Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase 2a, Randomized, Controlled, Observer Blind, Age De-Escalation, Multicenter and Multinational Study of the Safety, Reactogenicity and Immunogenicity of the NVGH Glycoconjugate Vaccine Against S. Typhi in Adults, Children, Older Infants and Infants
Brief Summary: This phase 2 trial is aimed to obtain information on the safety and immunogenicity of the Vi-CRM197 in subjects from various age groups in India and Pakistan where Typhoid Fever is highly endemic and an efficacious vaccine against this disease is very much needed.


Options:
A: Main eligibility criteria:

* Subjects belonging to 4 age groups will be enrolled into the trial: adults (18 to 45 years of age), children (24 to 59 months of age), older infants (9 to 12 months of age at enrollment) and infants (6 weeks of age at enrolment).
* Written informed consent will be obtained by the all subjects or their parents/ guardians (depending on the age group) before enrollment into the trial.
* Only females with a negative pregnancy test and willing to participate in family planning consultations (organized by the site study team) will be allowed to participate to the trial.
* Infants who have been vaccinated with 1 dose of BCG, HBV and OPV at birth can be enrolled into the trial, while infants who have received DTwP+HBV+Hib or OPV due at 6 weeks of age as per local EPI schedule cannot be enrolled into the trial.
B: Inclusion criteria:

* Male or female aged 18 - 60 years inclusive and in good health.
* Have an abdominal ultrasound scan result documented demonstrating no evidence of gallbladder pathology.
* Willing to allow their general practitioner and/or hospital consultant (if relevant) and the Health Protection Unit to be notified of participation in the study.
* Agree to refrain from blood donation in the future if diagnosed with typhoid fever.
* Be willing to have 24-hour contact with study staff during the four weeks post-challenge.

Exclusion Criteria:

* Have previously received any typhoid vaccine, been resident in a typhoid endemic country for over 6 months, been diagnosed with probable or confirmed typhoid infection or been challenged with Salmonella Typhi or enrolled in a typhoid challenge study.
* Have any known or suspected impairment or alteration of immune function.
* History of significant cardiovascular disease.
* History of significant respiratory disease.
* History of significant endocrine disorder.
* History of significant renal or bladder disease.
* History of biliary tract disease.
* History of significant gastrointestinal disease.
* History of significant neurological disease.
* History of significant metabolic disease.
* History of significant haematological diagnosis.
* History of psychiatric illness requiring hospitalisation, current known or suspected drug or alcohol misuse.
* History of significant infectious disease.
* History of non-benign cancer.
* Presence of any implants or prostheses.
* Hypersensitivity to any component of the vaccine or are hypersensitive to two or more of the following antibiotics: ciprofloxacin, azithromycin, ampicillin, trimethoprim sulfamethoxazole.
* Female participant who is pregnant, lactating or who is unwilling to ensure that they or their partner use effective contraception one month prior to vaccination and continue to do so until two negative stool samples obtained a week apart, a minimum of 1 week after completion of antibiotic treatment have been obtained.
* Current occupation involving: clinical or social work with direct contact with young children (defined as those attending pre-school groups, nursery or aged less than 2 years); highly susceptible patients or persons in whom typhoid infection would have particularly serious consequences (i.e. those who are immunocompromised or debilitated); care work involving the elderly.
* Current occupation as a commercial food handler involving the preparation or serving of unwrapped foods not subjected to further heating.
* Household contact with a young child (defined as above).
* Household/close contact who is immunocompromised.
* Scheduled elective surgery or other procedures requiring general anaesthesia during the vaccine/challenge period, at time of enrolment.
* Participants who have taken part in other research involving an investigational product (IMP) within the 30 days prior to enrolment.
* Have received blood, blood products and/or plasma derivatives including parenteral immunoglobulin preparations in the previous 3 months
* Any other significant disease or disorder which, in the opinion of the investigator, may put the participants at risk because of participation in the study, may influence the result of the study, or affect the participant's ability to participate in the study.
C: Inclusion Criteria:

* Registered in the project census
* Age \>=2 years
* Provide informed consent to receive vaccine

Exclusion Criteria:

* Fever (\>37.5 degrees Celsius)
* Pregnancy
* Lactating
D: Inclusion Criteria:

1. Males and females of age ≥18 to ≤40 years.
2. Individuals who, after the nature of the study have been explained to them, have given written consent according to local regulatory requirements.
3. Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.
4. Individuals with negative urine screening tests for drug addition (Opiate, Cocaine, Amph/Metamphetamine, Cannabinoides )
5. If women, use of birth control one month before study start, a negative pregnancy test and willingness to use birth control measures for the entire study duration.

Exclusion Criteria:

1. Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the subject's ability to participate in the study.
2. Individuals with any progressive or severe neurological disorder, seizure disorder or Guillain-Barré syndrome.
3. Individuals who are not able to understand and to follow all required study procedures for the whole period of the study.
4. Individuals with history of any illness that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study.
5. Individuals with known or suspected HIV infection or HIV related disease, with history of an autoimmune disorder or any other known or suspected impairment /alteration of the immune system, or under immunosuppressive therapy including use of systemic corticosteroids or chronic use of inhaled high-potency corticosteroids within the previous 30 days, or were in chemotherapy treatment within the past 6 months.
6. Individuals with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
7. Individuals with any serious chronic or progressive disease according to judgment of the investigator (e.g., neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease).
8. Individuals who have any malignancy or lymphoproliferative disorder.
9. Individuals with history of allergy to vaccine components.
10. Individuals participating in any clinical trial with another investigational product 30 days prior to first study visit or intent to participate in another clinical study at any time during the conduct of this study.
11. Individuals who have previously received any vaccines against typhoid fever (either oral live attenuated or injectable vaccines).
12. Individuals who received any other vaccines within 4 weeks prior to enrolment in this study or who are planning to receive any vaccine within 4 weeks from the study vaccine.
13. Individuals who have received blood, blood products and/or plasma derivatives including parenteral immunoglobulin preparations in the past 12 weeks.
14. Individuals who are part of study personnel or close family members to the personnel conducting this study.
15. Individuals with body temperature \> 38.0 degrees Celsius within 3 days of intended study immunization.
16. BMI \> 35 kg/m2.
17. Individuals with history of substance or alcohol abuse within the past 2 years.
18. Women who are pregnant or breast-feeding or of childbearing age who have not used any birth control measure one month prior to study start or do not plan to use acceptable birth control measures, for the duration of the study.
19. Females with history of stillbirth, neonatal loss, or previous infant with anomaly.
20. Individuals who have a previously ascertained or suspected disease caused by S. Typhi.
21. Individuals who have had household contact with/and or intimate exposure to an individual with laboratory confirmed S. Typhi.
22. Any condition which, in the opinion of the investigator may interfere with the evaluation of the study objectives.

Answer: A