NCT02825368

Brief Summary

The purpose of the study is to compare the immunological response of homeopathic vaccines to placebo and to conventional vaccines in healthy young adults.

Trial Health

55
Monitor

Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 24, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 7, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Last Updated

August 4, 2017

Status Verified

August 1, 2017

Enrollment Period

11 months

First QC Date

June 24, 2016

Last Update Submit

August 3, 2017

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (5)

  • Antibody levels for diphtheria

    3 weeks

  • Antibody levels for pertussis

    3 weeks

  • Antibody levels for tetanus

    3 weeks

  • Antibody levels for mumps

    3 weeks

  • Antibody levels for measles

    3 weeks

Study Arms (3)

Homeopathic vaccine group

EXPERIMENTAL

* Diphtheria (Diphtherinum®), pertussis (Pertussinum®), tetanus (Tetanotxicum®), measles (Morbilinum®) and mumps (Ourlianum®) nosodes. * Two sterile saline injections (0.5ml each, intramuscular and subcutaneous) as placebo.

Other: Diphtherinum®Other: Pertussinum®Other: Tetanotxicum®Other: Morbilinum®Other: Ourlianum®Other: Sterile saline

Conventional vaccine group

ACTIVE COMPARATOR

* One intramuscular dose of Tdap (tetanus, diphtheria, acellular pertussis) * One subcutaneous dose of MMR (measles, mumps, rubella) * Sugar pellets as placebo.

Biological: MMRBiological: TdapOther: Sugar pellets

Control group

PLACEBO COMPARATOR

* Sugar pellets oral dose * Two sterile saline injections (0.5 ml each, intramuscular and subcutaneous) as placebo

Other: Sterile salineOther: Sugar pellets

Interventions

MMRBIOLOGICAL

0.5 mL, subcutaneous

Conventional vaccine group
TdapBIOLOGICAL

0.5 mL, intramuscular

Conventional vaccine group
Diphtherinum®OTHER
Homeopathic vaccine group
Pertussinum®OTHER
Homeopathic vaccine group
Tetanotxicum®OTHER
Homeopathic vaccine group
Morbilinum®OTHER
Homeopathic vaccine group
Ourlianum®OTHER
Homeopathic vaccine group
Sterile salineOTHER

0.5 mL, intramuscular

Control groupHomeopathic vaccine group
Sugar pelletsOTHER
Control groupConventional vaccine group

Eligibility Criteria

Age18 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Between the ages of 18 and 24 years
  • Has received primary childhood DTaP and MMR vaccinations
  • Available for a follow up visit (3 weeks after initial visit)

You may not qualify if:

  • Received a live vaccine in the past 4 weeks
  • Has had a serious allergic reaction to a previous vaccination
  • Has allergies to one or more of the components of the vaccines to be used (Neomycin, egg protein)
  • Has a history of encephalopathy within 7 days of receiving DTP/DTap
  • Has received nosodes for Diphtheria, Tetanus, Pertussis, Measles and Mumps
  • Has received an adult booster dose of conventional vaccines of diphtheria, pertussis, tetanus, mumps, and measles (Tdap or MMR)
  • Has received immunosuppressive doses of steroids or anti-cancer drugs in the past 3 months
  • Is pregnant or if there is a chance they could become pregnant during the next month
  • Has a moderate to severe acute illness at the time of enrolment
  • Has cancer, leukemia, HIV/AIDS, or any other serious immune health condition
  • Has a history of Guillaume Barre Syndrome
  • Has received blood transfusion, blood products, or immune globulin within the past year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McMaster University

Hamilton, Ontario, L8S 4K1, Canada

RECRUITING

Central Study Contacts

Mark Loeb, MD, MSc.

CONTACT

905-525-9140loebm@mcmaster.ca

Sasha Eskandarian, MSc

CONTACT

905-525-9140eskand@mcmaster.ca

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2016

First Posted

July 7, 2016

Study Start

September 1, 2016

Primary Completion

August 1, 2017

Last Updated

August 4, 2017

Record last verified: 2017-08

Locations

CA(1)