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| ID | Type | Description | Link |
|---|---|---|---|
| UTN: U1111-1114-7909 | Other Identifier | WHO |
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The aim of this study is to evaluate the immunogenicity and safety of the CYD dengue vaccine in India adult subjects.
Primary Objectives:
Secondary Objective:
Participants will receive 3 doses of their randomized treatment (vaccine or placebo). Flavivirus status will be determined at baseline (before the first dose) and the vaccine immunogenicity assessment will be at 28 days after each vaccination. Reactogenicity data will be collected in all subjects after each dose. Serious adverse events and adverse events of special interest will be collected throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: CYD dengue vaccine | Experimental | Subjects will receive a dose of CYD dengue vaccine at 0, 6, and 12 months, respectively. |
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| Group 2: Placebo | Placebo Comparator | Subjects will receive a dose of placebo at 0, 6, and 12 months, respectively |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Live, attenuated, recombinant dengue serotype 1, 2, 3, 4 virus | Biological | 0.5 mL, Subcutaneous |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Virus Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). | Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1) |
| Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Virus Serotypes Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). | Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1) |
| Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). | Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1) |
| Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). | Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1) |
| Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Solicited injection-site: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Asthenia. Grade 3 Solicited Injection site reactions: Pain Significant; prevents daily activities; Erythema and Swelling >100 mm. Grade 3 Solicited systemic reactions: Fever ≥39.0˚C; Headache, Malaise, Myalgia, and Asthenia Significant; prevents daily activities. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo | Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) immune participants at baseline are defined as those participants with ≥10 (1/dil) for at least one serotype with the parental dengue virus strain or for Japanese encephalitis (JE) virus. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Sanofi Pasteur India Pvt Ltd | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bangalore | Karnataka | 560054 | India | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26291554 | Result | Dubey AP, Agarkhedkar S, Chhatwal J, Narayan A, Ganguly S, Wartel TA, Bouckenooghe A, Menezes J. Immunogenicity and safety of a tetravalent dengue vaccine in healthy adults in India: A randomized, observer-blind, placebo-controlled phase II trial. Hum Vaccin Immunother. 2016;12(2):512-8. doi: 10.1080/21645515.2015.1076598. |
| Label | URL |
|---|---|
| Related Info | View source |
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Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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A total of 189 participants who met all inclusion and no exclusion criteria were randomized and vaccinated in this trial; 187 were included in the Full Analysis Set.
Study participants were enrolled from 27 March 2012 to 28 June 2012 at 5 clinical centers in India.
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| ID | Title | Description |
|---|---|---|
| FG000 | CYD Dengue Vaccine Group | Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine. |
| FG001 | Placebo Group | Healthy adult participants received 3 vaccinations of placebo vaccine. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo: NaCl 0.9% solution | Biological | 0.5 ml, Subcutaneous |
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| Day 0 up to Day 14 post each injection |
| Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1) |
| Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo | Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) non-immune participants at baseline are defined as those participants with <10 (1/dil) for all serotypes with parental dengue virus strains and for Japanese encephalitis (JE) virus. | Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1) |
| Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo | Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) immune participants at baseline are defined as those participants with ≥10 (1/dil) for at least one serotype with the parental dengue virus strain or for Japanese encephalitis (JE) virus. | Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1) |
| Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo | Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) non immune participants at baseline are defined as those participants with <10 (1/dil) for all serotypes with parental dengue virus strains and for Japanese encephalitis (JE) virus. | Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1) |
| Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) immune participants at baseline are defined as those participants with ≥10 (1/dil) for at least one serotype with the parental dengue virus strain or for Japanese encephalitis (JE) virus. | Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1) |
| Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) immune participants at baseline are defined as those participants with ≥10 (1/dil) for at least one serotype with the parental dengue virus strain or for Japanese encephalitis (JE) virus. | Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1) |
| Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) non immune participants at baseline are defined as those participants with <10 (1/dil) for all serotypes with parental dengue virus strains and for Japanese encephalitis (JE) virus. | Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1) |
| Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) immune participants at baseline are defined as those participants with ≥10 (1/dil) for at least one serotype with the parental dengue virus strain or for Japanese encephalitis (JE) virus. | Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1) |
| Ludhiana |
| Punjab |
| 141008 |
| India |
| Kolkata | West Bengal | 700073 | India |
| New Delhi | 110002 | India |
| Pune | 411018 | India |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | CYD Dengue Vaccine Group | Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine. |
| BG001 | Placebo Group | Healthy adult participants received 3 vaccinations of placebo vaccine. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| 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 | Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Virus Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). | Dengue neutralizing antibody titers were assessed in the Full Analysis Set with available data for each time point. | Posted | Number | Percentage of participants | Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1) |
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| Primary | Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Virus Serotypes Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). | Dengue neutralizing antibody titers were assessed in the Full Analysis Set with available data for each time point. | Posted | Number | Percentage of participants | Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1) |
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| Primary | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). | Geometric mean titers were assessed in the Full Analysis Set with available data for each time point. | Posted | Geometric Mean | 95% Confidence Interval | Titers (1/dilutions) | Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1) |
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| Primary | Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). | Geometric mean titer ratios were assessed in the Full Analysis Set with available data for each time point. | Posted | Geometric Mean | 95% Confidence Interval | Titer ratio | Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1) |
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| Primary | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Solicited injection-site: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Asthenia. Grade 3 Solicited Injection site reactions: Pain Significant; prevents daily activities; Erythema and Swelling >100 mm. Grade 3 Solicited systemic reactions: Fever ≥39.0˚C; Headache, Malaise, Myalgia, and Asthenia Significant; prevents daily activities. | Solicited injection-site and systemic reactions were assessed in the Safety Analysis Set with available data for each time point. | Posted | Number | Percentage of participants | Day 0 up to Day 14 post each injection |
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| Secondary | Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo | Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) immune participants at baseline are defined as those participants with ≥10 (1/dil) for at least one serotype with the parental dengue virus strain or for Japanese encephalitis (JE) virus. | Dengue neutralizing antibody titers were assessed in the Full Analysis Set with available data for each time point. | Posted | Number | Percentage of participants | Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1) |
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| Secondary | Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo | Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) non-immune participants at baseline are defined as those participants with <10 (1/dil) for all serotypes with parental dengue virus strains and for Japanese encephalitis (JE) virus. | Dengue neutralizing antibody titers were assessed in the Full Analysis Set with available data for each time point. | Posted | Number | Percentage of participants | Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1) |
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| Secondary | Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo | Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) immune participants at baseline are defined as those participants with ≥10 (1/dil) for at least one serotype with the parental dengue virus strain or for Japanese encephalitis (JE) virus. | Dengue neutralizing antibody titers were assessed in the Full Analysis Set with available data for each time point. | Posted | Number | Percentage of participants | Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1) |
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| Secondary | Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo | Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) non immune participants at baseline are defined as those participants with <10 (1/dil) for all serotypes with parental dengue virus strains and for Japanese encephalitis (JE) virus. | Dengue neutralizing antibody titers were assessed in the Full Analysis Set with available data for each time point. | Posted | Number | Percentage of participants | Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1) |
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| Secondary | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) immune participants at baseline are defined as those participants with ≥10 (1/dil) for at least one serotype with the parental dengue virus strain or for Japanese encephalitis (JE) virus. | Geometric mean titers were assessed in the Full Analysis Set with available data for each time point. | Posted | Geometric Mean | 95% Confidence Interval | Titers (1/dilutions) | Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1) |
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| Secondary | Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) immune participants at baseline are defined as those participants with ≥10 (1/dil) for at least one serotype with the parental dengue virus strain or for Japanese encephalitis (JE) virus. | Geometric mean titers ratios were assessed in the Full Analysis Set with available data for each time point. | Posted | Geometric Mean | 95% Confidence Interval | Titer ratio | Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1) |
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| Secondary | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) non immune participants at baseline are defined as those participants with <10 (1/dil) for all serotypes with parental dengue virus strains and for Japanese encephalitis (JE) virus. | Geometric mean titers were assessed in the Full Analysis Set with available data for each time point. | Posted | Geometric Mean | 95% Confidence Interval | Titers (1/dilutions) | Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1) |
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| Secondary | Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) immune participants at baseline are defined as those participants with ≥10 (1/dil) for at least one serotype with the parental dengue virus strain or for Japanese encephalitis (JE) virus. | Geometric mean titers ratios were assessed in the Full Analysis Set with available data for each time point. | Posted | Geometric Mean | 95% Confidence Interval | Titer ratio | Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1) |
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Adverse event data were collected from Day 0 up to 1 year post injection 1.
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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 | CYD Dengue Vaccine Group | Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine. | 1 | 127 | 14 | 127 | ||
| EG001 | Placebo Group | Healthy adult participants received 3 vaccinations of placebo vaccine. | 1 | 61 | 3 | 61 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia megaloblastic | Blood and lymphatic system disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Viral upper respiratory tract infection | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site Pain | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Fever | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Malaise | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 14.0 | Systematic Assessment |
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Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Sanofi Pasteur Inc. | RegistryContactUs@sanofipasteur.com |
| ID | Term |
|---|---|
| D003715 | Dengue |
| D019595 | Severe Dengue |
| ID | Term |
|---|---|
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D007239 | Infections |
| D001102 | Arbovirus Infections |
| D014777 | Virus Diseases |
| D018177 | Flavivirus Infections |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006482 | Hemorrhagic Fevers, Viral |
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| ID | Term |
|---|---|
| D012996 | Solutions |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
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| >=65 years |
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| Male |
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| Serotype 1; Post-injection 2 (N=117, 58) |
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| Serotype 1; Post-injection 3 (N=115, 57) |
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| Serotype 2; Pre-injection 1 (N=126, 61) |
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| Serotype 2; Post-injection 1 (N=126, 61) |
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| Serotype 2; Post-injection 2 (N=117, 58) |
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| Serotype 2; Post-injection 3 (N=115, 57) |
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| Serotype 3; Pre-injection 1 (N=126, 61) |
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| Serotype 3; Post-injection 1 (N=126, 61) |
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| Serotype 3; Post-injection 2 (N=117, 58) |
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| Serotype 3; Post-injection 3 (N=115, 57) |
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| Serotype 4; Pre-injection 1 (N=126, 61) |
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| Serotype 4; Post-injection 1 (N=126, 61) |
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| Serotype 4; Post-injection 2 (N=117, 57) |
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| Serotype 4; Post-injection 3 (N=115, 57) |
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