No scripts included (appendix 3-4) 

Evaluating SARS-CoV-2 Vaccine Effectiveness 

Among Health Care Personnel During Early 

Phase Vaccination 

Protocol Version: October 9, 2020 

COVID-19 Response Vaccine Task Force, 

Centers for Disease Control and Prevention 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

No scripts included (appendix 3-4) 

Table of Contents 

INTRODUCTION ............................................................................................................................................ 1 

Key Personnel and Partners......................................................................................................................1 

Funding ..................................................................................................................................................... 2 

Objectives ................................................................................................................................................. 2 

METHODS ..................................................................................................................................................... 2 

Design........................................................................................................................................................ 2 

Participating healthcare facilities.............................................................................................................. 3 

Key definitions .......................................................................................................................................... 3 

Healthcare personnel (HCP):................................................................................................................. 3 

HCP case:............................................................................................................................................... 3 

HCP non-case: ....................................................................................................................................... 4 

Additional notes regarding HCP eligibility for inclusion: ...................................................................... 4 

Case and non-case finding, non-case selection, and compensation ........................................................ 5 

Data collection .......................................................................................................................................... 6 

Initial interview and HCP interview report form (IRF): ......................................................................... 6 

Follow-up interview: ............................................................................................................................. 7 

Medical record review: ......................................................................................................................... 7 

Sample size................................................................................................................................................ 8 

Data management .................................................................................................................................... 9 

Healthcare personnel privacy and confidentiality....................................................................................9 

Analysis ..................................................................................................................................................... 9 

PROJECT TIMELINE (preliminary and subject to change)..........................................................................10 

HUMAN SUBJECTS RESEARCH REVIEW..................................................................................................11 

REPORTING AND PUBLICATION .................................................................................................................11 

REFERENCES................................................................................................................................................12 

APPENDICES................................................................................................................................................13 

Appendix 1: Example of a weekly line list for HCP cases and non-cases ...............................................14 

Appendix 2: Interview report form (see attachments) ..........................................................................15 

Appendix 3: Proxy form (see attachment) .............................................................................................15 

Appendix 4: Medical Record Review form (see attachment) ................................................................15 

Appendix 5: Vaccination Record Review form (see attachment)...........................................................15 
 

 

 

 

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No scripts included (appendix 3-4) 

INTRODUCTION 

Since the World Health Organization was first notified of a cluster of respiratory infections in 

Wuhan City, China on December 31, 2019 [1], the novel coronavirus, SARS-CoV-2, has caused more than 

7,500,000 infections and 211,000 deaths in the United States and more than 35,000,000 infections and 

1,000,000 deaths worldwide as of October 7, 2020. Overall, 20–30% of cases in the United States have 

required hospitalization[2], resulting in substantial burden on healthcare personnel (HCP) and U.S. 

healthcare systems. 

Healthcare personnel (HCP) are at risk of contracting SARS-CoV-2 during their interactions with 

patients with suspected or confirmed infection with SARS-CoV-2 (COVID-19) or patients with 

unrecognized infection[3]. A key component of controlling the pandemic and protecting the U.S. 

healthcare workforce is deployment of a safe and effective SARS-CoV-2 vaccine. Evaluating the 

effectiveness soon after introduction of vaccine is a routine public health activity aimed to inform any 

revision of vaccine recommendations based on real-world experience in the early period of vaccine 

availability. Multiple vaccines are currently being evaluated in clinical trials. In the U.S., vaccines are 

expected to become available in limited supply starting November or December of 2020. SARS-CoV-2 

vaccines are expected to be distributed during early phases of introduction to front-line HCP. This early 

phase distribution of one or more vaccines provides an opportunity to evaluate the effectiveness of 

these vaccines in preventing symptomatic COVID-19 and to learn how these vaccines work in a realworld setting before widespread distribution to the general public but after favorable Phase III results 

are released. 

Key Personnel and Partners 

• Centers for Disease Control and Prevention: 

Principal investigator = Tamara Pilishvili, PhD MPH 

Coordinator = Ryan Gierke, MPH 

Co-investigators: 

 Katherine Fleming-Dutra, MD MPH 

 Jennifer Farrar, MPH 

• Emerging Infections Program sites (https://www.cdc.gov/ncezid/dpei/eip/index.html) 

• Project COVERED sites (https://medicine.uiowa.edu/emergencymedicine/research/covidevaluation-risk-emergency-departments-covered-project/study-overview) 
 

 

 

 

 

 

 

VE Evaluation among Healthcare Personnel_20201009 

• Safety and Healthcare Epidemiology Prevention Research Development (SHEPheRD) Program 

organizations (https://www.cdc.gov/hai/research/safehealthcare.html) 

Funding 

Partners are supported by CDC through cooperative agreements (Emerging Infections Program, 

Project COVERED) or through contracts (SHEPheRD). 

Objectives 

Primary: 

1) Evaluate post-introduction effectiveness of a complete schedule of the SARS-CoV-2 vaccine in 

preventing laboratory-confirmed symptomatic COVID-19 among HCP. 

Secondary: 

1) Evaluate post-introduction effectiveness of the SARS-CoV-2 vaccine in preventing severe disease 

among HCP with laboratory-confirmed symptomatic COVID-19; 

2) Evaluate effectiveness by HCP age groups and in subgroups with comorbidities; 

3) Evaluate effectiveness by various groups of HCP job categories and clinical practice settings; 

4) Evaluate effectiveness by vaccine product (if more than one product is in use) and for a single 

dose (if a 2-dose schedule is recommended). 

METHODS 

Design 

This project will be completed using a multisite test-negative case-control design in HCP over a 

period of a 6-month period or longer, depending on vaccine uptake and sample size needs. This study 

design has been well described in influenza vaccine evaluation, and it can be used in post-introduction 

vaccine evaluation for SARS-CoV-2 [4]. Sites will collaborate with occupational health clinics in 

participating healthcare facilities to identify HCP at the time of SARS-CoV-2 testing or to receive line lists 

of HCP who have already been tested. Cases and non-cases will be defined based on results of SARSCoV-2 testing, and detailed information on demographics, illness, exposures for SARS-CoV2, and medical 

and vaccination history will be collected via HCP interview. 

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VE Evaluation among Healthcare Personnel_20201009 

Participating healthcare facilities 

Selection of healthcare facilities to participate is at the discretion of the project partners, 

although partners should seek to engage healthcare facilities with healthcare workforces that provide 

geographic, socioeconomic, racial and ethnic diversity. Healthcare facilities that may participate in the 

project include (but are not limited to) hospitals, emergency departments, long-term care facilities, or 

outpatient clinics. 

Key definitions 

Healthcare personnel (HCP): 

HCP refers to all paid and unpaid persons serving in healthcare settings who have the potential for direct 

or indirect exposure to patients or infectious materials, including: 

• body substances 

• contaminated medical supplies, devices, and equipment 

• contaminated environmental surfaces 

• contaminated air 

For example, this includes any employee or contractor of a healthcare facility such as staff physicians, 

resident physicians, advanced practice providers (PA/NP), nurses, patient care technicians/nursing 

assistants, pharmacists, social workers, respiratory therapists, physical therapists, clerks and 

administrative staff, security personnel, dieticians, cafeteria staff, environmental services/custodial 

staff, managers and administrators, research staff, volunteers, transport, and health sciences students 

(medical, nursing, pharmacy, dentistry, or others, as available). HCP of any job classification in any 

department of participating healthcare facilities will be eligible for enrollment, regardless of exposure to 

patients or vaccination status. 

HCP case: 

A HCP case is defined as a HCP with ≥ 1 positive SARS-CoV-2 test result during the project period, with 

or without known exposures in healthcare or community settings. The presence of symptoms is not 

included in the case definition; HCP who test positive for SARS-CoV-2 are considered cases regardless of 

whether they are symptomatic or asymptomatic. However, during the HCP interview, clinical signs and 

symptoms of illness will be captured during the period of time ranging from 14 days before to 14 days 

after the positive SARS-CoV-2 test collection date to distinguish symptomatic from asymptomatic 

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VE Evaluation among Healthcare Personnel_20201009 

infections. A “positive SARS-CoV-2 test” includes reverse transcriptase (RT)-PCR or antigen tests 

performed on nasal or oral swabs (or similar upper respiratory specimen types, including saliva), sputum 

or other lower respiratory secretions. 

Note regarding HCP cases with recurrent or repeat positive tests for SARS-CoV-2: HCP cases who are 

subsequently identified as having had collection of a positive SARS-CoV-2 RT-PCR or antigen test at least 

60 days after the symptom onset date or (if asymptomatic) after the first positive RT-PCR or antigen test 

collection date of the prior SARS-CoV-2 infection during the project period are not eligible for reinclusion in this VE evaluation. 

HCP non-case: 

A HCP non-case is defined as a symptomatic or asymptomatic HCP who tested negative for SARS-CoV-2 

with or without known exposures in healthcare or community settings. A negative test for SARS-CoV-2 is 

defined as an RT-PCR test performed on nasal or oral swabs (or similar upper respiratory specimen 

types, including saliva), sputum or other lower respiratory secretions. Negative antibody tests are NOT 

included in the non-case definition. Negative antigen tests alone, WITHOUT a confirmatory negative RTPCR test, are NOT included in the VE non-case definition. 

Additional notes regarding HCP eligibility for inclusion: 

• Because HCP may have multiple tests for SARS-CoV-2 over time, it is possible for a HCP non-case 

to be selected randomly for inclusion multiple times (based on multiple negative tests) during 

the course of the investigation. 

• A HCP non-case who reported symptoms consistent with SARS-CoV-2 infection (despite having a 

negative test) during their interview is NOT ELIGIBLE to be included again in the project as a 

non-case until those symptoms have been resolved for at least 4 weeks. 

If a HCP non-case is selected again for inclusion as a non-case later during the project 

period, project staff should review the initial interview form to determine whether the 

non-case had symptoms at that time. When contacting the HCP non-case to re-interview 

them, project staff should first talk with the HCP non-case to determine when the 

previous illness resolved before proceeding with the full interview. If the illness did not 

resolve at least 4 weeks prior to the re-interview, the HCP non-case is not eligible for reinclusion. 

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VE Evaluation among Healthcare Personnel_20201009 

• HCP who were included as non-cases and later test positive for SARS-CoV-2 may be included as 

cases. However, once a HCP has met the case definition by testing positive for SARS-CoV-2 

infection, that HCP is no longer eligible to be included in the project as a non-case. 

• HCP who participated in a COVID-19-related vaccine trial may be included, but detailed 

information about enrollment and vaccine allocation will be required. 

• HCP who were unable to confirm test results using an acceptable method will be excluded 

Case and non-case finding, non-case selection, and compensation 

Case and non-case finding may vary by project partner and by healthcare facility. Project staff 

may need to work directly with a healthcare facility’s occupational health department to obtain the 

names, contact information and test results for all HCP who have been tested for SARS-CoV-2 (see 

Appendix 1 for an example of variables to be included in the line list). Project staff will seek to minimize 

the burden on healthcare facility staff to the extent possible. 

Other options for identification of HCP cases and non-cases that may be utilized by participating 

healthcare facilities include (but are not limited to) the following: 

1) At time of testing – HCP who are tested by the healthcare facility in which they work (for 

example, in the occupational health clinic or a facility-sponsored testing center) can be recruited 

at the time of specimen collection for SARS-CoV-2 RT-PCR or antigen testing; 

2) At time of reporting test results – HCP who report test results to their occupational health 

clinic can be recruited at the time of test result report (must be within 60 days of test collection, 

but after a project site is approved to enroll HCP); or 

3) Through HCP volunteering – Through e-mails, signs posted in staff patient care areas, 

screensavers in medical centers, and other employee-directed communication, HCP who are 

tested outside the health system will be able to submit their test results for participation in the 

project (must be within 60 days of test collection). 

An algorithm will be developed to enroll non-cases from among the eligible non-cases using 

random selection if the non-case accrual exceeds 3 times the cases. 

At the discretion of project partners and according to local policies, HCP cases and non-cases 

may be compensated for their participation in the project. Procedures for compensation may vary 

across project partners depending on local policies. Partners who are already conducting similar HCP 

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VE Evaluation among Healthcare Personnel_20201009 

COVID-19-related projects (such as Emerging Infections Program sites) should ensure comparability in 

HCP compensation across activities. 

Data collection 

Initial interview and HCP interview report form (IRF): 

Data collection should begin as soon as possible following receipt of HCP SARS-CoV-2 test results 

through telephone interviews with HCP cases or non-cases using an IRF (see Appendix 2) or through selfreporting by HCP cases or non-cases using a secure, electronic IRF (e.g., REDCap survey). For the 

purposes of this protocol, “interview” and IRF include telephone interview and IRF completion or 

completion of a self-administered electronic IRF. Each HCP case or non-case will be contacted by project 

staff up to five times to schedule a future time for the interview or to conduct the interview, unless the 

HCP case or non-case requests a call back, or if the HCP case or non-case returns the call from the 

project staff. In these instances, an additional contact attempt (i.e., a sixth call) is permissible. For 

example, if the project staff person makes contact with a HCP on the fifth call attempt, and the HCP 

requests a call back the next day, that will be permitted. Contact with HCP cases and non-cases may be 

via telephone, email or text message at the project partners’ discretion. 

If a HCP case or non-case is unable to be interviewed due to illness or incapacitation, or if the 

HCP case or non-case is deceased, project staff will attempt to interview the HCP’s primary caregiver or 

next of kin who will serve as the HCP’s proxy. Project staff will try to identify the person who is most 

familiar with the HCP’s medical history to serve as the proxy, and state-specific guidelines will be 

followed for determining which individual has legal authority to provide information on behalf of the 

deceased or incapacitated HCP. If appropriate, a proxy will be identified through review of medical 

records (including primary care provider records, where available) or contact with someone living at the 

HCP’s residence. 

Project partners are responsible for ensuring that partner-initiated communications with HCP or 

their proxies comply with applicable privacy and information security standards. Interviews will be 

conducted by partners’ project staff (unless an electronic tool is used). Interviewers will introduce 

themselves and the project using a standard, introductory script. Partners that choose to administer an 

electronic questionnaire will include standard, introductory language via email or text to HCP or their 

proxies. Partners may make minor modifications to the scripts as needed to meet local needs or 

requirements. HCP or their proxies will be informed that their participation is voluntary. 

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VE Evaluation among Healthcare Personnel_20201009 

Variable categories in the IRF include case status, demographics, underlying medical conditions, roles in 

healthcare facilities, workplace and community exposures, household income, education level, medical 

and vaccination history (including vaccines against SARS-CoV-2 and influenza), hospitalizations or 

outpatient visits related to the current illness episode (for symptomatic HCP seeking care), and providers 

from whom the HCP has received vaccinations, including vaccines against SARS-CoV-2. The survey and 

interview will be available to HCP cases and non-cases in English and Spanish. 

Partners’ project staff will obtain verbal or electronic consent from HCP during the initial 

interview to review HCP medical records and vaccination records. 

As with HCP case and non-case identification, partners may choose to implement a variety of 

approaches for determining eligibility, obtaining consent, and collecting data, depending on local 

resources, practices and policies. 

Follow-up interview: 

HCP cases and non-cases who are interviewed <14 days after the collection date of their SARSCoV-2 test and are asymptomatic at that time will be re-contacted 14 or more days after the collection 

date of their SARS-CoV-2 test and the IRF will be updated if they became symptomatic after the initial 

interview and during the 14 days after their test collection date. HCP cases and non-cases who remain 

asymptomatic 14 days after the collection date of their positive SARS-CoV-2 test will not be included in 

VE analyses. 

Medical record review: 

Medical record reviews will be completed for all HCP cases or non-cases who report having 

sought medical care for the current episode of illness as reported on the IRF. Project staff will complete 

a supplemental review of hospital and/or outpatient medical records, as appropriate. An Extended 

Medical Record Review Form (Appendix 6) will be used to abstract information from HCP medical 

records on clinical signs and symptoms of illness, laboratory tests for SARS-CoV-2 (test type, date, 

result), vaccination history, and underlying medical conditions. 

Vaccination history: 

To ensure complete capture of SARS-CoV-2 vaccination history for HCP cases and non-cases, 

project staff will query various sources of information, as appropriate and available at each site, 

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VE Evaluation among Healthcare Personnel_20201009 

 

 

 

 

 

 

 

 

 

 

 

 

including the state Immunization Information System (IIS) and/or a new vaccine tracking platform 

currently in development (known as the Vaccine Administration Management System, VAMS). Project 

partners should attempt to query VAMS, at least during early phases of SARS-CoV-2 vaccine roll-out, to 

record vaccine doses that may not be captured in the IIS until a later point. Project staff may also access 

HCP case or non-case records from vaccine providers (as reported on the IRF from the HCP interview) to 

capture vaccine type, date of administration, lot number, manufacturer and any information associated 

with the vaccination event. Vaccination history will be recorded using a Vaccine record review form 

(Appendix 7). 

Sample size 

Sample size calculations were made using 80% power with a range of precision for VE estimates 

of 0.3–0.6. To generate a range of sample size estimates vaccine coverage was assumed to range from 

30–70% of HCP. To reach 80% power at 30% coverage assuming a VE of 70%, a range of 60–190 SARSCoV-2 cases with 3 non-cases per case will be needed. As the vaccine coverage increases, the number of 

cases required to demonstrate 70% effectiveness decreases (e.g., at 70% coverage, between 30–100 

SARS-CoV-2 cases will be needed to demonstrate a VE of 70%) (Table 1). The number of cases needed 

under each assumption increases with <3 non-cases enrolled per case. Given the short window 

available to assess vaccine effectiveness and to minimize the target number of cases, the goal should be 

to enroll at least 3 non-cases per case to increase power. Enrollment will continue until at least one of 

the following criteria is reached: 1) vaccine coverage among eligible HCP population reaches 80%, or 2) 

the site enrolls the minimum number of cases and non-cases based on sample size estimated given the 

vaccine coverage achieved. 

Project partners may continue enrolling HCP after minimum numbers of cases and non-cases are 

reached if vaccine coverage has not yet exceeded 80%. The optimal time for completing the majority of 

enrollment for the VE evaluation is when vaccine coverage is between 30% and 80% of the included HCP 

population. 

Table 1: Sample Size Estimates for VE Evaluation 

Vaccine coverage 

among HCPs 

Number of HCP cases 

needed if VE=30%* 

Number of HCP cases 

needed if VE=60%* 

Number of HCP cases 

needed if VE=70%* 

30% 160–620 80–280 60–190 

50% 120–460 50–180 35–120 

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VE Evaluation among Healthcare Personnel_20201009 

70% 130–500 45–160 30–100 

*Assuming a 1:3 case: control ratio 

Data management 

Completed IRFs and HCP line lists will be maintained in project partner offices in secure 

locations according to applicable local or state regulations. The project staff will enter data from the IRF 

into a secure, web-based data system, such as REDCap. For partners where the electronic IRF is used, 

data will be first reported to the project partner and have HCPs’ identifiable information removed 

before submitting to CDC. Partners may also submit their data to CDC using a secure data upload 

function through CDC’s Secure Access Management System. Individual-level data will be transmitted to 

CDC on a bi-weekly basis. 

Healthcare personnel privacy and confidentiality 

Project partners are responsible for ensuring that site-initiated electronic communications with 

HCP comply with applicable information security and privacy standards. The CDC data system will also 

comply with applicable information security and privacy standards. Direct personal identifiers such as 

HCP name or contact information (e.g., phone number or email address) will not be transmitted to CDC. 

Analysis 

Data will be aggregated across project partners and healthcare facilities and analyzed at CDC 

using SAS version 9.4 (SAS Institute, Cary, NC) or other appropriate statistical software. Only HCP cases 

who develop symptoms will be included in the VE analysis. HCP cases must meet Criterion 1 or Criterion 

2, below, during a period from 14 days prior to 14 days after test collection date. These criteria were 

developed in consultation with sites to align with U.S. Food and Drug Administration criteria for vaccine 

clinical trials, but they are subject to revision during project startup activities. 

CRITERIA 1. At least ONE of the following respiratory signs/symptoms: 

• Shortness of breath or difficulty breathing; 

• Cough; or 

• Acute respiratory distress syndrome (ARDS). 

CRITERIA 2. At least TWO of the following: 

• Fever (within episode of illness); 

• Myalgia; 

• New olfactory or taste disorder(s); 

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VE Evaluation among Healthcare Personnel_20201009 

• Chills; 

• Rigors; 

• Headache; 

• Sore throat. 

Descriptive analyses will be performed. Characteristics of HCP cases and non-cases will be compared 

using chi-square tests or Fisher’s exact tests (for categorical variables) or median or Wilcoxon rank-sum 

tests (for continuous variables). 

To measure VE, we will calculate the odds ratio for vaccination (receipt of SARS-CoV-2 vaccine 

compared to no vaccine) among cases vs. non-cases, adjusting for potential confounders. Vaccine doses 

received within 14 days before HCP cases’ and non-cases’ SARS-CoV-2 test collection dates will be 

excluded from the analysis. We will estimate VE as follows: 

VE = (1 - adjusted odds ratio for vaccination) x 100% 

The primary analysis will evaluate the effectiveness of 2 doses of SARS-CoV-2 vaccine (if a 2-dose 

schedule is recommended) vs. no vaccine. A secondary analysis will evaluate the effectiveness of any 

vaccine doses vs. no vaccine, or one dose vs. no vaccine. More than one SARS-CoV-2 vaccine may be 

available during early phases of vaccine introduction among HCPs; analysis will be stratified by vaccine 

type. 

We will conduct interim analyses after approximately 3 months of enrollment to evaluate 

vaccine coverage among non-cases. If these analyses suggest that we will not have adequate sample size 

to meet our primary objective, we will consider conducting the evaluation for a longer period. 

PROJECT TIMELINE (preliminary and subject to change) 

● November 1, 2020 (or when SARS-CoV-2 vaccine introduced for HCPs): Enrollment and data 

collection for HCP cases and non-cases begin 

● January–February 2021 (if enrollment started in November): Interim analysis of vaccine 

coverage among VE non-cases; revise sample size estimates and enrollment timelines as needed 

● June 2021 (or after 6 months of enrollment or when sample size is reached): Complete VE 

analysis; report results 

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VE Evaluation among Healthcare Personnel_20201009 

HUMAN SUBJECTS RESEARCH REVIEW 

Project partners and CDC will each seek a determination about whether the project constitutes 

human subjects research. Where necessary, individual participating healthcare facilities will also obtain 

a human subjects determination. In some instances, partners may need to add additional language to 

this protocol to address state- and/or partner- or facility-specific IRB considerations, such as those 

pertaining to HIPAA waivers or waivers of informed consent. Project personnel will ensure that any sitespecific additions to the protocol will not affect the project objectives or data collection content or 

methods. Data generated by this project may be used to inform guidance to healthcare facilities and 

help protect HCP from COVID-19. Data collection will have no impact on the clinical care or work 

activities of participating HCP. 

REPORTING AND PUBLICATION 

CDC and project partner investigators may communicate the results of this project at scientific 

meetings or in publications. Given the urgent nature of the data collection, CDC will provide interim data 

updates to appropriate audiences as needed. Data may be reported in aggregate, across all participating 

partners, or at the level of individual project partners. Data may also be reported by healthcare facility 

type, depending on the numbers of participating facilities. Data may be used in partner, state health 

department, or CDC reports. 

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REFERENCES 

1. Phelan, A.L., R. Katz, and L.O. Gostin, The Novel Coronavirus Originating in Wuhan, China: 

Challenges for Global Health Governance. JAMA, 2020. 

2. Team, C.C.-R., Severe Outcomes Among Patients with Coronavirus Disease 2019 (COVID-19) — 

United States, February 12–March 16, 2020. MMWR Morb Mortal Wkly Rep, 2020. Weekly / 

March 26, 2020 / 69(12);343-346(Weekly / March 26, 2020 / 69(12);343-346). 

3. McMichael, T.M., et al., Epidemiology of Covid-19 in a Long-Term Care Facility in King County, 

Washington. N Engl J Med, 2020. 

4. Fukushima W, Hirota Y. Basic principles of test-negative design in evaluating influenza vaccine 

effectiveness. Vaccine. 2017;35(36):4796-4800. 

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VE Evaluation among Healthcare Personnel_20201009 

APPENDICES 

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 Start date: End date: 

 

 

 

VE Evaluation among Healthcare Personnel_20201009 

Appendix 1: Example of a weekly line list for HCP cases and non-cases 

Week reporting: ____ / ____ / ______ ____ / ____ / ______ 

Reported by: (Name) ______ 

Healthcare Facility: 

DOB Email Job Test type Test result 

RT PCR Symptomatic Positive 

RN Antigen Screening Negative 

14 

Last 

name 

First 

name 

Phone 

number 

Test collect 

date 

Specimen 

type 

Reason for 

test 
Appendix 2: Interview report form (see attachments) 

Appendix 3: Proxy form (see attachment) 

Appendix 4: Medical Record Review form (see attachment) 

Appendix 5: Vaccination Record Review form (see attachment) 

15