Seroprevalence of Pertussis Among Healthy Children and Adolescents in Kazakhstan: A Cross-Sectional Study
Conditions: Pertussis
Sponsor: Scientific and practical center of sanitary and epidemiological expertise and monitoring

 
1 
 
STUDY PROTOCOL 
 
 
 
 
 
Official Title of the study: 
 
«Seroprevalence of Pertussis among Healthy Children and Adolescents in 
Kazakhstan: A Cross-Sectional Study» 
 
Date of the document: October 09, 2020 
 
NCT number: n\a  
Internal Sanofi Pasteur Study Code: PER00075 
 
Scientific organization: Scientific and practical centre of sanitary and 
epidemiological expertise and monitoring, Almaty, Kazakhstan 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
2 
 
Contents 
1 
Synopsis .............................................................................................................................................................. 3 
1. 
Introduction ....................................................................................................................................................... 6 
2. 
Study goals and objectives ........................................................................................................................... 7 
Primary Objective ................................................................................................................................................. 7 
Secondary Objectives ........................................................................................................................................... 7 
Exploratory objectives .......................................................................................................................................... 7 
3. 
Outcomes ........................................................................................................................................................... 7 
4. 
Study design and methodology ................................................................................................................... 7 
4.1. 
Study design and setting ....................................................................................................................... 7 
4.2. 
Study population ...................................................................................................................................... 7 
Inclusion criteria ................................................................................................................................................... 7 
Exclusion criteria ................................................................................................................................................... 7 
Missing information .............................................................................................................................................. 8 
4.3. 
Sample size considerations .................................................................................................................. 8 
Sample Size for Frequency in a Population .......................................................................................................... 8 
5. 
Study procedures ............................................................................................................................................ 9 
5.1. 
Study Sites ................................................................................................................................................ 9 
5.2. 
Specimen and Data collection .............................................................................................................. 9 
5.3. 
Monitoring procedures ......................................................................................................................... 10 
5.4. 
Data handling .......................................................................................................................................... 10 
6. 
Laboratory methods ...................................................................................................................................... 11 
6.1. 
Laboratory procedure ........................................................................................................................... 11 
6.2. 
Cut-off definition. ................................................................................................................................... 11 
6.3. 
Quality control and monitoring procedures ................................................................................... 12 
7. 
Statistical analysis ........................................................................................................................................ 12 
8. 
Administrative and regulatory requirements ......................................................................................... 13 
8.1. 
Administrative data handling ............................................................................................................. 13 
Study documents and retention of records ....................................................................................................... 13 
Data Quality Assessment .................................................................................................................................... 13 
8.2. 
Ethics and regulatory ............................................................................................................................... 13 
Compliance to Law ............................................................................................................................................. 14 
Data Protection ................................................................................................................................................... 14 
9. 
Communication and publication ............................................................................................................... 14 
References ................................................................................................................................................................ 15 
Appendices ............................................................................................................................................................... 17 
 

 
3 
 
 
1 
Synopsis 
Study Sponsor 
Scientific and practical centre of sanitary and epidemiological expertise and 
monitoring 
Title of the study 
Seroprevalence of pertussis among older children and adolescents in 
Kazakhstan: A cross sectional study 
Vaccines 
or 
disease 
area 
Pertussis - Whooping cough 
Planned study period 
January 2021 - October 2021 
Background and 
rationale 
 
Pertussis due to infection with Bordetella pertussis (B pertussis) is a well-known 
cause of persistent cough primarily affecting infants and young children. 
Repeated administration of the vaccine is often needed to reduce the disease 
burden and control its transmission. At this time, no data are available on the 
epidemiology of pertussis in adolescents and adults in Kazakhstan. 
The aim of the present study is to estimate the prevalence of pertussis infection 
in different age groups in Kazakh children and adolescents using the anti-
pertussis toxin (PT) antibodies (IgA and IgG) as specific marker of pertussis 
infection or vaccination. The serosurvey will be conducted in 4 different regions: 
Aktobe, Karaganda, Taldykorgan, and Shymkent.  
Objectives 
Primary Objective: 
To describe the distribution of anti-pertussis toxin (PT) antibodies (IgA and IgG) 
in a population aged 10-18 years old according to sociodemographic 
characteristics, vaccination history, and risk factors of pertussis infection. 
Study design 
Cross-sectional  
Inclusion and exclusion 
criteria 
 
Inclusion criteria: 
10-18 years old  
•   Informed consent obtained from parents or guardian(s) and assent from patient. 
•   Enrollment following a visit at the study center. 
•   Documented vaccination history 
Exclusion criteria: 
•   ≤10 years and ≥ 19 years 
•   Pertussis immunization during the last 12 months 
•   No informed consent obtained from one parent or guardian. 

 
4 
 
•   Immunocompromised patients 
•   Patients with acute infectious diseases 
Study procedures 
 
Participants (≥ 10 years & < 19 years) attending the study centres will be asked to 
participate in the study. The adolescent participants and the parents/guardian(s) of all 
participants will be informed about the procedures and data handling. Written informed 
consent from one parent/guardian needs to be obtained by the physician before any 
blood samples can be taken. 
Upon obtaining informed consent for participant parent/guardian, the study coordinator 
will complete an investigation form (IF) for each participant and collect serum samples. 
The specimens will be coded by a unique participant number and delivered to the 
laboratory in charge of the assay. The specimens will be used for serological analyses.  
The study will be approved by the Ethics Committee of the Scientific and practical centre 
of sanitary and epidemiological expertise and monitoring. 
Monitoring procedures: 
Completed IFs, Informed Consent Forms, copies of laboratory and clinical data will be 
stored in the study center. Each IF will be coded with a unique identification code. The 
study team will check the IFs for completeness and consistency and resolve queries.  
Data analysis 
The mean of antibodies of antiPT will be described and variability measurements 
(standard deviation and inter quartile range). The seroprevalence of pertussis will be 
described using proportions. Correlation between IgG and IgA levels and risk factors will 
be analyzed by multivariable regression. A two-tailed P-value of ≤ 0.05 will be 
considered for statistical significance. 
Study report and 
communication plan 
An intermediary and final reports will be prepared summarizing the study results. The 
results will also be published in an (inter)national conference and in a peer-reviewed 
journal. 
 

 
5 
 
 
List of abbreviations 
 
Bp 
 
 
Bordetella pertussis   
°C  
 
 
Degrees Celsius 
CI  
 
 
Confidence Interval 
DTP 
 
 
Diphtheria, tetanus, pertussis vaccine 
ELISA   
 
Enzyme-linked immunosorbent assay 
ICH 
International Conference on Harmonization of Technical Requirements for 
Registration of Pharmaceuticals for Human Use 
PCR 
 
 
Polymerase Chain Reaction 
PT 
 
 
Pertussis Toxin 
SD 
 
 
Standard Deviation 
Tdap   
 
Tetanus, diphtheria, acellular pertussis vaccine 
  

 
6 
 
 
1. Introduction 
Pertussis infection with Bordetella pertussis (Bp) is a well-known cause of persistent cough primarily 
affecting infants and young children. Pertussis immunization programs designed to protect infants and 
young children resulted in a dramatic decline of pertussis incidence but not in its elimination [1,2]. 
Endemicity of the disease is due to waning of immunity against pertussis of vaccinated population either 
with whole cell or acellular pertussis vaccines [3]. The absence of repeated boosting of the protective 
immunity is known to cause an increase of the risk of infection and increased transmission to 
unprotected infants [4–6]. In Kazakhstan, the childhood routine vaccination covers children until the age 
of 6 years old with a schedule containing the primary series and two booster doses at 18 months and 6 
years old. Adolescents receive a booster dose of tetanus and diphtheria only without pertussis. It has 
been shown that pertussis is circulating among adolescents and adults, which contributes to the overall 
burden, and importantly furthers the transmission dynamic of the disease to other age groups.  
Currently, little data are available on the epidemiology of pertussis beyond the pediatric population in 
Kazakhstan. Risk of pertussis infection may be assessed to justify the need of repeated booster in the 
appropriate age among adolescents.  
Population-based or cross-sectional sero-epidemiology studies offer an appropriate approach to 
estimating a proxy of the risk of pertussis infection [9,10]. Sero-survey studies, using a standardized and 
reproducible serological test measuring the IgG and IgA pertussis toxin by ELISA, give an estimate of 
recent infection specific to Bordetella pertussis.  
Data using standardized methods to assess the serum anti-PT IgG and IgA levels are currently available 
in several developing and developed countries providing means of estimating the prevalence of recent 
infection in the targeted population [8,10–16]. These estimates are dependent on the calculated cut-offs 
used to define recent exposure. Using these prevalence estimates and mathematical models, annual 
sero-incidences can be extrapolated to assess the risk of pertussis infection, and results [16].  
  
 
 
 
 
 
 
 
 
 
 
 
 

 
7 
 
2. Study goals and objectives 
The aim of the present study is to estimate the seroprevalence of pertussis infection in a population aged 
10-18 years old in the cities of Aktobe, Karaganda, Taldykorgan, and Shymkent using the anti-PT IgG 
and IgA antibodies as specific marker of pertussis infection or vaccination in children and young 
adolescent. 
Primary Objective 
• 
To estimate the prevalence of recent infection Bp infection, using increased anti-PT antibody 
levels as markers of Bp infection in the serology test.  
Secondary Objectives 
• 
To evaluate the risk factors associated with higher seroprevalence of pertussis.  
Exploratory objectives 
• 
To evaluate the compliance with recommended vaccination schedule in study participants 
3. Outcomes 
• 
The anti-PT IgG and Ig A concentrations (in IU/ml) in the population sample.  
• 
The prevalence of recent Bp infection in the test in the selected population sample stratified by 
demographic and socio-economic criteria, vaccination history, and risk of infection.  
• 
Adherence to vaccination status defined as the. number and timeliness of doses received and 
potential exposure to booster vaccination as well as the concordance with the Kazakh 
vaccination status 
 
4. Study design and methodology 
4.1. Study design and setting 
This study will be a cross-sectional serosurvey of anti-PT levels in a sample of the population. The study 
will be conducted in the cities of Aktobe, Karaganda, Taldykorgan, and Shymkent. Enrolment will be 
done in health centres and paediatric hospitals. 
4.2. Study population 
Participants will be children and adolescents from 10 to 18 years of age, recruited from health centers 
and pediatric hospitals.  
Inclusion criteria 
The inclusion criteria for the population sample are: 
• 
Age ≥ 10 years and < 19 years. 
• 
Informed consent obtained from parents or guardian(s) and assent from patient. 
• 
Enrollment following a visit at the study center. 
• 
Documented vaccination history 
Exclusion criteria  
Potential study participants will be not eligible for inclusion in the study according to the following criteria: 
• 
Patient age less than 10 years or greater than 19 years old. 

 
8 
 
• 
No informed consent obtained from parent or guardian 
• 
More than five doses of pertussis vaccination in vaccination history. 
• 
Institutionalized children 
• 
Immunocompromised patients 
• 
Patients with acute infectious diseases 
Missing information  
Patients with missing information will be excluded from the main analysis  
• 
Missing information on the vaccine status (type of vaccine, number of doses and age of 
immunization) 
• 
Missing relevant medical information 
• 
Missing laboratory results 
The characteristics of individuals with missing key information will be compared to included study 
population.  
4.3. Sample size considerations 
In this study, the target sample size is 554 participants to see a prevalence of 10% ± 5% in 4 different 
regions, Box 1.   
Sample Size for Frequency in a Population 
Population size(for finite population correction factor or fpc)(N): 
1000000 
Hypothesized % frequency of outcome factor in the population (p): 10%+/-5 
Confidence limits as % of 100(absolute +/- %)(d): 
5% 
Design effect (for cluster surveys-DEFF): 
4 
Sample Size(n) for Various Confidence Levels 
ConfidenceLevel(%) 
Sample Size 
 
95%
554 
 
80%
237 
 
90%
390 
 
97%
679 
 
99%
956 
 
99.9%
1559 
 
99.99%
2180 
Equation 
Sample size n = [DEFF*Np(1-p)]/ [(d2/Z21-α/2*(N-1)+p*(1-p)]   
 
Results from OpenEpi, Version 3, open source calculator--SSPropor 
Print from the browser with ctrl-P 
or select text to copy and paste to other programs. 
Box. 1 Sample size calculation (OpenEpi®:  Dean AG, Sullivan KM, Soe MM. OpenEpi: Open Source Epidemiologic Statistics for 
Public Health, Version. www.OpenEpi.com, updated 2013/04/06) 
 
 
 
 
 

 
9 
 
5. Study procedures 
5.1. Study Sites 
For this study, we will choose the main directorates in the cities of Kazakhstan (Aktobe, Karaganda, 
Taldykorgan, and Shymkent). 
• 
For each directorate 4 pediatric hospitals and 8 policlinics. 
• 
From each hospital 50 samples will be taken (each age for 10 samples). 
• 
From each policlinic, 40 samples will be taken (each age for 10 samples). 
• 
Total 520 samples in age from 10 to 18 will be taken during the study. 
The table below shows more clearly the sample size that will be taken. 
 
Table 1. Site name and sample size 
Site name 
Location 
Age coverage 
Sample size 
Comment 
4 Pediatric Hospitals 1 pediatric hospital 
in each city (Total: 4 
hospitals)  
10-14 years 
200 samples (50 
samples from 
each hospital) 
In each hospital 
10 samples from 
each age (10, 11, 
12, 13, 14 y) 
8 Health Centers 
2 policlinics in each 
city (Total: 8 
policlinics) 
15-18 years 
320 samples (40 
samples from 
each policlinic) 
In each policlinic 
10 samples from 
each age (15, 16, 
17, 18 y) 
Total: 
12 sites 
10-18 years 
520 samples 
~60 samples in 
each age (10, 11, 
12, 13, 
14,15,16,17,18 y) 
 
5.2. Specimen and Data collection 
After receiving of an informed consent from the child’s legal representative, the study coordinator (HCP) 
in the medical organizations will take a blood sample by venipuncture – approximately 3-5 ml of whole 
blood. Blood samples will be sent to the laboratories of the National Centers of Expertise, Control and 
safety of goods and services (cities Aktobe, Karaganda, Taldykorgan, Shymkent). Serum separation will 
be done within 24-48 hours of blood collection. The samples will be transferred to the reference 
laboratory of Scientific-Practical Center of Sanitary-Epidemiological Expertise and Monitoring (NPC 
SEEM) in Almaty, Kazakhstan. Samples will be delivered within one week in a frozen form following the 
cold chains requirements. Serum samples will be stored in the reference laboratory at a temperature of -
20o C. 
Simultaneously with collecting the biological sample, the study coordinator will fill the IF to collect the 
demographic, socioeconomic, and clinical characteristics of each participant.  
The following list of variables must be collected for all participants unless refusal to provide the 
information by the participant or the parent or guardian  

 
10 
 
 
Demographics  
Household 
information 
Clinical history* 
Risk factors*  
Vaccination 
status 
Age 
Sex 
Residence  
Hospital or health 
center 
Sick sibling or 
parent in 
household  
Confirmed 
diagnosis of 
parents 
Suspected cases  
Cough, wheezing, 
cyanosis, and 
vomiting 
Passive cigarette 
exposure 
Other recent or 
chronic 
respiratory 
disease 
Recent antibiotic 
use (past month) 
Other chronic or 
medical condition 
Participant 
vaccination 
history 
Household 
vaccination 
history  
 
The study coordinator will also enter the vaccination history in the investigation form based on participant 
vaccination registry/record. In absence of vaccination registry or record, parents or guardians of the 
participating individual will be asked on the vaccination status. 
The study coordinator will collect a blood sample and assign the study code.  
 
5.3. Monitoring procedures 
All members of the study center involved in the study, will attend a training session at the study center, 
led by the study team. Training will include study procedures and methods of data collection. During the 
training session, they will receive a study start-up kit including study information (i.e., protocol, 
investigation form, informed consent forms and other study forms or study manuals/guidelines). 
Investigation forms will be coded with the participant unique study number. Every investigation form will 
be labeled with the same identification code as for the biological samples and checked for completeness 
and consistency. Each investigation form will be stored at NPC CEEM of MoH in Kazakhstan. Likewise, 
the informed consent forms of the study participants will be also stored at NPC CEEM of MoH in 
Kazakhstan. All forms will be stored in a locked cabinet. Only study team members will have direct 
access to these forms.  
 
5.4. Data handling 
Each focal site and laboratory will return the resolved and signed IFs to the study team. Data entry will 
be performed centrally by the study team into a relational database specifically designed for the study. In 
the study database, participant data from the investigation form and laboratory results will be stored for 
each participant using the same participant identifier.  
 
 
 

 
11 
 
6. Laboratory methods 
Pertussis antibody testing will be conducted at the Reference Laboratory in NPC CEEM of MoH in 
Kazakhstan. This laboratory is a member of the regional laboratories network for diagnosis of polio, 
measles, rubella and influenza. The Laboratory is accredited by the WHO for microbiology research and 
participates in external quality assessment programs with the WHO collaborating centers for ELISA and 
molecular genetic methods. 
 
6.1. Laboratory procedure  
In order to describe the distribution of anti PT antibodies, serum samples will be taken and tested for 
antibodies to pertussis toxin (PT) by enzyme-linked immunoassay (ELISA) using the SAVYON 
SeroPertussisTM kits (Savyon Diagnostics Ltd, Israel).   
 
6.2. Cut-off definition. 
Cut-off: According to recent literature and recommendations from reference laboratories across the EU, 
Savyon Diagnostics recommends the following interpretation of results for IgG concentrations:  
IgG IU/ml 
IU/ml 
Result Interpretation 
<40 IU/ml 
Negative 
No 
indication 
for 
an 
acute 
Infection 
 ≥40 to <100 IU/ml 
Intermediate 
Possible infection; re-test IgG in 
2-4 weeks or test for IgA levels 
≥ 100 IU/ml 
Positive 
 
Indication for an acute infection 
or recent contact (in absence of 
recent vaccination) 
 
IgA Cut-off: According to recent literature and recommendations from reference laboratories across the 
EU (16, 17), Savyon Diagnostics recommends the following interpretation of results: 
IgA IU/ml 
Result 
<12 IU/ml 
Negative 
>12 IU/ml 
Positive 
   
IgG/IgA antibody profiling: In order to achieve a comprehensive antibodies profile, Savyon Diagnostics 
recommends testing IgA levels: 
IgG 
IgA 
Interpretation 
 
Negative 
 
Negative 
No indication of B. pertussis infection 
(see test limitations) 
Intermediate 
Negative 
No recent infection 

 
12 
 
Intermediate or Negative 
Positive 
Indication of recent infection 
Positive 
Negative or Positive 
Indication of recent infection 
 
See Appendices for further details in the provider package inserts.  
 
6.3. Quality control and monitoring procedures 
The use of control samples in laboratory studies is aimed at identifying unacceptable random and 
systematic errors at the analytical stage of the study. The result of the measurement of the control 
sample is used to estimate the measurement error of the laboratory indicator in the studied samples. The 
principle of conducting laboratory quality control for enzyme immunoassay: each time the test is run, 3 
measurements of the same control material are taken with the patient's serum samples, and the results 
of these measurements are entered into the Shewhart control card. As a control sample, an 
interlaboratory standard is used, which (unlike international or national standards) can be prepared in the 
laboratory independently. 
 
7. Statistical analysis  
This is a cross-sectional sero-survey study in a population sample aged ≥ 10 and < 19 years of age. The 
data will be analysed descriptively. The database will contain several sections with different variables: for 
demographic, socio-economic, vaccination status, and infection risk factors.  The questionnaires will be 
grouped by grade and section to facilitate data entry. Information from the questionnaires will be entered 
into an online form created using Google Forms by specialists in 4 regions. Input inconsistencies found 
will be corrected by rechecking the relevant questionnaires until a clean database will be received. The 
data will be validated according to a logical sequence of questions. For this purpose, prime frequencies 
will be calculated for all variables, allowing inconsistencies and incomplete information to be detected. 
Any discrepancies found will be discussed by the principal investigators to determine the action to be 
taken, and changes will be made by a single data scientist. This completes the data cleansing process. 
EpiInfo 7 software for Windows will be used to calculate simple averages and frequencies, taking into 
account a confidence interval (CI) of 95% and to determine the statistical significance of the results 
obtained (p <0.05). Descriptive statistical tests, proportions and mean will be used to calculate 
demographic and socioeconomic factors, immune status and risk of infection. 
The analysis will be conducted using the Statistical Package for the Social Sciences (SPSS). 
Correlations between age group and anti-RT antibody levels will be analysed using multivariate 
regression or regression splines. Binary and multivariate logistic regression analysis will be used to 
determine the relationship and influence of independent variables on the dependent variable. 
 
 
 

 
13 
 
 
8. Administrative and regulatory requirements 
8.1. Administrative data handling 
Study documents and retention of records 
Study documentation includes all investigation forms, workbooks, laboratory reports, data correction 
forms, 
source 
documents, 
monitoring 
logs, 
sponsor/investigators 
correspondence, 
Ethics 
Committee/regulatory documents (e.g., confidentiality agreement, signed protocol and amendments, 
inventory list, shipping letter, etc.), and any other reports or records of procedures performed in 
accordance with the protocol. Whenever possible, the original recording of an observation should be 
retained as the source document. 
All study documents will be archived for five (5) years by the Principal Investigator at the study center. A 
copy of all CRFs will be archived for five (5) years after the results of the study have been published in a 
peer-reviewed journal. 
Data Quality Assessment 
The investigation form should be provided to all participants to collect demographics and risk factors 
data. Upon consent, all information requested in the investigation form should be completed. The 
Investigators will be responsible for implementing and maintaining quality control and quality assurance 
systems to ensure that the data are recorded in compliance with the protocol, standards of good 
scientific conduct, and all applicable government and local laws. 
 
8.2. Ethics and regulatory 
This is a cross-sectional observational study with no intervention. Thus, the study is not relevant for 
safety assessments of medicines. Information on medicinal products (post-authorization studies) or 
safety reporting will not be performed. However, routine pharmacovigilance will be collected as per the 
regulation in place.  
 As described in the study procedures, written informed consent will be sought from the participants or 
the parents or legal guardians before any samples or data will be obtained. Data on demographics’ 
characteristics including household characteristics and vaccination history will be collected using an IF. 
To obtain approval to conduct this study the protocol will be submitted for approval to the Local Ethical 
Committee.  
The study will meet the following ethical criteria: 
Patient risk: Patients will be subject to minimal risk. Blood draws will be performed only by Kazakhstani 
trained personnel. 
Autonomy: Informed consent and assent will be obtained before study enrollment. 
Benefit: The study provides a public health benefit, as it will provide data that will inform the decision of 
whether Kazakhstani authorities should implement routine booster immunization.  

 
14 
 
Justice: All participants meeting study criteria will be invited to enroll regardless of race, ethnicity, 
gender, socioeconomic status, or other characteristics. 
 
Compliance to Law 
The Investigators agree to conduct the study in an efficient and diligent manner in accordance with this 
protocol and local laws, rules, and regulations including the latest version of the declaration of Helsinki 
(Appendix B), the guidelines of Good Epidemiology Practices (Appendix C), and the International 
Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human 
Use (ICH) regulatory guidelines. The applicable country or local requirements regarding ethical 
committee review, informed consent, and other statutes or regulations regarding the protection of the 
rights and welfare of human subjects participating in biomedical research will be followed. 
The Investigators shall prepare and maintain complete and accurate study documents. Study documents 
will be promptly and fully disclosed by the Investigators upon request and will be made available at the 
Investigators' site upon request for inspection, review, and audit by any regulatory agency 
representatives. 
 
Data Protection  
For data protection purposes, individuals involved in the study processes must ensure the confidentiality 
of the data of the study participants. Furthermore, all must assure compliance with the law on Personal 
Data Protection in Kazakhstan and any further regulations governing the security measures that shall be 
adopted to keep the data confidential. Study subjects will be identified by a unique study number and the 
use of personal names, addresses, phone numbers or any other data that directly identifies the 
participant or his/her family will be avoided. Date of birth will be used to confirm the participant’s current 
age. The sponsor will comply with the existing law regarding data protection in Kazakhstan. 
 
9. Communication and publication  
In the interest of scientific openness and in order to inform the wider medical and scientific community, 
the investigator of the study team are jointly committed to submit for publication to a (inter)national 
conference or a reputable peer-reviewed journal an abstract/manuscript relating to the Study within a 
period of six (6) months following the finalization of the Statistical Analyses. Any publication draft in 
whatever form (manuscript, abstract, or presentation) will be circulated to all investigators of the study 
team for review and to comment on the contemplated publication draft.  

 
15 
 
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17 
 
 
Appendices 
 
Appendix 1. Study questionnaire and data log  
Case report form - 
06May19aa.xlsx  
Appendix 2. Informed Consent Forms 
Written Informed consent must be given to all enrolled participants or to their parent/guardian  
INFORMED 
CONSENT FORM Iraq 
Appendix 3. Declaration of Helsinki  
 
Appendix 4. Good Epidemiological Practices  
 
 
Appendix 5. Savyon Diagnostics Ltd - SeroPetussis® Package Insert   
 
  
SeroPertussis_Toxin
_IgA_1233-01E.V09-0
SeroPertussis_toxin
_IgG_1231-01E.V08-1