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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-000274-37 | Other Identifier | EudraCT Number | |
| PRI03C | Other Identifier | MCMVaccBV Protocol ID | |
| V419-012 | Other Identifier | Merck Protocol Number |
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
| Sanofi Pasteur, a Sanofi Company | INDUSTRY |
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This is a multicenter extension study of two European randomized, double-blind studies (V419-007 and V419-008). It describes long-term persistence of hepatitis B and pertussis antibody responses in healthy 4- to 5 year old children previously vaccinated with Vaxelis® or INFANRIX® hexa
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group Vaxelis (3+1) | Experimental | Participants previously vaccinated with a 3-dose primary series of Vaxelis® at 2, 3 and 4 months of age, and a toddler dose at 12 months of age (study V419-007). |
|
| Group Infanrix hexa (3+1) | Active Comparator | Participants previously vaccinated with a 3-dose primary series of INFANRIX® hexa at 2, 3 and 4 months of age, and a toddler dose at 12 months of age (study V419-007). |
|
| Group Vaxelis (2+1) | Experimental | Participants previously vaccinated with a 2-dose primary series of Vaxelis® at 2 and 4 months of age, and a toddler dose at 11-12 months of age (study V419-008). |
|
| Group Infanrix hexa (2+1) | Active Comparator | Participants previously vaccinated with a 2-dose primary series of INFANRIX® hexa at 2 and 4 months of age, and a toddler dose at 11-12 months of age (study V419-008). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood Sample | Other | Blood sample at approx. 4 years of age |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Responding to Hepatitis B Surface Antigen (HBsAg) | Participant serum samples were collected for testing with an enhanced chemiluminescence assay for antibodies to HBsAg. Response was defined as a titer >=10 milli International units (mIU)/mL. Confidence Intervals were calculated based on the exact binomial method of D. Collett. | Day 1 (approximately 4 years after completion of the 3+1/2+1 schedule) |
| Percentage of Participants Responding to Pertussis Toxin | Participant serum samples were collected for testing with an Enzyme-linked Immunosorbent Assay (ELISA) for antibodies to pertussis toxin. The unit of measure is ELISA units/mL. The lower limit of quantification (LLOQ)=4 EU/mL. Confidence Intervals were calculated based on the exact binomial method of D. Collett. | Day 1 (approximately 4 years after completion of the 2+1 schedule) |
| Percentage of Participants Responding to Pertussis Filamentous Hemagglutinin | Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin. LLOQ=3 EU/mL. Confidence Intervals were calculated based on the exact binomial method of D. Collett. | Day 1 (approximately 4 years after completion of the 2+1 schedule) |
| Percentage of Participants Responding to Pertussis Pertactin | Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin. LLOQ=4 EU/mL. Confidence Intervals were calculated based on the exact binomial method of D. Collett. | Day 1 (approximately 4 years after completion of the 2+1 schedule) |
| Percentage of Participants Responding to Pertussis Fimbriae | Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae. LLOQ=4 EU/mL. Confidence Intervals were calculated based on the exact binomial method of D. Collett. |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Concentration of Antibodies to HBsAg | Participant serum samples were collected for testing with an enhanced chemiluminescence assay for antibodies to HBsAg. The unit of measure is milli International Units/mL (mIU/mL). Confidence Intervals were calculated based on the t-distribution of the log-transformed antibody concentration. | Day 1 (approximately 4 years after completion of the 3+1 or 2+1 schedule) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With One or More Serious Adverse Events Related to Study Procedure | An SAE is any untoward medical occurrence or effect that at any dose results in death or is life threatening. Life-threatening in this context refers to an event in which the patient was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it was more severe. |
Inclusion Criteria
Exclusion Criteria:
Participant who has received any dose of hepatitis B (HB)-containing vaccine at any time other than study vaccine in V419-007 or V419-008 study.
Participant with a history of diagnosis (clinical, serological or microbiological) of HB virus infection of the V419-007 or V419-008 study.
Participant who has received any dose of pertussis-containing vaccine after completion of the V419-008 study.
Participant with a history of diagnosis (clinical, serological or microbiological) of infection due to pertussis after completion of V419-008 study.
Participation at the time of study enrolment or in the 4 weeks preceding the study enrolment in another clinical study investigating a vaccine, drug medical device, or medical procedure*.
Participant who received immunoglobulins, blood or blood-derived products within 3 months prior to inclusion*.
Receipt of immunosuppressive therapy or other immune-modifying drugs, such as anti-cancer chemotherapy or radiation therapy since completion of V419-007 or V419-008 studies.
Participant with suspected or known blood dyscrasias, leukemia, lymphomas of any type or other malignant neoplasms affecting the haematopietic and lymphatic systems since completion of V419-007 or V419-008 studies.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31689166 | Result | Vesikari T, Xu J, Johnson DR, Hall J, Marcek T, Goveia MG, Acosta CJ, Lee AW. Hepatitis B and pertussis antibodies in 4- to 5-year-old children previously vaccinated with different hexavalent vaccines. Hum Vaccin Immunother. 2020 Apr 2;16(4):867-874. doi: 10.1080/21645515.2019.1673119. Epub 2019 Nov 5. |
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Of the 760 screened participants, 754 were enrolled and completed the study. A total of 752 participants were included in the Persistence Analysis Set, 752 with blood samples available for hepatitis B surface antigen (HBsAg) analyses, and 751 for pertussis analyses.
This multicenter extension study was conducted in Finland at approximately 10 sites from studies V419-007 and V419-008, which had eligible participants(i.e. participants who completed the full 3+1 or 2+1 vaccination schedule in the original studies).
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| ID | Title | Description |
|---|---|---|
| FG000 | Group Vaxelis (3+1) | Participants previously vaccinated with a 3-dose primary series of Vaxelis® at 2, 3 and 4 months of age, and a toddler dose at 12 months of age (study V419-007). On Day 1 of this extension study (~4 years after completion of the 3+1 schedule), a 4 mL blood sample was obtained to assay for long-term antibody persistence. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Day 1 (approximately 4 years after completion of the 2+1 schedule) |
| Geometric Mean Concentration of Antibodies to Pertussis Toxin | Participant serum samples were collected for testing with an ELISA for antibodies to pertussis toxin. The unit of measure is ELISA units/mL (EU/mL). Confidence Intervals were calculated based on the t-distribution of the log-transformed antibody concentration. | Day 1 (approximately 4 years after completion of the 2+1 schedule) |
| Geometric Mean Concentration of Antibodies to Pertussis Filamentous Hemagglutinin | Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin. Confidence Intervals were calculated based on the t-distribution of the log-transformed antibody concentration. | Day 1 (approximately 4 years after completion of the 2+1 schedule) |
| Geometric Mean Concentration of Antibodies to Pertussis Pertactin | Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin. Confidence Intervals were calculated based on the t-distribution of the log-transformed antibody concentration. | Day 1 (approximately 4 years after completion of the 2+1 schedule) |
| Geometric Mean Concentration of Antibodies to Pertussis Fimbriae | Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae. Confidence Intervals were calculated based on the t-distribution of the log-transformed antibody concentration. | Day 1 (approximately 4 years after completion of the 2+1 schedule) |
| Up to 4 days following blood sample on Day 1 (approximately 4 years after completion of the 3+1 or 2+1 schedule) |
| FG001 |
| Group Infanrix Hexa (3+1) |
Participants previously vaccinated with a 3-dose primary series of INFANRIX® hexa at 2, 3 and 4 months of age, and a toddler dose at 12 months of age (study V419-007). On Day 1 of this extension study (~4 years after completion of the 3+1 schedule), a 4 mL blood sample was obtained to assay for long-term antibody persistence. |
| FG002 | Group Vaxelis (2+1) | Participants previously vaccinated with a 2-dose primary series of Vaxelis® at 2 and 4 months of age, and a toddler dose at 11-12 months of age (study V419-008). On Day 1 of this extension study (~4 years after completion of the 2+1 schedule), a 4 mL blood sample was obtained to assay for long-term antibody persistence. |
| FG003 | Group Infanrix Hexa (2+1) | Participants previously vaccinated with a 2-dose primary series of INFANRIX® hexa at 2 and 4 months of age, and a toddler dose at 11-12 months of age (study V419-008). On Day 1 of this extension study (~4 years after completion of the 2+1 schedule), a 4 mL blood sample was obtained to assay for long-term antibody persistence. |
| COMPLETED |
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| NOT COMPLETED |
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All participants previously vaccinated in studies V419-007 or V419-008 and with immunogenicity results available were included in the Persistence Analysis Set. 754 participants completed the study but only 752 were included in the Persistence Analysis Set (2 participants had protocol deviations).
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| ID | Title | Description |
|---|---|---|
| BG000 | Group Vaxelis (3+1) | Participants previously vaccinated with a 3-dose primary series of Vaxelis® at 2, 3 and 4 months of age, and a toddler dose at 12 months of age (study V419-007). On Day 1 of this extension study (~4 years after completion of the 3+1 schedule), a 4 mL blood sample was obtained to assay for long-term antibody persistence. |
| BG001 | Group Infanrix Hexa (3+1) | Participants previously vaccinated with a 3-dose primary series of INFANRIX® hexa at 2, 3 and 4 months of age, and a toddler dose at 12 months of age (study V419-007). On Day 1 of this extension study (~4 years after completion of the 3+1 schedule), a 4 mL blood sample was obtained to assay for long-term antibody persistence. |
| BG002 | Group Vaxelis (2+1) | Participants previously vaccinated with a 2-dose primary series of Vaxelis® at 2 and 4 months of age, and a toddler dose at 11-12 months of age (study V419-008). On Day 1 of this extension study (~4 years after completion of the 2+1 schedule), a 4 mL blood sample was obtained to assay for long-term antibody persistence. |
| BG003 | Group Infanrix Hexa (2+1) | Participants previously vaccinated with a 2-dose primary series of INFANRIX® hexa at 2 and 4 months of age, and a toddler dose at 11-12 months of age (study V419-008). On Day 1 of this extension study (~4 years after completion of the 2+1 schedule), a 4 mL blood sample was obtained to assay for long-term antibody persistence. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | 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 Responding to Hepatitis B Surface Antigen (HBsAg) | Participant serum samples were collected for testing with an enhanced chemiluminescence assay for antibodies to HBsAg. Response was defined as a titer >=10 milli International units (mIU)/mL. Confidence Intervals were calculated based on the exact binomial method of D. Collett. | All analyses were performed on the Persistence Analysis Set, defined as all participants previously vaccinated (with a complete 3+1 or 2+1 schedule, as part of studies V419-007 or V419-008) with available immunogenicity data for the respective endpoint. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Day 1 (approximately 4 years after completion of the 3+1/2+1 schedule) |
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| Secondary | Geometric Mean Concentration of Antibodies to HBsAg | Participant serum samples were collected for testing with an enhanced chemiluminescence assay for antibodies to HBsAg. The unit of measure is milli International Units/mL (mIU/mL). Confidence Intervals were calculated based on the t-distribution of the log-transformed antibody concentration. | All analyses were performed on the Persistence Analysis Set, defined as all participants previously vaccinated (with a complete 3+1 or 2+1 schedule, as part of studies V419-007 or V419-008) with available immunogenicity data for the respective endpoint. | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | Day 1 (approximately 4 years after completion of the 3+1 or 2+1 schedule) |
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| Secondary | Geometric Mean Concentration of Antibodies to Pertussis Toxin | Participant serum samples were collected for testing with an ELISA for antibodies to pertussis toxin. The unit of measure is ELISA units/mL (EU/mL). Confidence Intervals were calculated based on the t-distribution of the log-transformed antibody concentration. | The analysis population was the Persistence Analysis Set, all participants previously vaccinated with complete 2+1 schedule (V419-008) with available immunogenicity data for the respective endpoint. Due to pre-school enrollment and booster administration, assessment of pertussis antibody persistence was not possible for the 3+1 schedule (V419-007). | Posted | Geometric Mean | 95% Confidence Interval | EU/mL | Day 1 (approximately 4 years after completion of the 2+1 schedule) |
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| Primary | Percentage of Participants Responding to Pertussis Toxin | Participant serum samples were collected for testing with an Enzyme-linked Immunosorbent Assay (ELISA) for antibodies to pertussis toxin. The unit of measure is ELISA units/mL. The lower limit of quantification (LLOQ)=4 EU/mL. Confidence Intervals were calculated based on the exact binomial method of D. Collett. | The analysis population was the Persistence Analysis Set, all participants previously vaccinated with complete 2+1 schedule (V419-008) with available immunogenicity data for the respective endpoint. Due to pre-school enrollment and booster administration, assessment of pertussis antibody persistence was not possible for the 3+1 schedule (V419-007). | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 1 (approximately 4 years after completion of the 2+1 schedule) |
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| Primary | Percentage of Participants Responding to Pertussis Filamentous Hemagglutinin | Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin. LLOQ=3 EU/mL. Confidence Intervals were calculated based on the exact binomial method of D. Collett. | The analysis population was the Persistence Analysis Set, all participants previously vaccinated with complete 2+1 schedule (V419-008) with available immunogenicity data for the respective endpoint. Due to pre-school enrollment and booster administration, assessment of pertussis antibody persistence was not possible for the 3+1 schedule (V419-007). | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 1 (approximately 4 years after completion of the 2+1 schedule) |
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| Primary | Percentage of Participants Responding to Pertussis Pertactin | Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin. LLOQ=4 EU/mL. Confidence Intervals were calculated based on the exact binomial method of D. Collett. | The analysis population was the Persistence Analysis Set, all participants previously vaccinated with complete 2+1 schedule (V419-008) with available immunogenicity data for the respective endpoint. Due to pre-school enrollment and booster administration, assessment of pertussis antibody persistence was not possible for the 3+1 schedule (V419-007). | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 1 (approximately 4 years after completion of the 2+1 schedule) |
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| Primary | Percentage of Participants Responding to Pertussis Fimbriae | Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae. LLOQ=4 EU/mL. Confidence Intervals were calculated based on the exact binomial method of D. Collett. | The analysis population was the Persistence Analysis Set, all participants previously vaccinated with complete 2+1 schedule (V419-008) with available immunogenicity data for the respective endpoint. Due to pre-school enrollment and booster administration, assessment of pertussis antibody persistence was not possible for the 3+1 schedule (V419-007). | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 1 (approximately 4 years after completion of the 2+1 schedule) |
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| Secondary | Geometric Mean Concentration of Antibodies to Pertussis Filamentous Hemagglutinin | Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin. Confidence Intervals were calculated based on the t-distribution of the log-transformed antibody concentration. | The analysis population was the Persistence Analysis Set, all participants previously vaccinated with complete 2+1 schedule (V419-008) with available immunogenicity data for the respective endpoint. Due to pre-school enrollment and booster administration, assessment of pertussis antibody persistence was not possible for the 3+1 schedule (V419-007). | Posted | Geometric Mean | 95% Confidence Interval | EU/mL | Day 1 (approximately 4 years after completion of the 2+1 schedule) |
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| Secondary | Geometric Mean Concentration of Antibodies to Pertussis Pertactin | Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin. Confidence Intervals were calculated based on the t-distribution of the log-transformed antibody concentration. | The analysis population was the Persistence Analysis Set, all participants previously vaccinated with complete 2+1 schedule (V419-008) with available immunogenicity data for the respective endpoint. Due to pre-school enrollment and booster administration, assessment of pertussis antibody persistence was not possible for the 3+1 schedule (V419-007). | Posted | Geometric Mean | 95% Confidence Interval | EU/mL | Day 1 (approximately 4 years after completion of the 2+1 schedule) |
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| Secondary | Geometric Mean Concentration of Antibodies to Pertussis Fimbriae | Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae. Confidence Intervals were calculated based on the t-distribution of the log-transformed antibody concentration. | The analysis population was the Persistence Analysis Set, all participants previously vaccinated with complete 2+1 schedule (V419-008) with available immunogenicity data for the respective endpoint. Due to pre-school enrollment and booster administration, assessment of pertussis antibody persistence was not possible for the 3+1 schedule (V419-007). | Posted | Geometric Mean | 95% Confidence Interval | EU/mL | Day 1 (approximately 4 years after completion of the 2+1 schedule) |
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| Other Pre-specified | Percentage of Participants With One or More Serious Adverse Events Related to Study Procedure | An SAE is any untoward medical occurrence or effect that at any dose results in death or is life threatening. Life-threatening in this context refers to an event in which the patient was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it was more severe. | All analyses were performed on the Persistence Analysis Set, defined as all participants previously vaccinated (with a complete 3+1 or 2+1 schedule, as part of studies V419-007 or V419-008) with available immunogenicity data for the respective endpoint. | Posted | Number | Percentage of Participants | Up to 4 days following blood sample on Day 1 (approximately 4 years after completion of the 3+1 or 2+1 schedule) |
|
Up to 4 days after Day 1
Adverse Events (AE) are reported for the Persistence Analysis Set which included all participants previously vaccinated in studies V419-007 or V419-008 with immunogenicity results available. Vaccine safety was not assessed in this study.
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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 | Group Vaxelis (3+1) | Participants previously vaccinated with a 3-dose primary series of Vaxelis® at 2, 3 and 4 months of age, and a toddler dose at 12 months of age (study V419-007). On Day 1 of this extension study (~4 years after completion of the 3+1 schedule), a 4 mL blood sample was obtained to assay for long-term antibody persistence. | 0 | 191 | 0 | 191 | ||
| EG001 | Group Infanrix Hexa (3+1) | Participants previously vaccinated with a 3-dose primary series of INFANRIX® hexa at 2, 3 and 4 months of age, and a toddler dose at 12 months of age (study V419-007). On Day 1 of this extension study (~4 years after completion of the 3+1 schedule), a 4 mL blood sample was obtained to assay for long-term antibody persistence. | 0 | 189 | 0 | 189 | ||
| EG002 | Group Vaxelis (2+1) | Participants previously vaccinated with a 2-dose primary series of Vaxelis® at 2 and 4 months of age, and a toddler dose at 11-12 months of age (study V419-008). On Day 1 of this extension study (~4 years after completion of the 2+1 schedule), a 4 mL blood sample was obtained to assay for long-term antibody persistence. | 0 | 181 | 0 | 181 | ||
| EG003 | Group Infanrix Hexa (2+1) | Participants previously vaccinated with a 2-dose primary series of INFANRIX® hexa at 2 and 4 months of age, and a toddler dose at 11-12 months of age (study V419-008). On Day 1 of this extension study (~4 years after completion of the 2+1 schedule), a 4 mL blood sample was obtained to assay for long-term antibody persistence. | 0 | 191 | 0 | 191 |
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Vaccine safety was not assessed in the present study.
The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations based on these study results 60 calendar days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential will be deleted prior to submission. Whenever needed, Sponsor review may be shorter upon agreement between the Sponsor and the authors.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D014917 | Whooping Cough |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D001885 | Bordetella Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| C000617220 | Vaxelis |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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| Male |
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| OG002 | Group Vaxelis (2+1) | Participants previously vaccinated with a 2-dose primary series of Vaxelis® at 2 and 4 months of age, and a toddler dose at 11-12 months of age (study V419-008). On Day 1 of this extension study (~4 years after completion of the 2+1 schedule), a 4 mL blood sample was obtained to assay for long-term antibody persistence. |
| OG003 | Group Infanrix Hexa (2+1) | Participants previously vaccinated with a 2-dose primary series of INFANRIX® hexa at 2 and 4 months of age, and a toddler dose at 11-12 months of age (study V419-008). On Day 1 of this extension study (~4 years after completion of the 2+1 schedule), a 4 mL blood sample was obtained to assay for long-term antibody persistence. |
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| OG002 | Group Vaxelis (2+1) | Participants previously vaccinated with a 2-dose primary series of Vaxelis® at 2 and 4 months of age, and a toddler dose at 11-12 months of age (study V419-008). On Day 1 of this extension study (~4 years after completion of the 2+1 schedule), a 4 mL blood sample was obtained to assay for long-term antibody persistence. |
| OG003 | Group Infanrix Hexa (2+1) | Participants previously vaccinated with a 2-dose primary series of INFANRIX® hexa at 2 and 4 months of age, and a toddler dose at 11-12 months of age (study V419-008). On Day 1 of this extension study (~4 years after completion of the 2+1 schedule), a 4 mL blood sample was obtained to assay for long-term antibody persistence. |
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