A Phase 2 interventional study of Hecolin® Recombinant Hepatitis E Vaccine and Isotonic Sodium Chloride injection in Hepatitis E Virus Infection, sponsored by International Vaccine Institute. Recruiting at 3 sites in South Africa. Open to participants aged 2 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-29.
Sponsored by International Vaccine Institute · Phase 2, Interventional, and Prevention
The primary goal of this clinical trial is to demonstrate non-inferiority of 30 µg of Hecolin® in healthy children, compared to healthy adults as measured by seroresponse rates (SR) of anti-HEV IgG titers, 4 weeks after 3 doses (0, 1 and 6 months) and to assess and descriptively compare safety profile data intra and inter age Strata. As secondary objectives, Geometric Mean Concentration (GMC) of anti-HEV IgG ELISA will be evaluated 4 weeks after 3 doses (0, 1 and 6 months) and 4 weeks after 2 doses (0- and 6-months dose) in healthy children. SR and GMC will also be evaluated 24 weeks after 3 doses and 2 doses. The immune response will be compared among adult participants between HIV positive and HIV negative individuals and between virally suppressed and virally unsuppressed HIV positive individuals
The primary objective of the study is to demonstrate immune non-inferiority of 30 µg Hecolin® when given to healthy children (2-17 years) as compared to healthy adults (18-45 years) as measured by seroresponse rates (SR) of anti- HEV IgG ELISA antibody titers, 4 weeks after the 3 doses given at 0, 1- \& 6-months. Co-primary objective is to assess safety in each age cohort and descriptively compare lower age cohorts with higher age cohorts. Other immune parameters would be assessed as secondary objectives. Healthy children and adolescents collectively (2-17 years) will be compared for immune non-inferiority with healthy adults (18-45 years) as measured by geometric mean concentration (GMC) of anti-HEV IgG ELISA antibody titers, 4 weeks after the 3 doses given at 0, 1- \& 6-months. Among children (2-17 years) 3 doses of Hecolin® given at 0, 1 and 6 months will be compared with 2 doses of Hecolin® given at 1 and 6 months in terms of immune non-inferiority of SR and GMC of anti-HEV IgG ELISA antibody titers. The immune response will be compared between HIV positive and HIV negative adults in terms of SR and GMC as measured by anti-HEV IgG ELISA antibody titers at 4 weeks after completing 3 doses of Hecolin® (0, 1 and 6 months).
A total of 860 participants will be enrolled in the main study and will be divided into 4 age strata; 18-45 years (Cohort A), 12-17 years (Cohort B), 6-11 years (Cohort C) and 2-5 years (Cohort D) having 410, 175, 175 and 100 participants respectively. Cohort A will be further divided into Arm A1 and A2 having 232 HIV -ve and 178 HIV +ve participants respectively. All participants in cohort A will receive intramuscular injection of 3 doses of 30 µg Hecolin® at 0, 1 and 6 months. Cohort B will be further divided into Arm B1, B2 and B3 having 70, 70 and 35 participants respectively. Arm B1 will receive intramuscular injection of 3 doses of 30 µg Hecolin® at 0, 1 and 6 months. Arm B2 will receive intramuscular injection of 2 doses of 30 µg Hecolin® at 0 and 6 months while Arm B3 will receive intramuscular injection of comparator (placebo) intramuscularly at 0, 1 and 6 months. Similarly, Cohort C will be further divided into Arm C1, C2 and C3 having 70, 70 and 35 participants respectively. Arm C1 will receive intramuscular injection of 3 doses of 30 µg Hecolin® at 0, 1 and 6 months. Arm C2 will receive intramuscular injection of 2 doses of 30 µg Hecolin® at 0 and 6 months while Arm C3 will receive intramuscular injection of comparator (placebo) intramuscularly at 0, 1 and 6 months. Cohort D will be further divided into Arm D1, D2 and D3 having 40, 40 and 20 participants respectively. Arm D1 will receive intramuscular injection of 3 doses of 30 µg Hecolin® at 0, 1 and 6 months. Arm D2 will receive intramuscular injection of 2 doses of 30 µg Hecolin® at 0 and 6 months while Arm D3 will receive intramuscular injection of comparator (placebo) intramuscularly at 0,1 and 6 months.
In the main study a total of 6 blood samples for immunogenicity will be collected from all participants at Day 0 (baseline), one month after first vaccination, one month after second vaccination, 6 months after first vaccination, one month after third vaccination, and at 6 months after third vaccination.
Blood samples will be collected at screening and one month after third vaccination from the HIV + arm to document CD4 T cells and HIV Viral load.
Out of the 860 participants enrolled in the main study, 2 additional blood samples after reconsent for the 2-year long term follow up period will be collected at V8 (12 months after 3rd dose) and V9 (24 months after 3rd dose) from any 100 HIV negative adults in Cohort A and from participants in Hecolin arms in Cohorts B, C and D (B1, B2, C1, C2, D1, and D2) for immunogenicity assessment. In the additional 0-1-month dose schedule component/arm, a total of 4 blood samples will be collected from all participants at V2 (Day 0), V3 (28 days after 1st dose), V4 (28 days after 2nd dose), V5 (6 months after 2nd dose), and 2 additional samples will be collected from participants in Hecolin arms in Cohorts B, C and D (B4, C4, and D4) at V6 (12months after 2nd dose), and V7 (24 months after 2nd dose) for immunogenicity assessment.
All participants will be observed at the study site for 30 minutes after each Investigational Product (IP) injection for any reactogenicity events. Local and systemic solicited adverse events will be recorded in a diary card during 7 days after each IP dose while unsolicited adverse events will be recorded during the 4 weeks after each IP injection. Serious adverse events (SAEs), Medically attended adverse events (MAAEs) and Adverse of special interest (AESI) will be recorded during the entire study period i.e., until 6 months post last dose.
37 studies on the registry are indexed under Hepatitis E; 9 are open to participants now.
This study's planned enrollment of 1,040 is above the median of 330 across 26 interventional studies indexed under Hepatitis E.
Browse Hepatitis E studies →International Vaccine Institute is the lead sponsor of 47 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria (healthy participants only):
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in this study:
Inclusion criteria for HIV-positive arm:
Exclusion Criteria for HIV-positive arm:
An individual who meets any of the following criteria will be excluded from participation in this study:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Three doses of Hecolin® Recombinant Hepatitis E Vaccine administered at 0, 1 and 6 months to HIV negative participants, age 18-45 years old, 232 participants
Biological: Hecolin® Recombinant Hepatitis E Vaccine
Three doses of Hecolin® Recombinant Hepatitis E Vaccine, administered at 0, 1 and 6 months, to HIV positive participants, age 18-45 years old, 178 participants
Biological: Hecolin® Recombinant Hepatitis E Vaccine
Three doses of Hecolin® Recombinant Hepatitis E Vaccine, administered at 0, 1 and 6 months, to age 12-17 years old, 70 participants
Biological: Hecolin® Recombinant Hepatitis E Vaccine
Two doses of Hecolin® Recombinant Hepatitis E Vaccine, administered at 0, 1 and 6 months) and one dose of Placebo, administered at 1-month timepoint, to age 12-17 years old, 70 participants
Biological: Hecolin® Recombinant Hepatitis E Vaccine · Biological: Isotonic Sodium Chloride injection
Three doses of Placebo, administered at 0, 1 and 6 months, to age 12-17 years old, 35 participants
Biological: Isotonic Sodium Chloride injection
Three doses of Hecolin® Recombinant Hepatitis E Vaccine, administered at 0, 1 and 6 months, to age 6-11 years old, 70 participants
Biological: Hecolin® Recombinant Hepatitis E Vaccine
Two doses of Hecolin® Recombinant Hepatitis E Vaccine, administered at 0 and 6 months and one dose of Placebo, administered at 1-month timepoint, to age 6-11 years old, 70 participants
Biological: Hecolin® Recombinant Hepatitis E Vaccine · Biological: Isotonic Sodium Chloride injection
Three doses of Placebo, administered at 0, 1 and 6 months, to age 6-11 years old, 35 participants
Biological: Isotonic Sodium Chloride injection
Three doses of Hecolin® Recombinant Hepatitis E Vaccine, administered at 0, 1 and 6 months, to age 2-5 years old, 40 participants
Biological: Hecolin® Recombinant Hepatitis E Vaccine
Two doses of Hecolin® Recombinant Hepatitis E Vaccine, administered at 0 and 6 months and of Placebo, administered at 1-month timepoint, to age 2-5 years old, 40 participants
Biological: Hecolin® Recombinant Hepatitis E Vaccine · Biological: Isotonic Sodium Chloride injection
Three doses of Placebo, administered at 0, 1 and 6 months, to age 2-5 years old, 40 participants
Biological: Isotonic Sodium Chloride injection
Two doses of Hecolin® Recombinant Hepatitis E Vaccine, administered at 0, and 1 month, to age 12-17 years old, 50 participants
Biological: Hecolin® Recombinant Hepatitis E Vaccine
Two doses of Placebo, administered at 0, and 1 month, to age 12-17 years old, 10 participants
Biological: Isotonic Sodium Chloride injection
Two doses of Hecolin® Recombinant Hepatitis E Vaccine, administered at 0, and 1 month, to age 6-11 years old, 50 participants
Biological: Hecolin® Recombinant Hepatitis E Vaccine
Two doses of Placebo, administered at 0, and 1 month, to age 6-11 years old, 10 participants
Biological: Isotonic Sodium Chloride injection
Two doses of Hecolin® Recombinant Hepatitis E Vaccine, administered at 0, and 1 month, to age 2-5 years old, 50 participants
Biological: Hecolin® Recombinant Hepatitis E Vaccine
Two doses of Placebo, administered at 0, and 1 month, to age 2-5 years old, 10 participants
Biological: Isotonic Sodium Chloride injection
30㎍/dose, 0.5mL administered intramuscularly
0.5mL administered intramuscularly
Seroresponse rate
Seroresponse rate (antibody response greater than four times or more increase of anti-HEV IgG in paired sera) at 4 weeks post third dose of Hecolin® administered at 0, 1 and 6 months to healthy children (2-17 years) as compared to healthy adults (18-45 years)
Time frame: 4 weeks post third dose of Hecolin®
Proportion of immediate adverse events
Proportion of immediate adverse events within 30 minutes post each dose of vaccination in all study participants
Time frame: Within 30 minutes post each dose of vaccination
Proportion of solicited local and systemic adverse events
Proportion of solicited local and systemic adverse events within 7 days post each dose of vaccination in all study participants
Time frame: Within 7 days post each dose
Proportion of unsolicited adverse events
Proportion of unsolicited adverse events within 28 days post each dose of vaccination in all study participants
Time frame: Within 28 days post each dose
Proportion of SAEs, MAAEs and AESIs
Proportion of Serious adverse events (SAEs), Medically attended adverse events (MAAEs) and Adverse events of special interest (AESIs) post dose 1 until 6 months post last dose of vaccination
Time frame: Post dose 1 until 6 months post last dose
GMC of anti-HEV IgG
GMC of anti-HEV IgG at 4 weeks post third dose of Hecolin® administered at 0, 1 and 6 months to healthy children (2-17 years) as compared to healthy adults (18-45 years)
Time frame: 4 weeks post third dose
SR
SR (antibody response greater than four times or more increase of anti-HEV IgG in paired sera) 4 weeks post two doses of Hecolin® administered at 0, and 6 months as compared to three doses of Hecolin® administered at 0, 1 and 6 months to healthy children (2-17 years)
Time frame: 4 weeks post two doses of Hecolin®
GMC of anti-HEV IgG
GMC of anti-HEV IgG at 4 weeks post two doses of Hecolin® administered at 0, and 6 months as compared to three doses of Hecolin® administered at 0, 1 and 6 months to healthy children (2-17 years)
Time frame: 4 weeks post two doses of Hecolin®
SR and GMC of anti-HEV IgG
SR and GMC of anti-HEV IgG at 4 weeks post third dose of Hecolin® administered at 0, 1 and 6 months in healthy older children (6-17 years) and healthy adults (18-45 years)
Time frame: 4 weeks post third dose of Hecolin®
SR
SR (antibody response greater than four times or more increase of anti-HEV IgG in paired sera) at 24 weeks post two doses of Hecolin® administered at 0, and 6 months as compared to three doses of Hecolin® administered at 0, 1 and 6 months to healthy child
Time frame: 24 weeks post two doses of Hecolin®
GMC of anti-HEV IgG
GMC of anti-HEV IgG at 24 weeks post two doses of Hecolin® administered at 0, and 6 months as compared to three doses of Hecolin® administered at 0, 1 and 6 months to healthy children (2-17 years)
Time frame: 24 weeks post two doses of Hecolin®
SR
SR (antibody response greater than four times or more increase of anti-HEV IgG in paired sera) at 4 weeks post third dose of Hecolin® administered at 0, 1 and 6 months to HIV-positive adults as compared to HIV-negative healthy adults (18-45 years)
Time frame: 4 weeks post third dose of Hecolin®
GMC of anti-HEV IgG
GMC of anti-HEV IgG at 4 weeks post third dose of Hecolin® administered at 0, 1 and 6 months to HIV-positive adults as compared to HIV-negative healthy adults (18-45 years)
Time frame: 4 weeks post third dose of Hecolin®
SR
SR (antibody response greater than four times or more increase of anti-HEV IgG in paired sera) at 4 weeks post third dose of Hecolin® administered at 0, 1 and 6 months to virally suppressed (CD4 count \< 350) and virally unsuppressed (CD4 count ≥ 350) HIV-positive adults (18-45 years)
Time frame: 4 weeks post third dose of Hecolin®
GMC of anti-HEV IgG
MC of anti-HEV IgG at 4 weeks post third dose of Hecolin® administered at 0, 1 and 6 months to virally suppressed (CD4 count \< 350) and virally unsuppressed (CD4 count ≥ 350) HIV-positive adults (18-45 years)
Time frame: 4 weeks post third dose of Hecolin®
SR
SR (antibody response greater than four times or more increase of anti-HEV IgG in paired sera) at 4 weeks post first, second and third dose of Hecolin® /Placebo administered at 0, 1 and 6 months in healthy children (12-17 years), (6-11 years), (2-5 years) and adults (18-45 years) individually
Time frame: 4 weeks post first, second and third dose of Hecolin® /Placebo
GMC of anti-HEV IgG
GMC of anti-HEV IgG at 4 weeks post first, second and third dose of Hecolin® /Placebo administered at 0, 1 and 6 months in healthy children (12-17 years), (6-11 years), (2-5 years) and adults (18-45 years) individually
Time frame: 4 weeks post first, second and third dose of Hecolin® /Placebo
SR and GMC of anti-HEV IgG
SR and GMC of anti-HEV IgG at 4 weeks post first, second and third dose of Hecolin® /Placebo administered at 0, 1 and 6 months in healthy children (12-17 years), (6-11 years), (2-5 years) and adults (18-45 years) collectively and individually as per sero- status at baseline.
Time frame: 4 weeks post first, second and third dose of Hecolin® /Placebo
GMC of anti-HEV IgG for additional 0-1 dose schedule
GMC of anti-HEV IgG at 4 weeks post two doses of Hecolin® administered at 0 and 1 months as compared to three doses of Hecolin® administered at 0, 1 and 6 months to healthy children (2-17 years)
Time frame: 4 weeks post first, second of Hecolin
GMC of anti-HEV IgG for additional 0-1 dose schedule
SR and GMC of anti-HEV IgG in paired sera at 4 weeks post each dose of Hecolin® /Placebo when administered two doses at 0 and 1 months or at 0 and 6 months or three doses at 0, 1 and 6 months in individual age groups in healthy children (12 - 17 years, 6 - 11 years, and 2 - 5 years) or three doses at 0, 1 and 6 months in adults (18 - 45 years).
Time frame: 4 weeks post first, second and third dose of Hecolin® /Placebo
SR and GMC of anti-HEV IgG for additional 0-1 dose schedule
SR and GMC of anti-HEV IgG in paired sera at 4 weeks post each dose of Hecolin® /Placebo when administered two doses at 0 and 1 months or at 0 and 6 months or three doses at 0, 1 and 6 months in individual age groups in healthy children (12 - 17 years, 6 - 11 years, and 2 - 5 years) or three doses at 0, 1 and 6 months in adults (18 - 45 years).
Time frame: 4 weeks post first, second and third dose of Hecolin® /Placebo
SR and GMC of anti-HEV IgG for additional 0-1 dose schedule
SR (antibody response greater than four times or more increase of anti-HEV IgG in paired sera) at 24 weeks post two doses of Hecolin® administered at 0-, and 1- month in healthy children (2-17 years).
Time frame: 24 weeks post two doses of Hecolin®
SR and GMC of anti-HEV IgG for additional long-term follow up component
SR and GMC (defined as the percentage of participants with anti-HEV IgG antibodies above the detection limit, assessed at 1 year and 2 years post two doses of Hecolin® administered in healthy children (2-17 years) at 0- \& 6-months or at 0- \& 1-month or post 3 doses (0, 1 \& 6 month) in healthy children (2-17 years) and healthy adults (18-45 years)
Time frame: 1 and 2 years post two doses of Hecolin®
SR and GMC of anti-HEV IgG
SR and GMC of anti-HEV IgG at 4 weeks post first, second and third dose of Hecolin® /Placebo administered at 0, 1 and 6 months in healthy children (12-17 years), (6-11 years), (2-5 years) and adults (18-45 years) collectively and individually as per gender distribution
Time frame: 4 weeks post first, second and third dose of Hecolin® /Placebo
Safety in all participants as per gender distribution and serostatus
1. Proportion of immediate adverse events within 30 minutes post each dose of vaccination in all study participants. 2. Proportion of solicited local and systemic adverse events within 7 days post each dose of vaccination in all study participants. 3. Proportion of unsolicited adverse events within 28 days post each dose of vaccination in all study participants. 4. Proportion of Serious adverse events (SAEs), Medically attended adverse events (MAAEs) and Adverse of special interest (AESI) until 6 months post last dose of vaccination.
Time frame: 1. Within 30 minutes post each dose of vaccination. 2. Within 7 days post each dose of vaccination. 3. Within 28 days post each dose of vaccination. 4.Until 6 months post last dose of vaccination.
Safety profile intra and inter age strata
1. Proportion of immediate adverse events within 30 minutes post each dose of vaccination in all study participants. 2. Proportion of solicited local and systemic adverse events within 7 days post each dose of vaccination in all study participants. 3. Proportion of unsolicited adverse events within 28 days post each dose of vaccination in all study participants. 4. Proportion of Serious adverse events (SAEs), Medically attended adverse events (MAAEs) and Adverse events of special interest (AESI) post dose 1 until 6 months post last dose of vaccination.
Time frame: 1. Within 30 minutes post each dose of vaccination. 2. Within 7 days post each dose of vaccination. 3. Within 28 days post each dose of vaccination. 4.Until 6 months post last dose of vaccination
Plan to share: No
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