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| ID | Type | Description | Link |
|---|---|---|---|
| 200-2012-53663 0005 | Other Grant/Funding Number | Centers for Disease Control and Prevention |
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| Name | Class |
|---|---|
| Centers for Disease Control and Prevention | FED |
| Boston University | OTHER |
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This is a randomized controlled open-label trial. During the study, adolescents and young adults scheduled to receive at least one intra-muscular (IM) vaccine will receive either oral water hydration in addition to standard care or standard of care alone to evaluate the effect of water hydration on the primary outcome of presyncope. This study will also evaluate the acceptability of pre-vaccination hydration among adolescents and young adults.
Post-vaccination syncope is a rare but potentially serious adverse event in adolescents and young adults. Because few data are available regarding post-vaccination syncope, evidence regarding presyncope and syncope after blood donation provides useful insight. Based on studies of blood donors, acute water loading fifteen minutes prior to vaccination with 500 mL of water might reduce the risk of syncope. However, the degree to which hydration attenuates the risk of post-vaccination syncope or presyncope is unknown. Furthermore, little is known about the acceptability of pre-vaccination hydration to adolescents and young adults.
The objective of this study is to conduct a study to evaluate the acceptability and impact of oral hydration to prevent presyncope following vaccination in adolescents and young adults 11 through 21 years of age. The primary objectives are to determine if pre-vaccination hydration decreases the rate of presyncope in adolescents and young adults receiving at least one intra-muscular (IM) vaccine and to determine if pre-vaccination hydration is acceptable to adolescents and young adults.
This is a randomized controlled open-label study in adolescents and young adults receiving at least one IM vaccine. Vaccine administration will be part of routine care and will not be a study procedure. Adolescents and young adults 11- through 21 years of age will be eligible for participation. Minimal subject exclusion criteria will be used to best reflect how pre-vaccination hydration could be used outside of the controlled trial setting. For all primary and secondary objectives, data will be collected before and after vaccination, with data collection to be completed on the day of enrollment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Water Hydration | Active Comparator | Subjects will be given up to 15 minutes to drink up to 500 mL of water prior to the first IM vaccination. |
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| Usual Care | No Intervention | Subjects will receive usual care prior to the first IM vaccination. No water or food will be offered. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral Water Hydration | Other | Subjects in the hydration group will be allowed up to 15 minutes to drink up to 500 milliliters (mL) of water prior to the vaccines. Subjects will be encouraged to drink the entire 500 mL; however, they are free to drink as much as they want and can finish before the end of the 15-minute period. Subjects will be instructed not to share the water and to not otherwise empty the bottle. As with the control group, subjects will be instructed not to eat or drink anything else for the duration of the study, unless clinically indicated (e.g., as part of management of presyncope or syncope). |
| Measure | Description | Time Frame |
|---|---|---|
| Presyncope | Sudden onset of one or more of the following symptoms or signs during the post-vaccination observation period in the clinic: Symptoms
Signs
AND
| 20 minutes |
| Acceptability of oral water hydration in the intervention group, assessed by qualitative reports in the post-vaccination observation period and response to a survey about whether they liked getting water. | 20 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Syncope | Syncope (fainting) that occurs in an otherwise healthy person after receipt of a vaccine or during venipuncture is usually attributed to vasovagal syncope, and may occur alone (simple syncope) or may be associated with tonic-clonic movements (convulsive syncope, anoxic seizure). For the purposes of this study, we have defined syncope as: Any sudden and brief loss of consciousness or postural tone after vaccination from which recovery is spontaneous and is not attributed to another cause (e.g., anaphylaxis). For purposes of this study, cases counted as syncope must occur during the post-vaccination observation period. Individuals that develop syncope after presyncope will be classified only as having syncope. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alex R Kemper, MD, MPH, MS | Duke University | Principal Investigator |
| Elizabeth D Barnett, MD | Boston University | Principal Investigator |
| Theresa Harrington, MD | Centers for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Medical Center | Boston | Massachusetts | 02118 | United States | ||
| Duke University Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9080932 | Background | Braun MM, Patriarca PA, Ellenberg SS. Syncope after immunization. Arch Pediatr Adolesc Med. 1997 Mar;151(3):255-9. doi: 10.1001/archpedi.1997.02170400041007. | |
| 21293327 | Background | National Center for Immunization and Respiratory Diseases. General recommendations on immunization --- recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2011 Jan 28;60(2):1-64. |
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| ID | Term |
|---|---|
| D013575 | Syncope |
| ID | Term |
|---|---|
| D014474 | Unconsciousness |
| D003244 | Consciousness Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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| 20 minutes |
| Alternative Case Definition of Presyncompe | In secondary analysis, the case definition of presyncope (Outcome 1) will be defined as any response of self-report of the symptoms of presyncope at a level of "somewhat," "a lot," or "extremely" compared to "none" or "a little." | 20 minutes |
| Durham |
| North Carolina |
| 27705 |
| United States |
| 18451756 | Background | Centers for Disease Control and Prevention (CDC). Syncope after vaccination--United States, January 2005-July 2007. MMWR Morb Mortal Wkly Rep. 2008 May 2;57(17):457-60. |
| 15157261 | Background | Hanson SA, France CR. Predonation water ingestion attenuates negative reactions to blood donation. Transfusion. 2004 Jun;44(6):924-8. doi: 10.1111/j.1537-2995.2004.03426.x. |
| 17655598 | Background | Newman B, Tommolino E, Andreozzi C, Joychan S, Pocedic J, Heringhausen J. The effect of a 473-mL (16-oz) water drink on vasovagal donor reaction rates in high-school students. Transfusion. 2007 Aug;47(8):1524-33. doi: 10.1111/j.1537-2995.2007.01293.x. |
| 12239256 | Background | Soteriades ES, Evans JC, Larson MG, Chen MH, Chen L, Benjamin EJ, Levy D. Incidence and prognosis of syncope. N Engl J Med. 2002 Sep 19;347(12):878-85. doi: 10.1056/NEJMoa012407. |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |