTA: 04 / VAC-020
• Status: Completed
• Phase: Phase 3
• Start date: November 2015
• Est. completion date: June 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, open-label, randomized study to evaluate lot-to-lot consistency in the manufacture of Bovine Rotavirus Pentavalent Vaccine (BRV-PV).

Description:

The study is designed to evaluate lot-to-lot consistency in the manufacturing of Rotavirus vaccine by testing the vaccine in infants in order to demonstrate equivalence in the induction of specific anti-rotavirus IgA antibodies across three production lots. The study will also examine the potential interference of vaccine with UIP vaccines that will be administered concurrently by assessing non-inferiority in the immune responses to those vaccines when administered with / without the study vaccine.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1500
• Est. completion date: June 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Weeks to 8 Weeks

Eligibility

Inclusion Criteria:

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

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

3. Parental ability and willingness to provide written informed consent.

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

5. Receipt of birth dose of Hepatitis B vaccine and OPV.

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 or any systemic disorder 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.

6. History of congenital abdominal disorders, intussusception, or abdominal surgery.

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

8. Household contact with an immunosuppressed individual or pregnant woman.

9. Prior receipt or intent to receive rotavirus and / or diphtheria, tetanus, pertussis, Haemophilus Influenzae type b, Hepatitis B vaccine (other than birth dose) or inactivated polio vaccine (IPV) during the study period and outside of the study. OPV dose received during national / subnational immunization days will be allowed.

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

11. Clinically detectable congenital or genetic defect.

12. History of persistent diarrhea (defined as diarrhea that lasts 14 days or longer).

13. Receipt of any immunoglobulin therapy and / or blood products since birth or planned administration during the study period.

14. 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.

15. History of any neurologic disorders or seizures.

16. 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 written informed consent.

Related Conditions & MeSH terms

• Gastroenteritis
• Rotavirus Gastroenteritis

Intervention

Biological:
• BRV-PV Lot A + DPT-HepB-Hib + OPV
Dose 1: 6-8 weeks, Dose 2: 10 week, Dose 3: 14 week
• BRV-PV Lot B + DPT-HepB-Hib + OPV
Dose 1: 6-8 weeks, Dose 2: 10 week, Dose 3: 14 week
• BRV-PV Lot C + DPT-HepB-Hib + OPV
Dose 1: 6-8 weeks, Dose 2: 10 week, Dose 3: 14 week
• ROTARIX + DPT-HepB-Hib + OPV
Dose 1: 6-8 weeks, Dose 2: 10 week, Dose 3: 14 week (Third dose-Placebo)

Locations

Country	Name	City	State
India	Sri Ramachandra Medical Centre	Chennai	Tamil Nadu
India	Gandhi Medical College and Gandhi Hospital	Hyderabad	Andhra Pradesh
India	Institute of Child Health	Kolkata	West Bengal
India	Seth G S Medical College & KEM Hospital	Mumbai	Maharashtra
India	T. N. Medical College and B. Y. L. Nair Charitable	Mumbai	Maharashtra
India	JSS Medical College and Hospital	Mysore	Karnataka
India	Maulana Azad Medical College	New Delhi
India	Bharati Vidyapeeth Medical College and Hospital	Pune	Maharashtra
India	KEM Hospital and Research Centre, Vadu	Pune	Maharashtra
India	King George Hospital	Visakhapatnam	Andhra Pradesh

Sponsors (2)

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

Country where clinical trial is conducted

India, 

References & Publications (1)

Desai S, Rathi N, Kawade A, Venkatramanan P, Kundu R, Lalwani SK, Dubey AP, Venkateswara Rao J, Narayanappa D, Ghildiyal R, Gogtay NJ, Venugopal P, Palkar S, Munshi R, Bavdekar A, Juvekar S, Ganguly N, Niyogi P, Uttam KG, Kondekar A, Kumbhar D, Mohanlal S — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rotavirus vaccine lots Immunogenicity	Serum anti- rotavirus IgA antibody concentrations expressed as GMCs for the BRV-PV to demonstrate equivalence in lot consistency among three lots.	Four weeks after the third dose of vaccination
Primary	Immunogenicity of UIP vaccines		Four weeks after the third dose of vaccination
Secondary	Immediate adverse events and Solicited post -vaccination reactogenicity		AEs within 30 minutes post-vaccination and post vacc reactogenicity during 7 days after each vaccination
Secondary	Rotavirus Immunogenicity:	Serum anti- rotavirus IgA antibody concentrations expressed as GMCs and proportion of subjects with post-vaccination IgA antibody concentration =20 U/ml for the comparison of BRV-PV vaccine and licensed rotavirus vaccine.	Four weeks after the third dose of vaccination

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