NCT01860378

Brief Summary

This study is a small-scale randomized, placebo-controlled factorial trial of two interventions to increase Tetanus, diphtheria and acellular pertussis (Tdap) immunization rates among infant caregivers. Specifically, the trial will compare a full cost vs. $5 Tdap voucher with or without an educational video.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
149

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Jul 2013

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, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 22, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

April 3, 2015

Status Verified

April 1, 2015

Enrollment Period

8 months

First QC Date

May 20, 2013

Last Update Submit

April 2, 2015

Conditions

Whooping Cough

Keywords

Whooping CoughPertussisTdap vaccinationRandomized placebo controlled factorial trial

Outcome Measures

Primary Outcomes (1)

  • Rate of Tdap Vaccination

    The primary outcome of interest is the difference in vaccination rates between those who received the vouchers vs. those who did not and between those who received the educational video vs. those who did not. We are also interested in measuring whether the educational video acts as an effect modifier in the association between receipt of the voucher and vaccination rates.

    5 months

Secondary Outcomes (1)

  • Proportion of all vouchers that are redeemed

    5 months

Other Outcomes (1)

  • Feasibility of voucher distribution

    5 months

Study Arms (2)

No Video: Full price & $5 off

ACTIVE COMPARATOR

Participants will not view the pertussis video

Other: Full priceOther: $5 off

Video: Full price & $5 off

EXPERIMENTAL

Participants will watch a brief (\~ 1 minute) video about Tdap vaccination

Other: Full priceOther: $5 off

Interventions

Full priceOTHER

Participants will receive a voucher for the full price of a Tdap vaccine ($63.99) + a baby care product voucher or gift card

No Video: Full price & $5 offVideo: Full price & $5 off
$5 offOTHER

Participants will receive a voucher for $5 off a Tdap vaccine + a baby care product voucher or gift card.

No Video: Full price & $5 offVideo: Full price & $5 off

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All caregivers who report that they have never received Tdap
  • Mothers who did not receive Tdap during their most recent pregnancy or since the birth of the child, even if she received Tdap during a previous pregnancy, as Tdap is now recommended for all pregnant women during each pregnancy.
  • Previous receipt of a tetanus containing vaccine (i.e. Td or TT), regardless of the time interval since receipt of the tetanus-containing vaccine will be also eligible for the study.
  • If a participant is certain they have not received Tdap within the past year but uncertain whether he/she has ever received Tdap, we will offer enrollment and encourage participants to obtain immunization records to confirm their status before voucher redemption. Rite Aid will follow their screening procedures which also includes assessing immunization status. Participants who do not know their Tdap vaccination status will receive the voucher intervention.

You may not qualify if:

  • Any adult caregiver who has previously received Tdap
  • For recently-pregnant women: If a mother who received Tdap during her most recent pregnancy (2nd trimester or 3rd trimester) or since the birth of the child. Also, if the mother is unsure of her vaccination status and possibly received the vaccine during this pregnancy or in the last year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karabots Primary Care Center - The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19139, United States

Location

Related Publications (15)

  • Klein NP, Bartlett J, Rowhani-Rahbar A, Fireman B, Baxter R. Waning protection after fifth dose of acellular pertussis vaccine in children. N Engl J Med. 2012 Sep 13;367(11):1012-9. doi: 10.1056/NEJMoa1200850.

    PMID: 22970945BACKGROUND

  • Cherry JD. Epidemic pertussis in 2012--the resurgence of a vaccine-preventable disease. N Engl J Med. 2012 Aug 30;367(9):785-7. doi: 10.1056/NEJMp1209051. Epub 2012 Aug 15. No abstract available.

    PMID: 22894554BACKGROUND

  • Healy CM, Rench MA, Baker CJ. Implementation of cocooning against pertussis in a high-risk population. Clin Infect Dis. 2011 Jan 15;52(2):157-62. doi: 10.1093/cid/ciq001.

    PMID: 21288837BACKGROUND

  • Centers for Disease Control and Prevention (CDC). Pertussis--United States, 1997-2000. MMWR Morb Mortal Wkly Rep. 2002 Feb 1;51(4):73-6.

    PMID: 11837909BACKGROUND

  • Bisgard KM, Pascual FB, Ehresmann KR, Miller CA, Cianfrini C, Jennings CE, Rebmann CA, Gabel J, Schauer SL, Lett SM. Infant pertussis: who was the source? Pediatr Infect Dis J. 2004 Nov;23(11):985-9. doi: 10.1097/01.inf.0000145263.37198.2b.

    PMID: 15545851BACKGROUND

  • Wendelboe AM, Njamkepo E, Bourillon A, Floret DD, Gaudelus J, Gerber M, Grimprel E, Greenberg D, Halperin S, Liese J, Munoz-Rivas F, Teyssou R, Guiso N, Van Rie A; Infant Pertussis Study Group. Transmission of Bordetella pertussis to young infants. Pediatr Infect Dis J. 2007 Apr;26(4):293-9. doi: 10.1097/01.inf.0000258699.64164.6d.

    PMID: 17414390BACKGROUND

  • Centers for Disease Control and Prevention (CDC). Updated recommendations for use of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine (Tdap) in pregnant women and persons who have or anticipate having close contact with an infant aged <12 months --- Advisory Committee on Immunization Practices (ACIP), 2011. MMWR Morb Mortal Wkly Rep. 2011 Oct 21;60(41):1424-6.

    PMID: 22012116BACKGROUND

  • Centers for Disease Control and Prevention (CDC). Updated recommendations for use of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine in adults aged 65 years and older - Advisory Committee on Immunization Practices (ACIP), 2012. MMWR Morb Mortal Wkly Rep. 2012 Jun 29;61(25):468-70.

    PMID: 22739778BACKGROUND

  • Advisory Committee on Immunization Practices. Recommended adult immunization schedule: United States, 2012. Ann Intern Med. 2012 Feb 7;156(3):211-7. doi: 10.7326/0003-4819-156-3-201202070-00388. Epub 2012 Jan 31. No abstract available.

    PMID: 22298576BACKGROUND

  • Lessin HR, Edwards KM; Committee On Practice And Ambulatory Medicine; Committee On Infectious Diseases. Immunizing parents and other close family contacts in the pediatric office setting. Pediatrics. 2012 Jan;129(1):e247-53. doi: 10.1542/peds.2011-2937. Epub 2011 Dec 26.

    PMID: 22201157BACKGROUND

  • Centers for Disease Control and Prevention (CDC). Adult vaccination coverage--United States, 2010. MMWR Morb Mortal Wkly Rep. 2012 Feb 3;61(4):66-72.

    PMID: 22298302BACKGROUND

  • Walter EB, Allred N, Rowe-West B, Chmielewski K, Kretsinger K, Dolor RJ. Cocooning infants: Tdap immunization for new parents in the pediatric office. Acad Pediatr. 2009 Sep-Oct;9(5):344-7. doi: 10.1016/j.acap.2009.05.027. Epub 2009 Jul 12.

    PMID: 19596219BACKGROUND

  • Bearden DT, Holt T. Statewide impact of pharmacist-delivered adult influenza vaccinations. Am J Prev Med. 2005 Dec;29(5):450-2. doi: 10.1016/j.amepre.2005.08.003.

    PMID: 16376709BACKGROUND

  • Eades CE, Ferguson JS, O'Carroll RE. Public health in community pharmacy: a systematic review of pharmacist and consumer views. BMC Public Health. 2011 Jul 21;11:582. doi: 10.1186/1471-2458-11-582.

    PMID: 21777456BACKGROUND

  • Crawford ND, Blaney S, Amesty S, Rivera AV, Turner AK, Ompad DC, Fuller CM. Individual- and neighborhood-level characteristics associated with support of in-pharmacy vaccination among ESAP-registered pharmacies: pharmacists' role in reducing racial/ethnic disparities in influenza vaccinations in New York City. J Urban Health. 2011 Feb;88(1):176-85. doi: 10.1007/s11524-010-9541-6.

    PMID: 21279450BACKGROUND

MeSH Terms

Conditions

Whooping Cough

Condition Hierarchy (Ancestors)

Bordetella InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsRespiratory Tract InfectionsRespiratory Tract Diseases

Study Officials

  • Kristen A Feemster, M.D.

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2013

First Posted

May 22, 2013

Study Start

July 1, 2013

Primary Completion

March 1, 2014

Study Completion

March 1, 2015

Last Updated

April 3, 2015

Record last verified: 2015-04

Locations

US(1)