Clinical Trial Results:
Long-Term Persistence of Hepatitis B and Pertussis Antibody Responses in Healthy
4 To 5 Year-Old Children Previously Vaccinated With a 2-Dose Or 3-Dose Infants
Series and Toddler Dose With Vaxelis® or INFANRIX® hexa
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Summary
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EudraCT number |
2016-000274-37 |
Trial protocol |
FI |
Global end of trial date |
01 Aug 2016
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Results information
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Results version number |
v1(current) |
This version publication date |
09 Jun 2019
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First version publication date |
09 Jun 2019
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
V419-012
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02759354 | ||
WHO universal trial number (UTN) |
- | ||
Other trial identifiers |
Merck Protocol Number: V419-012 | ||
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Sponsors
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Sponsor organisation name |
Merck Sharp & Dohme Corp.
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Sponsor organisation address |
2000 Galloping Hill Road, Kenilworth, United States, 07033
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Public contact |
Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
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Scientific contact |
Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
01 Aug 2016
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
29 Jul 2016
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Global end of trial reached? |
Yes
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Global end of trial date |
01 Aug 2016
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The main purpose of this study was to assess the long-term persistence of hepatitis B surface antigen (HBsAg) and pertussis antibodies after vaccination with Vaxelis®. The present study was therefore an extended follow-up of the 4 to 5 year-old participants who participated in two previous clinical studies (V419-007 and V419-008), without any vaccine administration, and a blood sample as the main procedure. Its design was driven by both initial studies design and timing.
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Protection of trial subjects |
This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
26 Apr 2016
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Finland: 754
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Worldwide total number of subjects |
754
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EEA total number of subjects |
754
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
754
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
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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Pre-assignment
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Screening details |
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. | |||||||||||||||
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Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | |||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | |||||||||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Group Vaxelis (3+1) | |||||||||||||||
Arm description |
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 (approximately [~] 4 years after completion of the 3+1 schedule), a 4 mL blood sample was obtained to assay for long-term antibody persistence. | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
Blood Sample
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Investigational medicinal product code |
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Other name |
Vaxelis®
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Pharmaceutical forms |
Suspension for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Blood sample at ~4 years of age
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Arm title
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Group Infanrix hexa (3+1) | |||||||||||||||
Arm description |
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. | |||||||||||||||
Arm type |
Active comparator | |||||||||||||||
Investigational medicinal product name |
Blood sample
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Investigational medicinal product code |
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Other name |
INFANRIX® hexa
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Pharmaceutical forms |
Suspension for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Blood sample at ~4 years of age
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Arm title
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Group Vaxelis (2+1) | |||||||||||||||
Arm description |
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. | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
Blood sample
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Investigational medicinal product code |
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Other name |
Vaxelis®
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Pharmaceutical forms |
Suspension for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Blood sample at ~4 years of age
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Arm title
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Group Infanrix hexa (2+1) | |||||||||||||||
Arm description |
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. | |||||||||||||||
Arm type |
Active comparator | |||||||||||||||
Investigational medicinal product name |
Blood sample
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Investigational medicinal product code |
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Other name |
INFANRIX® hexa
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Pharmaceutical forms |
Suspension for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Blood sample at ~4 years of age
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Baseline characteristics reporting groups
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Reporting group title |
Group Vaxelis (3+1)
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Reporting group description |
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 (approximately [~] 4 years after completion of the 3+1 schedule), a 4 mL blood sample was obtained to assay for long-term antibody persistence. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Group Infanrix hexa (3+1)
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Reporting group description |
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. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Group Vaxelis (2+1)
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Reporting group description |
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. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Group Infanrix hexa (2+1)
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Reporting group description |
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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End points reporting groups
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Reporting group title |
Group Vaxelis (3+1)
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Reporting group description |
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 (approximately [~] 4 years after completion of the 3+1 schedule), a 4 mL blood sample was obtained to assay for long-term antibody persistence. | ||
Reporting group title |
Group Infanrix hexa (3+1)
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Reporting group description |
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. | ||
Reporting group title |
Group Vaxelis (2+1)
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Reporting group description |
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. | ||
Reporting group title |
Group Infanrix hexa (2+1)
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Reporting group description |
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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End point title |
Percentage of Participants Responding to Hepatitis B Surface Antigen (HBsAg) [1] | ||||||||||||||||||||
End point description |
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 respectively, for whom immunogenicity results were available.
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End point type |
Primary
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End point timeframe |
Day 1 (approximately 4 years after completion of the 3+1/2+1 schedule)
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No statistical analyses were reported for this end point. |
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| No statistical analyses for this end point | |||||||||||||||||||||
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End point title |
Percentage of Participants Responding to Pertussis Toxin [2] [3] | |||||||||||||||||||||
End point description |
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. LLOQ=4 EU/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 2+1 schedule, as part of study V419-008 respectively, for whom immunogenicity results were available.
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End point type |
Primary
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End point timeframe |
Day 1 (approximately 4 years after completion of the 2+1 schedule)
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| Notes [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint does not exist for the two groups in V419-007 and accordingly there are no statistics to report. [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Due to the enrollment dynamics in the initial studies and country specificities regarding administration of pre-school booster (children in the 007 study had already received a school-age booster at 4 years of age in Finland, before V419-012 study started), the assessment of pertussis antibody persistence was not possible for subjects from study V419-007 (3+1 schedule). |
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| No statistical analyses for this end point | ||||||||||||||||||||||
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End point title |
Percentage of Participants Responding to Pertussis Filamentous Hemagglutinin [4] [5] | |||||||||||||||||||||
End point description |
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. All analyses were performed on the Persistence Analysis Set, defined as all participants previously vaccinated with a complete 2+1 schedule, as part of study V419-008 respectively, for whom immunogenicity results were available.
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End point type |
Primary
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End point timeframe |
Day 1 (approximately 4 years after completion of the 2+1 schedule)
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| Notes [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint does not exist for the two groups in V419-007 and accordingly there are no statistics to report. [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Due to the enrollment dynamics in the initial studies and country specificities regarding administration of pre-school booster (children in the 007 study had already received a school-age booster at 4 years of age in Finland, before V419-012 study started), the assessment of pertussis antibody persistence was not possible for subjects from study V419-007 (3+1 schedule). |
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| No statistical analyses for this end point | ||||||||||||||||||||||
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End point title |
Percentage of Participants Responding to Pertussis Pertactin [6] [7] | |||||||||||||||||||||
End point description |
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. All analyses were performed on the Persistence Analysis Set, defined as all participants previously vaccinated with a complete 2+1 schedule,
as part of study V419-008 respectively, for whom immunogenicity results were available.
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End point type |
Primary
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End point timeframe |
Day 1 (approximately 4 years after completion of the 2+1 schedule)
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| Notes [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint does not exist for the two groups in V419-007 and accordingly there are no statistics to report. [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Due to the enrollment dynamics in the initial studies and country specificities regarding administration of pre-school booster (children in the 007 study had already received a school-age booster at 4 years of age in Finland, before V419-012 study started), the assessment of pertussis antibody persistence was not possible for subjects from study V419-007 (3+1 schedule). |
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| No statistical analyses for this end point | ||||||||||||||||||||||
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End point title |
Percentage of Participants Responding to Pertussis Fimbriae [8] [9] | |||||||||||||||||||||
End point description |
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. All analyses were performed on the Persistence Analysis Set, defined as all participants previously vaccinated with a complete 2+1 schedule, as part of study V419-008 respectively, for whom immunogenicity results were available.
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End point type |
Primary
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End point timeframe |
Day 1 (approximately 4 years after completion of the 2+1 schedule)
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| Notes [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint does not exist for the two groups in V419-007 and accordingly there are no statistics to report. [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Due to the enrollment dynamics in the initial studies and country specificities regarding administration of pre-school booster (children in the 007 study had already received a school-age booster at 4 years of age in Finland, before V419-012 study started), the assessment of pertussis antibody persistence was not possible for subjects from study V419-007 (3+1 schedule). |
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| No statistical analyses for this end point | ||||||||||||||||||||||
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End point title |
Geometric Mean Concentration of Antibodies to HBsAg | ||||||||||||||||||||
End point description |
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 respectively, for whom immunogenicity results were available.
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End point type |
Secondary
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End point timeframe |
Day 1 (approximately 4 years after completion of the 3+1 or 2+1 schedule)
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| No statistical analyses for this end point | |||||||||||||||||||||
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End point title |
Geometric Mean Concentration of Antibodies to Pertussis Toxin [10] | ||||||||||||
End point description |
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. All analyses were performed on the Persistence Analysis Set, defined as all participants previously vaccinated with a complete 2+1 schedule, as part of study V419-008 respectively, for whom immunogenicity results were available.
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End point type |
Secondary
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End point timeframe |
Day 1 (approximately 4 years after completion of the 2+1 schedule)
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| Notes [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Due to the enrollment dynamics in the initial studies and country specificities regarding administration of pre-school booster (children in the 007 study had already received a school-age booster at 4 years of age in Finland, before V419-012 study started), the assessment of pertussis antibody persistence was not possible for subjects from study V419-007 (3+1 schedule). |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Geometric Mean Concentration of Antibodies to Pertussis Filamentous Hemagglutinin [11] | ||||||||||||
End point description |
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. All analyses were performed on the Persistence Analysis Set, defined as all participants previously vaccinated with a complete 2+1 schedule, as part of study V419-008 respectively, for whom immunogenicity results were available.
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End point type |
Secondary
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End point timeframe |
Day 1 (approximately 4 years after completion of the 2+1 schedule)
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| Notes [11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Due to the enrollment dynamics in the initial studies and country specificities regarding administration of pre-school booster (children in the 007 study had already received a school-age booster at 4 years of age in Finland, before V419-012 study started), the assessment of pertussis antibody persistence was not possible for subjects from study V419-007 (3+1 schedule). |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Geometric Mean Concentration of Antibodies to Pertussis Pertactin [12] | ||||||||||||
End point description |
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. All analyses were performed on the Persistence Analysis Set, defined as all participants previously vaccinated with a complete 2+1 schedule, as part of study V419-008 respectively, for whom immunogenicity results were available.
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End point type |
Secondary
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End point timeframe |
Day 1 (approximately 4 years after completion of the 2+1 schedule)
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| Notes [12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Due to the enrollment dynamics in the initial studies and country specificities regarding administration of pre-school booster (children in the 007 study had already received a school-age booster at 4 years of age in Finland, before V419-012 study started), the assessment of pertussis antibody persistence was not possible for subjects from study V419-007 (3+1 schedule). |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Geometric Mean Concentration of Antibodies to Pertussis Fimbriae [13] | ||||||||||||
End point description |
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. All analyses were performed on the Persistence Analysis Set, defined as all participants previously vaccinated with a complete 2+1 schedule, as part of study V419-008 respectively, for whom immunogenicity results were available.
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End point type |
Secondary
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End point timeframe |
Day 1 (approximately 4 years after completion of the 2+1 schedule)
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| Notes [13] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Due to the enrollment dynamics in the initial studies and country specificities regarding administration of pre-school booster (children in the 007 study had already received a school-age booster at 4 years of age in Finland, before V419-012 study started), the assessment of pertussis antibody persistence was not possible for subjects from study V419-007 (3+1 schedule). |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Percentage of Participants with One or More Serious Adverse Events Related to Study Procedure | |||||||||||||||
End point description |
A serious adverse event (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 respectively, for whom immunogenicity results were available.
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End point type |
Other pre-specified
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End point timeframe |
Up to 4 days following blood sample on Day 1 (approximately 4 years after completion of the 3+1 or 2+1 schedule)
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| No statistical analyses for this end point | ||||||||||||||||
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|
Adverse events information [1]
|
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Timeframe for reporting adverse events |
Up to 4 days after Day 1
|
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Adverse event reporting additional description |
Adverse Events (AEs) 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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Assessment type |
Systematic | |||||||||||||||||||||||||
|
Dictionary used for adverse event reporting
|
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Dictionary name |
MedDRA | |||||||||||||||||||||||||
Dictionary version |
19.0
|
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Reporting groups
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Reporting group title |
Group Vaxelis (3+1)
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Reporting group description |
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 (approximately [~] 4 years after completion of the 3+1 schedule), a 4 mL blood sample was obtained to assay for long-term antibody persistence. | |||||||||||||||||||||||||
Reporting group title |
Group Infanrix hexa (3+1)
|
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Reporting group description |
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. | |||||||||||||||||||||||||
Reporting group title |
Group Vaxelis (2+1)
|
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Reporting group description |
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. | |||||||||||||||||||||||||
Reporting group title |
Group Infanrix hexa (2+1)
|
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Reporting group description |
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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| Frequency threshold for reporting non-serious adverse events: 0% | ||||||||||||||||||||||||||
|
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| Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: No vaccine was administered in this study; therefore, vaccine safety was not assessed in this study. |
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|
|||
Substantial protocol amendments (globally) |
|||
| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
|||
| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| Vaccine safety was not assessed in the present study. | |||
