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| Name | Class |
|---|---|
| National Institute of Hygiene and Epidemiology, Vietnam | OTHER |
| Hanoi Medical University | OTHER |
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This prospective, single-center, randomized, placebo-controlled, observer-blind Phase 1/2 study includes two separate parts.
Part 1 is a first-in-human, Phase 1 study designed to evaluate the safety, tolerability and immunogenicity of the COVIVAC vaccine at three different dose levels (1, 3, and 10 µg) without adjuvant, and at one dose level (1 µg) with the adjuvant CpG 1018, in a total of 120 subjects aged 18-59 years. (Part 2 will be registered in a separate record)
This prospective, single-center, randomized, placebo-controlled, observer-blind Phase 1/2 study includes two separate parts.
Part 1 is a first-in-human, Phase 1 study designed to evaluate the safety, tolerability and immunogenicity of the COVIVAC vaccine at three different dose levels (1, 3, and 10 µg) without adjuvant, and at one dose level (1 µg) with the adjuvant CpG 1018, in a total of 120 subjects aged 18-59 years.
An interim analysis of Phase 1 data conducted after the last subject last visit for V6 (D57) will serve as the basis for decisions about down selection and advancing to Part 2 of the study (Phase 2). Down selection and advancement to Part 2 (Phase 2) will be based on the following parameters:
Post-dose 2 immunogenicity results at the aggregate treatment level
o A threshold immune response at Visit 5 (D43) will be required: the observed seroresponse rate in a treatment group (defined as the percentage of subjects with at least a 4-fold rise from baseline in 80% neutralizing antibody titers) will need to be ≥52% at the LL of the 95% CI for that treatment (vaccine formulation) to be considered for advancement to Phase 2.
Post-dose 1 and post dose 2 safety results including all solicited and unsolicited adverse events, serious adverse events, and clinical laboratory results.
The following process will be followed for the decision about down selection and advancing to Part 2 (Phase 2):
The DSMB will review the unblinded safety data and provide a recommendation to the Sponsor on whether the safety profile is acceptable for advancing a formulation to Phase 2.
The Sponsor will review the DSMB recommendation in conjunction with the immunogenicity data and select two formulations to advance to Phase 2.
o If multiple formulations achieve the threshold immune response (as well as have an adequate safety and tolerability profile per the DSMB), the Sponsor will select two formulations to advance to Phase 2 based on consideration of such factors as the relative functional immunogenicity of these formulations, opportunity for dose sparing, and opportunity to limit cost and possible supply constraints associated with use of the CpG adjuvant.
The selection and recommendation to advance to Phase 2 along with the interim report will be jointly reviewed by NIHE's IRB and MoH prior to Phase 2 enrollment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COVIVAC 1mcg | Experimental | 1mcg IVAC COVIVAC vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart. |
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| COVIVAC 3mcg | Experimental | 3mcg IVAC COVIVAC vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart. |
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| COVIVAC 10mcg | Experimental | 10mcg IVAC COVIVAC vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart. |
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| COVIVAC 1mcg + CpG1018 1.5mg | Experimental | 1mcg + CpG1018 IVAC COVIVAC vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart. |
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| Placebo | Placebo Comparator | Phosphate buffered saline (pH 7.2) for intramuscular injection administered as two doses (0.5mL each) 28 days apart. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COVIVAC | Biological | COVIVAC vaccine, manufactured by IVAC with or without adjuvant CpG1018 for prevention of COVID-19 |
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| Measure | Description | Time Frame |
|---|---|---|
| Solicited Adverse Events | Percentage of participants with solicited local and systemic adverse events (AEs) | During the first 7 days after each vaccination |
| Clinical Safety Tests | Percentage of participants with clinically significant hematological and biochemical abnormalities | At 7 days post each vaccination |
| Unsolicited Adverse Events | Number of participants with any unsolicited adverse event | During the first 28 days after each vaccination |
| Serious Adverse Event | Number of participants with serious adverse events (SAEs) | Throughout the Study Period (until Day 197) |
| Medical Attended Adverse Events | Number of participants with medically-attended AEs (MAAEs) | Throughout the Study Period (until Day 197) |
| Adverse Event of Special Interest | Number of participants with adverse events of special interest (AESI) , including AESI relevant to COVID-19, and potential immune-mediated medical conditions (PIMMC) | Throughout the Study Period (until Day 197) |
| Measure | Description | Time Frame |
|---|---|---|
| GMT of 50% Neutralizing Antibody (NT50) | 50% neutralizing antibody (NT50) geometric mean titer (GMT) against SARS-CoV-2 pseudovirus | GMT of NT50 at 28 days after first vaccination, at 14 days and 6 months after the second vaccination |
| Geometric Mean Fold Rise (GMFR) |
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Inclusion Criteria:
Phase 1 Only:
Exclusion Criteria:
Use of any investigational medicinal product within 90 days prior to randomization or planned use of such a product during the period of study participation.
History of administration of any non-study vaccine within 28 days prior to administration of study vaccine or planned vaccination within 3 months after enrolment.
Note: receipt of any COVID-19 vaccine that is licensed or granted Emergency Use Authorization in Vietnam during the course of study participation is not exclusionary if administered after Visit 5.
Previous receipt of investigational vaccine for SARS or MERS, or any investigational or licensed vaccine that may have an impact on interpretation of the trial results
History of hypersensitivity reaction to any prior vaccination or known hypersensitivity to any component of the study vaccine
History of egg or chicken allergy
History of angioedema
History of anaphylaxis
Acute illness (moderate or severe) and/or fever (body temperature measured orally ≥38°C)
Any abnormal vital sign deemed clinically relevant by the PI
Abnormality in screening laboratory test deemed exclusionary by the PI in consultation with the Sponsor
A positive serologic test for hepatitis B (HBsAg) or hepatitis C (HCV Ab)
History of confirmed HIV
History of laboratory-confirmed COVID-19
History of malignancy, excluding non-melanoma skin and cervical carcinoma in situ
Any confirmed or suspected immunosuppressive or immunodeficient state
Administration of immunoglobulin or any blood product within 90 days prior to first study injection or planned administration during the study period.
Administration of any long-acting immune-modifying drugs (e.g., infliximab or rituximab) or the chronic administration (defined as more than 14 days) of immunosuppressants within six months prior to first study injection, or planned administration during the study period (includes systemic corticosteroids at doses equivalent to ≥ 0.5 mg/kg/day of prednisone; the use of topical steroids including inhaled and intranasal steroids is permitted).
History of known disturbance of coagulation or blood disorder that could cause anemia or excess bleeding. (e.g, thalassemia, coagulation factor deficiencies).
Recent history (within the past year) or signs of alcohol or substance abuse.
Any medical, psychiatric or behavior condition that in the opinion of the PI may interfere with the study objectives, pose a risk to the subject, or prevent the subject from completing the study follow-up.
Employee of any person employed by the Sponsor, the contract research organization (CRO), the PI, study site personnel, or site.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hanoi Medical University | Hanoi | 10000 | Vietnam |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35577631 | Derived | Duc Dang A, Dinh Vu T, Hai Vu H, Thanh Ta V, Thi Van Pham A, Thi Ngoc Dang M, Van Le B, Huu Duong T, Van Nguyen D, Lawpoolsri S, Chinwangso P, McLellan JS, Hsieh CL, Garcia-Sastre A, Palese P, Sun W, Martinez JL, Gonzalez-Dominguez I, Slamanig S, Manuel Carreno J, Tcheou J, Krammer F, Raskin A, Minh Vu H, Cong Tran T, Mai Nguyen H, Mercer LD, Raghunandan R, Lal M, White JA, Hjorth R, Innis BL, Scharf R. Safety and immunogenicity of an egg-based inactivated Newcastle disease virus vaccine expressing SARS-CoV-2 spike: Interim results of a randomized, placebo-controlled, phase 1/2 trial in Vietnam. Vaccine. 2022 Jun 9;40(26):3621-3632. doi: 10.1016/j.vaccine.2022.04.078. Epub 2022 May 14. |
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There should be an agreement and approval by IRB before sharing IDP
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This is a first-in-human with dose escalation. There are 4 groups, each group (25 subjects for each vaccine dose/formulation + 5 subject of placebo cohort) will be divided into two sequential subgroups, a sentinel subgroup (n=6) and a larger subgroup (n=24) that includes the remaining subjects to be evaluated at that dose level (or for that formulation in the case of the one adjuvanted treatment group).
The screening and enrollment were conducted from 10 Mar 2021 to 17 April 2021 at the clinical trial center of Hanoi Medical University. Total 224 subjects were screened, and 120 subjects were randomized to 5 treatment arms (25 for each of 4 study vaccine doses/formulation and 20 for placebo cohort).
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| ID | Title | Description |
|---|---|---|
| FG000 | COVIVAC 1mcg | 1mcg IVAC COVIVAC vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart. COVIVAC: COVIVAC vaccine, manufactured by IVAC with or without adjuvant CpG1018 for prevention of COVID-19 |
| FG001 | COVIVAC 3mcg | 3mcg IVAC COVIVAC vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart. COVIVAC: COVIVAC vaccine, manufactured by IVAC with or without adjuvant CpG1018 for prevention of COVID-19 |
| FG002 | COVIVAC 10mcg | 10mcg IVAC COVIVAC vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart. COVIVAC: COVIVAC vaccine, manufactured by IVAC with or without adjuvant CpG1018 for prevention of COVID-19 |
| FG003 | COVIVAC 1mcg + CpG1018 1.5mg | 1mcg + CpG1018 IVAC COVIVAC vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart. COVIVAC: COVIVAC vaccine, manufactured by IVAC with or without adjuvant CpG1018 for prevention of COVID-19 |
| FG004 | Placebo | Phosphate buffered saline (pH 7.2) for intramuscular injection administered as two doses (0.5mL each) 28 days apart. Phosphate-buffered saline: Phosphate buffer solution (pH 7.2), manufactured by IVAC |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | COVIVAC 1mcg | 1mcg IVAC COVIVAC vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart. COVIVAC: COVIVAC vaccine, manufactured by IVAC with or without adjuvant CpG1018 for prevention of COVID-19 |
| BG001 | COVIVAC 3mcg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Solicited Adverse Events | Percentage of participants with solicited local and systemic adverse events (AEs) | All participants receiving at least one dose of study vaccine/placebo will be included in the safety analysis population. | Posted | Number | 95% Confidence Interval | percent of participants | During the first 7 days after each vaccination |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | COVIVAC 1 mcg | Participants receiving 2 doses with 28 days apart reporting solicited AEs |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Adnexitis | Reproductive system and breast disorders | MedDRA (10.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Thang Tran Cong, Medical office | PATH | 84-913301883 | thangtran@path.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 5, 2021 | Jul 9, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 27, 2022 | Jul 9, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| C000721867 | COVI-VAC |
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In Phase 1 is dose escalation design, eligible participants will be randomized to received study vaccine or placebo from low dose to higher dose and later to the formulation with CpG adjuvant.
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| Phosphate-buffered saline | Biological | Phosphate buffer solution (pH 7.2), manufactured by IVAC |
|
Geometric mean fold rise (GMFR) (from baseline) in NT50 against SARS-CoV-2 pseudovirus |
| GMFR at 28 days after first vaccination, at 14 days and 6 months after the second vaccination |
| Seroresponse in NT50 | Percentage of subjects with NT50 seroresponse against SARS-CoV-2 pseudovirus as defined by (1) a ≥ 4-fold increase from baseline, and (2) a ≥ 10-fold increase from baseline | Seroresponse at 28 days after first vaccination, at 14 days and 6 months after the second vaccination |
| Anti-S IgG GMC | Immunogenicity outcome measurement | GMC of Anti-S IgG at 28 days after the first vaccination, at 14 days and 6 months after the second vaccination |
| GMFR in Anti-S IgG GMC | GMFR (from baseline) in anti-S IgG GMC | GMFR at 28 days after the first vaccination, 14 days and 6 months after the second vaccination |
| Seroresponse in Anti-S IgG Concentration | Percentage of subjects with seroresponses in anti-S IgG titer as defined by (1) a ≥ 4-fold increase from baseline, and (2) a ≥ 10-fold increase from baseline | Seroresponse at 28 days after the first vaccination, 14 days and 6 months after the second vaccination |
3mcg IVAC COVIVAC vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart. COVIVAC: COVIVAC vaccine, manufactured by IVAC with or without adjuvant CpG1018 for prevention of COVID-19 |
| BG002 | COVIVAC 10mcg | 10mcg IVAC COVIVAC vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart. COVIVAC: COVIVAC vaccine, manufactured by IVAC with or without adjuvant CpG1018 for prevention of COVID-19 |
| BG003 | COVIVAC 1mcg + CpG1018 1.5mg | 1mcg + CpG1018 IVAC COVIVAC vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart. COVIVAC: COVIVAC vaccine, manufactured by IVAC with or without adjuvant CpG1018 for prevention of COVID-19 |
| BG004 | Placebo | Phosphate buffered saline (pH 7.2) for intramuscular injection administered as two doses (0.5mL each) 28 days apart. Phosphate-buffered saline: Phosphate buffer solution (pH 7.2), manufactured by IVAC |
| BG005 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| OG002 |
| COVIVAC 10 mcg |
Participants receiving 2 doses with 28 days apart reporting solicited AEs |
| OG003 | COVIVAC 1mcg + CpG | Participants receiving 2 doses with 28 days apart reporting solicited AEs |
| OG004 | Placebo | Participants receiving 2 doses with 28 days apart reporting solicited AEs |
|
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| Primary | Clinical Safety Tests | Percentage of participants with clinically significant hematological and biochemical abnormalities | All participants receiving at least one dose of study vaccine/placebo will be included in the safety analysis population | Posted | Number | percent of participants | At 7 days post each vaccination |
|
|
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| Primary | Unsolicited Adverse Events | Number of participants with any unsolicited adverse event | All participants receiving at least one dose of study vaccine/placebo will be included in the safety analysis population | Posted | Number | 95% Confidence Interval | percent of participants | During the first 28 days after each vaccination |
|
|
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| Primary | Serious Adverse Event | Number of participants with serious adverse events (SAEs) | There are 116 subject attended the follow-up visit day 197 (23 subjects in 1mcg arm, 24 subjects in 3mcg arm, 25 subjects in 10mcg arm, 24 subjects in 1mcg + CpG arm, and 20 subjects in placebo arm) | Posted | Number | 95% Confidence Interval | percent of participants | Throughout the Study Period (until Day 197) |
|
|
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| Primary | Medical Attended Adverse Events | Number of participants with medically-attended AEs (MAAEs) | There are 116 subject attended the follow-up visit day 197 (23 subjects in 1mcg arm, 24 subjects in 3mcg arm, 25 subjects in 10mcg arm, 24 subjects in 1mcg + CpG arm, and 20 subjects in placebo arm). | Posted | Count of Participants | Participants | Throughout the Study Period (until Day 197) |
|
|
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| Primary | Adverse Event of Special Interest | Number of participants with adverse events of special interest (AESI) , including AESI relevant to COVID-19, and potential immune-mediated medical conditions (PIMMC) | There are 116 subject attended the follow-up visit day 197 (23 subjects in 1mcg arm, 24 subjects in 3mcg arm, 25 subjects in 10mcg arm, 24 subjects in 1mcg + CpG arm, and 20 subjects in placebo arm). | Posted | Count of Participants | Participants | Throughout the Study Period (until Day 197) |
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| Secondary | GMT of 50% Neutralizing Antibody (NT50) | 50% neutralizing antibody (NT50) geometric mean titer (GMT) against SARS-CoV-2 pseudovirus | NT50 GMTs are analyzed from subjects with seronegative anti-S IgG at baseline. There were 5 subjects with sero-positive at baseline (anti-S IgG ≥50.3 ELU/mL), 2 subjects (1 μg) with invalid result (IR) at visit 3 (Day 29), 8 subjects missed visit at visit 7 (Day 197), and 1 subject (visit 7 (Day 197)) was not having a sufficient quantity (volume) of specimen to test (QNS- Quantity not sufficient). | Posted | Geometric Mean | 95% Confidence Interval | IU/ml | GMT of NT50 at 28 days after first vaccination, at 14 days and 6 months after the second vaccination |
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| Secondary | Geometric Mean Fold Rise (GMFR) | Geometric mean fold rise (GMFR) (from baseline) in NT50 against SARS-CoV-2 pseudovirus | There are 2 subjects (1 μg) were invalid result (IR) at visit 3 (Day 29), 8 subjects were missed visit at visit 7 (Day 197), and 1 subject (visit 7 (Day 197)) was not having a sufficient quantity (volume) of specimen to test (QNS- Quantity not sufficient). | Posted | Geometric Mean | 95% Confidence Interval | fold rise | GMFR at 28 days after first vaccination, at 14 days and 6 months after the second vaccination |
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| Secondary | Seroresponse in NT50 | Percentage of subjects with NT50 seroresponse against SARS-CoV-2 pseudovirus as defined by (1) a ≥ 4-fold increase from baseline, and (2) a ≥ 10-fold increase from baseline | NT50 GMTs are analyzed from subjects with seronegative anti-S IgG at baseline. There were 2 subjects (1 μg) with invalid result (IR) at visit 3 (Day 29), 8 subjects missed visit at visit 7 (Day 197), and 1 subject (visit 7 (Day 197)) was not having a sufficient quantity (volume) of specimen to test (QNS- Quantity not sufficient). | Posted | Number | 95% Confidence Interval | percentage of participants | Seroresponse at 28 days after first vaccination, at 14 days and 6 months after the second vaccination |
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| Secondary | Anti-S IgG GMC | Immunogenicity outcome measurement | GMCs are analyzed from subjects with seronegative anti-S IgG at baseline. There are 5 subjects were sero-positive at baseline (anti-S IgG ≥50.3 ELU/mL), and 8 subjects were missed visit at visit 7 (Day 197). | Posted | Geometric Mean | 95% Confidence Interval | BAU/ml | GMC of Anti-S IgG at 28 days after the first vaccination, at 14 days and 6 months after the second vaccination |
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| Secondary | GMFR in Anti-S IgG GMC | GMFR (from baseline) in anti-S IgG GMC | There are and 8 subjects were missed visit at visit 7 (Day 197). | Posted | Geometric Mean | 95% Confidence Interval | fold rise | GMFR at 28 days after the first vaccination, 14 days and 6 months after the second vaccination |
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| Secondary | Seroresponse in Anti-S IgG Concentration | Percentage of subjects with seroresponses in anti-S IgG titer as defined by (1) a ≥ 4-fold increase from baseline, and (2) a ≥ 10-fold increase from baseline | There are 8 subjects were missed visit at visit 7 (Day 197). | Posted | Number | 95% Confidence Interval | percentage of participants | Seroresponse at 28 days after the first vaccination, 14 days and 6 months after the second vaccination |
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| 0 |
| 25 |
| 0 |
| 25 |
| 4 |
| 25 |
| EG001 | COVIVAC 3 mcg | Participants receiving 2 doses with 28 days apart reporting solicited AEs | 0 | 25 | 0 | 25 | 3 | 25 |
| EG002 | COVIVAC 10 mcg | Participants receiving 2 doses with 28 days apart reporting solicited AEs | 0 | 25 | 0 | 25 | 0 | 25 |
| EG003 | COVIVAC 1mcg + CpG | Participants receiving 2 doses with 28 days apart reporting solicited AEs | 0 | 25 | 1 | 25 | 2 | 25 |
| EG004 | Placebo | Participants receiving 2 doses with 28 days apart reporting solicited AEs | 0 | 20 | 1 | 20 | 0 | 20 |
| COMPLICATED WOUND AT LEFT HAND | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
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| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
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| GMT of NT50 at 14 days after second vaccination |
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| GMT of NT50 at 6 months after second vaccination |
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| GMFR at 14 days after first vaccination |
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| GMFR at 6 months after second vaccination |
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| Seroresponse at 14 days after second vaccination |
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| Seroresponse at 6 months after second vaccination |
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| GMC of Anti-S IgG at 14 days after second vaccination |
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| GMC of Anti-S IgG at 6 months after second vaccination |
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| GMFR at 14 days after second vaccination |
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| GMFR at 6 months after second vaccination |
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| Seroresponse at 14 days after second vaccination |
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| Seroresponse at 6 months after second vaccination |
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