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| ID | Type | Description | Link |
|---|---|---|---|
| UTN: U1111-1115-6579 | Other Identifier | WHO |
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The purpose of this study was to evaluate the safety and immunogenicity of Phase III lots of the CYD dengue vaccine in a pediatric population in Malaysia.
Primary Objectives:
Healthy participants aged 2 to 11 years received 3 vaccinations at pre-determined schedules and were followed-up for at least 6 months after the last vaccination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CYD Dengue vaccine group | Experimental | Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months. |
|
| Placebo Group | Placebo Comparator | Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Live, attenuated, recombinant dengue serotypes 1, 2, 3, and 4 virus | Biological | 0.5 mL (at 0, 6, and 12 months), Subcutaneous suspension |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Grade 3 Solicited injection site reactions: Pain: Incapacitating, unable to perform usual activities; Erythema and Swelling: >=50 millimeter (mm). Grade 3 Solicited systemic reactions: Fever: >=39°Degree Celsius (C); Headache, Malaise, Myalgia, and Asthenia: Significant: Prevents daily activity. | Day 0 up to Day 14 post-any and each vaccination |
| Percentage of Flavivirus-Immune Participants Reporting Solicited Injection Site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or Placebo Vaccine | Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Flavivirus-Immune participants were defined as participants with quantified antibodies against Japanese encephalitis and/or against at least 1 serotype with parental dengue virus strains (serotype 1, 2, 3, and 4) in the baseline sample. | Day 0 up to Day 14 post-each vaccination |
| Percentage of Flavivirus-Naïve Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or a Placebo Vaccine | Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Flavivirus-Naive participants were defined as participants without quantified antibodies against Japanese encephalitis and without antibody quantified against all serotypes (1, 2, 3, and 4) with parental dengue virus strains in the baseline sample. | Day 0 up to Day 14 post-each vaccination |
| Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Sanofi Pasteur Singapore | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ipoh, Perak | 30990 | Malaysia | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24135573 | Result | Hss AS, Koh MT, Tan KK, Chan LG, Zhou L, Bouckenooghe A, Crevat D, Hutagalung Y. Safety and immunogenicity of a tetravalent dengue vaccine in healthy children aged 2-11 years in Malaysia: a randomized, placebo-controlled, Phase III study. Vaccine. 2013 Dec 2;31(49):5814-21. doi: 10.1016/j.vaccine.2013.10.013. Epub 2013 Oct 14. |
| 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 250 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and randomized.
Study participants were enrolled from 02 December 2010 to 10 February 2011 at 4 clinical sites in Malaysia.
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| ID | Title | Description |
|---|---|---|
| FG000 | CYD Dengue Vaccine Group | Participants received 3 injections (Inj.) of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months. |
| FG001 | Placebo Group | Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Analysis was performed on all randomized participants who were randomly assigned to CYD Dengue vaccine Group or Placebo Group.
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| ID | Title | Description |
|---|---|---|
| BG000 | CYD Dengue Vaccine Group | Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months. |
| BG001 | Placebo Group | Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Grade 3 Solicited injection site reactions: Pain: Incapacitating, unable to perform usual activities; Erythema and Swelling: >=50 millimeter (mm). Grade 3 Solicited systemic reactions: Fever: >=39°Degree Celsius (C); Headache, Malaise, Myalgia, and Asthenia: Significant: Prevents daily activity. | Analysis was performed on safety analysis set which included participants who received any dose of CYD dengue vaccine or placebo and were analyzed according to the treatment received at this injection. Here, 'number analyzed' = participants with available data for each specified category. | Posted | Number | Percentage of participants | Day 0 up to Day 14 post-any and each vaccination |
|
Adverse events (AEs) were collected from Day 0 (post-vaccination) up to 6 months post-Injection 3 (up to 18 months)
Analysis was performed on Safety analysis set.
Not provided
| 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 | Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Overdose | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
None reported
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director | Sanofi Pasteur SA | Contact-US@sanofi.com |
Not provided
| ID | Term |
|---|---|
| D003715 | Dengue |
| D019595 | Severe Dengue |
| ID | Term |
|---|---|
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D007239 | Infections |
| D001102 | Arbovirus Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
Not provided
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|
| Placebo: NaCl 0.9% | Biological | 0.5 mL (at 0, 6, and 12 months), Subcutaneous suspension |
|
|
Seropositivity was defined as participants achieving neutralizing antibody titers >=10 (1/dilution) against each dengue serotype (1,2, 3 and 4) and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT).
| Pre-Injection 1 and Post-Injections 2 and 3 |
| Percentage of Participants With Seropositivity Against at Least One, Two, Three, or the Four Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Seropositivity was defined as participants achieving neutralizing antibody titers >=10 (1/dilution) against each dengue serotype (1, 2, 3, and 4) and was assessed using the dengue PRNT. | Pre-Injection 1 and Post-Injections 2 and 3 |
| Geometric Mean Titers (GMTs) Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | GMTs of antibodies against the dengue virus serotypes (1, 2, 3, and 4) were assessed using the dengue PRNT. | Pre-Injection 1 and Post-Injections 2 and 3 |
| Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo: Flavivirus-Immune Participants | Seropositivity was defined as participants achieving neutralizing antibody titers >=10 (1/dilution) against each serotype (1, 2, 3, and 4) and was assessed using the Dengue PRNT. Flavivirus-Immune participants were defined as participants with quantified antibodies against Japanese encephalitis and/or against at least 1 serotype (1, 2, 3, and 4) with parental dengue virus strains in the baseline sample. | Pre-Injection 1 and Post-Injections 2 and 3 |
| Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo: Flavivirus-Naive Participants | Seropositivity was defined as participants achieving neutralizing antibody titers >=10 (1/dilution) against each serotype (1, 2, 3, and 4) and was assessed using the Dengue PRNT. Flavivirus naïve participants were defined as participants without quantified antibodies against Japanese encephalitis and without quantified antibodies against all serotypes (1, 2, 3, and 4) with parental dengue virus strains in the baseline sample. | Pre-Injection 1 and Post-Injections 2 and 3 |
| GMTs of Flavivirus-Immune Participants Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | GMTs of antibodies against the dengue virus serotypes (1, 2, 3, and 4) were assessed using the Dengue PRNT. Flavivirus-Immune participants were defined as participants with quantified antibodies against Japanese encephalitis and/or against at least 1 serotype (1, 2, 3, and 4) with parental dengue virus strains in the baseline sample. | Pre-Injection 1 and Post-Injections 2 and 3 |
| GMT of Flavivirus-Naïve Participants Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | GMTs of antibodies against the dengue virus serotypes (1, 2, 3, and 4) were assessed using the Dengue PRNT. Flavivirus-Naive participants were defined as participants without quantified antibodies against Japanese encephalitis and without antibody quantified against all serotypes (1, 2, 3, and 4) with parental dengue virus strains in the baseline sample. | Pre-Injection 1 and Post- Injections 2 and 3 |
| Kuala Lumpur |
| 59100 |
| Malaysia |
| Kuching, Sarawak | 93586 | Malaysia |
| Negeri Sembilan | 70300 | Malaysia |
| Serious adverse event |
|
| Lost to Follow-up |
|
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| CYD Dengue Vaccine Group |
Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months. |
| OG001 | Placebo Group | Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months. |
|
|
| Primary | Percentage of Flavivirus-Immune Participants Reporting Solicited Injection Site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or Placebo Vaccine | Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Flavivirus-Immune participants were defined as participants with quantified antibodies against Japanese encephalitis and/or against at least 1 serotype with parental dengue virus strains (serotype 1, 2, 3, and 4) in the baseline sample. | Analysis was performed on safety analysis set. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category. | Posted | Number | Percentage of participants | Day 0 up to Day 14 post-each vaccination |
|
|
|
| Primary | Percentage of Flavivirus-Naïve Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or a Placebo Vaccine | Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Flavivirus-Naive participants were defined as participants without quantified antibodies against Japanese encephalitis and without antibody quantified against all serotypes (1, 2, 3, and 4) with parental dengue virus strains in the baseline sample. | Analysis was performed on safety analysis set. Here, ''overall number of participants analyzed" signifies participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category. | Posted | Number | Percentage of participants | Day 0 up to Day 14 post-each vaccination |
|
|
|
| Primary | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Seropositivity was defined as participants achieving neutralizing antibody titers >=10 (1/dilution) against each dengue serotype (1,2, 3 and 4) and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). | Analysis was performed on Full analysis set which included participants who received at least one injection of CYD dengue vaccine or placebo and had at least one valid post-injection serology result. Here, 'number analyzed' = participants with available data for each specified category. | Posted | Number | Percentage of participants | Pre-Injection 1 and Post-Injections 2 and 3 |
|
|
|
| Primary | Percentage of Participants With Seropositivity Against at Least One, Two, Three, or the Four Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Seropositivity was defined as participants achieving neutralizing antibody titers >=10 (1/dilution) against each dengue serotype (1, 2, 3, and 4) and was assessed using the dengue PRNT. | Analysis was performed on Full analysis set. | Posted | Number | Percentage of participants | Pre-Injection 1 and Post-Injections 2 and 3 |
|
|
|
| Primary | Geometric Mean Titers (GMTs) Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | GMTs of antibodies against the dengue virus serotypes (1, 2, 3, and 4) were assessed using the dengue PRNT. | Analysis was performed on Full analysis set. Here, 'number analyzed' = participants with available data for each specified category. | Posted | Geometric Mean | 95% Confidence Interval | Titers (1/dilution) | Pre-Injection 1 and Post-Injections 2 and 3 |
|
|
|
| Primary | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo: Flavivirus-Immune Participants | Seropositivity was defined as participants achieving neutralizing antibody titers >=10 (1/dilution) against each serotype (1, 2, 3, and 4) and was assessed using the Dengue PRNT. Flavivirus-Immune participants were defined as participants with quantified antibodies against Japanese encephalitis and/or against at least 1 serotype (1, 2, 3, and 4) with parental dengue virus strains in the baseline sample. | Analysis was performed on Full analysis set. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category. | Posted | Number | Percentage of participants | Pre-Injection 1 and Post-Injections 2 and 3 |
|
|
|
| Primary | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo: Flavivirus-Naive Participants | Seropositivity was defined as participants achieving neutralizing antibody titers >=10 (1/dilution) against each serotype (1, 2, 3, and 4) and was assessed using the Dengue PRNT. Flavivirus naïve participants were defined as participants without quantified antibodies against Japanese encephalitis and without quantified antibodies against all serotypes (1, 2, 3, and 4) with parental dengue virus strains in the baseline sample. | Analysis was performed on Full analysis set. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category. | Posted | Number | Percentage of participants | Pre-Injection 1 and Post-Injections 2 and 3 |
|
|
|
| Primary | GMTs of Flavivirus-Immune Participants Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | GMTs of antibodies against the dengue virus serotypes (1, 2, 3, and 4) were assessed using the Dengue PRNT. Flavivirus-Immune participants were defined as participants with quantified antibodies against Japanese encephalitis and/or against at least 1 serotype (1, 2, 3, and 4) with parental dengue virus strains in the baseline sample. | Analysis was performed on Full analysis set. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category. | Posted | Geometric Mean | 95% Confidence Interval | Titers (1/dilution) | Pre-Injection 1 and Post-Injections 2 and 3 |
|
|
|
| Primary | GMT of Flavivirus-Naïve Participants Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | GMTs of antibodies against the dengue virus serotypes (1, 2, 3, and 4) were assessed using the Dengue PRNT. Flavivirus-Naive participants were defined as participants without quantified antibodies against Japanese encephalitis and without antibody quantified against all serotypes (1, 2, 3, and 4) with parental dengue virus strains in the baseline sample. | Analysis was performed on Full analysis set. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure. | Posted | Geometric Mean | 95% Confidence Interval | Titers (1/dilution) | Pre-Injection 1 and Post- Injections 2 and 3 |
|
|
|
| 0 |
| 199 |
| 11 |
| 199 |
| 138 |
| 199 |
| EG001 | Placebo Group | Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months. | 0 | 51 | 7 | 51 | 29 | 51 |
| Skull fractured base | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
|
| Fibrous dysplasia of bone | Congenital, familial and genetic disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Febrile convulsion | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| VIIth nerve paralysis | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Acute tonsillitis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
|
| Enterocolitis infectious | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
|
| Gastroenteritis rotavirus | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
|
| Lobar pneumonia | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
|
| Pharyngotonsillitis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
|
| Scarlet fever | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
|
| Viral pharyngitis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
|
| Headache; Post-Any Injection | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Injection site Pain; Post-Any | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Injection site Erythema; Post-Any | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Injection site Swelling; Post-Any | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Asthenia; Post-Any Injection | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Fever; Post-Any Injection | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Malaise; Post-Any Injection | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Myalgia; Post-Any Injection | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
|
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.
| D014777 |
| Virus Diseases |
| D018177 | Flavivirus Infections |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006482 | Hemorrhagic Fevers, Viral |
| D017670 |
| Sodium Compounds |
| Injection site Erythema; Post-Injection 1 |
|
|
| Injection site Swelling; Post-Injection 1 |
|
|
| Asthenia; Post-Injection 1 |
|
|
| Fever; Post-Injection 1 |
|
|
| Malaise; Post-Injection 1 |
|
|
| Myalgia; Post-Injection 1 |
|
|
| Headache; Post-Injection 1 |
|
|
| Injection site Pain; Post-Injection 2 |
|
|
| Injection site Erythema; Post-Injection 2 |
|
|
| Injection site Swelling; Post-Injection 2 |
|
|
| Asthenia; Post-Injection 2 |
|
|
| Fever; Post-Injection 2 |
|
|
| Malaise; Post-Injection 2 |
|
|
| Myalgia; Post-Injection 2 |
|
|
| Headache; Post-Injection 2 |
|
|
| Injection site Pain; Post-Injection 3 |
|
|
| Injection site Erythema; Post-Injection 3 |
|
|
| Injection site Swelling; Post-Injection 3 |
|
|
| Asthenia; Post-Injection 3 |
|
|
| Fever; Post-Injection 3 |
|
|
| Malaise; Post-Injection 3 |
|
|
| Myalgia; Post-Injection 3 |
|
|
| Headache; Post-Injection 3 |
|
|
| Injection site Erythema; Post-Injection 1 |
|
|
| Injection site Swelling; Post-Injection 1 |
|
|
| Asthenia; Post-Injection 1 |
|
|
| Fever; Post-Injection 1 |
|
|
| Malaise; Post-Injection 1 |
|
|
| Myalgia; Post-Injection 1 |
|
|
| Headache; Post-Injection 1 |
|
|
| Injection site Pain; Post-Injection 2 |
|
|
| Injection site Erythema; Post-Injection 2 |
|
|
| Injection site Swelling; Post-Injection 2 |
|
|
| Asthenia; Post-Injection 2 |
|
|
| Fever; Post-Injection 2 |
|
|
| Malaise; Post-Injection 2 |
|
|
| Myalgia; Post-Injection 2 |
|
|
| Headache; Post-Injection 2 |
|
|
| Injection site Pain; Post-Injection 3 |
|
|
| Injection site Erythema; Post-Injection 3 |
|
|
| Injection site Swelling; Post-Injection 3 |
|
|
| Asthenia; Post-Injection 3 |
|
|
| Fever; Post-Injection 3 |
|
|
| Malaise; Post-Injection 3 |
|
|
| Myalgia; Post-Injection 3 |
|
|
| Headache; Post-Injection 3 |
|
|
| Serotype 1; Post-Injection 2 |
|
|
| Serotype 1; Post-Injection 3 |
|
|
| Serotype 2; Pre-Injection 1 |
|
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| Serotype 2; Post-Injection 2 |
|
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| Serotype 2; Post-Injection 3 |
|
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| Serotype 3; Pre-Injection 1 |
|
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| Serotype 3; Post-Injection 2 |
|
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| Serotype 3; Post-Injection 3 |
|
|
| Serotype 4; Pre-Injection 1 |
|
|
| Serotype 4; Post-Injection 2 |
|
|
| Serotype 4; Post-Injection 3 |
|
|
| At least 1 serotype; Post-Injection 3 |
|
| At least 2 serotypes; Pre-Injection 1 |
|
| At least 2 serotypes; Post-Injection 2 |
|
| At least 2 serotypes; Post-Injection 3 |
|
| At least 3 serotypes; Pre-Injection 1 |
|
| At least 3 serotypes; Post-Injection 2 |
|
| At least 3 serotypes; Post-Injection 3 |
|
| All 4 serotypes; Pre-Injection 1 |
|
| All 4 serotypes; Post-Injection 2 |
|
| All 4 serotypes; Post-Injection 3 |
|
| Serotype 1; Post-Injection 2 |
|
|
| Serotype 1; Post-Injection 3 |
|
|
| Serotype 2; Pre-Injection 1 |
|
|
| Serotype 2; Post-Injection 2 |
|
|
| Serotype 2; Post-Injection 3 |
|
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| Serotype 3; Pre-Injection 1 |
|
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| Serotype 3; Post-Injection 2 |
|
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| Serotype 3; Post-Injection 3 |
|
|
| Serotype 4; Pre-Injection 1 |
|
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| Serotype 4; Post-Injection 2 |
|
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| Serotype 4; Post-Injection 3 |
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| Serotype 1; Post-Injection 2 |
|
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| Serotype 1; Post-Injection 3 |
|
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| Serotype 2; Pre-Injection 1 |
|
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| Serotype 2; Post-Injection 2 |
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| Serotype 2; Post-Injection 3 |
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| Serotype 3; Pre-Injection 1 |
|
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| Serotype 3; Post-Injection 2 |
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| Serotype 3; Post-Injection 3 |
|
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| Serotype 4; Pre-Injection 1 |
|
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| Serotype 4; Post-Injection 2 |
|
|
| Serotype 4; Post-Injection 3 |
|
|
| Serotype 1; Post-Injection 3 |
|
| Serotype 2; Pre-Injection 1 |
|
| Serotype 2; Post-Injection 2 |
|
| Serotype 2; Post-Injection 3 |
|
| Serotype 3; Pre-Injection 1 |
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| Serotype 3; Post-Injection 2 |
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| Serotype 3; Post-Injection 3 |
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| Serotype 4; Pre-Injection 1 |
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| Serotype 4; Post-Injection 2 |
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| Serotype 4; Post-Injection 3 |
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| Serotype 1; Post-Injection 2 |
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| Serotype 1; Post-Injection 3 |
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| Serotype 2; Pre-Injection 1 |
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| Serotype 2; Post-Injection 2 |
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| Serotype 2; Post-Injection 3 |
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| Serotype 3; Pre-Injection 1 |
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| Serotype 3; Post-Injection 2 |
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| Serotype 3; Post-Injection 3 |
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| Serotype 4; Pre-Injection 1 |
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| Serotype 4; Post-Injection 2 |
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| Serotype 4; Post-Injection 3 |
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| Serotype 1; Post-Injection 3 |
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| Serotype 2; Pre-Injection 1 |
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| Serotype 2; Post-Injection 2 |
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| Serotype 2; Post-Injection 3 |
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| Serotype 3; Pre-Injection 1 |
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| Serotype 3; Post-Injection 2 |
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| Serotype 3; Post-Injection 3 |
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| Serotype 4; Pre-Injection 1 |
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| Serotype 4; Post-Injection 2 |
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| Serotype 4; Post-Injection 3 |
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