NCT02847026

Brief Summary

This is an open-label phase IV, randomized controlled trial of inactivated poliovirus vaccine (IPV) and rotavirus vaccines. This trial will assess immunogenicity of a booster dose of fractional IPV (fIPV) in comparison with a full dose of IPV when given after varying IPV and fIPV schedules. Differences in immunogenicity of the varying schedules of IPV and fIPV will also be examined. Concomitantly, immunogenicity to two different rotavirus vaccines will be evaluated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,144

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2016

Shorter than P25 for phase_4

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

July 25, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 27, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

July 18, 2018

Status Verified

August 1, 2016

Enrollment Period

8 months

First QC Date

July 25, 2016

Last Update Submit

July 16, 2018

Conditions

Poliomyelitis

Keywords

inactivated poliovirus vaccinefractional inactivated poliovirus vaccineRotavirusRotarixRotaTeqfIPVIPV

Outcome Measures

Primary Outcomes (3)

  • Immune response (yes/no) as measured by antibody titers to poliovirus types 1, 2, and 3 after vaccination with study vaccines.

    Immune response will be defined as either a four-fold increase in titer or a seronegative participant (\<1:8 titers) who becomes seropositive (≥1:8) between designated time points. For selected objectives, baseline maternal antibody titer will be determined at 6 weeks of age and the estimated maternal antibody level at each blood collection will be calculated assuming an exponential decline with a half-life of 28 days.

    Measured at 26 weeks of age.

  • Immune response (yes/no) as measured by antibody titers to poliovirus types 1, 2, and 3 after vaccination with study vaccines (priming).

    Priming is defined as the absence of type-specific immune response at 22 weeks with evidence of type-specific seroconversion at 23 weeks. That is, seronegative participants at 22 weeks (\<1:8 titers) who become seropositive at 23 weeks (≥1:8) or a four-fold rise in type-specific antibody titers at 23 weeks compared to 22 weeks.

    Measured at 23 weeks of age.

  • Immune response (yes/no) as measured by antibody titers to poliovirus types 1, 2, and 3 after vaccination with study vaccines.

    Immune response will be defined as either a four-fold increase in titer or a seronegative participant (\<1:8 titers) who becomes seropositive (≥1:8) between designated time points. Baseline maternal antibody titer will be determined at 6 weeks of age and the estimated maternal antibody level at each blood collection will be calculated assuming an exponential decline with a half-life of 28 days.

    Measured at 22 weeks of age.

Secondary Outcomes (6)

  • Median antibody titers at 26 weeks to poliovirus types 1, 2, and 3

    Measured at 26 weeks of age

  • Median antibody titers at 23 weeks to poliovirus types 1, 2, and 3

    Measured at 23 weeks of age

  • Median antibody titers at 22 weeks to poliovirus types 1, 2, and 3

    Measured at 22 weeks of age

  • Percentage of children achieving rotavirus IgA seroconversion

    Change after completion of study vaccine series in comparison with 6 weeks of age.

  • Rotavirus IgA geometric mean titers

    Change after completion of study vaccine series in comparison with 6 weeks of age.

  • +1 more secondary outcomes

Study Arms (8)

IPV at 14 and 22 weeks of age, Rotarix

ACTIVE COMPARATOR

Participants in this arm will receive a full dose of IPV at 14 weeks of age and a full dose IPV booster at 22 weeks of age. Rotarix will also be given at 6 and 10 weeks of age.

Biological: IPV at 14 and 22 weeks of age, Rotarix

IPV at 14 and 22 weeks of age, RotaTeq

ACTIVE COMPARATOR

Participants in this arm will receive a full dose of IPV at 14 weeks of age and a full dose IPV booster at 22 weeks of age. RotaTeq will also be given at 6, 10, and 14 weeks of age.

Biological: IPV at 14 and 22 weeks of age, RotaTeq

IPV at 14 and fIPV at 22 weeks, Rotarix

ACTIVE COMPARATOR

Participants in this arm will receive a full dose of IPV at 14 weeks of age and a fractional dose IPV (fIPV) booster at 22 weeks of age. Rotarix will also be given at 6 and 10 weeks of age.

Biological: IPV at 14 and fIPV at 22 weeks, Rotarix

IPV at 14 and fIPV at 22 weeks, RotaTeq

ACTIVE COMPARATOR

Participants in this arm will receive a full dose of IPV at 14 weeks of age and a fractional dose IPV (fIPV) booster at 22 weeks of age. RotaTeq will also be given at 6, 10, and 14 weeks of age.

Biological: IPV at 14 and fIPV at 22 weeks, RotaTeq

IPV at 6 and fIPV at 22 weeks, Rotarix

ACTIVE COMPARATOR

Participants in this arm will receive a full dose of IPV at 6 weeks of age and a fractional dose IPV (fIPV) booster at 22 weeks of age. Rotarix will also be given at 6 and 10 weeks of age.

Biological: IPV at 6 and fIPV at 22 weeks, Rotarix

IPV at 6 and fIPV at 22 weeks, RotaTeq

ACTIVE COMPARATOR

Participants in this arm will receive a full dose of IPV at 6 weeks of age and a fractional dose IPV (fIPV) booster at 22 weeks of age. RotaTeq will also be given at 6, 10, and 14 weeks of age.

Biological: IPV at 6 and fIPV at 22 weeks, RotaTeq

fIPV at 6-14-22 weeks of age, Rotarix

ACTIVE COMPARATOR

Participants in this arm will receive fractional doses of IPV (fIPV) at 6 and 14 weeks of age and a fIPV booster at 22 weeks of age. Rotarix will also be given at 6 and 10 weeks of age.

Biological: fIPV at 6-14-22 weeks of age, Rotarix

fIPV at 6-14-22 weeks of age, RotaTeq

ACTIVE COMPARATOR

Participants in this arm will receive fractional doses of IPV (fIPV) at 6 and 14 weeks of age and a fIPV booster at 22 weeks of age. RotaTeq will also be given at 6, 10, and 14 weeks of age.

Biological: fIPV at 6-14-22 weeks of age, RotaTeq

Interventions

IPV at 14 and 22 weeks of age, RotarixBIOLOGICAL

Participants in this arm will receive a full dose of inactivated poliovirus vaccine (IPV) at 14 weeks of age and a full dose IPV booster at 22 weeks of age. They will also receive the rotavirus vaccine, Rotarix, at 6 and 10 weeks of age.

IPV at 14 and 22 weeks of age, Rotarix
IPV at 14 and 22 weeks of age, RotaTeqBIOLOGICAL

Participants in this arm will receive a full dose of inactivated poliovirus vaccine (IPV) at 14 weeks of age and a full dose IPV booster at 22 weeks of age. They will also receive the rotavirus vaccine, RotaTeq, at 6, 10, and 14 weeks of age.

IPV at 14 and 22 weeks of age, RotaTeq
IPV at 14 and fIPV at 22 weeks, RotarixBIOLOGICAL

Participants in this arm will receive a full dose of inactivated poliovirus vaccine (IPV) at 14 weeks of age and a fractional dose IPV (fIPV) booster at 22 weeks of age. They will also receive the rotavirus vaccine, Rotarix, at 6 and 10 weeks of age.

IPV at 14 and fIPV at 22 weeks, Rotarix
IPV at 14 and fIPV at 22 weeks, RotaTeqBIOLOGICAL

Participants in this arm will receive a full dose of inactivated poliovirus vaccine (IPV) at 14 weeks of age and a fractional dose IPV (fIPV) booster at 22 weeks of age. They will also receive the rotavirus vaccine, RotaTeq, at 6, 10, and 14 weeks of age.

IPV at 14 and fIPV at 22 weeks, RotaTeq
IPV at 6 and fIPV at 22 weeks, RotarixBIOLOGICAL

Participants in this arm will receive a full dose of inactivated poliovirus vaccine (IPV) at 6 weeks of age and a fractional dose IPV (fIPV) booster at 22 weeks of age. They will also receive the rotavirus vaccine, Rotarix, at 6 and 10 weeks of age.

IPV at 6 and fIPV at 22 weeks, Rotarix
IPV at 6 and fIPV at 22 weeks, RotaTeqBIOLOGICAL

Participants in this arm will receive a full dose of inactivated poliovirus vaccine (IPV) at 6 weeks of age and a fractional dose IPV (fIPV) booster at 22 weeks of age. They will also receive the rotavirus vaccine, RotaTeq, at 6, 10, and 14 weeks of age.

IPV at 6 and fIPV at 22 weeks, RotaTeq
fIPV at 6-14-22 weeks of age, RotarixBIOLOGICAL

Participants in this arm will receive a fractional doses of inactivated poliovirus vaccine (fIPV) at 6 and 14 weeks of age and a fIPV booster at 22 weeks of age. They will also receive the rotavirus vaccine, Rotarix, at 6 and 10 weeks of age.

fIPV at 6-14-22 weeks of age, Rotarix
fIPV at 6-14-22 weeks of age, RotaTeqBIOLOGICAL

Participants in this arm will receive a fractional doses of inactivated poliovirus vaccine (fIPV) at 6 and 14 weeks of age and a fIPV booster at 22 weeks of age. They will also receive the rotavirus vaccine, RotaTeq, at 6, 10, and 14 weeks of age.

fIPV at 6-14-22 weeks of age, RotaTeq

Eligibility Criteria

Age6 Weeks - 6 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Infants 6 weeks of age (range: 42-48 days).
  • Parents that consent for participation in the full length of the study.
  • Parents that are able to understand and comply with planned study procedures.

You may not qualify if:

  • Parents and infants who are unable to participate in the full length of the study.
  • A diagnosis or suspicion of immunodeficiency disorder either in the infant or in an immediate family member.
  • A diagnosis or suspicion of bleeding disorder that would contraindicate parenteral administration of IPV or collection of blood by venipuncture.
  • Acute diarrhea, infection or illness at the time of enrollment (6 weeks of age) that would require infant's admission to a hospital.
  • Acute vomiting and intolerance to liquids within 24 hours before the enrollment visit (6 weeks of age).
  • Evidence of a chronic medical condition identified by a study medical officer during physical exam.
  • Receipt of any polio vaccine (OPV or IPV) before enrollment based upon documentation or parental recall.
  • Receipt of any rotavirus vaccine (RV1 or RV5) before enrollment based upon documentation or parental recall.
  • Known allergy/sensitivity or reaction to polio or rotavirus vaccine, or contents of polio or rotavirus vaccine.
  • Infants from multiple births. Infants from multiple births will be excluded because the infant(s) who is/are not enrolled would likely receive OPV through routine immunization and transmit vaccine poliovirus to the enrolled infant.
  • Infants from premature births (\<37 weeks of gestation).
  • History of intussusception, intestinal malformations, or abdominal surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

International Center for Diarrhoeal Disease Research, Bangladesh

Dhaka, Bangladesh

Location

Related Publications (2)

  • Velasquez-Portocarrero DE, Wang X, Cortese MM, Snider CJ, Anand A, Costantini VP, Yunus M, Aziz AB, Haque W, Parashar U, Sisay Z, Soeters HM, Hyde TB, Jiang B, Zaman K. Head-to-head comparison of the immunogenicity of RotaTeq and Rotarix rotavirus vaccines and factors associated with seroresponse in infants in Bangladesh: a randomised, controlled, open-label, parallel, phase 4 trial. Lancet Infect Dis. 2022 Nov;22(11):1606-1616. doi: 10.1016/S1473-3099(22)00368-1. Epub 2022 Aug 9.

    PMID: 35961362DERIVED

  • Snider CJ, Zaman K, Estivariz CF, Yunus M, Weldon WC, Wannemuehler KA, Oberste MS, Pallansch MA, Wassilak SG, Bari TIA, Anand A. Immunogenicity of full and fractional dose of inactivated poliovirus vaccine for use in routine immunisation and outbreak response: an open-label, randomised controlled trial. Lancet. 2019 Jun 29;393(10191):2624-2634. doi: 10.1016/S0140-6736(19)30503-3. Epub 2019 May 16.

    PMID: 31104832DERIVED

MeSH Terms

Conditions

Poliomyelitis

Interventions

AgingRIX4414 vaccineRotaTeq

Condition Hierarchy (Ancestors)

MyelitisCentral Nervous System InfectionsInfectionsEnterovirus InfectionsPicornaviridae InfectionsRNA Virus InfectionsVirus DiseasesCentral Nervous System DiseasesNervous System DiseasesSpinal Cord DiseasesNeuroinflammatory DiseasesNeuromuscular Diseases

Intervention Hierarchy (Ancestors)

Growth and DevelopmentPhysiological Phenomena

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2016

First Posted

July 27, 2016

Study Start

September 1, 2016

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

July 18, 2018

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

De-identified individual participant data will not be shared beyond use by co-investigators.

Locations

BA(1)