NCT02145000

Brief Summary

The study is a double-blinded, randomized, placebo-controlled, trial with two groups of infants receiving vaccine or placebo to assess the efficacy and safety of BRV-PV. Three doses of BRV-PV containing ≥ Log10 5.6 FFU/Dose of each serotype G1, G2, G3, G4 and G9 will be administered at 4 week intervals between doses. The first administration will occur at 6-8 weeks of age. We hypothesize a difference in vaccine efficacy of three doses of BRV-PV vaccine vs. placebo against severe rotavirus gastroenteritis in healthy infants in Niger. Active surveillance for gastroenteritis episodes will be conducted throughout the trial. Surveillance for adverse events will be carried out among all children from the time of first vaccination and 28 days post-Dose 3. Surveillance for all serious adverse events, including intussusception and death, will be conducted on all participants until they each reach two years of age. To assess the effect of prenatal nutrition supplementation on infant immune response to the BRV-PV vaccine, study villages in the immunogenicity sub-cohort will be randomized in a 1:1:1 ratio to provide pregnant women with daily iron-folate, multiple micronutrients or a lipid-based nutrition supplement. Infants of participating women, if eligible at 6-8 weeks of age, will be randomized in a 1:1 ratio to receive three doses of vaccine or placebo and enter the main trial as part of the immunogenicity sub-cohort.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,586

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jun 2014

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 22, 2014

Completed
10 days until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
5.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

September 22, 2023

Status Verified

September 1, 2023

Enrollment Period

1.5 years

First QC Date

May 20, 2014

Last Update Submit

September 21, 2023

Conditions

Severe Rotavirus Gastroenteritis

Keywords

RotavirusGastroenteritisDiarrheaVaccineNiger

Outcome Measures

Primary Outcomes (1)

  • Laboratory-confirmed episode of severe rotavirus gastroenteritis

    From 28 days post-Dose 3 until 117 cases are accrued or when all participating infants reach 2 years of age if 117 cases are not attained

Secondary Outcomes (10)

  • Laboratory-confirmed episode of rotavirus gastroenteritis of any severity

    From 28 days post-Dose 3 to 1 year of age, from 1 to 2 years of age, and from 28 days post-Dose 3 to 2 years of age

  • Laboratory-confirmed episode of rotavirus gastroenteritis with a Vesikari score of ≥ 17

    From 28 days post-Dose 3 to 1 year of age, from 1 to 2 years of age, and from 28 days post-Dose 3 to 2 years of age

  • Laboratory-confirmed episode of severe rotavirus gastroenteritis due to rotavirus serotypes G1, G2, G3, G4 and G9

    From 28 days post-Dose 3 to 1 year of age, from 1 to 2 years of age, and from 28 days post-Dose 3 to 2 years of age

  • Episode of gastroenteritis of any cause

    From 28 days post-Dose 3 to 1 year of age, from 1 to 2 years of age, and from 28 days post-Dose 3 to 2 years of age

  • Hospitalization due to laboratory-confirmed cases of rotavirus gastroenteritis of any cause

    From 28 days post-Dose 3 to 1 year of age, from 1 to 2 years of age, and from 28 days post-Dose 3 to 2 years of age

  • +5 more secondary outcomes

Study Arms (2)

Rotavirus vaccine (BRV-PV)

EXPERIMENTAL

Live attenuated bovine-human \[UK\] reassortant rotavirus vaccine manufactured by the Serum Institute of India, Limited (SIIL). The pentavalent vaccine (BRV-PV) contains rotavirus serotypes G1, G2, G3, G4, and G9 (≥5.6 log10 FFU/serotype/dose). The vaccine is in lyophilized form and supplied with 2.5 ml of citrate bicarbonate buffer that is added for reconstitution just before oral administration.

Biological: Rotavirus vaccine (BRV-PV)

Placebo

PLACEBO COMPARATOR

Same constituents as the active vaccine but without the viral antigens; manufactured by SIIL.

Biological: Placebo

Interventions

Rotavirus vaccine (BRV-PV)BIOLOGICAL

Three doses of BRV-PV containing ≥ Log10 5.6 FFU/Dose of each serotype G1, G2, G3, G4 and G9, or placebo, will be administered at 4 week intervals between doses (with a window of -1 to +4 weeks). The first administration will occur at 6-8 weeks of age.

Rotavirus vaccine (BRV-PV)
PlaceboBIOLOGICAL
Placebo

Eligibility Criteria

Age6 Weeks - 2 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • able to swallow and no history of vomiting within 24 hours
  • resident in Madarounfa Health District and within the catchment area of the central health facility
  • intending to remain in the study area for 2 years
  • parent/guardian providing written informed consent

You may not qualify if:

  • Any of the following will exclude an infant from randomization in the study:
  • known history of congenital abdominal disorders, intussusception, or abdominal surgery
  • receipt of intramuscular, oral, or intravenous corticosteroid treatment within 2 wks
  • receipt or planned administration of a blood transfusion or blood products, including immunoglobulins
  • any known immunodeficiency condition
  • any serious medical condition
  • any other condition in which, in the judgment of the investigator, would interfere with or serves as a contraindication to protocol adherence or the parent/guardian's ability to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Madarounfa Health District

Madarounfa, Maradi Region, Niger

Location

Related Publications (7)

  • Sudfeld CR, Bliznashka L, Salifou A, Guindo O, Soumana I, Adehossi I, Langendorf C, Grais RF, Isanaka S. Evaluation of multiple micronutrient supplementation and medium-quantity lipid-based nutrient supplementation in pregnancy on child development in rural Niger: A secondary analysis of a cluster randomized controlled trial. PLoS Med. 2022 May 2;19(5):e1003984. doi: 10.1371/journal.pmed.1003984. eCollection 2022 May.

    PMID: 35500028DERIVED

  • Kohlmann K, Sudfeld CR, Garba S, Guindo O, Grais RF, Isanaka S. Exploring the relationships between wasting and stunting among a cohort of children under two years of age in Niger. BMC Public Health. 2021 Sep 21;21(1):1713. doi: 10.1186/s12889-021-11689-6.

    PMID: 34548050DERIVED

  • Isanaka S, Garba S, Plikaytis B, Malone McNeal M, Guindo O, Langendorf C, Adehossi E, Ciglenecki I, Grais RF. Immunogenicity of an oral rotavirus vaccine administered with prenatal nutritional support in Niger: A cluster randomized clinical trial. PLoS Med. 2021 Aug 10;18(8):e1003720. doi: 10.1371/journal.pmed.1003720. eCollection 2021 Aug.

    PMID: 34375336DERIVED

  • Isanaka S, Langendorf C, McNeal MM, Meyer N, Plikaytis B, Garba S, Sayinzoga-Makombe N, Soumana I, Guindo O, Makarimi R, Scherrer MF, Adehossi E, Ciglenecki I, Grais RF. Rotavirus vaccine efficacy up to 2 years of age and against diverse circulating rotavirus strains in Niger: Extended follow-up of a randomized controlled trial. PLoS Med. 2021 Jul 2;18(7):e1003655. doi: 10.1371/journal.pmed.1003655. eCollection 2021 Jul.

    PMID: 34214095DERIVED

  • Isanaka S, Kodish SR, Mamaty AA, Guindo O, Zeilani M, Grais RF. Acceptability and utilization of a lipid-based nutrient supplement formulated for pregnant women in rural Niger: a multi-methods study. BMC Nutr. 2019 Jul 1;5:34. doi: 10.1186/s40795-019-0298-3. eCollection 2019.

    PMID: 32153947DERIVED

  • Coldiron ME, Guindo O, Makarimi R, Soumana I, Matar Seck A, Garba S, Macher E, Isanaka S, Grais RF. Safety of a heat-stable rotavirus vaccine among children in Niger: Data from a phase 3, randomized, double-blind, placebo-controlled trial. Vaccine. 2018 Jun 14;36(25):3674-3680. doi: 10.1016/j.vaccine.2018.05.023. Epub 2018 May 8.

    PMID: 29752026DERIVED

  • Isanaka S, Guindo O, Langendorf C, Matar Seck A, Plikaytis BD, Sayinzoga-Makombe N, McNeal MM, Meyer N, Adehossi E, Djibo A, Jochum B, Grais RF. Efficacy of a Low-Cost, Heat-Stable Oral Rotavirus Vaccine in Niger. N Engl J Med. 2017 Mar 23;376(12):1121-1130. doi: 10.1056/NEJMoa1609462.

    PMID: 28328346DERIVED

MeSH Terms

Conditions

GastroenteritisDiarrhea

Interventions

Rotavirus Vaccines

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Sheila Isanaka, ScD

    Epicentre

    PRINCIPAL INVESTIGATOR

  • Rebecca Grais, PhD

    Epicentre

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2014

First Posted

May 22, 2014

Study Start

June 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 31, 2020

Last Updated

September 22, 2023

Record last verified: 2023-09

Locations

NI(1)